RE-CONCEPTUALIZING RESPONSIBILITY IN CLINICAL TRIALS  (AN INSIGHT WITH THE AFRICAN NOTION OF SELF)  By  Ike Valentine Iyioke        A DISSERTATION  Submitted to Michigan State University in partial fulfillment of the requirements for the degree of  Philosophy  Doctor of Philosophy 2016         ABSTRACT   RE-CONCEPTUALIZING RESPONSIBILITY IN CLINICAL TRIALS  (AN INSIGHT WITH THE AFRICAN NOTION OF SELF)  By  Ike Valentine Iyioke  This dissertation aims to prominently position the African philosophical notion of the self within the clinical trials context (and the larger bioethics project). As opposed to autonomy-based principlism, this other-regarding or communalist perspective is touted as the preferred alternative model. This tact draws further attention to the inadequacy of the principlist approach particularly in multicultural settings. It also engenders a rethink, stimulates interest, and re-assesses the failed assumptions of universal ethical principles. As a novel attempt that runs against much of the prevailing (Euro-American) intellectual mood, this approach strives to introduce the African view point by making explicit the import of the self in a re-contextualized arena. Viewed as such, research ethics is guided to go beyond autonomy-based considerations for the individual with absolute right to self-determination; to embrace more holistic-based approach that embeds the individual in his/her family, community and the environment. By and large, a re-conceptualized responsibility in clinical trials transcends the bare bones of principlism to concentrically address the interests of all stakeholders in clinical   studies: human subjects, family, host community, distant communities with similar interests, the physical environment, animals, minerals and all else in the biota.  The content analysis has tied together related literature on the three main areas of responsibility, clinical trials, and selfhood. This Trinitarian thesis demands a careful conjoining for my purpose. Ultimately, this reconceptualization move implicitly captures the comprehensive fields of bioethics and environmental ethics as one unified field of philosophical inquiry, encouraging the development of a reliable and appropriate framework of analysis of issues for the field made whole. Also, it is hoped that Africanists and native African thinkers would find reason to be more engaged in shaping the discussion and promoting traditional philosophical and multicultural values from this perspective.                        Copyright by IKE VALENTINE IYIOKE 2016           v        I dedicate this dissertation to the Iyioke family: first, to my dear wife Ifeoma Iyioke, PhD., our sons IkeNna [10], ArinzeChukwu [7], IliloChi [5], and daughter SopuruChi [1 month!]; have made my experience at Michigan State University a life-long lesson to cherish. It is in them that I find my anchor.    Above all, I owe everything to God Almighty who is ever faithful even in my unfaithfulness.               vi ACKNOWLEDGEMENTS  Beyond stating the obvious, my committee members were invaluable: Dr. Ann Mongoven has been very supportive particularly assisting with skill acquisition in bioethics practice (for instance, serving as my practicum mentor and providing referrals for my IRB membership accreditation). Dr. Jim Roper is invaluable in so many ways, for instance, he has a knack for giving criticisms in the most humane and painless manner. Plus, he always reassures me that I could disagree with his views [and he means it].   Dr. Paul Thompson has bequeathed to me more published materials than I can  Manna from Paul   Framework for Testing of Genetically Modified Mhas been the icing on the cake. And for Dr. John McClendon III: what do you call someone who inspired your admission process; saw you through the thick and thin of the program, up until the very last end  Father figure? Thmore.   Next, my deep gratitude is also due to my big sister Mrs. Ifeyinwa Mary Ugwuoke, BA, MA, LLB. Her outpouring of homeland (Nigeria), has had profound positive effect on my family in the New World.   vii PREFACE    This dissertation is an attempt to explore the ethics of public health, specifically, ethical issues with clinical trials; it is also a reflection of the wider area of my specialization in bioethics. In it, I aim to re-conceptualize responsibility in clinical trials with the insight of the African notion of self. I strive to complement scholarly literature dealing with cross-cultural biomedical ethics, and emphasize the African perspective which is rare or even non-existent in some cases.    To take on this task of reconceptualization first, I note that bioethics as a field has continued to spread out of its American birthplace to numerous cultural milieus across the globe. Accompanying this spread is the challenge of how to integrate and apply its founding principles.  Faster still is the pace at which the Global South has become the choice site for a sizeable chunk of the clinical trial enterprise from the Global North.  Among the many problems with principlism, the one that is most directly antithetical to my thesis is its excessive individualist emphasis, focusing on individual rights, his autonomy, etc., to the detriment of everything else. In so doing, much is left  to be desired. Hence, its numerous revisions even in Western practice of research ethics clearly point to some inbred difficulties in its application. That, in and of itself, further buoys my argument for an African perspective (a communalist set of principles).   viii Further still, it has become obvious that the assumptions implicit in the Western framework that makes claim to universal validity are not shared by non-Western cultures. If not reined in, the concern seems to be that the Western approach is bound to globalize a less than global view of the world and reality. For instance, the mainstream research ethics which is grounded on principlism is itself inherently linked to Western individualistic notions of personhood, whereas the rest of the world, particularly Africa, sees the person not as an isolated individual, but as a part of the community who is embedded in kinship, group, and community. Moreover, the holism of the African world-d, and the societal activities which center on the promotion of vitality and fertility of human beings, livestock, and the land on which their livelihood depends, are entirely missed by principlism.    In the face of this, my dissertation urges for a reappraisal of sorts about the place      of responsibility for human subjects in research. More specifically, as clinical trials are  off-shored abroad, it provides an opportunity to weigh in on the Western emphasis on individualism and to acknowledge the cultural systems of other peoples, for instance, communitarianism. While opposing individuality (a Euro-American mantra), the African perspective stresses communitarianism. By definition, the communitarianist philosophical view point instantly recognizes that ethical issues with biomedical studies are far more broad-based.  ix This is why responsibility in clinical trials must in tandem, be broad-based. Research studies impact the individual all right, but that impact extends in varying degrees to everyone else around him  family, neighborhood, community and even the physical environment.  Put otherwise, responsibility in biomedical studies particularly, those dealing with human subjects (and in bioethics as a whole), must be seen to go beyond the individual person and to encompass the community and the entire environment within which the individual resides. Because the African notion of  selfhood is communitarian and broad-based, it is adequately structured to address the short-comings in the mainstream individualist perspective. As such, responsibility for (and by) the individual can only make sense through the community in which he/she is rooted. Consequently, I urge that the current understanding of responsibility be re-conceptualized. When this is done, responsibility for human subjects in research (particularly in adequately suited cultural environments), will henceforth mean responsibility for the individual rights, plus, those of his family, community, and the ecosystem.      x TABLE OF CONTENTS  LIST OF FIGURES. xiii KEY TO ABBREVIATIONS/TERMS  xiv CHAPTER ONE: INTRODUCTION .. 1                         CHAPTER TWO: BEING RESPONSIBLE  6  2. 6  2.2 UNDERSTANDING R 10  2.3 RESPONSIBILITY AS A  22  2.4  29  2.5 CONCLUDI 50         CHAPTER THREE: WHO IS RESPONSIBLE FOR HUMAN SUBJECTS                                       [WHEN EXPERIMENTS TRAVEL]? ......   56  3.1 INTRODUCTION ...  56  3.2 EXPERIMENTATION WITH HUMANS: A SELECTIVE REHASH  59                   [a] Burroughs Wellcome (now GlaxoSmithKline) experiments  61                   [b] Tuskegee Syphilis Study (1932-1972) 63                   [c] Nuremberg experiments  64                   [d] Radiation experiments ....   64                   [e] Mustard gas experiments 65        [f] Thalidomide .   65                   [g] Henry Beecher Report  .  66                   [h] Jewish Chronic Disease Hospital and Willowbrook tests .. 67   3.3 EMERGENCE OF RESEARCH ETHICS CODES   69  3.4 OUTSOURCING OF CLINICAL TRIALS .  76  3.5 TROVAN TEST CASE  83  3.6 CONCLUDING THOUGHTS .  89          xi CHAPTER FOUR: TRANSGENIC MOSQUITOES PROJECT AS MODEL   97  4.1 INTRODUCTION ..  97   4.2 SOME PRELIMINARIES ..  99  4.3 THE GMM MODEL  103  4.4 GMM MODEL AND BIODIVERSITY ................ 113  4.5 ENVIRONMENTAL ETHICS AND BIOETHICS   121          4.6 CONCLUDING THOUGHTS .  134      CHAPTER FIVE: RE-CONCEIVING RESPONSIBILITY: A ROLE FOR                       PERSONHOOD IN AFRICAN THOUGHT ...   139  5.1 INTRODUCTION  139  5.2 THE FRICAN MAN 144  5.3 AFRICAN Vs. EURO-AMERICAN PERSONHOOD   156  5.4 AFRICAN PERSONHOOD AND BIOETHICS 162     170  5.6 THE DIE IS CAST   171  5.7 CONCLUDING THOUGHTS ...  181             5.8 STUDY LIMITATIONS/DIRECTIONS FOR FUTURE STUDIES  .        193   BIBILIOGRAPHY   196               xii LIST OF FIGURES  Figure 1: Meeting of GMM framework, environmental/human health, and African       holism   134  Figure 2: Dynamics at p40 Figure 3: Polar opposites of selfhood (African vs. Euro-American) ........ 160 Figure 4: Balancing mainstream with multi-cultural practices  175 Figure 5: Study summary chart  192                                                                                                                                                                 xiii  KEY TO ABBREVIATIONS/TERMS  Adverse Drug Reaction (ADR): A response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function. Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure).    Adverse Event (AE): Any untoward medical occurrence in a patient or clinical investigation subject to whom a pharmaceutical product is administered. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.  All-in-one (one-in-all): A term I have coined to depict the suffusion and inseparability             of the individual into his/her community and environment.  Alleles: Different forms of the same gene, usually arising through mutation, that are        responsible for hereditary variation.    BEC: Bio-eco-communalism just like one-in-all, refers to the inseparability of the individual within his/her community and environment.                                                           Biome: A term from the Greek bios, meaning relation to life; used in ecology to include major life in the area, such as tundra biome, tropical rainforest biome and grassland biome.  Biomass: The amount of matter of biological origin in a given area, for example, the living and decaying matter in the soil, as opposed to the inorganic mineral components such as sand, silt and clay.  xiv  Biosphere: (a) Torganisms of the earth. Biota: All species of plants and animals occurring in a specific area.  CRS: Corporate social responsibility is a duty or an in-built commitment by corporate bodies to uphold ethical values and ensure quality of life of the workforce, the local community and the physical environment, while earning profits.  Ecosystem: A biological system composed of a community of organisms and the nonliving environment with which it interacts [same for Environment and Ecology].  GMM: Genetically Modified Mosquitoes, also called genetically engineered mosquitoes, transgenic mosquitoes, or living modified mosquitoes  mosquitoes that have heritable traits derived through use of recombinant DNA technology, which alter the strain, line, or colony in a manner usually intended to result in reduction of the transmission of mosquito--1  The Global North:2 Also known as the industrialized world, Western, or Euro-American -- refers to the 57 countries with high human development that have a Human Development Index above .8 as reported in the United Nations Development Program Report 2005.   Most, but not all, of these countries are located in the Northern Hemisphere.  Global South:3 The industrializing world or The Global South refers to the countries of the rest of the world, most of which are located in the Southern Hemisphere.  It includes both countries with medium human development index, HDI (88 countries with an HDI less than .8 and greater than .5) and low human development index (32 countries with an HDI of less than .5). Thus defined, the Global South is made up of some 133                                                            1 This is one of few definitions derived from the WHO GMM project (see Chapter 3). 2 Harold Damerow, http://faculty.ucc.edu/egh-damerow/global_south.htm. Viewed on February 25, 2015. 3 Ibid.                                                                                                                                                                                 xv countries out of a total of 197.  Most of the Global South is located in South and Central America, Africa, and Asia.  Holism: The interconnectivity and interdependence of all things in reality.  Serious Adverse Event, SAE, or Serious Adverse Drug Reaction, Serious ADR: Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.  Vulnerable subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, pregnant women, and those incapable of giving consent.    1  CHAPTER ONE: INTRODUCTION  Advances in biomedical research epitomize the dizzying strides in modern science. These quintessential characteristics, thanks to clinical trials, represent the unleashing of the human brain power in making his dreams a reality by improving his physical, emotional, and material conditions. However, scientific research has sometimes become more a search for material gains, absolute control and might, and less a science in quest of the truth. When science fashions a project to serve such agenda, the avowed purpose of dominating nature can easily turn into the domination of the human person,1 and ethical problems of enormous proportions often do arise; problems to which science has no clue, much less an answer. Hence, the very essence of humanity stands the risk of being compromised, sometimes irreversibly.2   While science cannot advance without experimentation, pursuit of narrow scientific goals and populist economic motives have sometimes led to troubling behaviors by some scientists which undermine research ethical guidelines and principles. And as Western3 research arenas continue to tighten their regulatory noose, coupled with the rapidly drying pool of volunteer enrollees,4 some researchers are                                                            1 Person, man, self, individual, human being/person, and to a lesser extent, identity, have been used interchangeably in this discussion to mean the same thing (in line with existing literary corpus). However, there are places where exceptions are made. 2 Okere, Theophilus. 2005. Philosophy, Culture, and Society in Africa. Nsukka: Afro-Orbis Publications Ltd., p 153. 3 Western, Euro-American, the Global North, the industrialized world, all mean the same thing in this study. On the other hand, the Global South, the industrializing world, Africa, all refer to the same region. 4 Find an exhaustive discussion on this in AdrWhen Experiments Travel (2009).  2  follows the path of least resistance.              As the Global South is becoming the choice site for a sizeable chunk of the clinical trials enterprise, in this study I urge for a reappraisal of sorts, and for a harder scrutiny about the place of responsibility in clinical trials. Question: should science be left to push its empiricist/materialist agenda unchecked? More specifically, as clinical trials continue to settle into new locales across the world including the Global South, it seems about time to halt the Western extreme emphasis on individualism and the tendency to fuse, at all costs, knowledge and might, and truly acknowledge the philosophical and cultural systems of other peoples?    It has been made apparent that the assumptions implicit in the framework that makes claim to universal validity are not shared by non-western cultures.5 If not reined in, the concern seems to be that the 6 For instance, the mainstream research ethics purports to adhere to the principlist quartet, 7 which is inherently linked to Western individualistic                                                            5 Bioethics without borders: An African perspective. An unpublished doctoral dissertation, Uppsala University, Uppsala, Sweden, 2007. 6 -colonialism? An investigation of the issue in the Bioethics, 21, 6: 305-315; 2007. Other commentators, just like Okere (2005: 154), have argued similarly. 7 The four principles of bioethics (a.k.a., principlism) for mainstream bioethics are: respect for autonomy (a norm of respecting the decision-making capacities of autonomous persons); non-maleficence (a norm of avoiding the causation of harm); beneficence (a group of norms for providing benefits and balancing benefits against risks and costs); and, justice (a group of norms for distributing benefits, risks, and costs fairly).  3  notions of personhood, whereas much of the rest of the world, including Africa, sees the person not as an isolated individual, but as a part of the community who is embedded in kinship, group and community.8 Moreover, a slew of other considerations are entirely missed by these principles. They include, the holism of the African world-view in which ; and the societal activities which center on the promotion of vitality and fertility of human beings, livestock, and the land on which their livelihood depends.9   This dissertation presents a tripartite thesis: responsibility, clinical trials, and personhood (specifically, the African notion of personhood)10.  (a) Chapter One deliberates on the concept of responsibility. is a conceptual theme theorists claim to have long analyzed and reduced to smithereens.                                                            8 Also, while the African concept of a person is unitary, the Euro-American concept is essentially split between persons and non-persons within the human species. For instance, fetuses, human infants, young children, people with mental disorder, and patients in persistent vegetative state may be considered technically as non-s any moral standing in the secular moral community. Tristram Engelhardt makes this strident point in The Foundations of Bioethics, a polemic  9 In essence, African philosophical concepts are never considered as individuated concepts, rather they are holistic. Hence, it is rife to see how an ethical discussion can morph into and encompass religious, metaphysical, ontological, social or cultural spheres.     10 Among the many tasks in this study is the challenge of coherently aligning or harmoniously blending these seemingly disparate themes (full-fledge concepts in their own rights), to justify why it makes sense to couple them together for my purpose. On another front, it is easy to misconstrue my reference to overgeneralizing. In fact, beneath the apparent diversity of African philosophical expressions of the self, there is a fundamental and undisputed uniformity, thus setting the stage for a clear-cut cultural relativity (ethical particularism). As with many other African concepts, values seem to vary from one society to another, but under a closee Egbeke Aja, 2006). Abundant literature backs up the fact that this is most   4  Ito reinvent the wheel, but I make bold to present what could pass as an unorthodox but valid perspective of the concept.  (b) Chapters Two and Three discuss respective sides (each in contra-opposition) of clinical trials that are germane to my study. For sure, the ctheme  both as the fulcrum of research ethics and as a concept  has endured since the dawn of experimentation, presenting a platform for analyses on a wide range of issues. That platform is pivotal (if not more so) today than it has ever been. Chapter Two starts out with a brief history of biomedical research and ends with the Nigeria-Pfizer Trovan case study. The 1996 clinical trials which followed severe meningitis and cholera outbreaks in a northern Nigerian city that involved huge ethical issues with the American pharmaceutical giant Pfizer, provide both the catalyst and a test case for this dissertation research.  Chapter Three reviews relevant aspects of the WHO-sponsored  Framework for Testing of Genetically Modified Mosquitoes, by highlighting the excellent and easily replicable examples it has set for clinical trial procedures. In sum, it prescribes remedies that could be used to fix all the glaring deficiencies in the Pfizer Trovan case. (c) Chapter Four examines personhood from an African perspective and hones in on my study conclusions. Personhood is introduced as a third panel to the equilibrium by bringing to bear its African philosophical dimension. I wish to use the notion of  5  personhood in African thought to provide a perspective of what responsibility can mean in an African context and then apply it to biomedical clinical trials with human subjects. Ultimately, the African philosophical notion of selfhood will put in perspective my argument to re-conceptualize responsibility in clinical trials. More specifically, while opposing individualism (a Euro-American mantra), the African perspective stresses communalism/communitarianism. As such, responsibility for (and by) the individual can only make sense through the community in which he/she is rooted. Ultimately, the themes of responsibility, clinical trials, and the African concept of personhood, come to a full circle.              6  CHAPTER TWO: BEING RESPONSIBLE  2.1 INTRODUCTION Are you responsible? Should you be? Ought you? For whom; for what?  For your livelihood, your wellbeing? For your two-year old son Chukwuzita? For your 93-year old father Ani? For licensing and vaccinating your dog? For your college loan? For your utility bills, your credit card debt, and your house mortgage? For taking action to fix the rental car you damaged while driving and tweeting? For the department or college, you are heading? For the military personnel in your platoon? For the safety of all passengers in the coach you are driving? For the young boy scouts in the summer camp you manage? For the players in the soccer team you coach? For the security of the nation you are leading? For the electorate whose tax money pays your salary? For the public who rely on the auto products you make? For consumers of your farm produce? For the human subjects in your clinical studies? For a stranger under attack by a rabid canine? For public servants like police officers and fire fighters? The list is endless, but you get the idea.    The theme of this chapter is of course responsibility. But I hasten to reassure the reader that this will not be a tortuous foray into the age-old philosophical debate on the  7  concept of responsibility.11  both a simple and an extremely difficult, even contentious conceptual or theoretical theme that theorists have wrestled with from the dawn of time with some claiming to have long analyzed and reduced it to tiniest of parts and then coupled back. But regardless of the presumption that it has been critically threshed and winnowed out since the cradle of time, it however continues to challenge philosophers, neuroscientists and psychologists as they strive to understand what motivates human actions. However, in this dissertation could pass as an unorthodox, yet valid perspective overall to validate my mission to reconceive the term (responsibility). Thus, in my quest to provide a working perspective or delineation of the concept, I plan to make whistle-stop mentions of the relevant aspects of it  moral, legal, etc.  in a way that achieves my purpose. This chapter contains three sections. In the first section, I will consider a select view of some schools of thought, historical references and/or explanations about the concept of responsibility (while avoiding a recast of worn out details). It is with such hindsight that the reader can appreciate the trajectory of my argument for a reconceptualization which will be introduced later in the project. This approach will hopefully supply the relevant substrate on which to hoist my new project.                                                            11 My apologies for revisiting a philosophical concept that seem to have been surfeitly discussed through history. Nonetheless, my approach here promises a fresh breath on a concept so old it could belong to the antediluvian era.  8  The second section will deal with responsibility as a virtue. I will show how the virtue of responsibility can point to what it means to act responsibly12 (a theme that will ultimately be tailored to fit the public health sector, clinical trials, to be exact). I will resist to be drawn into the sea-saw argument (a common exercise in the literature) of whether or not we are responsible for our actions; to argue that living by a sense of responsibility can help to resolve issues that confront us on a day-to-day basis.  In summary, the obligation to be responsible can at times be formal, i.e., codified responsibility comes across as both a normative as well as a descriptive term. But besides the great emphasis on the normative side of responsibility, I wish to draw attention to the fact that it also ought to be conceived of in terms of a virtue. In presenting an account of the virtue of responsibility, I aim to add fillip to the reasoning that goes with both individual and collective responsibility. In the third and final section, and given that the 1996 drug experimentation with some Nigerian children by Pfizer provided the stimulus for this research (details in Chapter 2), it bodes well to devote some space  essentially join the fray  to address whether or not private enterprises and big corporations have other responsibilities in                                                            12 It is almost impossible not to think of ancient historical foundations of virtue ethics which often connects with Plato, Aristotle or even the pre-ancient African mysticism. But I will reference some recent works as well such as the one by Sabina Lovibond, 2002. Ethical Formation. Cambridge, Massachusetts: Harvard University Press.    9  addition to the responsibility to generate revenue for their owners and/or shareholders.  In brief, I am opposed wholesale, to the argument that shields corporations from, for instance, social responsibility, merely on the claim that profit-making trumps everything else. Hence, I will claim that just as companies cannot engage in such questionable practices as polluting the environment with toxic chemicals, producing unsafe and lethal products, or lying and deceiving in advertising without adequate sanctions;13 so too would, say, biomedical corporations not be left to their whims to engage in questionable practices but held to high standards of responsibility, including corporate social responsibility, CSR, when they conduct research with human subjects.  Hence, I will offer an explanation and defense of including corporations (as persons) within the moral community. This is contained in my overarching project for the reconceptualization of the requirements for the rational application of responsibility, à la CSR. My approach will in turn address the objections by opponents of CSR.  My ultimate aim is not to satisfy these objectors. To the contrary, the burden of proof is upon them to show how contemporary enterprises could thrive without some reasonable measure of CSR. I contend that it is no longer possible to supply valid arguments to prove CSR morally irrelevant not withstanding that objectors continue to                                                            13 White, James. 1985. Contemporary Moral Problems. St. Paul Minnesota: West Publishing Company.  10  ignore the realities of action theory and pretend as if corporation actions and the social environments exist in parallel universes that never influence each other. 2.2 UNDERSTANDING RESPONSIBILITY Certain things are easy to imagine however, most rational people will concede that no amount of insight will render a society recognizable as a human society14 without some reasonable conception and appropriate application of responsibility. This in other words, is a tacit reminder that the core ingredients of acts of responsibility so conceived, are encoded in the genetic building blocks of all human systems, constituting their social life thereof.15  The dictionary meaning of responsibility refers to the quality or state of being responsible as in, moral, legal, social or mental accountability.16 At the rudimentary level that most rational people agree with, responsibility is a term that describes activities in situations involving moral agents or entities on a day-to-day basis. In particular, it suggests as well as assumes a form of obligation or duty (moral, social,                                                            14 the Internet Encyclopedia of Philosophy. Accessed at http://www.iep.utm.edu/virtue/ on April 09, 2014. 15 evolution of social behavior is rooted in many aspects of moral codes that are based in human psychological predispositions which in turn, have become codified in the course of time. In essence, several aspects of the moral code are based on pan-cultural human psychological characteristics. Also in psychological foundation explanation as to how the attribution of responsibility provides a broader psychological foundation for the critical aspect of human activity. 16 Merriam-y. 2005. Eleventh Edition, Massachusetts: Merriam Webster, Inc.   11  legal, etc.) which we owe to ourselves, to others, to the society and/or the environment within a given circumstance.  Not uncommonly, we are wont to recognize such compelling accounts as this one by Gustafson and Laney.17 Structures of mutual responsibility appear to be built into human experience; they provide the framework within which orderly interaction between persons and groups takes place. Such structures seem to be a fundamental requisite for the maintenance of human life in communities. We are at least irked, and at times thrown into chaos, when this fabric of mutual responsibility begins to break down.   It amounts to stating the obvious therefore to say that the key to effective functioning of human interactions in any given setting is predicated on mutual expectationhabituated, requires (for the most part) no contract signing or an external force with power of sanction to ensure conformity. This would be the norm except of course when some persons or entities choose to infringe on the rule or standard of behavior shared by members of the social group; in which case they would be judged untrustworthy and irresponsible. Otherwise put, we constantly face situations in which we have to make decisions, hard or simple, on what to do, how, when, etc.; and whatever cause of action we choose inevitably carries significant repercussions for ourselves, for others around and beyond us, and for the physical environment. In the words of Gustafson and Laney,  therefore moves between the inward look  where we examine ourselves  and the                                                            17 Gustafson, James and Laney, James. Eds. 1968. On Being Responsible: Issues in Personal Ethics, New York: Harper & Row, Publishers.  12  outward survey  where we attempt to appreciate the possibilities open to us within the limits of time and place in which we live.18  That responsibility is so fecund is proof that it relentlessly loops with our daily actions (and even inactions). Gustafson and Laney characterize the reflection about different responsibilities as a natural occurrence of daily human experiences. These fleeting human experiences, it must be noted, come in a spectrum, from the very unsophisticated to the highly sophisticated and complex ones; and considerations of weight are judgment calls. For the unsophisticated, we tend to make decisions relatively quickly and on the fly; but sophisticated situations demand (or ought to demand) deeper and more thoughtful deliberations.19   Thus far, besides the import that the two authors highlight, namely the centrality of responsibility in the proper functioning of societies, there is the fact that responsibility is more than a given of experience. According to them, it is an ought  But I will defer for later discussion the emphasis on ought.  Being responsible involves a call for a response or a call to action, not merely a reaction. It is that type of responsiveness that is somewhat proactive even as it often                                                            18 Ibid, p. 14. 19 The authors provide sample questions and responsible?  For what am I responsible? By raising these questions, we are forced to make explicit certain things that might have missed our attention. Responsibility is not a thing, a substance that is everywhere and always one and the same. It is a relationship between myself and others, or a relationship I have to   13  comes after the action. Richard Niebuhr and Bernard Haring underscore these interrelated attributes in their respective reflections on responsibility.20 Christian theological ethicist Niebuhr identifies the symbol of responsibility as containing hidden understanding of ourselves and toward definition of ourselves in action.21 Similarly, Gustafson and Laney seem to carry the argument further in their claim that, persons who have the capacity (freedom) to govern their responses to what occurs to them, and to give direction to the responses they in turn make.22  What about other attributes so often associated with responsibility, such as, , , idelity? By associative resonance, the hint is that some of these may ring ancient bells with historical roots to, for instance Nichomachean Ethics.23 In apparent recognition of this Niebuhr aims not to contrive a novel idea but to highlight what has been in existence for centuries and then tie it to real life experiences. At issue are considerations of the process of assessment and interpretation of what is going on in a given moment                                                            20 Concepts of MorOn Being Responsible: Issues in Personal Ethics, New York: Harper & Row, Publishers. 21 Niebuhr, p. 20. 22 Ibid, p. 11. 23 This theme will be explored later.  14  and the need to respond to situations in light of various commitments and obligations.24 Responsible individuals are adjudged to be so because of the faith that is placed on their commitments and fulfill their obligations unless there is a just cause  a higher obligation  that requires them to violate that trust.25 An anecdote of a higher obligation looks like this: As a tribal leader, I have campaigned, raised money, and even galvanized my subjects to vote en masse for Congressman D, but then discover that he has instead been propping the interest of the timber industry whose decades old logging activities have decimated the livelihood of our indigenous people. Normally the fact that I have, for four straight electoral cycles, buoyed  grip on political power with our would be a reason to continue in the hope that he will change; some reason to return him to office and more reason to put him out. I have no reason at all to return him to office, but instead to build another political alliance that would be answerable,26 nay, responsible to our community interest and wellbeing.  Hence, this intuition is in consonant with suggestions about responsibility as                                                            24 Niebuhr, p. 20. 25 Gustafson and Laney, p. 12. 26 Moral Reasons, Cambridge, Massachusetts: Blackwell, 1993.  15  Whether one does or does not fulfill these obligations is a point on which we are judged by others and by ourselves.27  28 conceives of a concentric relationship whereby responsibilities to persons tee off from within  inner circle and extends to the outer parts  seen also as the proximate to the ultimate, or the nucleus to the periphery paradigm. And as this umbra to the penumbra relationship goes, so does the degree of responsibility fades. He emphasizes the importance of this cognitive framework of responsibility which is initiated with kinship and extends to friendship, social group, citizenship, and so on. This network of our lives worthwhile, and it is within such relationships that we come to best understand what is involved in the notion of responsibility.29 of responsibility resides not just within the individual and his intimates but can (and does) stretch out to a wide array of a network including strangers within the neighborhood or in locales near and far, to the unborn child, to persons in persistent vegetative state, to generations past and future, to non-human animals, to the ecosystem, to a creator, etc. Responsibility in this broader amalgam of chain relationships can as well exist between persons with common                                                            27 Ibid. p. 12-13. 28 Gowans, Christopher. 1994. Innocence Lost: An Examination of Inescapable Moral Wrongdoing. New York: Oxford University Press, p. 122. 29 Ibid, p. 129.  16  interests, needs, beliefs and aspirations. Hence Gowans envisions such umbrella groups as corporations, faith groups, race, ethnicities, professions, social movements, political parties, and schools.30   As would be expected these collective groupings differ fundamentally from individual persons in a number of ways. As a result, Gowans says that, nothing that constitutes a person as persons constitute social entities.31 This substantially means that, for one, the social entities have overarching objectives that collectively transcend the individual needs of the persons that make them up (such as a ertain time-honored custom). Also, the survival of the social groups is not tied to the membership of some specific persons. The author takes this shared fact to be one of the key determining factorour relationships with these groups and responsibilities to them are not reducible to our relationships with and responsibilities to some list of persons.32  To illustrate, it is totally conceivable that the entire members of  could (God forbid) perish in a plane crash (or abducted by some aliens) with no effect on a previous federal investigation on that institution regarding for instance, alleged violations of clinical trials guidelines.  Another relevant tack to responsibility to persons framework is his point  a familiar idea in moral philosophy  about the intrinsic value of persons which                                                            30 Ibid, p. 129. 31 Ibid, p. 129. 32 Ibid, p. 130.  17  in other words sees individual persons as valuable in and of themselves. He cleverly avoids the classical epistemological empiricism (with reasons such as autonomy, rationality, freedom, and capacity for affection) for this position, thus evading the Myth of the Given; feature of moral experience that individuals are regarded as valuable in themselves.33 If this passes for a look-Gowans is quick to register objection, noting a couple of differences.  One, -polar world of noumena and phenomena, with only the noumenal person enjoying such attributes as rationality and freedom and by implication is accorded the an end-in-itself status. The phenomenal person (the merely empirical with no moral significanceparadigm, the whole person is included along with such things as all the features associated with his particular history and culture.34 Two, moral law dictated by pure practical reason.35 Rather, he regards persons as intrinsically valuable not by the application of a priori moral law, but through the experience of concrete interaction; in other words, this is determined from particular individual cases. So while Gowans regards each person as both intrinsically valuable as                                                            33 Ibid, p. 123. 34 Ibid, p. 123. 35 Ibid, p. 123.  18  well as uniquely valuable, for Kant, (noumenal) persons are ends in themselves in a way that is unequally shared by all. To nail home his point about the unmatched value of each person, Gowans cites the loss of a mother or a sibling; yes, they could be replaced by a step-mother or a sister, but these are only partial compensations, and he thinks morality must consider this as a central point.36  Taken together, on Gowans account, the potentiality for responsibility is established the instant persons connect  through different forms of interactive relationships  and each side should duly be accorded the attributes of being intrinsically and uniquely valuable. This way, persons are beings deserving of certain sense of duty or obligation either through chosen or unchosen circumstance whereby relationships are established, be it via family relationships (proximate) or outside circumstance of common or extended interest (ultimate). I his concentric paradigm of responsibility. It could have been hugely problematic if it were restricted only within relations of kinship and friends. Admittedly, and depending on the circumstance, it covers much more  strangers, foreigners, living or dead, unborn or disabled, non-human animals, the environment, and so on.                                                            36 Cognizant that he could be accused of propagating a recipe for prejudice, Gowans labors to make clear that it would be illogical to conclude that the fact that the point is made about the unique value of persons does not make it a tenable argument to regard some persons as more valuable than others; in other words, assigning valency to persons in a stacked order of preference cannot be valid. Thus, he says, any per  19  My mission in this dissertation is to re-conceive the concept of responsibility (possibly touching on some of its different forms  legal, moral, etc.). While it is novel particularly given its anchor hook  the role of personhood in African thought (to be explored later in Chapter Four)  it would be simplistic to assume that there had existed no previous ground breaking philosophical proposals which have sought to re-conceptualize the concept.37 peculiar reversal of the concept is a prime case in point. His unorthodox approach to responsibility  often put in such qualifiers as being  , expropriatory or a view  detaches completely from any in modern Western tradition before him from Descartes to Husserl, in the manner he overturns the superiority of egology and the supremacy of the will.38 Instead, he posits that responsibility is primordially a being for the otherresponsibility for the other and for the sake of the other; no longer following the .39 It is important to                                                            37 (2013) Rethinking Responsibility, Oxford University Press, is just but one recent effort at perspective on what has become to some a stale dialectic regarding free will and moral Matt King, UCLA School of Law, a reviewer of that publication. 38 Raffoul, François. 2010. The Origins of Responsibility, Indianapolis: Indiana University Press, p. 164. It is Sartre places all the weight on the self and its freedom, Levinas empties such a free subject and  39 Ibid, p. 163.  20  understand that for Levinas, the ethicality of ethics lies in responsibility.40 And since moral persons are not abstract idealizations but individuals experiencing the physical life, the environment and each other in social systems, responsibility is cardinally significant only if it is to the other; so much so that the most authentic relationship one can have with the other lies in taking upon oneself the fate of the other.41  What makes humans human is the ethical, as responsibility for the other human. Understood in this way, ethics represents what is truly human in human beings, a humanism of the other that breaks with the ego-centered philosophies and opens onto the infinite character of the alterity of the other to whom I am responsible.42   In rethinking the totality of ethics and of ethicality itself, and by implication, of responsibility, Levinas proposal is an explication of responsibility in the context of ethics of hospitality  a pre-originary openness to the other. But quite unlike our normal understanding of a host-guest relationship, Levinas defines the subject as hôte (which in French means both host and guest), that is, the subject is welcome to the other before any self-posited identity -given substantial identity that would constitute the basis for a capacity to welcome,-exist the encounter with the other but is pre-assigned to the other.43 This uncanny view of responsibility presents                                                            40 philosopethics is beyond knowledge, in fact, beyond being. P. 166. 41 Ibid, pp. 196 and 191.  42 Ibid, p. 168. 43   21  the subject as a host, a guest and a hostage  someone who is visited in his home (by a neighbor, a relative, even a stranger, an exile, an immigrant) but seems to be in the home of the other and expropriated toward the other for whom he is now obligated.  According to Levinas, the experience of responsibility as a face to face encounter  the irreducible form of relationship  seems to cohere somewhat with the social nature agents with whom he/she interacts. Henresponsibility is rooted is essentially of an ethical nature which is a relation to the other as opposed to some transcendent Good.44 It is in this meeting that agential emotions are observed, evaluated, exchanged and/or acted upon, be they fragile or virile, vulnerable or secure, as a result of which Levinas calls for the obligation to be responsible for the other.   Briefly, it seems clear radical moral phenomenology borders on the ideal  some might say the utopic  but probably something worth aspiring to if we must make some appreciable progress.45 The view pictures a moral theory in the mold of the Christian religious tradition, for example, the Good Samaritan                                                           44 Ibid, p. 184. 45 By analogy, it is exactly the same reason for which movies are exaggerated to jolt the senses in order to elicit emotional appreciation; so too should the bars of morality be raised so high as to lift moral agents from languidness. Except of course, moral systems are neither staged nor induced to ignite or elicit emotions.  22  46 If  precepts were to be realized, human conflicts and suffering would be eternally erased. Otherwise, how do you plot the empirical practicality of a moral system that he envisages? Perhaps, one-word answer would suffice: selflessness. Indeed, the ultimate form of it. This responsibility for the other is non-reciprocal, dissymmetrical or asymmetrical, infinite, and non-chosen; it is the experience of a being devoted to the other in the guise . All concerns for reciprocity, contracts and agreements with others are inadequate to capture my original responsibility to the other as pre-47   2.3 RESPONSIBILITY AS A VIRTUE  To view responsibility within the context of virtue ethics is useful in anchoring my argument and perhaps further crystalize its trajectory. Thus far, whether it be responsibility to fellow moral agents as being intrinsically and uniquely valuable; the obligation to be responsible for the other by Levinas; Gustafson é of responsibility as an ought; or Richard Niebuhr and Bernard occasions a response or a call to action; all may be judged to exhibit some trappings identifiable with virtue. They all emphasize the acquisition of moral character  an attribute that harks back to Plato and Aristotle (or                                                            46 Ibid, p. 196. 47 Ibid, p. 197.  23  more appropriately even earlier).48 Not surprisingly, virtue ethics (which has witnessed a rebirth of sorts in recent times49) ruminates over such things as, Motives and moral character, moral education, moral wisdom or discernment, friendship and family relationships, a deep concept of happiness, the role of the emotions in our moral life and the fundamentally important questions of what sort of person I should be and how we should livedisposition which is well entrenched in its possessor.50  As I have indicated, should we go in search of how responsibility might be rooted in virtue, Nicomachean Ethics is one source (emphasis intended) we might resort to.51 In it Aristotle espouses to great lengths what virtue is and what it means to be virtuous. Of the two kinds that he identifies, moral virtue (intellectual virtue being the other), is an attribute that is imbibed habitually (etymologically termed ethiké, a variant of ethos). Moral virtues arise not by nature since nature is a given;                                                            48 The Stanford Encyclopedia of Philosophy point to ancient Chinese philosophy. Information was accessed at http://plato.stanford.edu/entries/ethics-virtue/  on April 2, 2014. Other more convincing sources point to, believe it or not, ancient African philosophy. For more, see Innocent Onyewuenyi (2005), The African Origin of Greek Philosophy, and Cheikh Diop (1974), The African Origin of Civilization. 49 Some accounts of this revival can be found in Roger Crisp, "Modern Moral Philosophy and the Virtues." How Should One Live? Essays on the Virtues, Crisp, Roger (Ed.), Oxford: Oxford University Press, 1996), 1-18; Gregory Trianosky. 1990. "What is Virtue Ethics All About?" American Philosophical Quarterly 27: 335-344; Sosa, E., 1991. Knowledge in perspective. Cambridge: Cambridge University Press; Zagzebski, L. 1996. Virtues of the mind. Oxford: Clarendon Press; Greco, J. 2000. Putting skeptics in their place. Cambridge, Cambridge University Press; Greco, J. (Ed.). 2004. Ernest Sosa and his critics. Oxford: Blackwell Publishing; Sosa, E. 2007. A virtue epistemology. Oxford: Clarendon Press. 50 The online Stanford Encyclopedia of Philosophy information was accessed at http://plato.stanford.edu/entries/ethics-virtue/  on April 2, 2014.  51 I have emphasized one source concept of Maat, a moral principle that was invented and taught by African priest-philosophers and scientists of the ancient Egyptian Mystery system. Aristotle was a pupil of Plato who in turn learned firsthand, from the Egyptian mystery tradition. Also, Aristotle inherited a massive amount of library and home teacher and greatly aThe African Origin of Greek Philosophy by Innocent Onyewuenyi, 2005, pp. 154-159.  24  ues] are made perfect by habit.52  Virtue accothat we are defined (not by passions  appetite, anger, fear, etc.; nor by faculties  becoming angry or being pained or feeling pity). In other words, being virtuous is both being reference to anger we stand badly if we feel it violently or too weakly, and well if we .53 Obviously, this seems to point to the widely used cliché that virtue is in the middle  mean or intermediate  extremes. It can also be viewed never a goal that is achieved overnight; hence it is by practice (formed over time as a habit) and attained through what Lovibond54 own words, That moral virtue is a mean, then, and in what sense it is so, and that it is a mean between two vices, the one involving excess, the other deficiency, and that it is such because its character is to aim at what is intermediate in passions and in actions, has been sufficiently stated. Hence also it is no easy task to be good. For in everything it is no easy task to find the middle, e.g. to find the middle of a circle is not for everyone but for him who knows; so, too, anyone can get angry- that is easy- or give or spend money; but to do this to the right person, to the right extent, at the right time, with the right motive, and in the right way, that is not for everyone, nor is it easy; wherefore goodness is both rare and laudable and noble.55                                                            52 Nichomachean Ethics, Book II, Section 1. 53 Ibid: section 5 54 For a detailed overview see Sabina Ethical Formation, 2002. 55 Nichomachean Ethics, section 9.  25  Thus, in exact same way, appropriate sense of responsibility, for instance, would be cultivated and habituated over time. And it makes a great difference if fostered early     On this much, morality is firmly rooted in human nature such that to live a good and rewarding life entails living in accordance with virtue. However, that goodness of character, is formed by learned customary practice or behavioral response.56 Still, there is more to be said about  two-part domains of virtue.    excellence owes its origin and development chiefly to teaching, and for that reason requires experience and time. Moral virtue, on the other hand, is formed by habit, ethos, and its name, thike´, is therefore derived by a slight variation, from ethos. This shows, too, that none of the moral virtues is implanted in us by nature.57  In apparent adoption of this view, Lovibond explicates ancestry of the concept of (moral) virtue traditionally consists  under one aspect  in a capacity for thinking correctly about how to respond to particular situations as they arise. (This is the capacity summed up in the concept of  be understood by abstracting the common cognitive element from a range of different virtues that are genuinely moral: virtues consisting in the reliable disposition to deal in an appropriate, felicitous, or at least not contemptible way with the various sorts of                                                            56 Cahn, S. 2008. Seven Masterpieces of Philosophy. New York: Pearson Longman, p.34. 57 Ibid, p. 51.  26  circumstances attendant on human life).58  Virtue ethics, then, can be seen as aiming at the evaluation of the rational character ideal as it relates to practical rationality, and within practical rationality, to the proper appreciation of those (potentially action-guiding) values that lie beyond the range of ordinary self-interest.59  From all indications, Lovibond strives to revive and rebrand the Platonic-Aristotelian ethical tradition and rejuvenate the account that forms its arrow-head, specifically, that moral virtue is the outcome of a successful process of formation. we should strive to imitate) but also in an epistemological one: it follows Aristotle in holding out a standard of correct judgment.60  Properly considered, the ancient notion of virtue ethics ought to be connected with what it is today as Philip Cafaro61 has done: Most modern ethical theories have been deontological in both form and content. important consequence of the turn towards virtue ethics [or its resurgence] has been to ... In reasserting the importance of the realm of judgments concerning our flourishing, excellence, and happiness, virtue ethics reclaims for us this neglected half of our ethical lives for intelligent, philosophical consideration.                                                             58 Lovibond, p. 10-11. I wish to add that in formulating this thesis, Lovibond relies in some good measure on other philosophical icons such as David Hume, along with Emmanuel Kant, John McDowell; Alasdair MacIntyre; Martha Nussbaum; and, David Wiggins. 59 Ibid, p.12. 60 Ibid, p. 14. 61 Auslegung: A Journal of Philosophy, 22: 49-67.   27  Enough has already been said to make it clear, I hope, that virtue ethics presents some sort of an outline demanding of continuous moral growth as well as a disposition Cultivating a virtuous disposition entails habituating our emotions in particular ways as well as the exercise of practical reasoning (deliberative judgment, ) so as to learn how and why to act the right way in any given situation, as well as, more broadly, conduct our lives in such a way as to reveal our dedication to (the fundamental value of) the 62 To assist in realizing family members, teachers, peers, etc., who contribute to a peinformally).63 To fashion a fitting alignment between responsibility and virtue, a recourse to a couple  reliability and trust  might help. Just like reliability, the concept of responsibility is both central in contemporary moral systems and important for the moral assessment of persons and certain entities (perhaps much more so in some instances). 64 rendering of reliable persons so conceived as people we can count on, is something that would not be possible without the                                                            62 Virtue Ethics: An Introduction  Part 1, Ratio Juris: Law, Politics, Philosophy, October 09, 2009. http://ratiojuris.blogspot.com/2009/10/virtue-ethics-introductionpart-1.html. Viewed on April 09, 2014. 63 Ibid. 64 Philosophical Studies, 142: 43.  28  inculcation of virtue and realized through reasoned assessment and voluntary choices.  Likewise, we can speak of counting on a reliable person in the same way as we can speak of trusting them. usually speak of such people only in relation to moral appraisal. The virtue  and the duties  of fidelity are the chief normative notions pertinent to understanding trustworthiness in persons.65 And should the analogy be drawn out further, I agree that, how someone chooses to follow through or not keep faith with commitments and responsibilities usually weighs heavily toward character vis-a-vis the sorts of commitments and responsibilities he/she takes.66 In the main, exerf living a virtuous life typifies our innate excellences (aretaié, areté) which hankers for the Good, and responsibility is essentially other-regarding and through which we are fulfilled, then the basis for responsibility as a 67 That way one of the major critiques leveled against virtue ethics (of being self-centered) is apparently voided. For as Nafsika Athanasoulis, a moral theorist and applied philosopher says, demands of                                                            65 Ibid, p. 52. 66 Kupperman, Joel. 1991. Character. New York: Oxford University Press. 67 Annas, Julia. 1993. The Morality of Happiness. New York: Oxford University Press.  29  s do not conflict. While the good life for humans is the life of virtue, it is as well in our interest to be virtuous.  The virtues are other-regarding. Kindness, for example, is about how we respond to the veloping the right sort of character that will respond to the needs of others in an appropriate way. The virtue of kindness is about being able to perceive situations where one is required to be kind, have the disposition to respond kindly in a reliable and stable manner, and be able to eudaemonist account of virtue ethics claims that the good of the agent and the good of others are not two separate aims. Both rather result from the exercise of virtue. Rather than being too self-centered, virtue ethics unifies what is required by morality and what is required by self-interest.68    In a nutshell, virtue ethics essentially aims to examine and determine the character ideal in relation to practical rationality, to the proper appreciation of those (potentially action-guiding) values that lie beyond the range of ordinary self-69  2.4 CORPORATE RESPONSIBILITY  In the preceding sections, I have tried to articulate (albeit cursorily given the magnitude of the literary corpus), the concept of responsibility mostly on the individual level. In this concluding part of the chapter I will try to summatively consider responsibility at the corporate70 level with a hindsight on the ascription of corporations as legal persons or legal entities.71 Right off the bat, I acknowledge that this can pose an                                                            68 This was culled from Internet Encyclopedia of Philosophy: A Peer-reviewed Academic resource. Accessed at http://www.iep.utm.edu/virtue/ on April 09, 2014. 69 Lovibond, p. 11. 70 corporations and organizations and to such concepts as legal entities and group agents. 71 Collective responsibility: Five decades of debate in theoretical and applied ethics, Larry May and Stacey Hoffman, (Eds.), p. 133. Suffice it to add  30  extremely knotty and touchy discussion, for instance, when social responsibility is considered alongside with roles of corporations.  Questions that crop up include: Are corporations, persons (do they exhibit capacities associated with personhood)? Should corporations have morality; or do they belong to the moral community (also, is the morality of the individuals in a group equivalent to the group agents they constitute)? Should corporations be held socially responsible? These questions are unavoidable and touch on the core of the main case study of this work. I have in mind the hugely controversial clinical trial protocol by the multinational drug maker Pfizer, in Nigeria in 1996, (see details in Chapter 2). On the broad-based universally accepted standards that group agents should be held responsible for their actions, this dissertation argues that the brazen conduct of that clinical protocol in 1996  administration of the experimental drug Trovan, to a large number of pediatric patients  provides yet another powerful reason to revisit the concept of corporate responsibility in an attempt to reconceptualize and redefine it.    Also, it should be borne in mind that synonymous to corporate responsibility is the concept of collective (legal, moral, social) responsibility. Presently, I aim to pitch in                                                                                                                                                                                            2009. When he did, French, a towering figure in the collective responsibility debate assigned legal equal standing with the traditionally acknowledged residents: biological human beings. He traces its origin to the Roman, through the English legal systems, and to what is today widely understood by a   31   to the poser about whether or not corporations have other responsibilities (for instance, social responsibility) in addition to the responsibility to generate revenue for their owners and shareholders.    In the introduction to this chapter, I might have blown the tops on whose side  by stating my point blank opposition to the argument which shields corporations from social responsibility merely on the claim that profit-making trumps everything else. Bkeep my intuition from rationalizing in any other way: corporations, large and small, public and private, ought to make provision to embed social responsibility (among other types) in their operational policies and practices. In fact, as a matter of common sense, to do otherwise in this day and age, namely, sole pursuit of maximum profits and shareholder base, would be injudicious. More on this, momentarily.   The claim that maximizing profits is in itself being socially responsible probably originates from -businesses are in and of themselves socially responsible just by pursuing their own self-interest, or so it seems. As a result, such businesses are easily touted as job boosters and economic developers locally, regionally and globally.  After contesting this Smithian position, James Roper considers the question whether it is even possible for a corporation to be socially responsible without jeopardizing its own existence  or worse. He considers several arguments to this  32  conclusion, but I will mention just a few. One, a corporation that engages in ethically beneficial acts that reduce profits will be vulnerable to stiff resistance by shareholders. Roper cites the early 20th Century suit by the Dodge brothers (who owned stocks in Ford Motor Companyhis auto workers. When matters could not be settled in the lower courts, the U.S. Supreme Court decided against Ford on the grounds that his action would reduce shareholder dividends. Two, it is contended that a corporation that engages in ethically beneficial acts that reduced profits will be vulnerable to a hostile takeover by another competition with the intent of breaking it up and dismantling any ethically desirable structures the corporation might have instituted.72 Three, ,public goods, it is argued, cannot come from corporations (at least not at socially optimal levels),73 because 74 The inherent incapacitation here is meant to show that the duty of providing social responsibility is inconsistent with the traditional roles of corporations. That is to say that provision of                                                            72 The immediate fallacy in this argument is that of non sequitur. For that I ask, why must it be assumed that whenever a corporation engages in ethically beneficial acts, it must necessarily lead to reduced profits? It seems to put beyond our imagination and practicality, the possibility of any other option being the case. Wrong. 73 influence stems from the kinds of deontological considerations that play a profound role in the  term is clearly linked to the kinds of deontological considerations that play a profound role in the Constitution of the U.S. 74 Roper apparently basis this claim on the view that major corporations represent a social technology that view is apparent in the remainder of this work. This excerpt is from a presentation by James Roper at the 20th Annual International Vincentian Business Ethic Conference DePaul University  Oct. 17-19, 2013. Roper is a professor of business ethics at Michigan State University.  33  social responsibility belongs as part of government services, just like public health, security, and education.  I agree with Roper flawed, but I contest his own claim that it is not possible for a corporation to be socially responsible. In rejecting Smith, he goes too far in the other direction. I will show in what follows that it is indeed possible, and eve desirable for a corporation to be socially responsible in the sense of acting ethically  not in the Smithian sense of simply maximizing profits. Roper and others would probably reply that the apparently ethical actions of a major corporation may simply be part of their marketing strategy since being perceived to be unethical is terrible for business. I am not cynical as to view corporate acts through such a jaded lens.   The vehemence with which these and other arguments have been pushed against the countervailing view from the other side certainly ensures that the heat from the collective responsibility debate is unlikely to simmer in the near future. But, the infixed tussle continually calls for appropriate arrangements in response to some of the effects of the actions of corporations. Undoubtedly, while some of the actions associated with corporations and other organized collective groups are quite beneficial, others have certainly constituted widespread harm and wrongdoing. In his reflection, David  34  Risser75 aims to provide a platform on which to explain the bone of contention between explained by who contend that 76  Collective moral responsibility raises disagreement between conceptions of collective responsibility which maintain that only individual human agents can be held morally responsible, and conceptions which maintain that groups, such as corporations, can be held morally responsible as groups, independently of their members.77    Risser relies 78 taxonomy of collective responsibility to execute this task. There, Feinberg posits a set of four Group Liability without Fresponsible for the actions of either a single member, a coterie few, or the whole members. Just by its very nature, namely of subsuming the individual autonomy within the group, Risser is of the opinion that this arrangement seems to collide with Western individualism and bodes well with more communitarian societies such as found in parts of Africa and Asia.79 But                                                            75 the Internet Encyclopedia of Philosophy. Accessed at http://www.iep.utm.edu/virtue/ on April 09, 2014. 76 Ibid. 77 Ibid. 78 Doing and Deserving: Essays in the Theory of Responsibility. Princeton: Princeton University Press, pp. 222-251.   79 banal understanding of these societies. Otherwise, one wonders why he thinks this could only fit with where conditions are frequently so harsh and barren that life depends on groups sticking  35  it is important to locate this type of arrangement within groups that show appreciable level of community of purpose and bonded by common interest such that both benefits and harms are collectively shared.   - refers to some sort of common vices  say, binge drinking, recreational drug peddling, and over speeding  which though frequently committed by the citizenry, are however not always punished. With the example of driving under the motorist actually involved in the accident is guilty of the resultant injury. He is guilty  and more harm is his fault, but it does not necessarily follow that he is guiltier or more 80 This can as well be said of what happens with researchers who flout clinical trial protocols. As we shall see later on in Chapter 2; despite the age-old guidelines for the protection of patient-subjects in research, breaches of certain aspects of research protocols still occur. The main difference between a drunken driver and an errant researcher is that one is impaired by alcohol, the other is probably impaired by rampant desire for fame and profits.                                                                                                                                                                                            together, it is accepted practice for a family, a clan, or a tribe to be held liable and to be punished for the harsh life conditions before they see the need for solidarity among their members? And why would this be found only in African and Asian societies? Interestingly, even as Risser has identified the practice of collective responsibility in some Western organizations, e.g., the U.S. military, he nevertheless insists that this arrangement is clearly unsuitable for most human communities (my emphasis); oblivious that Africa and Asia constitute overwhelming majority of mankind. 80 Ibid, p. 242.  36    , arrangement, is a composite which corrals together all manner of loose collectives from mob formations to improvised or fleeting teams or clubs. A group of soccer or basketball enthusiasts who regularly gather to play at a certain time and place (say, on Saturday mornings at a public park) might serve as a good example. It is quite conceivable that such a group can for instance, gang up to harm someone on sexual or racial grounds. The relevant question that Risser raises is how moral responsibility could be shared among members of a random aggregate such as this. Just like Feinberg, Virginia Held and Larry May have weighed in in search of answers but they all struggle with the thorny issue of adequately assigning moral responsibility to individual members in a group. Feinberg,81 and to some extent May82 seem to agree that the group ring leaders ought to bear greater responsibility than passive participants who might have simply tagged along in the act. Risser summates and I agree Degree judgments of blame present even greater challenges because they are based on each  [Nonetheless] This factor must always be included in moral responsibility judgments and may mitigate or aggregate aresp83                                                            81  Doing and Deserving: Essays in the theory of responsibility. Princeton: Princeton University Press, pp. 222- 251. 82 May, Larry. 1992. Sharing Responsibility. Chicago: University of Chicago Press. 83 the Internet Encyclopedia of Philosophy. Accessed at http://www.iep.utm.edu/virtue/ on April 09, 2014.   37  However, both Held84 and Michael Zimmerman85 are of the view that moral responsibility should be shared equally among actors in a wrongdoing. But, on the naughty issue of appropriate distribution of moral responsibility, Held thinks that the mere presence of any member actor while the group developed and/or carried out a method of action is enough for judging culpability in the group action. -presents a collective responsibility arrangement that shields ascription of culpability for an individual or members of a group for a bad action. The reality that government obligation to provide certain services is a continuous irreducible function irrespective of who is in authority could be a fitting illustration; just as it is the responsibility of the board of directors of a company to carry through a decided course of actionable policy by its previous members. Or example of a philosophy department that fails to keep faith with its policy of finding substitute faculty personnel to assist with of his committee members had left the department. In any of those cases, organizations ought to keep their commitments regardless of a change of guards. This is a view that resonates or finds the survival or continued activities of a given social group is not validated or tied to the membership of some specific                                                            84 Journal of Philosophy, 67: 471-481.  85  American Philosophical Quarterly, 22: 115-122.   38  persons. In other words, there is a moral obligation for continuity of purpose in establishments. Also, no member or members should be indispensable. I return to briefly address the three niggling questions posed earlier:  1. Are group agents or corporations, persons (do they exhibit capacities associated with personhood)?86  consider an example: U.S. Securities and Exchange Commission has accused Citigroup of lying to investors in a 2007 deal where it sold subprime mortgages that it knew would default; what is there to debate that both SEC and Citigroup do exhibit capacities (in asterisks) attributable to personhood.  This was part of the tasks Christian List and Philip Pettit set for themselves as they probed the historicity of the problem of responsibility. In the book, Group Agency, the authors hold that the classical connection between corporate responsibility and personhood has roots in 1246 when Pope Innocent IV referred to group agents as fictional or artificial persons without souls. But while disagreeing that they are fictional, List and Pettit concede that corporations are artificial persons, and that it is in that capacity that 87 The authors adopt this position, which I endorse, based not on the intrinsic nature or character of corporations, but by what they do extrinsically, the roles they play or the functions they                                                            86 To reiterate, by groups or corporations I mean commercial firms, political parties, nation states, government departments, religious groups, trade unions and similar assemblages or aggregations. 87 List, Christian, and Pettit, Philip. 2011. Group Agency: The possibility, design, and status of corporate agents. Oxford: Oxford University Press, p. 155. The widening spread of the legal origins of the edification of the corporations got a boost back in 1444 in the provisions of the Rolls of British Parliament from where it   39  discharge; hence, it is the performative conception. This legal approach (later adopted as a philosophical thought), which derived from the Roman law during the Middle Ages, sees the legal person as, An entity capable of legal rights and duties: an entity that can own, buy and sell, enter into contracts and sue for breach of contract, or otherwise have standing as a plaintiff or defendant in the courts. This legal sense of personhood focuses on what persons do rather than what they are. It allows that an entity may be a legal person without being a natural person like an individual human being. To be a person on this conception, does not depend on the stuff out of which one is made social norms.88   There is little wonder therefore why contemporary legal provisions allow corporations to perform many of the things attributable to human persons and regularly accord them the status and name of persons.89 Instances where corporations are protected in the US legal system include the 14th amendment to the Constitution. That amendment which came on the heels of the Civil War, gave the freed slaves the standing and protection of other natural persons. And from 1886, when the Supreme Court decided on the Santa Clara County vs. Southern Pacific Railroad90                                                             88 Ibid, p. 171-172. 89 University of Pittsburg Law Review. 50:575-654.  90 Ibid, p. 175. Get additional detail at Justia US Supreme Court: Santa Clara County vs. Southern Pacific R. Co., 118 U.S. 394 (1886). Viewed on August 29, 2014 at, https://supreme.justia.com/cases/federal/us/118/394/case.html.   40  More recently, sother means, something that was inconceivable not too long ago. They invoke for instance, the affirmation in 2010 by the US Supreme Court of the right of corporations to express their political views in the unrestricted campaign contributions they make to political parties (in the Citizens United vs. FEC case).91 If group agents can do this, then they have to count as persons, albeit ones of an -requisites of personhood. Not only do they form and enact a single mindand desires and acting on their basis. They can speak for that mind in a way that enables them to function within the space of mutually recognized obligations.92 I stand to explicate that having basic pre-requisites of personhood does not put group agents in exact same status as normal persons with flesh and blood. They are pachydermic and rigid in a number of ways, and lack the perceptive and emotive attributes of human individuals.93 To be sure, such rights and privileges that are not obliged to corporations include, not able to marry or be married, adopt children, be                                                            91 Other analysts seem to indicate that this claim seems a bit stretched. Nonetheless, what is undebatable is the impact political war chest can sometimes have on election outcomes. Perhaps a far more exerting anthropomorphization of corporations is the June 2014 decision of the U.S. apex court in the case of Burwell vs. Hobby Lobby, Inc.  The Supreme Court ruled 5-4, that requiring family-owned corporations to pay for insurance coverage for contraception under the Affordable Care Act violated a federal law protecting religious freedom. In essence, the court ruled that some corporations (for instance, the ones that are owfemale employees against the beliefs of their owners. At issue are regulations promulgated by the Department of Health and Human Services under the Patient Protection and Affordable Care Act of 2010, which requires specified employers' group health plans to furnish preventive care and screenings for women without any cost sharing requirements. However, opponents assert that this decision violates Religious Freedom Restoration Act, of 1993 which prohibits the "Government [from] substantially burden[ing] a person's exercise of religion even if the burden results from a rule of general  92 List and Pettit, pp. 176-177. 93 Ibid, p. 176.  41  voted for or run a government, and the right to education. But despite the abundance of dissimilarities between a corporation and a flesh-and-blood human, there are enough resembling attributes that have made the law to regard the corporation as a person,94 thus making it a vastly well accepted artificial, but not fictional person. So without a doubt, I affirm that corporations are persons, but they are persons in the performative sense that I have espoused. 2. Should corporations be held responsible (legally, morally, socially, etc.)? Put in another way, can group agents be subjected to disciplinary treatment and deprived, restricted or punished as a result of some irresponsible conduct? This is a question that requires extensive deliberation. But. Legally: the short answer is yes, history is dotted with innumerable instances. For instance, in August 2014, Bank of America agreed to pay almost $17 billion in a settlement with the Justice Department, much of which was used for consumer relief for mistreatment of its mortgage lenders. Morally: , and my rationale is lumped with the answer to the third question below. Socially: certainly yes, corporations ought to be socially responsible particularly given their power and influence in contemporary business environment. Unlike the early 19th century era when legislative acts allowed the establishment of corporations only within closely defined terms; the gradual relaxation of regulations which led to the explosion of commercial corporations in later half of the                                                            94 Tulane Law Review, 61, p. 563.  42  century and onwards to the 20th and 21st centuries changed all that.95 That development proved to be the precursor, a harbinger of sorts, to the present day globalization of free market economy  the somewhat idealized transactional or economic regime based on supply and demand with little or no government control; that is, the unbridled economic climate where anyone can freely buy, sell, or trade with little or no state intervention in the form of taxes, subsidies or regulation. This has occasioned a groundswell of an atmosphere of survival of the fittest where powerful corporations easily suck up weaker ones and metamorphose into multinational behemoths with unimaginable power and clout. To illustrate,  Think of the small country where the corporation would trigger an enormous crisis by moving elsewhere, as it is always free to do. Or think of the community that has suffered serious or other environmental harm at the hands of a corporation, and even if it is successful in the courts, finds itself thwarted by endless appeals and other legally rigged delays in payment. Or think of those in government who depend on the financial support of corporations in their electoral campaigns and dare not get a corporation offside.96 In defense of corporate power, some have argued that the fact of possessing power does not imply that that power is always used or misused. To refute that, I would point out that even when this power is not applied it is ever present and continues to radiate disabling fear in individuals, communities and other entities.                                                            95 Ibid, p. 184. 96 Ibid, p. 184.  43  power that does not n97 That much power (and any power, for that matter) cannot afford to be wielded without some responsibility, in this case, social responsibility. Plus, we must not be fooled to think that self-restraint is enough to constrain excessive power; after all, if you are a hammer, everything tends to look like a nail.  3. Do, or should corporations have morality (and is the morality of the constituent elements in a corporation equivalent or reducible to the group agents)? My immediate response is to use the cliché: if it walks like a duck and quacks like a duck, then it must be a duck. However, I would insert a proviso, which is that just like in the first question above, group agents are deemed as having morals in the actions they exhibit or the functions they discharge (hence, in the performative sense). My proposition can be expressed in the following simple syllogism:  A. If corporations or group agents (as legal persons) can be held responsible and punished under the law. B. And, laws are often evaluated on moral grounds or by morality (descriptively or normatively)  C. Then, corporations or group agents have morality.                                                            97 Ibid, p. 184.  44  I can clearly see how my reasoning would 98 who characterizes  (a term adopted by James Roper99) with maximum profit making as the arrow head of their operations. He claims that ancillary goals such as the growing of their market share, are mere appendages to this primary goal. It follows that the things these companies do are hypothetically related to their goal of maximizing profits. Therefore, these  businesses are not part of 100 Lest we forget, morality refers to a set of codes which govern agential conducts in terms of whether they are good or bad. In exercising such characteristics attributable to human persons, group agents or corporations can create or shed jobs; establish scholarships/trust funds, fellowships; apply aggressive strategies that defraud or reward clients; pollute or clean the environment; engage in or discourage racist or sexist policies that discriminate (or accommodate); institute policies that favor the elite or policies that encourage minorities, etc. These are moral conducts and are clearly performative activities that take place daily in the space of social norms. In fact, rather as Roper101 has stated given the way corporate law has evolved, I contend that group agents as legal entities should be                                                            98  The Monist, 54, 4:488-516. 99 Roper, James. 2012. The covenant of democracy: Should government by run like a business?Hunt Publishing Company. 100 Ibid: 70. 101 Ibid: 77.  45  assuming more responsibilities, not less. As I have argued above, these responsibilities cover such spheres as legal, social and moral. And indeed, given the broadening interpretation and the permutation of the law over Roper suggests has already witnessed a reinvention of sorts to the extent that much of radically changed in order for corporations to operate in 102   The journalist and author of The Impulse Society103, Paul Roberts has spoken up about something many are hesitant to acknowledge: that the pursuit of short-term self-gratification, something that was once scorned as a sign of personal weakness, has now become the default principle for all sectors of our society. This is showing up in individuals, in our financial markets, and in institutions that we have traditionally relied on to curb impulsiveness.   Roberts posits that this trend sort of went into the overdrive in the latter part of the last century with the industrial revolution, the computer revolution, the financial revolution, etc., whereby profits (for example, quarterly financial earnings) and share price became the dominant factors of consideration while every other considerations are put aside. And what is radical about this is that for most of the earlier part of the century, most corporations were the stewards of long-term thinking. They made long-                                                           102 Ibid: 82. 103 Roberts, Paul. 2014. The Impulse Society: America in the Age of Instant Gratification, New York, NY: Bloomsbury.  46  term investments on factories, innovations, employee training, etc. And almost overnight, all that is thrown out because they now have to focus almost entirely on the  good social impacts.104 In light of positioning corporate entities as legal persons, I readily adopt outlining of the three criteria that organizations should have in order to be considered as morally responsible: (1) Corporations must be intentional agents able to act. (2) They must be able to conform to rules and appreciate the effects of their actions on other individuals, groups and the environment. (3) They must be capable of responding to moral censure with corrective measures.105 While these conditions appear to give a fair prescription, the status of formal organizations and specifically corporations, has remained at center stage, and the question of whether some organizations can be morally responsible is seen to hinge on questions of the metaphysical identity of organizations.106    But in a doggy-dog world where persons (individual or corporate) do whatever it takes to get ahead, contending views on this matter are certain to continue particularly from opponents of corporate responsibility. For instance, it was Eric                                                            104 Most of this narrative derive from my verbatim notes during the PBS broadcast. More details can be obtained online at Well Read, http://www.tvw.org/index.php?option=com_tvwplayer&eventID=2015020019. Accessed on February 5, 2015. 105 the Internet Encyclopedia of Philosophy. Accessed at http://www.iep.utm.edu/virtue/ on April 09, 2014. 106 Ibid.  47  Palmer107 who stated starkly that both Michael Jensen and Milton Friedman  two of the most prominent objectors of corporate moral responsibility  actually think that it is irresponsible for corporations to be socially or morally responsible; their familiar but dubious reasons include, considerations for high importance of freedoms, and preservation of shareholder value.108 But I think they overlook significant possibilities that undermine their fundamental values. This may be unsettling and downright subversive of the long term common good.  Let me make one more point by way of a question: Does ethics pay? Certainly, when so much weight is attached to immediate profits there is a danger to lose sight of the greater benefits of planning for the long run. the time it takes fixed costs to become immediately variable. Though it is usually much shorter and, on rare occasions slightly longer, the long run is generally about seven years.109 disagree with it. To reiterate, Corporate Social Responsibility (CSR) ought to be seen as short-term pain for long-term gain. As I see it, the sooner entrepreneurships started                                                            107 Conference proceedings in ethics and international development on accountability, responsibility, and integrity in development: The ethical challenges in Sub-Saharan Africa and beyond: From 19th-22nd July 2006, Rukooko, Byaruhanga (Ed.), Makerere University, Kampala, Uganda. 108 Ibid, p. 140. And as James White reveals in his Contemporary Moral Problems, 1988: 180, opponents of duty to reduce [environmental] pollution or elimination of racial and sexual discrimination at work places, all in a bid to prop up profits.  109 James Roper, 2013.  48  infusing from the ground up, ethical virtues with economic principles, the better they would realize what a win-win vantage position they assume. Stephen Hicks speaks likewise in his recommendation for more of business ethics. (1) to stop predatory business practices and, (2) to encourage philanthropy and charity by 110 This would entrench more of ethical behavior which by the way does not 111 This is crucial because what is apparent in the argument for the rejection of CSR, is the unstated fear that moral considerations would detract from the primary aim of doing business which is to make profits. Whereas, under a careful scrutiny, it is clear that the mission of ethics is not antithetical to applied disciplines like business in capitalistic societies. In a word, the two are not at cross purposes. To the contrary, they are complementary and mutually beneficial to each other. It is almost farcical that while some ardent theorists are busy defending the indefensible, many corporations have discerned the signs of the time and moved on. Many of such corporate entities now have dedicated policies that front such things as rich cultural exchange within the communities where they operate to ensure that positive benefits transpire; promotion of long-term sustainability and stewardship;                                                            110 Hicks, Stephen. 2009. "What business ethics can learn from entrepreneurship." The Journal of Private Enterprise 24(2), 2009, p. 49. 111 Journal of Business Ethics, 89:139.  49  adequate engagement with stakeholders, including employees; and, sustainable commitment to curb environmental impact.112 Come to think of it, there is hardly any way around conducting business today and staying afloat to harvest profits tomorrow without some appreciable infusion and adherence to ethical standards and social responsibility. It takes nothing to see that doing otherwise can only mean exhibiting abject lack of foresight. It takes only but one error or the flouting of the law such as negligence or lax adherence to regulations,113 for the errant organization to turn around and make painful compensations, beat back bad publicity, strive to burnish and recover public image, and start making profits again.114 Why the fuss you might ask; and why do we have to prove an axiom in defense against                                                            112 http://www.fairmont.com/corporate-responsibility/responsible-business/ Viewed on July 9, 2015. 113 Here, think of such instances as oil spills, tainted pills or defective medical devices, malfunctioning merchandise, recall of E-coli infected meat or veggies, or clinical trial catastrophe. 114 I have just two illustrative examples: The 2010 BP oil spill on the U.S. Gulf of Mexico is only but a case in point. As I write, BP is reeling under the weight of that crass negligence of drilling regulations. To say accidental oil spill the world has ever seen which began with the explosion of the Deepwater Horizon in which 11 crew members were killed. The gusher flowed for 87 days and thousands of businesses suffered along an oily arc from Texas to Florida. The resulting environmental impact is still hard to gauge. So big is the ongoing compensation that the oil giant has agreed to pay the largest environmental settlement in U.S history -- $20 billion. Get more at PBS Newshour, http://www.pbs.org/newshour/bb/long-legal-fight-bp-agrees-largest-environmental-settlement-u-s-history/. Viewed on July 9, 2015.   In January 2015 the Nigerian arm of the Anglo-Dutch energy giant Royal Dutch Shell agreed to pay, following a six-year legal battle, the record-setting amount of about $84 million to Bodo, a Nigerian fishing community devastated by two serious oil spills in 2008. The compensation will go to 15,600 Nigerian fishermen and farmers whose livelihoods were affected and to the wider community. Read more by Margaret Coker and Benoît Faucon, The Wall Street Journal, at: http://www.wsj.com/articles/shell-to-pay-80-million-compensation-for-2008-oil-spills-in-nigeria-1420617029. Viewed on January 7, 2014. nline posting by Bill Chappell, at http://www.npr.org/sections/thetwo-way/2015/10/05/445983039/u-s-resolves-claims-against-bp-over-deepwater-horizon-spill. Viewed on October 12, 2015.  50  the onslaught of relentless and increasingly shameful attack of CSR? White answers it best: It is sad that this argument needs to be made, and if it were not for what appears we take strong and appropriate mode of behavior that is maximally disrespectful of human life, just as society would be reinforcing a value system that so emphasizes monetary gain as a standard of human success that murder for profit could be a corporate policy if the penalty for being caught at it were not too dear.115   What I can properly conclude from all of this is that in assessing the responsibility of groups, business corporations have received most of the attention and for obvious reasons.  2.5 CONCLUDING THOUGHTS  In this chapter, I set out not to reinvent the wheel on the subject of responsibility which has bemused analysts from time. I set out to blow some fresh breath by laying the foundation on which to validate my aim of reconceiving the concept. To sum up, if indeed it is possible to really sum up or arrive at any agreeable, quotable ending, having become more acquainted with the complexity of the different problematic aspects I have touched upon in this analysis. However, a number of conclusions could be drawn. For one, individual responsibility for oneself is not in                                                            115 White, p. 203.  51  question, it is taken for granted. It is also a given that all agents and entities, by virtue of their social existence, are (or ought to be) responsible for something or someone else.  The literary corpus on responsibility is obviously deep and dense, but of the much I have reviewed, I find quite a few of them instructive. They include, espousal of responsibility to fellow moral agents as being intrinsically and uniquely valuable; the obligation to be responsible for the other by Levinas; Gustafson and ought; or Richard Niebuhr and Bernard view that responsibility occasions a response or a call to action. Not surprisingly, most of these viewpoints may be judged to exhibit the trappings identifiable with virtue. They all emphasize the acquisition of moral character  an attribute that harks back to Aristotle, Plato and of course the ancient Egyptian/Nubian mystics. In effect, I have argued that responsibility can very well be viewed as a virtue. As a character trait or a disposition which is entrenched in its possessor, responsibility as a form of virtue, is a state of character by which, according to Aristotle, persons are defined. I extend this understanding to persons/entities in the legal sense. And just as virtue can be cultivated and habituated in persons with flesh and blood, so too can it be embedded or inculcated in the formations of legal entities in ways that are action-guiding. As noted, the central question in  is the pursuit of the good life for humans, likewise, apply to legal persons  corporations or group agents. Yes, if put in  52  ranking order, the good life for legal entities is profit making, it ought to be within a social, not a self-centered context.    For sure, this may be objectionable to those who reject the idea that corporate bodies do not belong to the moral community. corporations cannot eat their cake and have it. In their public relations, corporate entities seek to be reliable, even trustworthy, etc. These concepts, just like responsibility, are moral appraisals or normative notions by which entities are judged or assessed in the space of social norms. As I have stated, both the good of the agent and the good of the others, result from the exercise of virtue. I have also underscored the point that moral responsibility is neither contractual nor optional, yet innately other-regarding. As a cue to that, I presented responsibility in the context of virtue as a way of determining character ideal which lies beyond the range of self-interest. In light of the above, the 18th and19th centuries Industrial Revolution perspective which saw corporations as legal establishments solely for profit making must be cast aside as jaded and moribund given where we are in the 21st century. cast off the cloak of inhibition when it comes to making consideration only to bottom line; to do so is to create a dangerous circularity. Resistance to this argument must no longer be made in subdued displays and lacking in conviction; a trend that is all the more mystifying given the abundance of obvious realities. Facing up to this fact is a challenge one would expect proponents of CSR to embrace, not shy away from. It's time  53  we stopped pussy-footing around this issue; it is time to take it up by the scruff of the neck.    At a first pass, emphasis on profit making might have made sense during industrial revolution era when human conditions seemed to be receiving a new lease of life with new technological discoveries. But little could anyone predict some of the fall outs down the line. For instance, the likelihood that it could impede the development of genuinely shared moral understandings was beyond the raider. I argue that to insist solely or mainly on profit making is in fact retrogressive and signals a throwback to the -technical success or technical advancement is measured only in terms of usefulness, efficiency and control. As such, quantification, measurement, cost-benefit analysis become the language for evaluating political, economic, cultural, scientific and moral questions and decisions. The eminent critical theorist Andrew Feenberg116 who is world renowned for his insights in philosophy of technology and constructivist technology studies, has effectively critiqued this technical rationality which essentially is an instrumental view that rejects value-laden argument in favor of value-free or morally neutral view to our modern life. Defenders of this view -- technical rationality -- believe in infinite technological progress. In other words, the greater the technical control over nature, the better humanity is served.                                                             116 Defining Technological Literacy: Towards an Epistemological Framework, Dakers, J. (ed.)  54    Contrarily, and in agreement with Feenberg, the instrumental view that means are linked to ends or that technology always ensures endless progress is wrong. Technology is not a neutral tool. Or we can look at it this way: the science of economics [production, distribution, and consumption of commodities] and ethics [particularly, business ethics  the applied ethics discipline that addresses the moral features of commercial activity], are reciprocally conditioning: shaping influence goes both ways. The tunnel vision which focuses primarily on profit making does often lead to what Freeman Dyson has termed evenge effects, that is, solving one problem while creating unexpected problems elsewhere; or an attempt that boosts profits to benefit a few people while wreaking havoc on a much greater number of people in tow.117 As I have shown without responsibility (legal, social, moral, etc.) no human society would be recognizable. Finally, I have argued in favor of adopting and adapting ethics into entrepreneurships by way of inculcating corporate social responsibility, stressing that to do otherwise would mean ultimately undermining vibrant capitalism (as well as socialism) upon which we all rely for survival. The argument that group agents or corporations do not belong to the moral community, or that they do not exhibit enough performative capacities associated                                                            117 Dyson, FrPolicy, Carnegie Council on Ethics and International Affairs.   55  with personhood to be treated as such legally, morally, etc., does not stand up to critical analysis.                                                                                                                                                                  56  CHAPTER THREE: WHO IS RESPONSIBLE FOR HUMAN SUBJECTS [WHEN                                        EXPERIMENTS TRAVEL]?  3.1 INTRODUCTION The question that this chapter seeks to answer  as shown in the title  is not new. In fact, it is so old it is now trite and rhetorical. But if you are curious, the upshot for posing it is that it needs to be re-in the context of a new dispensation  a globalized clinical trials dispensation.  In the current globalized world, it is daunting to keep track of the tremendous amount of clinical trial projects that are ongoing at any one time. As such, some of the questions that dogged us in the wake of landmark clinical trial abuses including the ones by the Nazi doctors118 in concentration camps have both lingered on as well as become more complicated. The challenge still is how to end abusive research and promote quality ones that protect research subjects everywhere. Hence, the following questions remain pertinent: How should human research subjects be protected? Who should provide them protection? In our increasingly interconnected world, how can we ensure compliance, guideline consistency, and checks and balances across borders?119                                                            118 The atrocities led to the Nuremberg code of 1947, a direct result of Nuremberg War Crime Trials after WWII. It set standards for judging physicians and scientists who conduct biomedical experiments to guarantee that research involving human subjects are carried out in an ethically accepted manner. As I will shortly review, other codes and guidelines that have emerged include the Helsinki Declaration (of 1964, but has been revised numerous times); the 1974 U.S. Code of Federal Regulations (45 CFR Part 46); and the 1979 Belmont Report of the U.S. National Commission, which outlines ethical principles and guidelines for the protection of human subjects of biomedical and behavioral research. 119 The 2001 Presidential Ethics Advisory Board Report suggests two principal approaches to improving the protections of human participants in international clinical trials are 1) relying on reviews by U.S. IRBs  57  These questions are relevant particularly because even as most clinical studies today are initiated and registered in the Global North (predominantly in the U.S.), the actual trials are mostly outsourced and offshored120 (often to the Global South).  Coupled with the changing geography is the fact that private sector research by, for example, pharmaceutical companies, have led the way since the 1980s. And foremost in their approach is speed and profitability.121 That is a concern that triggers further questions: If they are so disposed, would responsibility for study subjects be paramount on their minds? Even so, would they be additionally bound by the local systems (socio-cultural, political, and legal systems where available) and/or would they abide only by international codes of research conduct as though they were in their home countries (where enforcements are strict)?122 It has forcefully been argued that the financial interest and overwhelming corporate influence in test results by companies,                                                                                                                                                                                            and assurance processes to supplement and enhance local measures or determining that a host country or host country institution has a system of protections at least equivalent to that of the United States; and, 2) helping host countries build the capacity to independently conduct clinical trials and to carry out their own scientific and ethical review. But sadly enough, these idealities emerge from flawed though moral epistemological assumptions. In practice, real world ethical problems take place within non-ideal circumstances. 120 Refer to When Experiments Travel (2009), pp2ff. Also, confer the U.S National Institutes of Health, Trends, Charts, and Maps http://clinicaltrials.gov/ct2/resources/trends#RegisteredStudiesOverTimePostedResults. Viewed on October 11, 2013. 121 Ibid, p 12. 122 These questions inevitably regurgitate the vexed issue about corporate social responsibility that I discuss in Chapter 1.  58  unduly influence the drug testing system. It is therefore the in-built bias that distorts the accuracy and acceptability of drug research.123 The core questions of, how should human research subjects be protected; who should protect them; and how can we ensure compliance and guideline consistency across borders, directly link up with the overarching claim in this dissertation for the need to re-conceive responsibility in clinical trials. As I will make apparent (particularly context of an increasingly globalized world, including complexities associated with cultural, social, and political realities. The burden of my argument will be to demonstrate that this recommendation is a crying urgency if we must truly reflect the meaning of our moral condition in the field of biomedical research.  This chapter is divided into four main parts. I will start out by sketching out an overview of the historical background to human experimentation in medicine. Next, I will review some of the U.S. and international research ethics guidelines which resulted from the events that preceded them. The intent is to revisit and re-reflect on provisions they have for protecting human study subjects. Third, I will briefly examine the concomitant implications of outsourcing of biomedical research to the Global South.                                                            123 Divorcing profit motivation from new drug research: A consideration of Duke Law Journal, Ninth Annual Administrative Law Issue, p. 155.  59  Fourth  and for serving as the inspiration for this dissertation  I will introduce the Pfizer-Nigeria (Trovan) case study for illustration and analysis.   3.2 EXPERIMENTATION WITH HUMANS: A SELECTIVE REHASH  Hippocrates.124 It also is one that probably traces the historical explanation for why the  either as a patient or a patient-subject  is always of preeminent consideration in healthcare settings. Thereafter, the principal ethic of Western medicine (and later much of non-Western world) profess it as part of the 125  The understanding at the time is that the Hippocratics routinely experimented 126  from the Latin root experimentum, meaning, trying out or proof  with patients particularly because doctor-patient interaction always meant some sort of testing out or discovering the unknown,  Any encounter between a doctor and a patient can be experiential and thus experimental, if only in a passing sense. The Hippocratics, who were interested in the rhythms and natural histories of disease, and in carefully observing sick people, were increasing their own experience. Further, any therapeutic                                                            124 It has however been demonstrated that the Hippocratics of the third and fourth centuries BC actually Epidemics, Bk. 1, The Ethics and Regulation of Research with Human SubjectsHippocratic Writings (translated by J. C. Chadwick and W.N. Man, 1950). 125 Ibid, p. 3. 126   60  experiment.127  In addition, the Hippocratics sometimes treated the socially and economically disadvantaged public as motivated by philanthropia (love of man) and philotechnia (love of the art [of healing]). The art of healing also included the quest to expand scientific knowledge and as such encompassed experimentation with new procedures and drugs.128 Most of the human subjects were prisoners and condemned criminals. The Medieval era that followed witnessed a health care delivery system that differed markedly between the rich and the poor. And just as it is today, religious moralists and ethicists of the time not only defined and crystalized the need for moral responsibilities, they also pilloried the tendency to use the poor (and other vulnerable populations) for experimentation.129 This was happening as testing for new drugs and medical procedures were gaining currency. Experiments were sometimes also conducted on animal models; other human subjects like friends and neighbors; and curiously, on physicians themselves and thei-human animals                                                            127 The use of human beings in research. Spicker, Stuart et al, eds., 32 128 Ibid, p. 32-33 129 Transactions and studies of the college physicians of Philadelphia, Part 1, in Series 5, 3, 22:34-35  61  such as birds and brutes, to hospital patients and to a group that was then called the ty and inmates of mental institutions), etc.130 David Rothman recounts further as follows. Legends tell of ancient and medieval rulers who tested the efficacy of poison po[r]tions on condemned prisoners and released those who survived. Much better documented is the example of Lady Mary Wortley Montagu, wife of the British ambassador to Turkey, who learned about Turkish success in inoculating patients with small amounts of the smallpox material to provide immunity. Eager to convince English physicians to adopt the procedure, she persuaded King George I to run the trial by pardoning any condemned inmate at the Newgate Prison who agreed to the inoculation. In August 1721, six volunteers were inoculated; they developed local lesions but no serious illness, and all were released.131  [a] Burroughs Wellcome (now GlaxoSmithKline) experiments Fast forward to a 20th century biomedical experimentation. In June 2014, a hot-off-the-press news flash by the British paper, Daily Mail,132 divulged the discovery of a macabre mass grave of about 800 infants who were victims of diphtheria vaccine trials [in Irish Republic and the UK]. Historian Catherine Corless and Professor Michael 2,051 children and babies in several giant Burroughs Wellcome (now GlaxoSmithKline) between 1930 and 1936. Though shocking as it is, this revelation was apparently only but a tip of a very large and                                                            130 Bynum, p. 34. 131 Rothman, David. 2003. Strangers at the bedside: A history of how law and bioethics transformed medical decision making. New York: Aldine de Gruyter, p. 21. 132 Harriet Arkell and Neil Michael, Daily Mail, http://www.dailymail.co.uk/news/article-2650475/More-mass-baby-graves-Ireland-Prime-Minister-Enda-Kenny-orders-investigation-memorial-800-dead-babies-planned.html. Viewed on June 6, 2014.   62  submerged iceberg. All the more bewildering still is that no record of these experimentations can be traced to the local government and public health departments, s archives in London. One can only assume that this style of vaccine trials was frowned upon and rejected by the Irish reports of these trials were published in the most prestigious medical journals suggests that this type of human experimentation was largely accepted by medical practitioners 133   I detour. While a good number of the early experiments with human subjects took place in Europe and elsewhere, the American medical environment was not immune to the practice. In fact, some of the most egregious episodes in the last century, for instance, have happened on the American soil.134 Here, I randomly revisit (deliberately and with trepidation) a few examples that took place in the U.S. (and sometimes jointly in Europe). This intentional move is aimed to highlight how each of the events presented a critical piece of lesson in the history of biomedical research.                                                            133 Ibid. 134 More detailed historical narratives and the American judicial reaction to crimes committed in the guise Strangers at the bedside and The Ethics and Regulation of research with Human Subjects, New Jersey: Matthew Bender and Company, Inc. Also, get more Report of Robert H. Jackson to the PresidentDepartment of State Bulletin, at http://www.ibiblio.org/pha/war.term/trib_07.html. Viewed on May 13, 2014.  63  [b] Tuskegee Syphilis Study (1932-1972)   The share size, the length of time, the bleating racial intent, and the funding source, all make this study stand out like a sore thumb. In all, 600 poor black sharecroppers (399 with latent syphilis infection, 201 without the disease) were harvested from rural Macon County, Alabama into the Tuskegee Syphilis Study. For about 40 years the subjects were denied any genuine treatment and corned to believe they were being treated for a blood d135 In return, the subjects got free food, basic stipends, medical care and burial insurance. The outing of this study in the New York Times, detailed it as 136 a fact that was made even worse by the revelation that indeed the U.S. government bankrolled it.     On May 16, 1997, and at the invitation of six surviving study subjects and relatives of other families, President Bill Clinton tendered a state apology declaring his heart-felt mea culpa on behalf of a government which orchestrated a study so clearly racist. He signaled it can never be allowed to happen again. The despicable act stands                                                            135 Ibid, p. 42. 136 Ibid, p. 41.  64  in contrast with everything the country, a self-styled leader of the free world, stands for and which it must stand against.137 [c] Nuremberg experiments   The superlative headliner of all biomedical experimental atrocities involving humans were perhaps the set of medical experiments in concentration camps mainly during World War II and the Holocaust in the early 1940s. As is now common knowledge, the atrocities were committed by Nazi German doctors on war victims including children of Jewish, Polish, Russian and Roman (Gypsy) origins, but had, and continues to have a worldwide impact. The crimes resulted in the prosecution of the perpetrators as war criminals before the Nuremberg military tribunal. American judges oversaw the legal proceedings during which 16 of the physicians were found guilty; seven were sentenced to death and executed on June 1948.138  [d] Radiation experiments   The 1940s and the 1950s were replete with U.S. government-sponsored experimentations surreptitiously conducted on patients and other human subjects for the testing of radiation mostly for military purposes due to the Cold War. In the words of Coleman, et al.:                                                            137  138 Refer to Carl Colman et al, pp. 16-17. Contrast this with the Tuskegee experiment which got only state apology after decades of protestations. No one was either prosecuted or executed.  65  Between 1944 and 1974, the federal government funded a series of radiation experiments, including the injection of plutonium into unsuspecting hospital patients as well as the intentional release of radiation into the environment for research purposes. Some were conducted to advance biomedical science, while others related to national interests in defense or space exploration.139  [e] Mustard gas experiments  In secret chemical weapons experiments conducted during World War II, the U.S. military experimented with a whopping 60,000 lowly ranked American troops in chambers filled with mustard gas. Subjects were oblivious of this and threatened with dishonorable discharge and military prison terms if they resisted. The tests evaluated protective equipment like gas masks and suits. They also compared the relative sensitivity of soldiers, including tests designed to look for racial differences. When those experiments were formally declassified in the 1990s, most of the affected guinea pigs had passed. More heinously, military records about the experimental subjects were shoddy and incomplete with no identifying information, such as Social Security numbers and addresses. The few surviving subjects who are today in their 80s and 90s  though still suffering from impacts of those chemical tests  (or their relatives), cannot be duly identified for appropriate compensation, due to burden of proof.140  [f] Thalidomide   Either partly because of its worldwide disastrous impact, or partly because of circumstances surrounding its original purpose (or both), the secrecy shrouding the                                                            139 Ibid, p. 44. Also, refer to the Roadmap to the ProjectDOE Openness: Human Radiation Experiment. Viewed on May 14, 2014 at http://www.rst2.edu/ties/radon/ramfordu/pdffiles/med8.pdf.  140 Read more NPR, at http://www.npr.org/2015/06/22/415194765/u-s-troops-tested-by-race-in-secret-world-war-ii-chemical-experiments, and http://www.npr.org/2015/06/23/416408655/the-vas-broken-promise-to-thousands-of-vets-exposed-to-mustard-gas, accessed on July 16, 2015.  66  reason for the development of this pill may yet to be definitively made clear. The German pharmaceutical company Grünenthal is said to have developed it as an antidote to nerve gases such as sarin in Germany in 1944, prior to which it was first synthesized by British scientists at the University of Nottingham in 1949.141 But it was introduced into the market in Germany in 1957 as a wonder drug for insomnia, morning sickness (in pregnant women), coughs, colds and headaches.  By 1960 it had spread to the rest of the world, but was soon linked to miscarriages, severe deformities in children of mothers who took it in their first trimester of pregnancy. By this time more than 10,000 children in 46 countries had already been born with these defects. Though it had not been approved by the FDA, in the U.S., some doctors, nevertheless, administered it to a selection of pregnant mothers (without their consent) on these conditions as a result142   [g] Henry Beecher Report   -yearlong study which jolted the medical community and repulsed the general public about the -biomedical studies. With 22 examples to show (trimmed down from a much higher                                                            141 For more navigate to News Medical http://www.news-medical.net/health/History-of-Thalidomide.aspx. Viewed on May, 13, 2014. 142 Carl Coleman et al., p. 35.  67  number) Beecher made evident that American investigators had risked the health or 143 whose ages ranged from a few hours (from birth) to over 70 years  many of whom healthy, others in a variety of health conditions. While citing inordinate drive for scientific progress and name recognition as motives for such experiments, Beecher also recalls Pope Pius XII admonitions that science should never 144 [h] Jewish Chronic Disease Hospital and Willowbrook tests   revelations, deserve a special mention due to their significance. In 1963, a study that received funding from the National Institutes of Health, NIH, was carried out by an unnamed Sloan-Kettering Cancer Research physician and conducted at the Jewish Chronic Disease Hospital during which live cancer cells were injected into 22 indigent, chronically ill, and debilitated elderly patiethat live cancer cells were being used or that the experiment was designed to measure  a test unrelated to their normal therapeutic 145                                                              143 New England Journal of Medicine, 274, 24:1356. 144 Ibid, p. 1354. 145 Carl Coleman et al., p. 39.  68   Similarly, Willowbrook State School in New York was, between 1956 and 1971, the site of a Dr. Saul Krugman-history of hepatitis and the effects of gamma globulin in preventing or moderating its 146 The study subjects, all children, were deliberately infected with the hepatitis virus without their knowledge or assent (claims of signed consent forms by parents were unproven). In the end, even as this experiment established clear distinctions between Hepatitis A and B, a point for biomedical advancement,147 however, its horrendous method did not go without condemnation.   So much for instances of experimental callousness with human subjects. Obviously, the above cursory outline of the historical antecedents of experimentation with human subjects in the U.S. and elsewhere clearly projects a grim picture. While these few examples pertain only to biomedical testing, numerous other studies in fields such as the social sciences abound as well. It is beyond the ambits of this analysis to conscience, it was inevitable that some ethical codes of conduct would have to be formulated, if not to eliminate completely, to at least curtail future recurrence of similar abuses. Below is a cursory mentioning of a few of them (not in any particular order).                                                               146 Ibid, p. 39. 147 Ibid, p. 39.  69  3.3 EMERGENCE OF RESEARCH ETHICS CODES   By default, most clinical trials, say of experimental drugs, start out with lab animals. But with greater level of confidence a series of phased148 trials is introduced which involve human subjects but not without adherence to research ethics procedures. Underlying this fact is the degree of importance of the human person and the onus of responsibility we owe to human dignity.    The Nuremberg Military Tribunals under Control Council Law No. 10, 8-17, entailed a 140-day long proceedings, including the submission of about 1, 500 documents, testimonies of 85 witnesses, verdicts, and sentencing by presiding American judges. Significantly, it also produced a terse landmark one-and-a half page framework  The Nuremberg Code  which aimed to guard against possible human subject protection violations. It was the first of its kind and consent of the human subject is absolutely essential. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs                                                            148 As defined by the U.S. National Institutes of Health, clinical trials (of drugs, medical devices, etc.) are conducted in a series of steps, called phases (four in all); each phase is designed to answer a separate research question. In phase I, for instance, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. As it progresses exponentially, in phase IV, studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-- NIH: US National Library of Science, at http://www.nlm.nih.gov/services/ctphases.html. Viewed on October 28, 2013.   70  or engages in the experiment. It is a duty and responsibility which may not be delegated to ano149  Next, the role of doctors in matters that determine rational actions in biomedical research is evident in the fashioning of mechanisms which ensure that similar issues are properly managed. Such is the case that was made by the World Medical Association in its Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, first adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, and revised multiple times since then (the last being at the 64th WMA General Assembly, Fortaleza, Brazil, October 2013) to accommodate updates and shortcomings of previous ones.150 The 37-point four-page document retains its usual elements which essentially stress the importance of ethical principles for medical research involving human subjects. Also, the Good Clinical Practice, GCP, protocol that guides ethical research conducts originating in Europe is worthy of mention here. It is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials                                                            149 Trials of War Crime before the Nuremberg Military Tribunals under Control Council. 1949. No. 10, Vol. 2, pp. 181-182. Washington DC: U.S. Government Printing Office. Read more at Coleman et al. p. 16; and U.S. Holocaust Memorial Museum, at, http://www.ushmm.org/information/exhibitions/online-features/special-focus/doctors-trial. Viewed on May 14, 2014. It suffices to add here that though the Nuremberg Code was conceived and drafted by legal flaw remains to be one of its main short comings and one wonders why such a milestone event could not produce a legally binding document. 150 The Journal of American Medical Association. Published online October 19, 2013.  71  that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki and the World Medical Association (WMA)151 In recognition that clinical development of medicines has inevitably become a global undertaking, the London-based European Medicines Agency, nurtured an initiative to collaborate with the U.S. Food and Drug Administration, FDA. This procedure was launched in July 2009 and aimed -trial subjects in the context of the increasing 152  On the U.S. front, it is scarcely surprising that given the history of research with human subjects, regulations are plentiful. In comparing the culture of research ethics in Australia, Europe, and North America, Paul M. McNeill, an Australian attorney and ethicist, attests that the American research ethics climate is far more widely publicized, witnesses much more regulations, and that those regulations are more detailed than in any other country.153 For a comprehensive understanding of this, an extended list of examples would be appropriate:                                                             151 Refer to the European Medicines Agency, at, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000072.jsp. Viewed on May 21, 2014. 152 Ibid. 153 The Hastings Center, 11, 3:4.  72   As noted in the Thalidomide saga, the impact cut across many countries. In the U.S., it -Harris Amendments to 154  The National Institute of Health's Policies for the Protection of Human Subjects, which were first issued in 1966, attained regulatory status and were promulgated on May 30, 1974 by the Department of Health, Education and Welfare (DHEW). They established the Institutional Review Board (IRB) which are empowered to approve research protocols that guaranteed adequate protection for human subjects in research.155  In July 1974, the National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The principles that should underlie the conduct of biomedical and behavioral research involving human subjects and recommending guidelines to ensure that 156 The Commission's report was a precursor to The Belmont Report.  Research ethics and bioethics as a whole are indebted to The Belmont Report for originally formulating three basic ethical principles (a.k.a., principlism) that have become a condicio sine qua non in any conduct of research involving human subjects. As a moral decision-making approach, principlism is now however                                                            154 Coleman et al, pp. 35-36. Also see, Bren, L. 2001. Frances Oldham Kelsey: FDA medical reviewer Leaves her mark on historyConsumer FDA at http://www.fda.gov/fdac/features/2001/201_kelsey.html  155 http://www.mclaren.org/northernmichigan/TheHistoryoftheHumanSubjectsProtectionSystemirb.aspx. Viewed on May 9, 2014. 156 Ibid.  73  more often associated with Tom Beauchamp and James Childress  two most prominent stalwarts of bioethics.157 But having borrowed the idea from The Belmont Report,158 the two ethicists extended the theory to four pillars of respect for autonomy (a norm of respecting the decision-making capacities of autonomous persons); non-maleficence (a norm of avoiding the causation of harm); beneficence (a group of norms for providing benefits and balancing benefits against risks and costs); and, justice (a group of norms for distributing benefits, risks, and costs fairly).159   Further still, following the recommendations of the National Commission's report in 1981, both the Department of Health and Human Services (DHHS, formerly DHEW) and the FDA promulgated significant revisions of their human  January 16, 1981, and were revised effective March 4, 1983, and June 18, 1991. The June 18, 1991, revision involved the adoption of the Federal Policy for the Protection of Human Subjects. The Federal Policy [a.k.a. Common Rule] was promulgated by the 16 federal agencies that conduct, support, or otherwise                                                            157 To clarify, principlism was originally formalized as a moral decision-making approach by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in a document which produced the Belmont Report on April 18, 1979. But Beauchamp and Childress, for better or for worse, have come to be routinely identified with it in their widely celebrated (and critiqued) bioethics text Principles of Biomedical Ethics, first published in 1979 and now in its 6th edition, New York: Oxford University Press. This text, more than any other, has grown to become the foundational basis of bioethics in America (its birth place), the rest of the Global North, and is extending to other parts of the world. However, the application of these principles  and this is where it pertains to my thesis in this dissertation  have been problematic not just in the West but increasingly so in other parts of the world, scrutiny leading to significant revisions of the book. It serves as a testimony to the scale of influence the criticisms have brought to bear on the method since its inception. 158 er at the Smithsonian Institution where the discussions which resulted in its formulation were held. 159 Beauchamp, Tom and Childress, James, 2001, p. 38.  74  regulate human subjects research; the FDA also adopted [some parts of] its provisions. As implied by its title, the Federal Policy is designed to make 160   By an Executive Order 12975, the U.S. president established the National Bioethics Advisory Commission on October 3, 1995.161 The expired on October 3 2001, nevertheless it provided advice and made recommendations to the National Science and Technology Council and to other appropriate government entities on a range of matters; among them was the appropriate ethical conduct in research involving human participants. Not surprisingly, this was mandated by President Bill Clinton, who as I noted earlier, tendered a heartfelt apology for the Tuskegee atrocity.   To speak specifically on the powers of FDA in the protection of human research subjects, Stuart Nightingale, FDA associate commissioner for health affairs, indicates that it vis-a-162 Thus, in its regulatory mission, the FDA reviews applications for market products which have a direct, often vital effect on human health and welfare. Drugs and biologics, medical devices, radiation-emitting equipment, and food and color additives, are examples of such products. To approve them, FDA is required to                                                            160 http://www.mclaren.org/northernmichigan/TheHistoryoftheHumanSubjectsProtectionSystemirb.aspx. Viewed on May 9, 2014. 161 National Bioethics Advisory CommissionEthical and Policy Issues in Research Involving  162 The Food and Drug Administration's Role in the Protection of Human IRB: Ethics and Human Research, 5, 1: 6.  75  closely examine the procedure and results of research conducted and paid for by interested parties outside the government.163 not-so-rosy record with biomedical human experimentation, there are also political and cultural factors, including individuality and individual rights which join up to shape the field. Bioethics itself is an intellectual and cultural phenomenon, which rose from the ashes of aforementioned medical scandals that seemed to culminate in the 1970s. It was a turning point decade marked by other landmark movements such as the anti-Viet Nam war and the environmental movements both of which are rooted in the civil rights movement.164  In addition to the factors already named, the following has to be underscored: the scope of governmental influence over the regulatory process of ethics review. This is unique like no other. For instance, the U.S. federal government has for long devised a mechanism of channeling research monies directly by designated departments. This has meant that the government exercises greater oversight over disbursed funds for intended research purposes.165    All of this lend credence to the claim that the U.S. arena is head and shoulders                                                            163 Ibid, p. 6. 164 Other captivating details of the historical metamorphosis of the bioethics field, starting with the Martensen, R., Journal of the History of Medicine, 56: 168-Kennedy Institute of Ethics Journal, 9.1: 73-88, 1999; and Judy Bioethics as Practice, The University of North Carolina Press, 2002. 165 McNeil, p. 4. More of this history has been traced by Jercker, Jonsen, and Pearlman, (1997), Bioethics: An Introduction; and, Jonsen, Albert, (1998) The Birth of Bioethics.  76  above all other countries in just about all considerations in biomedical research, including, those that involve human subjects. However, it remains to be seen how far that goes. For instance, despite the well-established regulations and guidelines, water-tight responsibility for human subjects in research are still elusive. In fact, by some uncanny twist one might deduce that the legal, social, cultural and political structures that are in place (not discounting burning economic reasons) might account for the accelerated rate of outsourcing of biomedical studies to the Global South. In the section that follows, I discuss some of the convoluted implications that have become the by-products of off-shoring and outsourcing of biomedical research. 3.4 OUTSOURCING OF CLINICAL TRIALS U.S. Department of Health and Human Services, set a historic milestone in biomedical research.166 Right off the bat, this report succumbs to admitting at least two major issues. One, the decades-long inadequacy of oversight systems that existed for human subject protections particularly, given the emergent globalizing trend that I have noted. Two, and drawing on a similar report the department did the previous year, it is an admission that industry-sponsored research has taken the lead in swiftly moving                                                            166 U.S. Department of Health and Human Services, Office of Inspector General, Janet Rehnquist, In  77  clinical trials mostly from the Global North to the Global South (of which Africa forms a significant swath). Many of the government-sponsored ones also have either willingly followed in tow or been dragged along, albeit, kicking and screaming.   Other findings from the DHHS inquiry are that while sponsors have expanded research sites into many countries that appear to have limited experience in clinical trials, FDA cannot assure the same level of human subject protections in foreign trials as domestic ones. It therefore recommended a barrage of measures. For instance, that FDA should obtain more information about the performance of foreign institutional review boards by working with the regulatory authorities in foreign countries; help foreign boards build capacity; encourage sponsors to obtain attestations from foreign investigators; encourage greater sponsor monitoring by encouraging more rigorous monitoring of foreign research sites by sponsors and their agents; and, develop a database to track the growth and location of foreign research. In addition, they urge the Office for Human Research Protections to exert leadership and encourage participation of institutional review boards in a voluntary accreditation system.167   Obviously, these recommendations are inherently inadequate simply because they are, recommendations, not directives backed by enforceable legal sanction. Statutory provisions establishing the DHHS apparently allow for enforcement. Also, these set of recommendations falls flat on its face mainly because much of the foreign-based                                                            167 Ibid, p. iii.  78  research are industry-sponsored; so even if Office for Human Research Protections were to exert sanctions, they are limited mostly to government-sponsored research which are currently in the minority. The hamstrings that these recommendations suffer could be compared to those of international standards, which are essentially principle-based, voluntary, not embedded in enforceable legal instruments, and lack aggressive quality to verify implementation process. Not surprisingly, these are consequences that naturally flow from such bureaucratic caveats.   It seems appropriate at this stage to pause and take a bite at the question posed earlier: Who is responsible for human subjects [when experiments travel]? If I must risk a snappy and hackneyed answer given the foregoing, I would say that (at the very least) common sense dictates that all clinical research must be primed to abide by any and all approved ethical codes (international and local) to protect human subjects. The primary responsibilities of clinical investigators are to protect the rights, integrity and confidentiality of trial subjects (everywhere and at all times). And for researchers with US federal government and industry funding, the international good clinical practice guidelines, etc., must in addition be complied with. But    To apprise the reader with what is at stake, let me offer instead a flip side to that now? Richard Carpentier, of the Canadian National Council on Ethics in Human Research and FOCUS Secretariat raised a similarly instructive poser and followed with  79  equally instructive answers that we are keen to anticipate. Protections are increasingly important because of a host of reasons: research activities are increasing more than ever before; multiple ethical breaches are happening more frequently; research is moving into countries with less experience and infrastructures; research is less and less in control of academic/public institutions and more in control of for-profit corporations; and lastly, there is a crying need to create and sustain trust.168   Research ethics guidelines are universal, at least they are crafted to apply largely universally.169 Since the Nuremburg Code, the Belmont Report, Declaration of Helsinki, DoH, (or The Council for International Organizations of Medical Sciences, CIOMS), etc., the primary aim has always been to guarantee the protection of human subjects. I will reserve for another time a proper assessment of how far the objective of research subject protection has been attained.    trials off--shoring comes mainly at the instance of globalization  a fleeting concept that assumes different meanings                                                            168 Richard Carpentier made this point in a keynote joint public presentation in 2001 along with Janet Rehnquist, Inspector General, USDHHS, and Daniel Lenvinson, Inspector General, Office of Inspector General. 169 Bizarre as it might sound, later I will argue that the assumptions implicit in the mainstream (Western) ethical framework that makes claim to universal validity are not shared by many non-Western cultures. For instance, the mainstream research ethics purports to adhere to the principlist quartet (autonomy, beneficence, non-maleficence and justice) which are inherently linked to Western individualistic notions of personhood, whereas the rest of the world, particularly Africa, sees the person not as an isolated individual, but as a part of the community who is embedded in kinship, group and community. So by the board without discrimination. For specifics on how this could apply, for instance in the African context, refer to Chapter Four of this dissertation.  80  a laudable development uniting 170 As I have alluded to, it also connotes a phenomenon that enables entities to escape sanctions in certain locales and exploit loopholes in other places for maximization of quick profits.    A contemporary African philosopher, Theophilus Okere, thinks that the intended positives that might have emerged from globalization have by some unfortunate way assumed a one-way traffic whereby the world is being unified essentially by westernizing or assimilating western values (individualism and materialism as ideal). It seems also to have become a process of unifying socio-economic systems (democracy and capitalism) as a way of defining success and progress. In fact, Okere type of war by another means; a subtle war, obviously raging but rather surreptitiously and aims to eviscerate the identity of others and threatens to reduce the world to a drab monotony.171    But, in spite of the apparent misguided sidetracking, globalization, rightly applied should actually signal the realization of both the diversity (ecological, biological, cultural, and linguistic) and the interdependence of the various parts of the world. Godfrey Tangwa elucidates this nicely in saying that globalization arises as well s a whole, even if                                                            170 Cambridge Quarterly of Healthcare Ethics, 14:404. 171 Okere, Theophilus. 2005. Philosophy, Culture and Society in Africa. Enugu: Victojo Productions, pp. 60-61.  81  emanating largely from only a small part of it, can best be tackled only from a global 172   All of this conveys a sense of legitimate activities operating across national boundaries. And whether or not you know it, like it, or understand it, globalization has since become unavoidable. Which leaves me with this trite but instructive quip that literally everything is already swept up by the globalization phenomenon. Yes, research ethics too.    Thus, the fact that transnational biomedical research has increased in scope (particularly from the Global North to the Global south), thanks mostly to throes of globalization, is a long established fact.173,174  As a consequence, evidence of concern and substantial debate about the ethics of research in the developing countries where they are off-shored to has worried analysts.175, 176 The application of principlism abroad (having evolved out of Western philosophical traditions) in research ethics and bioethics in general, in disregard of alternative and competing ethical frameworks, and different civilizational traditions and socio-political conditions, seems to present its own                                                            172 Tangwa, A Companion to African Philosophy. Wiredu, Kwasi (Ed.). Massachusetts: Blackwell Publishing Ltd. p. 387 173 Fitzgerald, D. Wasuna, Angela, and Pape, Jean. 2003. Ten Questions Institutional Review Boards Should Ask When Reviewing International Clinical Research Protocols. IRB: Ethics and Human Research, The Hastings Center. 174 National Bioethics Advisory Commission Report: Ethical and Policy Issues in International Research. 2001. The Hastings Center, 23, 4: 9-12.  175 The Journal of Infectious Diseases, 189, 5: 930-937. 176 Away from Exploitation and Towards Engagement: An The Journal of Law, Medicine & Ethics, 33, 3: 559-565.  82  significant challenges as well.177 A catalogue of other concerns about biomedical studies that are initiated in the industrialized world and conducted in the emerging world are widespread. They include, the appeal to harvest ignorant, willing, and desperate subjects for expeditious trial which leads to early registration of drugs and ultimately the enhancement of considerable corporate profits. But in all of this, Ruth Macklin178 has posed the question that I have asked here as well: How does (or should) the research ethics standards apply and who does (or should) the experimenter answer to, the local or international regulatory authorities, or bothe over those questions which I will answer momentarily, with a detailed case study.   I want to introduce a real life public health scenario and relate it to my analysis of responsibility. With this test case, I claim that in public health, just as in medical ethics generally, responsibility is both subliminal as well as overt. In the case of population-based research in particular, the concern is that biomedical scientists, while riding on readily available trust, might sometimes be inclined to renege on their charge with responsibility and force unwanted procedures on the public. In doing so, patient-subjects are made to sacrifice personal dignity, autonomy, safety, liberty, and cultural identity in the name of doing research for the public benefit. This seems to be the case                                                            177 Annals of Behavioral Science and Medical Education. 7, 2: 80-86. Also, of controversies on such issues reflects, in part, the fact that existing ethical guidelines can be interpreted p. 930. 178 Macklin, Ruth. 2004. Double Standards in Medical Research in Developing Countries. Cambridge, UK: Cambridge University Press.  83  with the experimental drug, Trovan. As I will make clear shortly, the Pfizer experiment may be emblematic of all that should not happen particularly when clinical trials travel abroad: hubris, disrespect for other cultures, apparent emphasis on profit, use of patient-subjects solely as means, disregard for local authority, betrayal of trust, etc.  all hallmarks of irresponsibility. 3.5 TROVAN TEST CASE179  In 1996, concurrent epidemics of cerebro-spinal and bacterial meningitis, measles, and cholera were affecting children in Kano, a northern Nigerian city. This coincided with the development of Trovafloxacin (or Trovan), a quinolone antibiotic by Pfizer. The American pharmaceutical giant learned of this outbreak in the news and dispatched a research team to a local hospital providing treatment. Pfizer administered Trovan to a large number of pediatric patients as part of its effort to determine the effectiveness of the experimental drug in treating meningitis. The drug had never been tested on children. All the children in the study were picked from among the long lines of people seeking care.180   A Nigeria government investigative report later blamed the drug trial for a combination of effects ranging from adverse drug reaction, adverse events, to serious                                                            179 This test case happened in the mid--mentioned DHHS report. Apparently, incidents like this must have informed that report. 180 The experiment took place at the same hospital where a team of Mèdicins Sans Frontières was already providing free treatment with Ceftriaxone, a gold standard antibiotic medication internationally recommended for treating meningitis.  84  adverse events.181 For instance, in the immediate aftermath of the trial, 11 of those trial subjects died; many more suffer (ongoing) permanent disabilities such as brain damage, paralysis, muteness, slurred speech, and blindness.182 A series of law suits by the victims and the Nigerian government (filed in the U.S. under the Alien Tort Claims Act) commenced in 2001,183 but aborted by the U.S. Supreme Court in the fall of 2010. Pfizer had struck a $75-million out-of-court settlement for claims related to the experiment. 184  The moral import of this could be that the drug makeror effectively quenched every chance to either validate or dismiss a laundry list of allegations which include that:    Pfizer took advantage of the chaos from the medical crises as an opportunity to quickly conduct the study (a potentially dangerous treatment) on young children, something it had been unable to obtain permission to do elsewhere  Pfizer obtained no informed consent [assent] from any of the children participating in the trial                                                            181 y. Definitions were culled from the International Conference on Harmonization of Technical Requirements, for Registration of Pharmaceuticals for Human Use, ICH, Harmonized Tripartite Guideline for Good Clinical Practice 96. 182  of the Washington Post relates the controversial saga in the edition on Sunday May 7, 2006; p A01. 183 The New York Times, August 30, 2001. 184 In late 2010, Pfizer also offered to build a $25-million hospital in the city, a gesture aimed to further appease the people. See http://www.sunnewsonline.com/webpages/news/national/2010/dec/02/national-02-12-2010-005.htm. Accessed December 02, 2010. Pfizer made the first compensation payment to Nigerian families affected. The amount, $175,000 (£108,000) each went to four families in the first of a series of payments it was expected to make. See BBC News, http://www.bbc.co.uk/news/world-africa-14493277. Accessed April 11, 2013.  85   Pfizer provided no explanation to the children or their parents that the treatment was experimental and that they were free to refuse it in favor of the known effective treatment available at the same hospital free of charge  Pfizer never received the necessary approvals (either from the Nigerian government or the hospital administration) to conduct the research, but when forged approved the Trovan study.185  Unanswered posers still linger as to possible motives: is it for reasons of advancing biomedical science; promoting corporate (and/or individual) record, achievement and major profit gusher, estimated to net billions of dollars in yearly sales if approved by the FDA. Meanwhile, victims of that experiment have continued to suffer (even as I write) and to die in their teens and twenties; reigniting debates concerning ethics of biomedical research that involve patient-subjects. One of the immediate impacts is the scar of suspicion and erosion of trust  two prime factors that are linked to the near failure of on-going vaccination campaigns in the adjoining regions of that country. As such this Moslem-dominated area has harbored and witnessed the recurrence of preventable diseases, such as polio, that have long been wiped out in most parts of the world. Such is one instance where lack of faith in scientists might justify opposition to the technologies their work has spawned. Public trust  an indispensable ingredient in the                                                            185 The investigation established that at the time the trial took place, the hospital neither had an ethics   86  success of any clinical trials  can easily be eroded as a result of some or all of these reasons: if there is persistent perception that subjects of clinical trials are there as a means to an end; if there is the perception or even suspicion that only lip service is paid to ethics; if clinicians are not upfront as to the nature, the risks, possible benefits of the research; and, if or where conflicts of interests might lie. Concerns could rise even further when these facts are placed on the back of a research finding from a survey of more than 200 developing countries which concluded that one-quarter of clinical trials carried out in developing countries do not undergo any kind of ethical review in the host nations.186   In spite of the lessons of history  recall the many push factors that led to the  when a clinical trial disaster recurs, as in the Pfizer-Nigeria example, we are bound to return to the soul-searching question of how did we get it wrong, again? The broader philosophical prodding could be the reason why some have urged that epistemologists must make use of results from the sciences that study human reasoning in pursuing epistemological questions. In other words, epistemology should become a branch of psychology and charged with not worrying whether what we claim to be the facts is true; epistemologists should rather be concerned with figuring out                                                            186 Ethical review of health research: a perspective from developing country Journal of Medical Ethics, 30, 1: 68.    87  what the mechanisms are by which we believe by taking up the empirical psychological study of our cognitive processes.   In the case of human-subjects, we ought to place in tandem the epistemic content of biomedical training and its application in the field of clinical practice in order to evaluate their value and relevance in terms of pursuing and attaining mutual goals. Unfortunately, while this is supposed to result in a meeting point, a bifurcation emerges instead: there is a difference between treating others respectfully (paying back trust) and treating them respectfully because to do otherwise (irresponsible behavior) would be either morally wrong or instrumentally troublesome or both. It may be fair to say that clinicians in the Pfizer-Nigeria test case apparently squandered the faith entrusted in them by failing to demonstrate epistemic interest in their subjects.    To act with epistemic interest assumes the intrinsic value of persons; seem like that was displayed here. Acting with epistemic interest, nay repaying trust, is one way to earn public trust (I will return to this subject later). Meanwhile, I wish to /her from his/her object (or in this case, subject) of knowledge. The opposite is rather urged. The proof of the efficacy of the scientific product which is the result of endless lab hours and of mental labor, must be guided to make a reasoned landing in the field of practice. That, to use the common parlance, is where the rubber meets the road.   88  Because knowledge is meant to apply to, and to be applicable in, the world outside the laboratory, it is important to ask what the knowledge is knowledge of. Real problems arise about the applicability of research findings beyond the research setting, and one way of framing those problems is in terms of whether, and to what extent, the objects of the research are relevantly different from the objects in the wider world they are taken to exemplify.187 As a related matter, I observe with glee that the trust analysis Annette Baier188 -makes references to (among other things) not just individual human beings or groups of people, but denotes natural or artificial, such as firms (i.e., business enterprises), and nations. It is hard to ignore the person of Pfizer and the share force of its enormous influence in the international community. Given this, or even in spite of it, it is intriguing that Pfizer (whose clout on the world stage easily surpasses that of many individual countries) would apply tricky, deceptive, and hoodwinking tactics to recruit pediatric patient-subjects for the experimental drug. Adding to that, it seems inappropriate that Pfizer finds it suitable to do in an African country something it coul   Added to the medical privilege are, racial contractarianism and vestiges of colonial mentality and influence. Since a forceful tactic for maintaining cognitive authority and control is to insist on the conceit that at of the other, some clinical investigators from the Global North often confirm the perception                                                            187 Naturalized Bioethics, Cambridge: Cambridge University Press, p. 111. 188 Ethics, 96, 2: 231-260.  89  e chasm between them and their patient-subjects who they should primarily care for. In consonant with Eva Kittays189 acting out of hubris. It is an epistemic tunnel vision that detracts from the goals of ethics of care. In the trenchant words of Jay Katz, even as the interests of the patient-subject not been accompanied by a thoroughgoing re-obligations in a post-190  3.6 CONCLUDING THOUGHTS   To address the question that this chapter poses, Who is Responsible for Human Subjects When Experiments Travel? I purposely revisited the history of experimentation with humans for some background. The not-so-pretty picture led to, at various times and on a variety of platforms nationally and internationally, the composition of numerous regulations, polices, assurances and guidelines which aim to protect human subjects in research. To reiterate, prior to the now familiar regulations and guidelines to protect human subjects in research, there were documented abuses.                                                            189 Naturalized Bioethics: Toward responsible Knowing and Practice, (eds.) Hilde Lindemann, Marian Verkerk and Margaret Walker. Cambridge University Press, p. 235. 190 The Ethics and regulation of research with Human Subjects, (eds.) Coleman, C. et al., New Jersey: Mathew Bender and Company, p. 308.   90  As I have made apparent, the glaring historical antecedents in experimentation with human subjects prompted the formulation of research ethics principles to guide every study at every stage, everywhere.    Nonetheless, it is my contention that with certain developments such as globalization, the nature and terrain of our actions in biomedical research has changed. that fundamentally touches on the conduct, ethics, and cultural shift in carrying out biomedical research. My tcharacterization of the ethics of an endangered future when he says: case material on which received rules of conduct are to be applied, but in the more radical sense that qualitatively novel nature of certain of our actions has opened up a whole new dimension of ethical as well as relevance for which there is no precedent in the standards and cannons of traditional e191  I have also noted the mismatch in adherence to rule compliance between on one hand, the industrialized world (Global North) which are adequately structured for sufficient monitoring, and on the other hand, the industrializing world (Global South) which are hamstrung by inadequate or non-existent infrastructure to aid monitoring and compliance. As a corollary, the effective compliance regimen in the Global North, coupled with the excuse of globalization have meant that increasing amounts of                                                            191 Responsibilities to Future Generations, New York: Prometheus Books, p. 23.  91  research efforts (read, clinical trials) are conducted in the Global South having been conceived in the Global North. And with this development come untold consequences in the recipient countries.  As far as the history of biomedical research goes, the importance given to human value and the protection of that value, are never in question. I have argued that the intension for which the now familiar series of guidelines and codes for human subject protection ought to keep pace with the emerging socio-economic World trend, for instance, globalization. Thus, there must not be application of double standards irrespective of the study site. In fact, rather than do less, research teams should expect to lean over backwards and to do much more when experiments are off-shored by incorporating both international and local guidelines and codes (wherever possible). But with the Nigeria-Pfizer example, one wonders why some foreign-sponsored biomedical research tend to apply a different set of rules, particularly, in regard to protection of human subjects, that they would otherwise not do in stricter climes.  Authors have noted the obvious opportunity for exploitation192 of the weak and the poor by the powerful and the rich as attempts to address health research issues increasingly hinge on the intertwining of the needs of different countries at the international level. What had been hoped to possibly pose a challenge in the distant                                                            192 Read more by Hyder, A. et al. Ethical review of health research: a perspective from developing Journal of Medical Ethics, 30:6872.  92  future has all but suddenly enveloped us as national borders and boundaries are made ever more porous and transgressed by technologies and trade.  A truth-apt attempt would be to starkly state that the guidelines are just what they are, guidelines. Extra efforts would have to be made, as Fitzgerald et al., suggest (something that hints on inculcation of virtue ethics), for any meaningful outcome to be realized in this area. For instance, they prescribe a 10-point list of questions IRBs must seek satisfactory answers for before international clinical research protocols are approved.  The questiDoes the research protocol address the ethical challenges of conducting research in a developing country? Is the purpose of the research responding to the health needs of the host country? Does anyone else in the host country know about the research? Are the risks to volunteers acceptable in the social 193   Arguing along the same line, Ezekiel Emanuel, et al., expand on such issues as unwavering respect for recruited participants and study communities before, during and long after studies have been conducted. They underscore enduring obligations                                                            193 Fitzgerald, Daniel et al. 2003. p. 14-18. Also, see Away from exploitation and towards engagement: An ethical compass for medical researchers working in resource-The Journal of Law, Medicine & Ethics; Ethical oversight of ncy et al. 2003.Ethics and Human Research, The Hastings Center 25, 2: 1-10.  93  researchers should have to participants, former participants, and the host community.194 The challenge of striking a balance between the need to protect the subjects, and to reduce the much-resented bureaucratic burden on field officers remains a big one. In spite of frequent complaints and accusations by researchers against independent gatekeepers or IRBs for bogging down their studies through micromanaging consent forms and rinclined to stick with the recommendation to be steadfast and focused on the importance of oversight so as to get things right. I agree with Emanuel and colleagues in fending off any possible insinuation or objection to the suggested framework as another layer of barriers to research in developing countries. Their benchmark clearly provides explicit and systematic delineation of steps for conscientious researchers doing work in the Global South so as to make coherent the already widely accepted principles and benchmarks in the Nuremberg Code, the DoH, the Belmont, etc.195 No doubt, the answer to the question for this chapter has been made apparent from the foregoing. Put differently, I have proved my thesis (even as it is axiomatic) that researchers must abide by research ethics doctrines and are deemed fully responsible                                                            194 The Journal of Infectious Diseases, 189, 5: 930-937. Chicago: The University of Chicago Press. For more on fair benefits, refer to El Setouhy, "fair benefits" The Hastings Center Report, 34, 3: 17-27. 195 Ibid, p. 936.  94  for all human subjects in their study whether or not experiments travel (outsourced/off-shored) or are conducted locally. In many circumstances, stakes might even be higher along with level of responsibility when research scientists engage with local authorities (at clinical trial sites) and should take on additional rules. Besides, if the historical significance of Hippocrates is anything, the following attribution to him should find resonance in contemporary biomedical research arena: it is more important to know that a person has a disease than to ask who it is that has the disease. In other words, it is irrelevant who it is that has disease, what is relevant in an unbiased healthcare delivery atmosphere is finding ways to treat or cure the person with disease.   Thus far, I have demonstrated that as the research arenas in the Global North continue to (rightfully, if I might add) tighten the regulatory noose, a reality that has been nudged further afield by the phenomenon of globalization, researchers tend to cast their net farther off-shore (following the natural law of physics: water always follows the path of least resistance) including Africa which is notorious for lax or non-existent apparati for such experiments. And operating in structurally weak environments for proper enforcement of research ethics guidelines, some researchers tend to feel no urgent obligation to strictly abide by widely established ethical guidelines and principles, and to renege on the charge to be adequately responsible to human research subjects.   But for the grander picture for the future, I have alluded that research ethics, as  95  reflected in the mainstream principles, is not a one-size-fits-all template that you can simply conjure up and apply at will. We are at a point, indeed, that the cry grows loudest for a new deal. Like John Passmore who argued for a new morality to deal with the future of our environment, I argue here for a new perspective which can only grow out of emerging mindset, just because, unlike a speculative hypothesis, it is pointless unless it actually shapes our conduct and the way forward. But, on the evidence of it, it might not be completely shocking to see that our attitudes might already be primed for one choice: change196 A pointer to this promise of a new direction can be gleaned from the WHO-sponsored study,  Framework for Testing of Genetically Modified the relevant parts of which I have reviewed for Chapter 3.197   It is a very considerable presumption that given the current trend, the task of mresearch environment requires a concerted and well-coordinated international commitment. Because all ethics are local, you should not get giddy contemplating how to integrate ethical review systems of the nearly 200 member states of the WHO countries (and regions) along with their multiple political, social, cultural, and                                                            196 Passmore, John. 1974. . New York:  197 The WHO compendium outlays a set of genuine clinical trial process that clearly goes beyond the individualistic basis of principlism and recognizes the crucial role of other cultures in the understanding of personhood as a concept that is embedded in the community.   96  economic vagaries  all managed and tied into the requirements for achieving a harmonized ethical practices in the globalized clinical trials marketplace. It has thus thinking is likely to come into fruition if we are prepared to double down and constantly remind ourselves of some basic facts:  International guidelines and national law[s] alone will not suffice. Without a systematic approach to information gathering and capacity building, standards alone will not achieve greater protections for research subjects through independent and competent ethical review in all countries.  Given the enormous complexity of cultural variations, national laws, and local medical and research practices, local knowledge and local engagement are essential to develop ethical review. In addition, the principles of bioethics and the need for sustained development demand that responsibility be born at the local level, as close to the patient as possible.198 I concur.                                                                   198 Crawley, Francis, Esber, Elaine, Lin, Melody, Karbwan, Juntra. Ethical Review and the Applied Clinical Trials Online. Viewed on June 18, 2014 at http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/EU/Ethical-Review-and-the-Globalization-of-Clinical-T/ArticleStandard/Article/detail/83804.   97  CHAPTER FOUR: TRANSGENIC MOSQUITOES PROJECT AS MODEL  4.1 INTRODUCTION A well-developed clinical trial protocol that is burning on all elements may be  Framework for Testing of Genetically Modified 199 (hence forth to be called GMM report or GMM framework), the WHO has set an excellent example; one that is easily replicable.  Bent on tackling the widely known pair of stubborn diseases, malaria and dengue fever, with a new age technology that enjoys a rich vein of form, the latest attempt is a gilt-edged opportunity for the WHO. The depth and breathe of its craft are immense. If modern clinical trials with humans were looking for a responsible model, they have one in the GMM framework.  In this chapter, the GMM framework is the major source material used. More specifically, the bulk of the first half of this chapter will be spent reflecting on the relevant aspects of this astutely packaged health information. In the event that other source materials are discussed, they will be as they relate to the GMM model. In time my intention to heavily rely on its use will become obvious, including, how it sharply                                                            199 Sponsored by the World Health Organization   compendium is the product of the meeting of the minds of some of the best experts in the field. However, not all aspects of this dense report will pertain to my discussion, hence I will be referencing only the parts that are relevant to my thesis.  I am greatly indebted, and I pay special tribute to Paul B. Thompson (my committee member) for providing this document for my use. Having learnt about the thesis for my dissertation, Thompson, a member of the think tank which formulated the report, made it available to me early as it was still receiving reviews and comments prior to its publication.  98  contrasts with the Nigeria-Pfizer clinical trial example discussed in Chapter 2. Ultimately, this GMM report backs up what I would readily recommend as a paragon of what responsibility in clinical trials really ought to be. I will argue that the steps it suggests should be standard practice for all clinical trial protocols particularly those that use human subjects including those with both direct and indirect ecological implications. Actually, this persuasive argument presages the thesis for this dissertation: re-conceptualizing clinical trials with the concept of African personhood. Details later.  In the second half of the chapter, I will point out (with some personal sense of satisfaction) that the GMM approach apparently boosts, without intending to do so, two important issues that relate with this dissertation. One is my inclination for ecocentrism  a widely shared philosophical perspective in African thought (and elsewhere), and, holism or interconnectedness and the intrinsic value of the biosphere in ranked order of being.200 Two, by calling to mind the intimate connection between environmental and human health, the GMM report hits at the heart of a long nursed intuition of mine, to reunite bioethics (here via clinical trials) in a homecoming encounter with its estranged                                                            200 This will become clearer in Chapter 4 which discusses personhood in African thought. I will also draw  with individualist deontology and individualist consequentialist positions that pervade much of Western Environmental Ethics: An Anthology, Andrew Light and Holmes Rolston, (eds.), Blackwell Publishers Ltd., 2003.  99  sibling, environmental ethics.201 Hacking back to the African philosophical context where holism reigns, it comes as no surprise that these two broad issues can be merged into what I will refer as bio-eco-communalism (BEC).202  4.2 SOME PRELIMINARIES  To put in perspective the challenge malaria and dengue fever scourges currently present, a few statistics are in order before turning to the GMM model. According to  most recent available figures (2013), an estimated 3.4 billion people in 97 countries were at risk of malaria, of whom 1.2 billion were at high risk. In comparison, there were an estimated 207 million cases of malaria in 2012; and an estimated 627, 000 deaths (482, 000 children under five years of age  1, 300 children every day, or one child almost every minute); 90% of the total number of malaria-related deaths occurred in Africa. Between 2000 and 2012, the scale-up of interventions helped to reduce malaria incidence rates by 25% globally, and by 31% in the WHO African Region. The global malaria mortality rate was reduced by 42% during the same period, while the decrease                                                            201 Few people today are aware that bioethics and environmental ethics were joined at the hip at birth in the 1970s. But soon after, they were separated and each seemed to have evolved an individuality of their argue that their fraternity, or rather their genetic unity, should always be apparent.  202 I give credit to -Wiredu (Ed.). A Companion to African philosophy (Oxford: Blackwell Publishers), 387-395. There he fuses eco-ethics, environmental ethics, developmental ethics, medical ethics, and bioethics under one label. The nomenclature I formulate here though related, is however different.  100  in the WHO African Region was 49%.203 In spite of the seeming progress, the abatement, though a remarkable suppression, seems to hold down the scourge only momentarily, while the scourge continues to gulp more funding resources.  disbursements for malaria control rose from US$ 100 million in 2000 to US$ 1.94 billion in 2012 and US$ 1.97 billion in 2013. National government funding for malaria programs has also increased since 2004 but not at the same pace; the total for 2012 was US$ 522 million. The currently available funding is far below the resources required to reach universal coverage of interventions. The WHO estimates that US$ 5.1 billion is needed every year for this purpose. In 2012, the global total of international and domestic funding for malaria was US$ 2.5 billion  less than half of what is 204  On its part, dengue is reportedly the most common mosquito-borne viral disease of humans that in recent years has become a major international public health concern. Globally, 2.5 billion people live in areas where dengue viruses can be transmitted. The geographical spread has led to the global resurgence of epidemic dengue fever and emergence of dengue hemorrhagic fever in the past 25 years with the development of hyperendemicity in many urban centers of the tropics. At the moment, dengue ranks as one of the most important mosquito-borne viral disease in the world. In the last 50                                                            203 Information was culled from the World Health Organization actsheet on the World Malaria Report http://www.who.int/malaria/media/world_malaria_report_2013/en/. Viewed on May 28, 2014. 204 Ibid.  101  years, incidence has increased 30-fold. An estimated 2.5 billion people live in over 100 endemic countries and areas where dengue viruses can be transmitted. Up to 50 million infections occur annually with about 500, 000 cases of dengue hemorrhagic fever and 22,000 deaths mainly occurring among children.205   Both malaria and dengue are vector-borne diseases, meaning, diseases that are transmitted via a carrier or transporter. Mosquitoes are the agents of transportation that convey pathogens for these diseases into the host cells (for example, humans). The GMM report note that mosquitoes transmit several diseases of major global public health importance, but it focuses mainly on malaria and dengue fever.   It is against this backdrop; and owing to the intensified practice of transnational biomedical research (particularly the outsourcing of clinical trials from the Global North to the Global South); plus, the considerable controversy about the ethics of research, (see Chapter 2), that the GMM report could not have come at a better time. In that preceding chapter, I alluded as well to the enticing potential for exploitative tendencies for economic gains associated with some clinical trials, etc. To the contrary, I am claiming that the expectation is how ethical principles and community engagement, not profit motives, etc., should guide actions in determining how the cultural milieus of patient-subjects and residents of research sites must be engaged, respected, adequately                                                            205 Read more at World Health Organization, ,http://www.who.int/csr/disease/dengue/en/. Viewed on May 28, 2014.  102  compensated, and if possible, made to benefit from research outcomes. The urgent desire for further and continuing retooling of international guidelines or codes of research ethics and the considerable stakes involved also make the GMM guidance framework most timely. Approaches such as this, has long been recognized to study, benefits should include the linkage of otherwise unavailable health care to research projects, provision of proven treatments following completion of trials, as well 206    For a quick comparison, I see a semblance of sorts between the GMM framework and a working paper that emerged in the early 1990s from a symposium on ethics and public health which examined the challenges of trans-cultural clinical malaria research in the developing world. While highlighting the need that such investigative collaboration requires a unique bridging of cultural differences with respect to human subject investigation, the setting addressed other germane issues. They include the difficulties of informed consent in different cultural settings; whether there is any role for community involvement; whether drug and vaccine trials not approved in an industrialized country are ever defensible if performed in an industrializing country; potential conflicting priorities between investigators; and, issues regarding conflict                                                            206 Health and Human Rights, 8, 1: 197- Double Standards in Medical Research in Developing Countries.  103  resolution.207 close (as we will soon see) to the full-throated manner the GMM report formulates all the substantive and procedural aspects of the issues involved. Moreover, while the symposium analysis asks, for instance, whether or not there is a role for community involvement, the GMM framework provides a convincing logic why there have to be, while pointing out the flaws in the mainstream informed consent process, etc. Altogether, the comprehensive footnotes and illuminating cross-references reflect the consummate knowledge of the multidisciplinary areas experts in the GMM project represent. 4.3 THE GMM MODEL In line with the age-old adage that prevention is always beffort, a preventionist approach. It is a strategy built on attacking mosquito vectors ab initio, a method known to be one of the most effective ways to reduce transmission of diseases in endemic areas. This method accounted for the successful elimination of malaria transmission in parts of Europe and the U.S. at the turn of the 20th century, as well as stemming the spread of dengue fever in the Americas in the early 1960Moreover, it has been widely observed that the more prevalent method of relying on insecticides for vector control increases, rather than diminishes, increases the risk that                                                            207 Barry, Michele and MolJournal of Medical Ethics, 18: 189-192. The symposium was sponsored by the Institute of Medicine and The American Society of Tropical Medicine and Hygiene.  104  mosquitoes will develop resistance.208       Irked by the menacingly high death tolls in spite of control efforts amidst depleting funding resources, the new WHO guidance framework aims to perfect a mechanism with the aid of molecular biology to develop genetically modified mosquitoes as an efficient public health tool to halt the transmission of malaria and dengue fever.209 Due to its innovative, potent and more cost-effective approach, it is adjudged to trump other comparable methods such as radiation- and chemo-sterilization. Nonetheless, and specifically for reasons not to leave anything to chance, the multidisciplinary think tank behind this report (with expertise in molecular biology, medical entomology, ecological, legal, ethical, social and cultural areas) insists on the orough, thoughtful and transparent preparation for, and conduct of field trials of the 210    In a nut shell, the mechanics of the technology works when lab-hatched genetically modified mosquitoes are,   sterile and thus unable to pass the genetic modification on to future generations through mating. In other cases, the GMM are meant to mate and introduce the effect briefly into the local mosquito population, but the modification will gradually be diluted out by crossing with local mosquitoes over a number of generations until it is lost.211                                                             208 WHO GMM, p. xi. 209 Ibid. p xi 210 Even as the purpose of this was obvious, nonetheless the experts reiterate that the GMM method hints at providing a reliable model for all countries to emulate. 211 Ibid.  105  The research team are duly aware that in any novel method, some unknown outcomes could mean the possibility that this could take on a different trajectory outside of its intended purpose, potentially engendering among other things, grave ethical, environmental, social and other concerns. In light of this, they met at intervals over several years to debate and fine tune implementation strategies for the testing of the genetically modified vectors. The result was the following broadly formulated two-tenet agreements which became their guide:  First, field testing should begin with release of sterile or otherwise self-limiting modified male mosquitoes in order to gain experience with the technology under circumstances where its effects can be reversed by halting releases.   Second, testing of modified mosquitoes incorporating gene drive should begin under physical confinement. No genetically-modified mosquitoes designed to replicate and spread the modification to wild-type mosquitoes [should be] tested outside of the laboratory.212  This guarantee is bound to further boost confidence in the approach as it strives to foster quality and consistency in the processes for testing and regulating new genetic technologies. omparability of results and credibility of conclusions in addressing the requirements for decision-making by countries interested in potential use of these technologies as public health tools for control of [other] vector-borne diseas213                                                            212 Ibid, p.  xi. 213 Ibid, p. xv.  106  Intense calls for ethics and public engagement in public health research is a claim that is often made, and the GMM report seems to underscore its importance to the hilt: Public dialog and outreach are important for realizing research goals, especially in the development of new technologies. Sincere and well-developed engagement can help to direct technical goals, reduce the chance of a misunderstanding of the science needed to meet the goals, and improve the performance of the research project in both technical and social contexts. Although engagement activities may overlap with regulatory requirements, researchers should not assume that regulatory compliance also implies that ethical and engagement responsibilities have been adequately addressed. Respect for communities should be an overarching ethical goal in GMM trials.214  So crucial and integral are ethics and engagement efforts that it is urged that they be initiated pretty early and at intervals throughout the study (and even after). Rightly noted, the role of ethics and engagement becomes crystal clear in the way that tensions are doused between scientists who are absorbed in the quest to realize the envisioned results of their research, and some in the public who view them as lacking in moral sensibility or fellow-feeling. Primed to be a 4-phased trial, the GMM report recommends that engagement activities be introduced during Phases 1 and 2,215 in order to ensure                                                            214 Ibid, p. xv. 215 My evaluation of the GMM set of guidelines acknowledges both the strengths and possible weaknesses. On the strength of that I suggest that considerations for ethics and engagement activities should commence at the planning stage (long before Phase 1). The advantage of this early application is to test the waters, meet with third party (outside) groups and individuals, and gauge the strategies in order to tweak any areas that might need improvements. It is at this stage that the GMM acknowledgment makes completEngagement and involvement with the communities hosting the GMM trials must be guided by detailed knowledge of the local community, its institutions and common practices. Finding out what kinds of concerns the community might have, any past engagements around science that went badly, or determining what the community wants/expects in terms of engagement or consent [and assent] will be importan I also would suggest that it should outlast the research study in fading intervals.  107  that the goals and methods of the project are well defined and communicated to meet genuine stakeholder needs.  Field researchers stand to benefit when community engagement activities are expanded in Phase 3 specifically because they address ethical responsibilities beyond the formal permissions required at the individual level (informed consent/assent) and the governmental level (regulatory compliance). already, meaningful engagement with the community, among other related actions, The concept of ommunity authorization entails providing those living in the trial site with methods to give or withhold agreement for trial activities, and to identify elements they believe to be important for the research to continue. During field testing, scientists also should expect to interact with third parties who express interest in the activity and its outcomes, both to ensure that the project is well understood and to avail the project team of information and insights that such interested parties might provid216 With tenacity and goodwill, by Phase 4, all stake holders would have gained deep appreciation of the research procedure to the point that the responsibilities for implementing the technologies being tested and interacting with affected individuals likely will shift to the relevant local, regional or national public health authorities.                                                            216 Ibid, p. 59.  108   Thus, the scope of ethical responsibilities and community engagement becomes the overarching goal in any project similar to the GMM project. My suggestion for engaging the community early on for greater understanding of purpose and successful project undertaking is supported by the idea that it would afford trial studies the opportunity to become aware of a laundry list of important issues likely to affect the study. For instance, John Olin, et al., in their analyCommunity preparedness for either motivate individuals to volunteer for a vaccine trial or disincentivize them to participate, along with preparedness of the larconcerns for health and for the impact of the epidemic on families and country were common motivations for participation. The danger of an experimental vaccine and the stigma of a positive HIV antibody test as the result of vaccination are major concerns and disincentives. The health, educational, and local non-governmental sectors are identified as having important roles to play in assuring [community] preparedness for 217 The larger philosophical point that the GMM proposal precisely advocates is that ethics of engagement aims to identify and recognize the interests of stakeholders and their legitimate entitlements, rights, other types of claims and obligations, including what actions or activities that are necessary by the principle of respect for                                                            217 Community preparedness for HIV vaccine trials in the Democratic Republic of Culture, Health & Sexuality, 8, 6: 529.  109  communities hosting the trials. As such, it brings into focus, such ethical issues as: how these rights and interests should be recognized in a decision for trials to proceed; how researchers can strike an ethically robust balance between the interests and rights of individuals, the collective interests of the host communities and the properly mandated activities of their public institutions; and, determining the appropriate role for communication and engagement with media, civil society organizations and others that take an interest in the research.218  Even on an individual level, the impact of ordinary word of mouth is not underrated particularly in how it can effectively disseminate a widely shared impression of research goals, intended applications and methods, including within village, sub-urban, or city settings. Such broad representations of science can have the beneficial effect of expanding opportunities to obtain key informants, participants and partners. But if the community does not buy into it, the opposite effect will likely result: widespread misrepresentation, suspicion, distrust and even outright blackmail and antagonism against the scientific research project.  The GMM ethics and community engagement approach, like some of the concepts I have discussed in this study, also take on a concentric relational web: from the core human research subjects, to their friends, families, and the larger community. The outer spectrum recognizes individuals who do not typically fall                                                            218 WHO GMM report, p. 60.  110  within the definition of human subjects but who might be affected by the conduct of research, either because they reside near the research project site, or that their daily activities and/or livelihood, including economic interests, could be affected by the research activities.  On the other hand, people living at a distance from the trial site and are unlikely to be physically affected by the trial activities themselves, might still stake a very strong interest in the conduct or outcome of research simply because their interests overlap with those of their friends and relatives at the trial site. For instance, people who are under certain health conditions (and/or their friends and family) would likely have an obvious interest in the outcome of research or clinical trials, even if they are not involved with that specific trial. Such groups are likely to be strongly supportive of research intended to improve their condition. Similarly, people who care about causes such as protecting vulnerable groups or endangered species are likely to take an interest in a wide range of research activities, and may as well be supportive of certain research goals or procedures. Although the nature of responsibilities to such individuals or groups is quite different from those of the research subjects and communities hosting the trial, it is clear that an effective plan for engaging a wide scale of such interested parties can be critical to the success of research, especially for projects that can possibly draw a significant public media attention or monitoring from civil society organizations. In this way, the onus of  111  ethical responsibilities by researchers can be quite encompassing and even complicated, and meeting these responsibilities requires an adequate preparation which can go a long way to smoothen rough edges by addressing the full range of stakeholder interests.219 Ordinarily, these are not the sorts of circumstances or communication activities (and there are more to come) standard research budgets accommodate as far as most scientific studies are conceived and conducted. However, it would be conceded that many scientists often view their work as having value and a social purpose, and this may be especially so for those conducting research on public health and disease control. But as the GMM report attests, the problem is that scientists are often not very transparent (particularly given the new global dispensation, plus the issue of private interest involvement in clinical trials, see Chapter 2). Also, scientists do not always articulate the purpose of their research explicitly, or discuss its value with others. The GMM guidelines certainly seeks to make explicit the value and social                                                            219 The GMM report provides a long list of such interested parties which include, persons associated with global or regional public health and international development organizations such as, governments; scientists and members of scientific organizations with disciplinary or inter-disciplinary links to research activities associated with field testing activities, including sciences dedicated to public health and infectious disease. Others are, persons and organizations engaged in competing approaches to control of infectious diseases; environmental and human rights activists. See, Ibid, p. 72 for more details. There can have, and in what ways. Also, refer to p. 67 for more.  112  purpose of the scientific research project and initiate a broader reflection that serves several key functions and interests.220 John Ziman makes that ethical burden more become more tightly woven into the social fabric, scientists are having to perform new 221 This beam of thought is likewise 222 di,sharing their study plans and findings; a move that will in turn assist the citizens, activists and policy makers as well to, for instance, enable them to better understand the societal ramifications of the research they do. In particular, it is noted that hitherto, there was a lack of appetite in developing EOE for researchers even as the complexity involved in disseminating scientific findings to mention their specific responsibilities for disseminating information) have received less analysis than ethical issues internal to scientific practice (e.g., management of data, 223                                                             220 Ibid, p. 66. 221 on Science and Society, Science, 282, 4. 222 Elliot, Kevin. 2011. Is a Little Pollution Good for You? New York: Oxford University Press, p. 133. 223 Ibid: 135  113   Thus far, there are enough grounds to be persuaded by the argument about the saliency of ethics and community authorization/engagement. But I want to take it further and make clear that it merely prepares the ground for other ethical requirements (for instance, the ethical principles in the Belmont Report, see Chapter 2) which are expressed in the informed consent/assent process. As I indicated in that chapter (to be discussed further in Chapter 4), one of the major shortcomings of principlism is the lack of recognition that all research, directly or otherwise, do affect the larger communities and not just the individual study subjects (in fact, in most non-Western cultures, every research, just like all social activities, is considered to have either a direct or indirect effect on the community and/or environment, etc.) Likewise, the GMM guidelines have accurately highlighted the apparent implications particularly because the effects of the trials will largely be at the community level as well as on the environment.  4.4 GMM MODEL AND BIODIVERSITY In this section, I turn to the GMM recommendations as they emphasize the connection between human and environmental health. As I have already indicated, it is with delight that I encounter this factual rarity (particularly in Western literature) that fuses human health and environmental health. To be fair, pioneers of the larger bioethics project built their vision on that unity of purpose before the field witnessed  114  the current splinterization (more on that later). But more importantly, it is a widely shared philosophical perspective, for instance, in Africa which recognizes the holism or interconnectedness and the intrinsic value of the biosphere in ranked order of being.    My point here is simply to give readers a picture of some of the reasons a research team on a clinical trials mission might find the prospect of considering the safety of the environment appealing and as an integral part of their work. In certain clinical trial cases (e.g., the GMM trial) the connection is obvious, in others (e.g., the Trovan trial, see Chapter 2), it might be subliminal. Here, the GMM draft gets at the point by way of biosafety. By biosafety, the guidelines highlight the connection and hence proffer plans to address the safe use of technologies hrough the management of risks to the environment and to human health posed by the application of the new technology224 Essentially, the design of this public health intervention tool seriously considers the need to target the pathogens in a way that does not harm either environmental or human health (and need I add, health of non-human animals, etc., too). This is in addition to other set targets that risks be set primarily against improving human health; and that the overarching ethical goal should be to respond to obligations to individuals being asked to participate as human research subjects and/or to communities being asked to host trials; while maintaining transparent and respectful channel of communication throughout                                                            224 Ibid, p. 33.  115  and long after the trial period.  The key word here is, risk,225 how to avoid it if possible, or limit it as much as possible, and manage it to acceptable levels, if and when a hazard results. This, which when teased out gives rise to risk concern, risk assessment, risk management and risk communication. It explicates risk concern to mean alertness to and reason to worry about issues pertaining to both technology and social values, and in both cases supported evidence that a concern is valid. For risk assessment and management, the development of risk frameworks are necessary whereby qualitative, and where possible, quantitative pieces of evidence are used to assess the probability that an adverse event (a hazard) will occur and the consequences associated with the occurrence of that event. In essence, a risk analysis procedure accounts for the possibility of an event happening but which may or may not be harmful in particular circumstances. Ultimately, effective risk management can render many risks acceptable and manageable.226 Per the WHO framework, biosafety risk assessment aims to determine, (i) the potential hazards and the mechanisms of impact for GMM on wild populations of target and non-target organisms; (ii) the likelihood and magnitude of impact of the GMM on the receiving environment; (iii) the                                                            225 Risk is defined as the combination of the magnitude of the consequences of a hazard (an unwanted event), if it occurs, and the likelihood that the consequences occur. Ibid, p. 34.   226 Ibid, p. 33  116  levels and consequences of uncertainty associated with the effects, and (iv) appropriate risk management measures needed to mitigate any harm or uncertainty associated with changes to target organism populations or the wider receiving environments. Risk communication ensures that there is a well-documented explanation of what risks have been identified, how they have been assessed, what the acceptable level of risk is, and how risk management may be able to achieve acceptable levels of risk with implementation.227   Just like the ethics and community engagement approach, biosafety measures are phased in with the different stages of the trial protocol during which specific possible hazards are addressed at their respective appropriate stages  from laboratory and cage environments to open field releases. In this way further testing stages that follow are made more workable and the protocol becomes better defined as appropriate decisions are reached. With respect to the GMM project, possible relevant hazards that might occur are covered in the following questions: Will release of the GMM increase transmission of the target or other diseases? Will release of the GMM cause a significant biting nuisance? And, will release of the GMM result in disruption to valued ecosystem components?228  It is apparent that estimating the degree of ecological risk from the introduction of a new technology such as GMM, involves an admixture of ethics, culture, science, economics and health. As noted already, the complexity can be illustrated by the experience of genetically engineered crops. An instance that helps to underline this                                                            227 Ibid, p. 33. 228 Ibid, p. 34.  117  abstruseness in the GMM project is the locomotive capabilities of mosquitoes. The report simply confirms what we have long known about mosquitoes in saying that they make unpredictable movements between locations, in which case, it will be impossible, in advance, to say for sure all persons (or non-human animals) with whom they make contact. Moreover, knowledge from vector biology research had previously proposed that biosafety oversight may be a more appropriate model than individual human subject protection. Equally useful would be to apply lessons from other environmental health programs, which typically involve unavoidable risks and as such not amenable to ethical procedures that presume an opportunity to exit or opt out of the risk bearing situation. What is more, environmental risks raise ethical questions about the way that risks are distributed across economically, politically or ethnically vulnerable populationsproblems of environmental justice. There are no ready analogs to environmental justice in standard human subject research ethics. Thus, research intended to better understand environmental health or that involves exposure to potential environmental hazards may need to be evaluated from an ethical perspective that incorporates considerations rarely contemplated within standard human subject deliberation229  In releasing transgenic mosquitoes into a designated site, it is hypothesized that some of the key consequences will likely be the alteration of ecosystem functions (such                                                            229 Ibid, p. 69.  118  as role of mosquito larvae in the food chain for predators) and other impacts on target organisms through destabilization of local mosquito populations. The possibility of these unintended reality may pose a risk, according to the guideline, particularly to human health if the GMM vector control system fails after a release program is well advanced. might include assessing local mosquito populations for the evolution of resistance to the transgene function, the evolution of the disease pathogen to resist transgene function or changes in host range of targeted mosquito speci230   To itemize specifics, the ecological consequences that might occur, as identified by the GMM report, include,   Effects on biological diversity  Vertical gene transfer  Horizontal gene transfer  Persistence of the transgene in the ecosystem  Evolutionary responses (especially in target mosquito vectors or pathogens)  Unintentional trans-boundary movement (including international borders).231   The GMM literature therefore suggests that evolution and adaptive processes be considered and appropriate regulatory structures, mechanisms and methods need to be in place as integral parts of the risk assessment to ensure that clear lines of responsibility                                                            230 Ibid, p. 49. It notes further the possibility of resurgence of disease when immunologically naïve human populations are exposed to disease after a prolonged period of low incidence as a concern that should be assessed in post-implementation monitoring. However, this is not unique to GMMs. P. 50.  231 Ibid, p. 49.  119  are delineated on post-implementation surveillance. In effect, post implementation monitoring should draw on evidence from earlier Phases to determine the need for and design of monitoring to observe the key impacts identified. The guidelines conclude that biosafety measures ought to be buoyed further by independent constituencies or review boards. This appears to fit with its promise of  establishment of independent safety review groups or the formulation of GMM biosafety regulations for consideration by existing review groups (local bodies such as Institutional Biosafety Committees, national advisory bodies such as Advisory Committee on Release to the Environment, and regional or supranational agencies such as European Food Safety Authority,) is recommended. Such groups can provide oversight of the risk assessment and risk management within each phase of testing and provide independent scientific advice on the risks of GMM to human health and the environment232 All in all, the foregoing mark a shift from considering ethics of research within the bare bones of principlism, to considering the ethics of research in a much broader sense. The GMM model for biosafety, ethics of engagement, etc., reveal the need to improve the links between research and health care delivery and to promote the environmental, cultural, socio-political and economic                                                            232 Ibid, p. 51.  120  processes that are involved so we can begin to widen our understanding of the vicissitudes of the impacts of public health research (or any other research for that matter).233  As observed, the successful implementation of GMM interventions requires transparent, focused, proportionate and credible biosafety assessments. The significance of the role of stakeholder groups and individual communities is evident as they provide the key to appropriately deal with the ethical and cultural dimensions. They should likewise provide consistent and strong voice within both biosafety and benefit-cost analyses associated with the testing and implementation of GMMs.234  I can understand if some curious observer thinks that the GMM model and traditional clinical trial model are like apples and oranges. I however see more similarities than dissimilarities: Yes, the GMM model contains no typical human subjects. That is about the only major difference. But when we think comprehensively and holisticallythe GMM recommendation extends to just about all clinical trials.  Couched within the philosophical commitment to evaluate clinical trials in terms                                                            233 After reviewing and analyzing 14 case studies and articles in 2006, Dianne Quigley came to somewhat similar conclusions. Her work focused on research ethics issues in the conduct of environmental and lustrates how community-based participatory research practices can provide working guidelines that can overcome Public Health Research: Case Examples from NatHealth Educational Behavior, 33: 130. 234 Ibid, p. 51.  121  of ecological and human health, the GMM project seem to have rejigged a healthy debate. It does so while resolutely pursuing efficacy, transparency, responsible sense of purpose, quality and consistency in the process of testing and regulating new genetic technologies. After several decades of treating bioethics and environmental ethics as distinct disciplines, it appears that our collective capacity to understand and discuss them jointly need revamping. Bioethicists and environmental philosophers should hence forth take up the gauntlet to refocus on that discussion. That is the thrust of the next segment. 4.5 ENVIRONMENTAL ETHICS AND BIOETHICS  To ask how or why bioethics and environmental ethics parted ways, is certainly a fair question.235 Except that it borders on areas beyond the purview of this analysis. A more appropriate inquiry would likely be to ask, can they reconcile as they were originally conceived so as to address practical concerns that are common to them? For sure, the inspiration that GMM framework presents already has given us a solid heads-up in that direction. Properly considered, environmental and human matters should not as a whole be separated from each other; that in practical terms includes ecological and human health issues.                                                            235 It should be recalled that bioethics and environmental ethics were of the same allele which came to life simultaneously in the 1970s but seemed to have gone separate ways soon after. Since that parting of ways each seem to have evolved an individuality of their own without maintaining overt affinity. The opening salvo in the book, The Ethics of Environmentally Responsible Health Care by Jessica Pierce and Andrew Jameton (2004) laments that separation into (what looked like) irreconcilable paths even as they remain hinged on a common philosophical substratum.   122   When in 1970 Van Porter used the term bioethics,236 his concern went beyond the confines of medical ethics. He was troubled by the emerging global environmental crisis reframed it as global bioethics, to accurately reflect his thinking and foster a re-conceptualization of an ethics of health care as it relates to Earth care and global survival. Porter, an oncologist, saw a constant thread of unity whether it was in his cancer research or any other aspect of life and concludproblems were our inability to forge a synergy between the two broad cultures of We are in great need of a Land Ethic, a Wildlife Ethic, a Population Ethic, a Consumption Ethic, an Urban Ethic, an International Ethic, a Geriatric Ethic, and so                                                            236 Robert Martensen credits statesman Sargent Shriver, for coining , Maryland living room one night in 1970. It was at the instance of meeting with physician Andre´e Hellegers, a Jesuit philosopher and then president of Georgetown University and others to discuss (President) Kennedy family sponsorship of an institute for the application of moral philosophy to concrete medical dilemmas. Martensen however cedes that Van Rensselaer Potteristory of Bioethics: Journal of the History of Medicine and Allied Sciences, 56, 2: 168-175. Dianne Irving on her part, locates the formal embryonic formation of increasing number of knotty and bewildering problems especially being generated by medical research What is (?). Now rewind and listen, the Internet Encyclopedia of Philosophy labels these oft-Theologian Fritz Jahr whose three published articles in 1927, 1928, and 1934, that first used the German --to issues concerning human beings and the environment. Jahr famously proclaimed his bioethical gly wherever   123  237   To the extent that we have endured this disconnect for too long presses the need for the immediate bridging of medical and ecological ethics recognizing (them as one) its critical role in the future of health and environmental planning for all species, human and non-human. Peter Whitehouse draws directly from Van Potter's original intuition to characterize the syndrome and to recommend a treatment plan. The bridging effort 238   Similarly, the work of Jessica Pierce and Andrew Jameton239 is primed exactly to achieve that aim. It maintains that high quality, ethically sound health care is                                                            237 Potter, Van. 1971. Bioethics: Bridge to the Future. Englewood Cliffs, New Jersey: Prentice-Hall, Inc. There is little wonder why he dedicated this work to the memory of Aldo Leopold who he says anticipated the able in the following publications: Global Bioethics: Building on the Leopold Legacy. East Lansing Michigan: Michigan Perspectives in Biology and Medicine, 34, 1:89-Medicine and Global Survival, 2, 3:185-The ScientistHastings Center Report 29, 1:38-40, 1999. 238 The Hastings Center Report, 29, 1: 41. 239 Pierce, Jessica and Jameton, Andrew. 2004. The Ethics of Environmentally Responsible Health Care. Oxford: Oxford University Press, p. vi. While I certainly agree with these authors on most of their arguments, some of the explicit ideals they identify as underlying the moral principles of both fields fail by way of not accurately accounting for their supposed defining differences. For instance, they state that health-care ntal ethics deals in large populations; and that clinical ethics episodes are usually resolved in days and months, while ecological issues play out over decades and even millennia. Many concrete bioethical instances ioethical issues might be short-term, but most outlast generations. And yes, some also deal with individual patients but most deal with very large populations too. In onger if they recognize that defining similarities are far greater, and that differences (between bioethics and environmental ethics) are far fewer than they have articulated.  124  guaranteed to be available, if and only if (i.e., a logical condition) the larger environment is robustly viable enough to sustain good health.  It all seems so intuitive yet we are reminded that we cannot, in our constant quest for specialization, continue to compartmentalize our daily lives, our health and wellbeing, from reality  essentially, the myriad elements in the ecosystem (human and non-human) that are interdependent on each other in the web of life. From microorganisms and tiny entomological species to large mammals, and the role each plays; from thinking about the safety of the water we drink to thinking about the quality of air we breathe. That we continue to simply insist that there is a distinction between environmental implications of our decisions and ethical judgments in health care and paying little attention to axiomatic philosophical action theory, seems a serious lapse in scholarly rigor. Genetic epidemiology has long proven that human diseases result from a combination of genetic inheritance and the environment and no other affirmation highlights the premise of that argument better.240  It is easy to discern why there is constant connection in everything. As an illustration, consider the long process in a drug or medical device production whereby biomedical scientists produce a medical device or cancer drug; IRB committees determine which of them meet clinical trial protocols  federal and state laws; and FDA                                                            240 Epidemiology Reviews, 19,1:176.  125  decides when to approve for market-wide use. What is less known is how often, if at all, any of the actors involved pauses to ponder the ecological root cause or causes of the cancer disease that is being targeted. But a WHO study may have put paid to that disconnection just as Porter envisioned. Data for the WHO finding claim that 223,000 deaths from lung cancer around the world were caused by air pollution in 2013.   The International Agency for Research on Cancer, a branch of the WHO that did the study, now classifies air pollution in the same category as tobacco smoke, UV radiation and plutonium. And although air pollution had been known to cause heart and lung diseases, latest evidence provides additional reliable data supporting the fact it also was causing cancer.241 Case closed.   Questions that Pierce and Jameton pose and the compelling answers they proffer environmental ethics can be applied to health care and how can they be combined with more traditional health-care ethics concepts? What kinds of case studies in health care Ultimately, they are of the view that environmental principles are the pivot of a responsible inclusive understanding of bioethics and conduct of health care (and probably, vice-versa).242  Further still, prescriptions in the GMM report regarding ecological health could have been informed by sentiments akin to the ones echoed in the complex theory of                                                            241 WHO: International Agency for Research on Cancer, Press Release, No. 221, October 17, 2013. 242 Ibid.  126  environmental responsibility that Akadémiai Kiadó243 has developed. In its broadest ry covers such areas as political, bioethical, scientific, and economic systems. Its emphasis on environmental protection is palpable in the way it environmental responsibility is impregnated by the ubiquitous natural and civilizational responsibilities (borne by humans), whose presence and proportions determine both the quality and quantity of responsibility for the environment. In brief, the theory of complex environmental responsibility not only extends theoretical science, but also promotes orientation in the practice of environmental protection. It may be regarded as a new means of interpretation, though its main goal is to promote the 244          There is a moral burden to maintaining this order or else, the positive relation between individuals and between humans and the natural ecosystem will be negatively impacted. In tune with typical African philosophy and traditional belief, nature (reality) is an organic whole, and the creation and sustenance of ecological balance or interdependence between human and non-humans, the visible and the invisible is most desired. This in other words, points to holistic perspective (an emphasis on the interrelatedness or interconnectedness of everything in nature), as opposed to Western                                                            243 Kiadó, Akadémiai. Társadalomkutatás,29, 3: 303-314.  244 Ibid.  127  anthropocentrism (a social paradigm that values nature instrumentally and in so doing maintains the isolation of humans from nature and only sees its usefulness to humans).    One influential view that seemed to differ from this was that of John Muir, a Scottish-American naturalist and early advocate of preservation of wilderness in the U.S. While he believed in the intrinsic value and rights of all creatures and that a divine 245 quite distinguish him just like most of his 19th century contemporary preservationists in America. However, one distinctive 19th century perspective   seems  the view that our moral concern should cover the natural environment and its nonhuman contents  toward ecological wholes, such as species, communities, and ecosystems, not just their 246 hat individual interests and well-being should be subsumed under the holistic good of the earth's biotic community.247 Hence his famous line: That land is a community is the basic concept of ecology, but that land is to be loved and respected is an extension                                                            245 Cited in Kelbessa, Workineh. 2011. Indigenous and Modern Environmental Ethics. Washington DC: Cultural Heritage and Contemporary Change, Series II, Africa, 13: 51. 246 Stanford Encyclopedia of Philosophyhttp://plato.stanford.edu/entries/ethics-environmental/. Viewed on June 20, 2014. 247 Ibid.  128  preserve the integrity, stability, and beauty of the biotic community. It is wrong when it tends otherwise.248    With that, I segue into the more expansive African philosophical point of view about which Workineh Kelbessa apparently illuminates with the Oromo ecotheology which teaches a positive relationship between the environment, humanity and their deity.249  There is a positive relationship between God and the Earth, humans and the natural environment. All creatures are essentially effected and affected by the harmonious relationship between Waaqa and the Earth. Waqaa is the creator of various creatures and is responsible for their existence. He requires humans to responsibly cohabit the Earth with other    For the Oromo, the land is not simply property to be exploited by humans without due respect and care. It is intrinsically valuable and requires respect and protection on the part of its inhabitants. If humans continuously despoil the land by breaking traditional rules and the cosmic purpose, it may not support all creatures indefinitely. The Oromo believe that the present generation has responsibility to pass on natural resources in good order to a future generation. That is why the Oromo are concerned with the health and peace of the environment and its inhabitants. They                                                            248 Leopold, Waldo. 1949. A Sand County Almanac, Oxford: Oxford University Press, pp. vii-ix, 224-225. 249 All African communities, with a varying wealth of symbolism, have akin interpretations. I could have the world view of the Oromo ethnic group, the largest in Ethiopia, is indeed representative of a typical perspective that can easily be replicated across Africa. Kelbessa used a combination of desk research, descriptive methods, and field research to analyze primary and secondary data.  129  depend on environmental resources to heal themselves.250  The point seems to be that the continued neglect of this philosophical perspective in favor exclusively of anthropocentrism, is the bane of much of human crisis. A review paper by Richard Ingwe, Joseph Ebegbulem and C. Ikeji has tried to effectively link anthropocentric policies and crises in climate/environment, finance and economy (especially by advanced economies) to the complete neglect of ecocentric world view as it pertains to contemporary African situation.  The crisis in climate, finance, and economy, among other sectors at the global and national levels reflect the way policy has ignored ecocentric principles and limitation in the concept and operation of anthropocentrism. Specifically, pursuing the objectives, goals and interests of human beings without considering ecological principles or the inter-relatedness of human and non-human natural systems is responsible for the climate-environmental crisis. While the corruption of anthropocentric institutions, processes, structures and attitudes by top functionaries of global and national financial and economic systems has led to the crisis in these sub-sectors.251   They recommend a back-to-the roots solution under the aegis of the African Union whereby think-tanks are formed to refocus and reinstitute various disciplines in                                                            250 Kelbessa, Workineh. 2011. Indigenous and Modern Environmental Ethics: A Study of the Indigenous Oromo Environmental Ethic and Modern Issues of Environment and Development, Washington DC: Cultural Heritage and Contemporary Change, Series II, Africa, Vol. 13, pp. 85-86. His other relevant works include, The Oxford Handbook of World Philosophy. Oxford: Oxford discussion paper], 2005. 251 Ingwe, crises in climate/environment, finance and economy: Implications of the emerging green policy of the  African Journal of Political Science and International Relations. 4, 1: 1-012.   130  the nexus of the development of both human and non-human natural environmental systems.  eco-bio-and influential theorist who has blazed a trail in philosophical discussions on environmental ethics from an African point of view, attempts to strike some balance. Though preferring eco-bio-communal (or ecocentrism) outlook over anthropocentric -all panacea to all health and environmental problems. However, he thinks it is certainly a better option that is guaranteed to abate the urgent global hazards which have arguably been soil); global climate change; of massive risks to plants, animals, and humans from toxic industrial wastes and from sophisticated weapons (conventional, nuclear, chemical, and the collapse of the very foundations of life via gene technology252  t yet t noticed my discussion of holism and eco-centrism as if they were synonymous; it is intentional (and indeed they are somehow synonymous in a way particularly as they ease into my preferred nomenclature, bio-eco-communitarianism, BEC.). There is the claim that in the last few decades,                                                            252 A Companion to African philosophy. Kwasi Wiredu (Ed.), Oxford: Blackwell Publishers, p. 393.  131  environmental ethics has become an inherently holistic pursuit in large part due to Aldo in environmental ethics have assumed Doppler proportions each time the matter comes up for discussion.    Michael Nelson253 moral significance attaches to wholes over and above the individuals they include, or the idea that environmental wholes can and do matter morally and directly, or that they desiring a system that allows us to directly morally include species, ecosystems,    -pronged view of holism is as well illuminating. First, it is a claim that all reality constitutes a single being; then that it is a commitment to join together what has been split apart; and lastly, that it is a claim that a single principle binds all existence together.254 While Aldo Leopoauthoritative influence on those who propose holistic ethics, very little (if any) credit has been attributed to the ancient African root of that philosophical orientation. Citing Cheikh Anta Diop, Verharen explains that most ancient Egyptian cosmologies attribute                                                            253 pedagogical paper by Michael Nelson, a professor of environmental ethics and philosophy with interests in wilderness, wolves, and wildlife ecology, 2010. 254  Journal of Black Studies, 36, 6: 960. This view point is however original to Don Marietta and espoused in his 1995 work, For People and the Planet: Holism and Humanism in Environmental ethics, Philadelphia: Temple University Press.  132  the origins of the universe to a single principle such as Nun, through a process of becoming out of an original chaotic matter (water). Through that same creative process, Khepera, the basic physical elements come into being, and from those elements In essence, the ancient Egyptians joined spirit together with matter, in which case humans were not separate from animals and even gods. Hence, the ancient African progenitor inspired holistic philosophies that have exerted a powerful hold on human imagination.255   By some unintended way, I have come to think that globalization might shed off its negative image with the saving grace embedded in the ontological concept of African holism. For one, the immensely complex global economy (and everything else), have within the last 20-odd years, surged to integrate at a vortex, thanks to globalization (but with some unalterable consequences). By the same token, the ultimate reduction of complexity to simplicity which is found in the philosophy of holism might just be the solution we need.  nlike the history of the universe [the Big Bang Theory], the history of thought has moved in the direction of simplicity, defined as the smallest number of symbols capable of describing the greatest                                                            255 Ibid, pp. 960-961. Molefi Asante reflects further on the contributions of ancient African philosophy in The Egyptian Philosophers: Ancient African Voices from Imhotep to Akhenaten, Chicago: African American Images.  133  humans, as the whole world is finally beginning to discover, a256 I agree.   To wrap up, I reference a recent call out of Southern Queensland, Australia  one of the few efforts resembling the African perspective  that reinterpreting the definition of sustainable development for a more ecocentric reorientation.signals the shifting posture which adds impetus to the fact that ecocentrism could be catching on. It examines the limitations in the contemporary anthropocentric conceptualization of sustainable development with a utilitarian ethic and argues for a more ecocentric reinterpretation of its definition that is more inclusive and incorporates recognition of the socio-ecological values. That in practical terms, is a recourse to finding lasting global resolution and a framework for sustainable development based on a reinterpretation that recognizes the interdependence of humans with the rest of the ecosphere, nay ecocentrism.257                                                                  256 Ibid, p. 961. 257 Imran, Sophia; Alam, Khorshed; and Beaumont, Narelle. 2014. Reinterpreting the definition of sustainable development for a more ecocentric reorientation.Sustainable Development. 22: 134144.  134  4.6 CONCLUDING THOUGHTS Figure 1: Meeting of GMM framework, environmental/human health, and African holism.         This chapter has witnessed a rich constellation of ideas including a blaze-trailing clinical trial GMM protocol that threads together eco-centric environmental philosophy which origin I have traced all the way to the ancient African thought. As summarized in Figure 1, the GMM framework has unintentionally rendered a catalogue of services that fit perfectly with my thesis. 1) My over-arching aim to reconceive responsibility in  135  clinical trials with comprehensive considerations for research subjects and family, community engagement, respect for culture, biosafety, etc. 2) By calling to mind the intimate connection, namely the inseparability between environmental and human health, the GMM report hits at the heart of a long nursed intuition of mine, to bring together bioethics (here via clinical trials) with its lost sibling, environmental ethics. 3)  s methodology buoys my inclination for eco-centrism  a widely shared philosophical perspective in African thought (and elsewhere), and holism or interconnectedness, and the intrinsic value of the biosphere in ranked order of being. 4) The protocol  directly deal with human study subjects, nonetheless its approach is yet another indictment of sorts on the four principles of research ethics (principlism). In the main, it marks a shift from considering ethics of research solely within the bare bones of principlism to considering the ethics of research in a much broader sense. It engages the transgenic project in the fight against malaria and dengue fever as an all-encompassing endeavor; revealing the need to improve the links between environmental health research and health care delivery, and to promote the cultural, socio-political and economic processes that are in-built.    Put together, I have benefited from relevant parts of the compendium to build a persuasive argument that presages the thesis for this dissertation, namely a re-conceptualization of responsibility in clinical trials with the concept of African personhood (see Chapter 4).  136    From  Framework for Testing of Genetically Modified collectively been the recurrent index for reflection. As a clinical trial protocol with an exceptional merit, I have argued that the steps it recommends should be standard practice for all clinical trial protocols particularly those that use human subjects and/or have ecological impact. For instance, this public health intervention tool lays out a well-developed ethical and engagement strategies by reducing the chance of misunderstanding the science needed to meet the goals, and improving the performance of the research project in both technical and social contexts. As such it made respect for individuals within communities the arrow head of its overarching ethical goal.   Then, for unusually melding human and environmental health  a move that bolsters the views of a section of the philosophy community (me included) that have pined for the urgent reconciliation of bioethics and environmental ethics  two areas (that should remain as one specialized field) with a fundamental basis for the pursuit of a common purpose. So fundamentally similar that they both share significant overlap on many issues  ethical approaches, concepts, and moral considerations. That, in and of itself, extends to the eco-centric philosophical view point of holism or interconnectedness and the intrinsic value of the biospheral elements in ranked order of being. It comes as no surprise that these two broad issues can be merged into what I have referred to as bio-eco-communalism or BEC.   137    It is thus unprecedented that a clinical trial protocol with a Western origin has gone beyond the four-corners of principlism to recognize the possibility of a new technology (such as GMM), of having the potential to simultaneously impact human individuals, the community and the ecosystem in tandem. This fusion of elements in the biosphere (human and non-human) by implication makes a strong statement about the interrelatedness/interconnectedness of such factors as ethics, culture, the biota, science, economics and health (environmental and human). In so doing it has adequately positioned biosafety, namely the management of risks, as an integral point of consideration on issues relating to the environment and to human health as brought about by the application of the new technology.   In this same reasoning, if considerable attention is paid to the individual human subjects in clinical trials and how they exist only in reference to their community and the environment (the African notion), the import of my recommendation becomes crystal clear. Obviously, humans do not exist in a vacuum (forget the skewed emphasis on anthropocentrism). In essence, I suggest that while individualism and individual rights might be the primary concern for research ethics in the mainstream (Euro-American) practice, that and much more would be the case in research ethics at other places (such as Africa). And with more frequent off-shoring of biomedical studies, thanks to globalization, etc., clinical investigators should pivot to BEC  an  138  understanding that results from re-conceptualizing personhood within the context of communitarianism and eco-centrism. That is taken up by the next chapter.                                                                                                                          139  CHAPTER FIVE: RE-CONCEIVING RESPONSIBILITY: A ROLE FOR                          PERSONHOOD IN AFRICAN THOUGHT 5.1 INTRODUCTION    In the previous chapters, my proposition to re-conceptualize responsibility in 23 and 4). This concluding chapter starts with the presentation of the remaining part  the African notion of personhood.258 With this last piece added on, my proposal is now triaxial. As a capstone of this dissertation, I aim to demonstrate how personhood (as viewed within the African communitarian/holistic backdrop), can fundamentally present a different equation when evaluating responsibility in clinical trials.                                                                   258 One of the many tasks in this essay is the challenge of coherently aligning or harmoniously blending these seemingly disparate themes (full-fledge concepts in their own rights) to justify why it makes sense to couple them together for my purpose. The study structure and rationale therefore is cognizant of the need to establish the intersectional standpoints and the confluence between the three arms of the topic  responsibility, clinical trials, and African personhood.  essentializing. As I shall make clear in this Chapter, I am not overgeneralizing. In fact, beneath the apparent diversity of African philosophical expressions of the self, there is a fundamental and undisputed uniformity, thus setting the stage for a clear-cut cultural relativity (ethical particularism). As with many other African concepts, valusee Egbeke Aja, 2006). There is abundant literature backing up this prevalent view in Black Africa, and similar perspective in much of   140  Figure 2: Dynamics at play.         African panel to the equilibrium, I wish to provide a perspective of what responsibility can mean in an African context and then apply that understanding to biomedical clinical trials with human subjects. The overall analysis therefore follows through as the trifecta themes of responsibility, clinical trials, and African personhood, come to a full circle (see y analyze the study thesis earlier formulated.   Ultimately, this philosophical notion of selfhood will put in perspective my argument to re-conceptualize responsibility in clinical trials. While opposing individualism  a Euro-American mantra  the African perspective stresses communitarianism (and even holism). As such, responsibility for (and by) the individual can only make sense through the family, community, and environment in which he/she is rooted.    141   In an attempt to reconceive and redefine responsibility, this dissertation draws a sharp contrast between the role of selfhood or personhood in the Euro-American a better responsible approach to clinical trials in the African context. In effect, while the human person has mostly been the prime focus of ethicists; how this selfhood is viewed in mainstream Euro-American bioethical practice is radically different from the rest of the world, particularly Africa. In what has thus far become a recurrent index in this study, the Euro-American emphasis is on the individual (individualism) in contrast to the African perspective that emphasizes the community (communitarianism).259 It is with this notion of personhood in African thought that I would suggest a reconceptualization of responsibility in clinical trial endeavors. Put another way, it is an understanding of the --that the reader can discern the full import of my exegesis. I will elaborate this later.   As a guide, this chapter has four main parts. First, I will articulate in detail the notion of personhood by recasting or outlining some of its major features as expressed by a selection of prominent 20th century African philosophers. The intent is to prompt interest and plot a path to understanding its multiple implications in bioethics (for instance, in clinical trials). I will demonstrate that in African philosophical thought, the                                                            259 Obviously, I am not simply claiming that communitarian (or holistic) view is novel. Rather, I claim that as the movement towards cultural diversity in global bioethics gathers steam, researchers would have to face up to the fact about African world view on morality; essentially, that the devolution of the individual into his/her community is key.       142  concept of personhood is both pivotal on its own and on the collective bioethical project.  Second, I will compare and contrast the African vs. Western perspectives of personhood to highlight the stark differences and further demonstrate my preference for choosing one (African version) over the other (Euro-American version).   Third, I will parse through the subject matter (selfhood) within the bioethical framework. Though the concept of self has long been a well-worn path in Western philosophy and its contra opposite in African philosophy260, I will strive to lay the foundation on which to extend the discourse to include the larger ethical questions that frame the emerging field of bioethical practice in Africa. Considerations from relevant authors such as Godfrey Tangwa will help to explain and situate it in a broader context. In the course of this, I will consider some general criticisms one could levy against the concept of personhood as found in African philosophy.   Forth, having laid out the logical premises, I will conclude by reconfiguring responsibility. A brief housekeeping note: it is pertinent to observe that considerations of personhood261 as an ethno-socio-anthropological subject matter can cross the                                                            260 t array of available literature and strands of viewpoints regarding the concept. I however wish to highlight enough areas and ginger enough interest within the limited time and space for this analysis. 261  Person, man, self, individual, human being, and to a lesser extent, identity, may be used interchangeably in this analysis to mean the same thing (in line with existing literary corpus). However, there are places where exceptions would be made or implied.  143  boundaries of quite a few scholarly disciplines while assuming normative, thematic, descriptive as well as analytic tones262. Whether as a body, an embodiment, an identity, a selfhood, an individual, a human being, a man or a person  objectivized or subjectivized  the discourse is guaranteed to be richly animating. For the purpose of analysis, personhood will not be viewed within a narrow confine such as ethno-philosophy  the study of collective forms of culture as manifestations of African philosophical systems. I will engage the topic as a concept in African philosophy qua philosophy. My approach will take the form of a second-order critical evaluation of first-order thinking within African cultural experience  a critique and revision of traditional African thought and culture. Nevertheless, I am cognizant of the vital role of other relevant areas of academic gnosis, for instance anthropology. To borrow from Ivan Karp and Dismas Masolo, Both anthropology and philosophy share questions about how the concept of the person is defined and used in social interaction. These disciplines take rather different approaches to the answers they provide. Both are concerned with distinguishing between the continuity over time that enables agents to  and with the epistemological problem posed by the differences between social attribution and self-knowledge.263   Buoyed by a plethora of conspectuses in African philosophy, the overriding thesis of this chapter sails on the fact that the African philosophical sphere, like its                                                            262 Some authors, example Polycarp Ikuenobe (2006), ascribe only two philosophical conceptions to personhood in African thought, namely, descriptive metaphysical, and normative. I am of the view that a more expansive analysis of the notion would include other related epistemologies and thus accumulate broader analytic frameworks and conceptions in the process. 263 Karp I. and Masolo, D. (eds.) 2000. African Philosophy as Cultural Inquiry, Indiana University Press.  144  counterparts in other traditions, brims with familiar as well as not so familiar conceptualizations some of which are yet-to-be fully explored. The list of empirical, ontological and metaphysical concepts is probably endless; they include (not in any particular order) the concepts of time, marriage, life (human, animals, plants, living-dead), spirits, God, nature, evil, justice, destiny, magic, and witchcraft. In both conceivable and pragmatic terms, each of these does have notable implications for bioethics. But to deliberate on personhood in African philosophy is like threading through virtually all of these concepts, such that a comprehensive analysis of it (self) amounts to analyzing most (if not all) other concepts in tandem. But I will limit myself and make manifest that in African philosophical thought, the concept of man (or personhood) is crucially significant by itself and thus commands extra ordinary influence on the collective bioethical project (as can be witnessed through clinical trial lenses).  5.2 THE FRICAN MAN   The understanding of the different expressions of man in African philosophy and religion264 may be pluralized, but essentially it is singularized. Less clear is precisely why this statement seems paradoxical; but it is not. Let me rephrase: African notions of                                                            264 I hasten to note that African philosophical discourse on just about any subject can rarely, if at all, be analyzed without adherence to religion or the spirit world, and for that matter, everything else (not to preclude atheistic opinions). In essence, African philosophical concepts are never considered as individuated concepts, rather they are holistic. Hence, it is rife to see how an ethical discussion can morph into and encompass religious, social or cultural spheres. On the concept of man for instance, the ives in a religious universe, so that natural phenomena and objects are intimately associated with God. They not s, and each people has its own religious system with a set of beliefs and practices. Religion permeates into all the departments of life so fully that it is not easy or possible    145  personhood might seem many but they are similar in their essentials, albeit expressed in different ways. This fact can be gleaned from relevant literature which remarkably posit look-alike, sometimes even identical depictions of what it is to be human in African traditional religion and philosophy. As we delve deeper, we shall see why this factuality should not be construed as essentializing (by way of devaluing) the African view point. It should in fact, be seen as a positive trait.   In the oft-cited primordial text, Bantu Philosophy, the Belgian cleric and missionary Placide Tempels,265 portrays man (or Muntu) as a vital force, a living being not to immediately notice the similitude of this view with the Judeo-Christian tradition. Man is the supreme force, the most powerful among created beings. He dominates plants, animals and minerals. These lower beings exist, by Divine decree, only for the assistance of the higher created being, man.    relation to other humans and the environment. This view runs common among numerous other authors on the philosophical expressions of personhood in Africa (Mbiti, J. 1970; De Craemer, W., 1983; Menkiti, I., 1984, 2004; Riesman, P., 1986; Onyewuenyi, I., 1991; Owomoyela, O., 1991; Kaphagawani, D., 2004; Kelbessa, W. 2005;                                                            265 Tempels, P. 1959. 1959. Bantu Philosophy.  64. I will be remiss to not note that sometimes been a target of stinging excoriation and his work labeled as ethno-philosophy, i.e., philosophy deriving from the study of ethnic Africans. Tempels has particularly been singled out for able views however depict him as presenting a body of work that generally project the African as having robust intellectual and moral-spiritual capacity. Observations from both sides seem to be fair, but in this study, I choose to not take sides specifically because I am not critiquing his work.  146  and Ikuenobe, P. 2006.).   brethren, with his family and with his descendants. He is in a similar ontological relationship with his patrimony, his land, with all that it contains or produces, with all that grows or lives on it.266  By implication therefore, the fulfillment of a s life depends on and is enhanced by the support and enrichment of all other life forces (humans/spirits) around as well as other elements in the environment (say, minerals). In concert with this logic it is conceivable that a perscollaterally be enhanced or diminished by other forces and elements around. So beyond being a social being, man is suffused and suffuses in all creation. This relationship is so constitutive of the self that any serious disruption can lead to ominous damage to the person. And in the view of De Craemer,267 the far-reaching relationship is in addition supernaturally, as well as naturally threatening and potentially destructive to the family Seen via the Bantu philosophical lens, the Bantu cannot and is [in] intimate and personal relationship with other forces acting above him and below him in the hierarchy of forces. The human being, apart from the ontological 268                                                             266 Ibid, p. 66. 267 De Craemer, -The Milibank Memorial Fund Quarterly, Health and Society, p. 23. t, it ought to be more positive than negative. 268 Tempels, pp. 68-9.  147    To further illustrate, let me borrow from the science of physics: if man were to be projected spatially in thin air, it would be impossible to detect his acuity without a backdrop. This is because gratings of different waveforms and spatial frequencies make it impossible for the visual system to measure the band-pass characteristics of the environing channels for the eye to pick out. In like manner, a person cannot exist without his/her rooting in the community.    an extended citation here:  In traditional life, the individual does not and cannot exist alone except corporately. He owes his existence to other people, including those of past generations and his contemporaries. He is simply part of the whole. The community must therefore make, create or produce the individual; for the individual depends on the corporate group. Physical birth is not enough: the child must go through rites of incorporation so that it becomes fully integrated into the entire society. These rites continue throughout the physical life of the person, during which the individual passes from one stage of corporate existence to another. The final stage is reached when he dies and even then he is ritually incorporated into the wider family of both the dead and the living. Whatever happens to the individual happens to the whole group, and whatever happens to because we are; and since we are, therefore I am. This is a cardinal point in the understanding of the African view of man.269    This person-community relationship is an idea that has variously been referred as group solidarity (Menkiti, 2004); communalistic character (Wiredu, 2004); communitarian view (Matolino, 2011); eco-communalism (Tangwa, 2004); cultural collectivism (Schwartz and Bilsky, 1987); communalism (Ikuenobe, 2006); or                                                            269 Mbiti, J. 1970. African Religions and Philosophy, New York: Praeger Publishers, p. 108.  148  communalism thesis (Kaphagawani, 2004). This characterization sticks out as the most outstanding feature in understanding man in the African thinking. I call it one-in-all relationship or bio-eco-communalism (BEC).  Citing two separate studies, Niehaus270 makes bold the point that it is inadequate numbers without reference to other humans and the environment. This validates the eternally being added to others, and is fully evolved after he/she is enmeshed and is meshed with others in his/her milieu.   271 broad brush on the concept of person across a selection of West, East and Southern African ethnic groups, leads him to identify three main characteristics of the human person: the force, communalism, and shadow thesis (the first two discussed above). As noted above and reiterated here by Kaphagawani who vital forces. Force is not only a necessary attribute of being, but is (the essence of) to contrast the Western conception of being which is held static, to the African view point, which is constitutively dynamic or                                                            270 Ethnology, 41, 3: 190. 271 A Companion to African Philosophy, Wiredu, K. ed., Blackwell Publishing.  149  usually viewed in a processual continuum.272  As I have noted, the most outstanding of the three features is the one-in-all socio-centric view of personhood or communalism thesis, the origin of which like the force doctrine, Kaphagawani ascribes to Tempels and to a lesser degree, Mbiti. In this view, also noted earlier, the status of an individual is determined through cultural criteria or validation.273   The shadow thesis seems to be the least on the totem pole. Credits go to Alex Kagame for his work in highlighting that aspect of the human being in Bantu  , 274   Further reflections on the concept of man in the African thought reveals how it applies to the wider moral, juridical, epistemological, ontological and metaphysical realms. Given that man as a force, does not exist in a vacuum, we are reminded that he is a force in the hierarchy of forces. In descending order, this ranked order of forces begins with God, the Great Force, then the spirits, founding fathers, the dead, according to the order of succession; then the living according to their rank in terms of seniority.                                                            272 Ibid, p. 335. 273 Ibid, p. 337. 274 Ibid, p. 339.  150  ing men come animals, vegetables, and minerals, which are in turn 275 Hence, the perceived bond between persons  an intimate ontological relationship  leads the African to f to be in intimate and personal relationship with other forces 276    Sequencing it further, African epistemology could be seen to follow suit by in how deeply he understands the nature of forces and their interaction. [With God as the First Force and the ultimate wisdom], He knows all forces, their ordering, their dependence, their potential, and their mutual interaction. A person is said to know or have wisdom 277 Thus, this proximity to divine knowledge is attained the older one gets.    The entwining of the realms of ethics and law seems to be the next logical step to  will be accounted ethically good if it can be 278 Viewed as both that the human conduct is always within the confines of a consideration for the community of vital forces whenever decisions of goodness or evil of his/her proper                                                            275 African Philosophy: The Essential Readings, Serequeberhan, T. ed., Paragon House, MN, USA, p 40. 276 Ibid, p. 41. 277 Ibid. 278 Ibid, p. 41.  151  animated, and justified from the African point of view, by the philosophy of living forces, or growth, of influence, and of the vital hierarchy. The validity and strength of the customary law of indigenous peoples reside in its foundation in their 279    With all of the above it seems suitable at this juncture to consider Kwasi Wiredu.280 A person is not just a certain biological entity with a certain psycho-physical endowment, but, rather, a being of this kind who has shown a basic willingness and ability to fulfill his or her obligations in the community. Personhood, on this showing, is something of an achievement.281    This definition points specifically to the fulfillment or full realization of ntologically speaking we conceive him/her as an organism that has process of social and ritual transformation until he attains the full complement of excellences seen as truly definitive of manhood. And during this long process of a282                                                                 279 Ibid, p. 44. 280 As I have noted ascriptions about personhood can be more than just normative, and include descriptive, analytic and thematic. 281 Wiredu, K. A Companion to African Philosophy, Wiredu, K. ed., Blackwell Publishing, p. 17. 282 African Philosophy. Wright, R. A. (Ed.), New York: University Press of America, p. 172. But one would be wont to ask, so are kids not considered humans in African philosophy? The short answer is, of course kids are humans. A more  152    It needs pointing out that the fact that the African cultural settings are founded and sustained by shared beliefs, practices and values, does not make the individual to be inert or robotic with no autonomy and self-determination (as the individualistic perspective would have us believe). There is social control no doubt, but the apparent absence of metaphysical features such as voluntariness or freedom ought to be seen in the context of the fact that one cannot rationally act to meet communal obligations the group.       n individual of human parentage, but also one evincing in his or her projects and achievements and adequate 283 principles, processes, and structures that defines social norms, moral expectations, and uct for personal interests and 284 And to press home the bonding duty the individual owes the                                                                                                                                                                                            comprehensive answer will emerge in subsequent segments of this chapter, beginning with the examination of contrasting viewpoints between African and Western notions of personhood. 283 Things Fall ApartPhilosophia Africana, 9, 2, p. 118. 284 Ibid, p. 119.  153  society, Heidi Verhoef and Claudin Michel285 argue that an individual ought to but because it [the community, that is] is   As if that was not enough, here is how Theophilus Okere sees it, Man is not just an individual, an Island, left to himself and sufficient to himself, on his own. Man is essentially community. No one ever came to being as a bolt from the blues, like an oil bean seed falling from the sky, as our proverb says, I am always a we. We in the nuclear family, we in the extended family, we in the village and town, etc. One often Africa generally, the community, the common good is the dominant reality and it alone ultimately provides the context and guarantee of individual rights.286    In clear opposition to Wiredu and Menkiti, to name just two, and in a move that As such he opines that no community exists without its component parts; likewise, -exists the individual is to argue that we can indeed have a community without a person for the community is necessarily 287 neither can you argue the ontologically contradictory                                                            285 Verhoef, H. and Michel, C. 1997. 1997. "Studying morality within the African context: A model of moral analysis and construction," Journal of Moral Education, 26, 4: 389-407. The authors quote L. J. Myer, Journal of Black Psychology, vol. 12 (1986): 31-42, quote from 35. 286 Okere, T. 2005. 2005. Philosophy, Culture, and Society in Africa, Afro-Orbis Publications Ltd., Nsukka, Nigeria, pp. 3-4. 287 Eze, South African Journal of Philosophy, 27, 4, p. 389.  154  opposite. Thus, Eze posits that the identity or subjectivity of the individual and the community are mutually constitutive and that none is supreme. In other words, the individual and the community are engaged in a contemporaneous formation as neither pre-existed the other.     person-community relationship is mutual and constitutive, I doubt that it is equally so. Granted that the community is the sum of its parts; however, it is also true that the community can live on without one or some of its parts while one individual part cannot survive on its own for long.    288 community that makes the individual, to the extent that without the community, the Put otherwise, though a community can and does suffer the case if reversed the other way around. Hence, I question the apportionment by Eze of equal valence to both sides. Nonetheless, while I concede that the community has a autonomous expression and self-fulfillment (something I have already noted above).    I am not enthused by the efforts of a coterie of Western-trained African                                                            288 Philosophy from Africa. Oxford University Press, Cape Town, South Africa.   155  intellectuals (for instance, Anthony Appiah); and their home-grown backers influenced by alien literature and funding (including Paulin Hountondji and Uwaezuoke Obioha289) who would rather replace the time-honored African values and ways of life with some imports. For instance, they reject communalism on the basis that its emphasis on conformity, consensus, custom, loyalty and solidarity makes it constrictive of the individual liberty. They fail to see the import of the communitarian argument e 290 It is by recognizing the humanity of others that one realizes the fullness of his/her own humanness. As we shall see in the next segment, the African person is distinctively infused in the African conception of the community and of the world writ large. According to Jensen and Gaie, while Western notions of self tend to draw us inward the natural and social environment.291                                                              289 ObiohaRadical communitarian idea of the human person in African Philosophical The Western Journal of Black Studies, Vol. 38, No. 1, p. 13. 290 Senghor, S. 1965. L. 1965.On African Socialism. Stanford University Press, NY, USA, p. 5. 291 African Journal of AIDS Research, 9, 3: 297-305.   2010: 298)  156  5.3 AFRICAN VS. EURO-AMERICAN PERSONHOOD   The notion of Western292 personhood vis-à-vis African personhood is like night and day. Authors who have made comparisons in this area have commonly singled out the Western perspective as the odd one out from the rest of the world (De Craemer, 1983; Tangwa, 2000, 2004); Tempels, P., 1969; Mbiti, J., 1990; Akabayashi, A. and Skigsby, B. 2003; Menkiti, I., 2004). But even as the Euro-American notion is undoubtedly the minority view, it is paradoxically the most publicized. If left as is, the concern seems to be that it is bound to globalize a less than global view.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         A distinguishing trait you are wont to notice in many contemporary Euro-American settings is the quest phenomenon that risks the danger of devolving into the narcissistic. According to De -day American society we conceive to a remarkable degree of the person in individualistic terms, emphasizing in this connection, his or her rights, autonomy, self-293 In a twist that is laced with irony this                                                            292 -reason may be obvious. For instance, in bioethics, a field that took off in the U.S. in the 1960s  70s, it is clear that its philosophical principles are Eurocentric (deriving for instance, from the deontological theories of Kant and Mill-Bentham utilitarian principles). Further still, while bioethics is traditionally practiced in the West within the four-corner stone principles of autonomy, non-maleficence, beneficence, and justice; in other parts of the world, incongruities with these principles tend to emerge at the local level when their West-centric biases are subjected to closer scrutiny. Examples can be found in Akabayashi, A. and SkigsbCambridge Quarterly of Healthcare Ethics, 12: 261-264; DeVries, R. et al. International Research Collaborations: Much to be Gained, Many Ways to Get in Trouble, in Normative Environments of International Science. Anderson, Melissa S., and Steneck, Nicholas H. (Eds.), New York: Routledge; and, Globalizing feminist ethics, ed. Tong, R. et al., Westview Press, Colorado. 293 De Craemer, W. 1983, p. 20.  157  has become the norm, despite the dominant Judeo-Christian tradition and doctrine that have for centuries been used to proselytize the need to love our neighbors as ourselves; other cheek when we are struck on one side. Yet contrarily, in the Euro-American tradition, filial relationships are highly restrictive, recognizing mostly members of the proximate (nuclear) family such as spouses, parents, siblings (and may be grandparents).   A review of studies on Euro-American personhood conclude that theoretical -interested, accumulative and having independent agency  measured in terms of its  to both the 294 When viewed in this way, a veritable chasm is thus created between the interests of the individual and those of the larger social group. There is even a deeper divide when you drill the analysis further to expose pervasive logical-rational dichotomies. This view sharply opposes body and mind, thought and feeling, the conscious and the unconscious. Self and other, reality and non-reality (imagining, dreaming, and hearing voices for example are not real).   Taken as a whole, our conception of personhood has at least one major paradoxical attribute. Although it places a high positive value on a universalistic                                                            294 Piot, C. 199. Remotely Global: Village Modernity in West Africa. Chicago p. 18.  158  definition of the worth, dignity, and equality of every individual person, it tends to be culturally particularistic, and inadvertently ethnocentric.295    Areas of commonality between the Western and African perspectives on personhood are at best marginal. For instance, both perspectives regard a person to be not just fully self-conscious but also rational, free, and self-determining.296 Barring these, other aspects of the concept are widely contrasted. From all indications, the two viewpoints can largely be construed as contra opposites.    Harking back to my earlier point, the most prominent contrast is that whereas the Euro-American view of man is that of an autonomous, lone individual; the African man is far more dynamic and can only be defined by reference to the environing nly ontologically, but also in regard to epistemic accessibility the sense of self-identity which the individual comes to 297   The second point of contrast that needs reiterating is the element that a person in  from birth to naming ceremony and several initiation rituals, to marriage and taking part in the regeneration of the human species. Thus,                                                            295 De Creamer, p. 21. 296 The Hastings Center Report, 30, 5, p. 42. 297 Menkiti, 1984: 171.  159  298   These two traits, according to Jagers and Mock (1995: 153), meld under the communalist concept in the Afro-cultural setting that highlights the fundamental interdependence of people and expressed in terms of worldviews, sensibilities, and behavioral inclinations. The authors argue further that because communalism emphasizes the importance of social relations, it can similarly be expressed attitudinally destiny, and corporate well-299    Two empirical studies by Schwartz, and Schwartz and Bilsky, 300 strongly lend support to this thesis. In highlighting the polar opposites between the Euro-American and African conceptions of the person; they argue that in African culture collectivism emphasizes the promotion of wellbeing of social others, care and protection of kith and kin, sanctions against the violation of group expectations and mores, and a universal adherence to group customs. Conversely, individualists are groomed to be self-centered; accomplish personal goals; and, claim to possess unfettered functioning in pursuit of pleasure, sensuous gratification, and status and control.                                                             298 Ibid, p. 172. is here being addressed. But more of this can be found under the African Personhood and Public Health section of this analysis. 299 -individual tendencies: some Journal of Black Psychology, 21, 2, p. 153-155. 300  Schwartz, S. 1990. Individualism-collectivism: Critique and proposed refinements. In Journal of Cross-Cultural Psychology, 21; and, Schwartz, S. and Bilsky, W. 1987. Towards a universal psychological structure of human values. In Journal of Personality and Social Psychology, 53.  160    301 is reputed to be unique in using an analytic methodology   Figure 3: Polar opposites of selfhood (African vs. Euro-American).     The opposing conceptions in the two views (Western vs. African) are quite 302 As shown in Figure 2, while the African view allocates ontological independence to human society, and moves from society to individuals, the Euro-American perspective asserts autonomy and moves instead from the individual to the society.                                                            301  Philosophical perspectives on communalism and morality in African traditions in Journal of Contemporary African Studies, (2008) 26, No. 2: 231-239. 302 Menkiti, I. 1984.  161    The work by Godfrey Tangwa303 further illuminates this African vs. Western juxtaposition, arguing that the Western conception of a person is appropriate only for the ascription of moral responsibility rather than for the ascription of moral worth. Contrarily, the African perception of a person is drawn from the African worldview intimately belonging to an eco-bio-communitarian moral community made up of moral agents.    Tangwa surmises that the Western ethical theory seems to concentrate on the object of morality, the individual, to the neglect of the subject, the agent. This he says, further conjures up the attribute of the principle of might is right, a characteristic of Western imperialism, colonialism, domination, exploitation and monopoly of theory successfully shifts critical ethical attention from themselves and their actions 304 This, Tangwa concludes, is a value judgment that seems to be nomic considerations and the push for scientific progress and technological refinement. Science, technology, and commerce [thus] constitute the unholy trinity of engines behind the constant rethinking of moral categories in the Western                                                             303 The Hastings Center Report, 30, 5, p. 42. 304 Tangwa, Ibid: 40.  162  There are, of course, problems that are kicked up in creating a duality between the object of morality, the individual, to the neglect of the subject, the agent. And not surprisingly too, J. S. Mill might be influencing this thought process. In Logic, Mill -objects alternative term which might lighten the perceived ontic burden, or carry rather less 305 The knob of this suggestion is that for certain purposes, any implicature of substantiality ought to be detached, meaning nothing more than something, anything, to which one may be counted as one.306  5.4 AFRICAN PERSONHOOD AND BIOETHICS   Who does bioethics? Everyone does it, but approaches differ (or should differ) mostly because it is conditioned by particular environing circumstances. Like politics, all bioethics is local. Put otherwise, sal -cultural level.307 Prima facie, it seems innocuous that personhood projects a universal notion. But under a closer                                                            305 related sense the Aristotelian abstract and concrete objects. Stanford Encyclopedia of Philosophy (online), http://plato.stanford.edu/entries/object/. Viewed on October 2, 2015. 306 Ibid. 307 Principles that convey universalismautonomy, beneficence, non-maleficence, and justice  are inherently linked to Western individualistic notions of personhood, whereas the rest of the world mostly sees the person not as an isolated individual, but embedded in kinship, group and community. Get more details from International research collaborations: much to be gained, many ways to get in , In Normative Environments of International Science. Anderson, Melissa S., and Steneck, Nicholas H. (Eds.), New York: Routledge.  163  consideration it is fitting to ascribe that understanding a relativist interpretation in order for bioethics to serve the multicultural interests of persons in other milieus. Thus, argument in positing two aspects of a people's worldview relevant to bioethical issues: [people] consider themselves to be and what they consider to be the principles of causation will normally influence their attitudes to health and illness and their choices 308    Let me --Though a composite and unique identity, the African person is vivacious; always in continuous process of waxing and waning in response to the play of forces within and upon its individuality from interpersonal, physical and supernatural sources. This communalist element and its deep-rooted impact can be felt in no less way than in health care. The individual is integrally located and anchored in a mesh of relationships within the family, village and clan (living and dead), all of whom are primordial true of relatives or significant others, whose closeness may generate any type of                                                            308 Bioethics, 7, 2/3, p. 257.  164  contraposing attributes such as pride or envy, excitement or malice, likeness or hostility, love or rancor, and the capacity to harm or help through the harnessing of the shades of energy residing in the beings within his/her sphere.    development and traditional conceptions and practices of handling mental health, provides one more inroad to examining this subject matter. The fact that it is common to think that your misfortune  sickness, lack of progress in the family, at work or business, etc.,  could be attributed to other beings with whom you commune (people around, ancestral spirits, etc.), -- can be a huge issue for public health. As a understanding of the person, which perceives the self as connected to forces and entities outside it, could present considerable challenges of its own.309 On the surface of it, this attribute may be viewed only negatively or as a potential downside. Doing so does not represent the total picture. But casting a wider perspective would reveal the overarching realization that African societies are organized around the requirements of duty and obligation to the larger community (as opposed to Western individualism). This broader spectrum makes for better understanding.                                                            309 African Studies Review, 29, 2, p. 77.  165   I proceed to test this reality with a health-related question: in matters of reproductive health and sexual rights, who owns the body  the woman, the unborn, the husband, the family, or the society? With empirical research finding as proof, community fertility desires have been known to inform or, indeed, to override the very not310 This reality endues, in spite of numerous international declarations adopted by various (typically non-governmental) organizations and labeled along the so-called universal human rights.    The upshot here is that many of similar worldwide declarations ignore cultural milieus that are affiliated with strong community-oriented traditions; thus resulting in incontrovertible tension between African ideas and Western discourses of the body and their implications. For instance, in African culture individuals reach their full stature only with the support and fellowship of their kit and kin.311 This is the only way that the community allows the individual to indeed actualize himself/herself. Consequently, international sexual rights declarations  from abortion, family planning, sex education to sexual orientation  that are constructed along individualistic Western world-views, often result in tensive backlash in much of Africa. To reiterate a point I made earlier, the /she is                                                            310 and contemporary sexual rights Reproductive Health Matters, 16, 31, p: 165. 311  Ibid, p. 162.  166  perennially incomplete and perpetually fused in the framework of a larger structure and built upon by the gifts of others. Together their actions are always in context and ultimate group objective is embodied in their dispositions.312   campaign in Botswana, Jensen, K. and Gaie, J.313 point to how yet another foreign-conceived idea is force-fed on an African setting without regard to prevailing an exclusive Western model of HIV prevention, testing and counseling program  an individual rights-based prototype  which negates the indigenous understanding of personhood or human agency as rooted in African communalism, and other existing ethno-medical beliefs and cultural practices.                                                             312 Niehaus, 2002, p. 190. But I would reiterate for the umpteenth time that strong allegiance to the community does not completely vitiate the element of individuality. If it did, there would be no rights. Yet, there is tacit de-ssarily that Africans do not believe in individualism. Any society that encourages heroism and worships it, as Africans certainly do, evidently encourages individual excellence. claim and proprietorship to it, whereas traditional society frowns on the implied possessiveness and ostentatious self-Citing Kwame Gyekye, Bernard Matolino (2011) reminds us that there is a difference between radical and moderate communitarianism, with Ifeanyi Menkiti representing the radical side and Gyekye the other. African thinking is communitarian, there is significant difference in the articulation of what that communitarian conception might be and the consequence 313 indigenous concepts of personal identity to African Journal of AIDS Research, 9, 3: 297-305. Similarly, Samuel Jegede (2009) has used an HIV/AIDS surveillance project as a Western concept of autonomy to research involving human subjects in the African context without adequate   167    The result of the prevention campaign has been insignificant if tepid in a country wimonths and above was HIV-positive in 2008). Akin to the recommendation above, Jensen and Gaie are of the view that it would serve the recipient community well if future public health policies or programs were designed and implemented with the realization that ethical principles or human rights norms are [actually not alien but] inherent in African communalist practice. Failure to, 1) recognize this cultural reality, 2) respect it, and 3) apply standard methods of research protocols, undermine our ability 314   When communitarianism is applied to the public health sphere, at least two outcomes are immediately discernible. One, because of the interconnectedness and interrelatedness of human persons (and indeed of everything else in nature) whatever happens to the individual happens to the community in which he belongs. This is apparent because the individual is integrally located and anchored in a mesh of relationships within the family, village and clan (living and dead), all of whom are primordial sources of that implication, if you are responsible for one, you are responsible for all (hence, I view it as a one-in-An action is right just (sic) insofar as it expresses respect for                                                            314 Ibid, p. 302.  168  315   Two, the African disposition sees health topics (wellbeing or illness) as a communal affair, sometimes to the point that family (or community) have a stake in regarding his treatment  a phenomenon that conflicts with the Euro-American proclivity to individual right to confidentiality. This comparative analysis should be a teaching moment for researchers, clinicians, bioethicists, students and academics as they confront multi-cultural perspectives on socio-political and morality matters.316   Next, a sure way to gauge the importance of the human person in African thought and tradition is in the premium value placed on human reproduction. Tangwa reminds us that children are so highly valued that procreation has always been the mere companionship is rare, if not completely nonexistent. A child is always welcome 317 Indeed, a human life is unaccomplished without a child. Ultimately, it becomes an integral part of what defines                                                            315 Developing World Ethics, 10, 13: 158-163. 316 Journal of Moral Education, 39, 3: 381-391, 2010. 317 Tangwa, G. A Companion to African Philosophy, K Wiredu, ed., Blackwell Publishing, p. 391. Circumstances involving taboos such as pregnancies are terminated or newborns from such wrenching events exterminated. In addition, newborns are by and large, accepted even if they were born with disabilities at birth.  169  personhood.318   There is thus a meeting (yet contra-opposite) point of interest between the African view and these sorts of outlook with the assisted reproductive methods of the industrialized world for people unable to conceive through natural methods. While the Western perspective focuses mostly on people wishing to withhold, limit (temporarily or permanently), ; the typical African cultural perspective is inclined mainly to aid the birthing of more and healthy off-springs (but would not hesitate to accept human infants even if they were born with disability) and to accord them equal (sometimes more) respect and rights as any other person. It is in this connection that biomedical or assisted reproductive methods will certainly find fertile ground in the exploration of the epistemologies of the cultural belief systems of the African.   The point above immediately opens up yet another point of departure between the African and Euro-American perspectives but However, it suffices to note that while the African concept of a person is unitary, the Euro-American concept is essentially bifurcated between persons and non-persons within the human species. As such, fetuses, human infants, young children, people with mental disorder, and patients in persistent vegetative state may be technically considered as non-                                                           318 Gbadegesin, 1993, p. 257.  170  secular moral community.    Tristram Engelhardt makes this strident point in The Foundations of Bioethics, a polemic publication that has shaped a significant chunk -conscious, rational, free to choose, and in possession of a s319 Among other things, he -this score, the African conception of person would certainly find it problematic (indeed, unacceptable).   5.5 SUMMARY  I have presented a review of the concept of personhood as commonly found in 20th century African thought. In the process, I have noted that of the different attributes that define the person in African traditional societies, what I have called the one-in-all trait, a.k.a. BEC, stand out. A remarkable perspective is here prompted  the communalist perspective which assumes priority in some sense over the individual in matters that guides right action, political choice, theoretical reflection and moral agency as the dominant approach when deciding how to enquire or act.    of communalism as well as socio-ethical duties and obligations and beyond the                                                            319 Engelhardt, T. 1996. The Foundations of Bioethics, p. 139.  171  purposes of self-African person as immersed in the various philosophical spheres, such as metaphysics and ethics (and by implication bioethics). In so doing, I think I have provided a platform on which to extend the discourse to include the larger ethical questions that frame the emerging field of bioethical practice in Africa.       Present among the numerous public health and biomedical scenarios across Africa are challenges besetting public policies and programs which cry for more articulate formulation and approach. I have thus tried to use the unique notion of personhood in African philosophical thought to bridge the bioethics discourse. This trend of thought is perhaps accurately supported by the argument that global bioethics will succeed only to the extent that it is culturally relevant. As a consequence, bioethics must expand its vision. It is with such backdrop that a host of salient bioethical issues  including issues involving human reproduction, organ transplantation and biomedical studies with human subjects  can be hashed out.   5.6 THE DIE IS CAST   In terms of positioning, the time is about ripe to gore the bull now that I have fully run the gamut and cleared the premises for my thesis. But for a quick reminder, here is the buildup. Research ethics principles grew out of the high value placed on protecting human subjects in research against a catalogue of biomedical atrocities of the past. This high value calls for commensurate high degree of responsibility for which the  172  four principles were instituted to uphold. As I have shown, while numerous studies have both extoled as well as lampooned principlism in research ethics over the years, illustrating that while they might be more suited for bioethical practice within the Euro-American tradition (even with some difficulties nonetheless), they are not exactly so suited for other multi-cultural environments (to be exact, much less suited for the Global South).   Hence, I have proposed the need to re-conceptualize responsibility in clinical trials. My proposal is hinged on the concept of selfhood; more specifically, I recommend the African philosophical understanding of selfhood.320 This conceptual relativity has become exigent given the imposition of the mainstream (read, Euro-American) autonomy-based philosophical principles worldwide (but which have clearly proved inadequate in addressing multi-cultural ethical requirements). To restate, the Euro-American influence in the formulation of research ethical principles321 are borne out of individualism, whereas if we must be fair to admit multiculturalism, much of the rest of the world, particularly Africa, would take the opposing view. The crux of this bipolarity                                                            320 There is no dispute in the fact that the underlying focus or the main ingredient of bioethics practice establish thematic issues in medical policy, practice, and research, or teasing out ethical questions that relate to the life sciences, biotechnology, medicine, politics, law, culture, religion and philosophy; the primary task essentially pertains to values  human values within a given environing sphere. The objective of bioethics always involves sorting out the ethical tension between the social world and the persons who inhabit it. 321 Due to their Eurocentric roots, (deriving for instance, from the deontological theories of Kant and Mill-Bentham utilitarian principles) the four principles  autonomy, non-maleficence, beneficence, and justice  have met with resistance in other parts of the world where incongruities tend to emerge at the local level when their West-centric biases are subjected to closer scrutiny.  173  rests largely with the philosophical conception of personhood (which in the African context, cannot be divorced from the perspectives of communalism, eco-centrism and even holism).    Given that the origination of mainstream ethical principles are founded primarily on individualistic terms, supreme emphasis is laid on personal rights, autonomy, self-determination, and privacy. In tandem, it goes with theoretical approaches which view the person as self-interested, propertied, accumulative, and possessing independent agency with power of control over others. As a result, conflicts between individual interests and those of the larger social group are ultimately inevitable. In terms of ethical theory and for instrumental reasons, this translates to assigning significant emphasis on the object of morality, the individual, to the neglect of the subject, the agent.   Contrast that with my preferred version: the African version, which portrays man not as a self-interested loner who is obsessed with privacy, status and control, but a vivacious, unique entity who is ceaselessly waxing and waning within himself but more within the dynamic interplay of relationships with forces around him both on the physical and the supernatural plains. I see the African self as a being that is hooked on a grid. The energy that he generates serves his individual needs, but is also shared with other forces around him. But as the need arises, he as well supplements his individual energy with those of other elemental forces. In other words, existing as a power point in  174  an interconnected network, he is a generator, a supplier as well as a consumer of the voltage energy of the distribution network. Note how the African man is capable of these interpersonal dynamism due to his elemental attributes of being a vital force who is imbued and animated with a vital principle and above all, is anchored in the communal operations of other forces. As such, he is a force in the hierarchy of forces, habitually in intimate consanguinity with other forces above and below him. Therefore, the fulfillment of his life is predicated on the support of other forces (humans, spirits, the biota, etc.). As a consequence, consideration for the community of other forces is always in the mix whenever ethical, juridical, ontological, epistemological, and other decisions are made. It is upon this platform that my reconceptualization stands.   Doubters might still want to ask: So if man is essentially community to the point that he is not just duty bound to contribute to it, but because it (that is, the community) is him, where then are his autonomy and self-determination? Well, I have addressed it by pointing out that the two are not contradictory  the individual can exhibit independence and voluntariness as well as attain full communal or social obligations. Indeed, it is by dialogue and reciprocity and recognizing the common good that individual rights are ultimately guaranteed. Anything short of that leads to one    I am under no illusions that my overarching suggestion about the relevance of ethico-cultural relativity, nay, re-conceptualizing responsibility from an African  175  perspective (particularly for research ethics projects in Africa), is certain to collide with mainstream accounts within bioethics. Refuters of this argument are likely to question ,r or not it would change much, if anything. But a more objective assessment will recognize that the four principles are not an all-purpose set of tools fitting enough to sufficiently serve the gigantic enterprise of global bioethics. At best, it can be handy as a convenient lever that steers different value judgments close enough so everyone can keep their own opinions.   Figure 4: Balancing mainstream with multi-cultural practices.    autonomy-driven mainstream orientation within bioethics, and that orientation has  176  322 has historically aligned with the goals of public health, has since become a force to be reckoned and effectively turned the argument on its head: the freedom of the individual can no longer be seen to trump the common good or the public interest. Hence, calls have been increasing for the balancing of individualism with a multicultural approach (communalism). This is because individualism has been the view that drives much of bioethics today and weighing disproportionately in favor of Euro-Americanism (in Figure 3 above, to these calls, I aim to insert the African epistemology about personhood, a major perspective in African philosophy that changes the equilibrium in deliberations pertaining to responsibility for research subjects in clinical trials.    I argue that when clinical trials (much of which are currently conceived in the Global North) involve other cultures (particularly Africa  in the Global South, where many of the trials are often offshored to), there is need to frame and apply some additional considerations. The status quo has yet to properly formulate these considerations. As I have already articulated, the philosophical/cultural significance of the person in the African setting differs markedly from the Western perspective. I therefore see my suggestion to re-conceptualize responsibility from an understanding of the African perspective as a landmark point at which to address myriad bioethical                                                            322 American Journal of Public Health, 92, 2:170.  177  issues one of which is responsibility in clinical trials; and providing a path to head off unnecessary philosophical, cultural and ideological tensions that are still lurking ahead.   The crux of my re-conceptualizing project, if it must be restated, is as follows: when communalist principle (personhood within the context of the community and his milieu) is applied to the public health sphere, at least two outcomes are immediately discernible.    One, because of the interconnectedness and interrelatedness of human persons (and indeed of everything else in nature) whatever happens to the individual happens to the community in which he belongs. The individual is integrally located and anchored in a mesh of relationships within the family, village and clan (living and emotional, and spiritual existence  wellbeing or otherwise. By implication, if you are responsible for one, you are responsible for all (at least in some degree hence, I view it as a one-in-all paradigm). Research ethics is right, just, proper, and culturally sensitive so long as it expresses respect for communal relationships in which people both identify with each other and exhibit solidarity with each other.    Two, because of this communal disposition, it follows that almost every issue with the individual is correspondingly regarded as a communal affair, sometimes to the point th 178  illness/wellbeing and having a role in the decisions regarding their treatment or upkeep  a phenomenon that conflicts with the Euro-American proclivity to individual right to confidentiality. This comparative analysis should be a teaching moment for researchers, clinicians, bioethicists, students and academics as they confront the African perspectives on morality.   Furthermore, I point out (with some personal sense of satisfaction) that the recommendations of the GMM project (see Chapter 3) directly boosts, without intending to do so, some crucial points that relate with my thesis (to re-conceptualize responsibility in clinical trials). They include the validation of the ramifications that are inseparability between humans and the environment (including human health and environmental health) as well as the interconnectedness and interrelatedness of all reality. Notwithstanding that the transgenic mosquitoes project had no primary human subjects, yet it is remarkable how the design of this public health intervention tool seriously considers the need to target the pathogens in a way that does not harm either environmental, or human health (plus, anything else in-between, e.g., the health of non-human animals). In addition, it recommends that the overarching ethical goal in human subject research should be to respond to obligations to individuals being asked to participate, in this case, people living within the trial site who are classified as  as well as others in the adjoining communities being asked  179  to host trials; while maintaining transparent and respectful channel of communication and protection plans throughout and long after the trial period. Thus, to accept the GMM recommendations, particularly the linkage between human and environment health, etc., is to commit us to the widely shared African philosophical perspective which expresses first, the intrinsic value of the human person, and the holism or interconnectedness  the unity  of the ecosystem at large.323       Overallin public health research particularly remarkable in the way it provides for respectful manner of approach, the role of effective education and communication of goals and methods, and the provision of opportunities for follow-up discussions. That to me is an important element in reconceiving responsibility in clinical trials. As I have noted, the community engagement approach takes on a concentric relational web: from the core non-traditional human research subjects, to families, neighbors, communities, etc. at the research site. The outer spectrum recognizes individuals who do not typically fall within the definition of human subjects but who might be affected by the conduct of research in some way.                                                             323 In its complete sense, this would cobble together both the physical and metaphysical/ontological realms of existence.  180  It is scarcely surprising that this suggestion lends support to the community permission model324 that have long been prescribed by many authors. It is a model that requires permission and approval (my emphasis) from local authorities before biomedical studies are conducted.325 As a practical, ethically appropriate, and common-sensical standardized practice with a potential to eliminate or minimally reduce the chances of disrupting traditional social structure and customs of host communities.  My reconceptualization project is further aided by the GMM model for biosafety, ethics of engagement, etc. It thus reveals the need to improve the links between research and health care delivery and to promote the environmental, cultural, socio-political and economic processes that are involved so we can begin to widen our understanding of the vicissitudes of the impacts of public health research (or any other research for that matter). The GMM project, as a public health initiative, shrewdly recognizes that clinical trials ought to be applied within the context of prevailing social, cultural, legal, regulatory and political institutions. Couched within the philosophical commitment to evaluate clinical trials in terms of ecological and human health, the GMM project seems to rejig our thinking and thus spark a healthy debate. It does so while resolutely                                                            324 I stand corrected by Paul Thompson who rightly notes that the two themes are not exactly the same. from the community permission model. 325 One of the many suggestions to this model include that of Clinical Infectious Diseases, 41, 2: 255-259.  181  pursuing efficacy, transparency, responsible sense of purpose, quality and consistency in the process of testing and regulating new genetic technologies.    After several decades of viewing bioethics and environmental ethics as strangers (distinct fields of inquiry), it appears that our collective capacity to holistically understand and discuss these issues is witnessing a revamping of sorts. It is another admission of the inadequacy of principlism particularly in non-Western milieus. Also, it could be seen as a benchmark that clearly provides explicit and systematic delineation of steps for conscientious researchers doing work particularly in the Global South so as to make coherent the already widely accepted principles and benchmarks in international agreements or treaties including the Nuremberg Code, the DoH, and the Belmont Report.  5.7 CONCLUDING THOUGHTS   In ancient Greece (critical in shaping Western thought), philosophy was a search for the truth about nature and truth about man. In African thought (a philosophical tradition that precedes all others) it is about the search for the meaning of being, existence, life  all life in their order, interrelated as one continuum that finds fulfillment in the creator (God). At the fulcrum of that continuum is man, the center of all earthly life, all creation and in which creation is most made manifest. In light of this, there is little doubt why the subject of personhood is both pivotal and zesty in African thought.  182  Indeed, the richness of African philosophy can best be seen in ethics and metaphysics. are the dominant issues. [More specifically], the concept of a person is probably the topic that has evoked the most interesting di326   Advances in biomedical research exemplify the many strides in modern science. Thanks to clinical trials, these medical advances represent the unleashing of the human brain power in making his dreams a reality and in improving his/her physical, emotional, and material well-being. Sometimes though, scientific research has turned from being a quest for truth to becoming a search for material gains. This drive to dominate nature easily risks the domination of the human person along with attendant ethical problems  problems to which science has no clue, much less an answer. In this way, the very essence of humanity stands the risk of being compromised, sometimes irreversibly. This dissertation primarily aims to reconfigure our understanding of responsibility in clinical trials from the standpoint of African philosophical notion of personhood. To accomplish this task, we must be willing to recognize that the West-centric research ethics principles have both been inadequate overall, and have continually presented incongruous dispositions in non-Western societies, hence the urgent need to complement them with other multicultural perspectives.                                                             326 Wiredu, K. 2004. p. 16.  183    While I have not advocated a total renouncement of principlism, I have recommended the higher-order and more encompassing valuation of the human person (which by the way incorporates principlism but goes beyond it). This is done through the African philosophical lens of viewing the human person primarily with reference to his/her immediate surrounding  family, community, physical, and spiritual/metaphysical environment.   To sum up; in Chapter One, my analysis first took on the complex issue of what is meant by being responsible. For so longtheme theorists claim to have long shredded into tiny analyzable pieces and cobbled back. But regardless of this presumption, it however continues to challenge philosophers, neuroscientists and psychologists as they labor to understand our drives and motivations. In this study, I have not ventured to reinvent the wheel; instead, I have tried to present a valid perspective in an unorthodox fashion.    I have noted that responsibility is a term that describes situations and actions involving moral agents  on a day-to-day basis. In particular, it suggests as well as assumes a form of moral (social, legal, etc.,) obligation which we owe to ourselves, to others, to the society, and to the environment within a given circumstance. The obligation to be responsible can at times be formal, i.e., codified into laws as in laws guiding business transactionshuman conduct, e.g. without trespassing into  184   property such as simply mowing your own lawn. In these instances, responsibility comes across as both a normative as well as a descriptive term.    Besides, I have also drawn attention to the fact that responsibility ought to be conceived of in terms of a virtue. In presenting an account of the virtue of responsibility, I went to great lengths to add impetus to the reasoning that goes with both individual and collective responsibility. I have resisted to be drawn into the sea-saw argument of whether or not we are responsible for our actions, to argue that responsibility especially that which is situated within the African cultural milieu, can help resolve issues that confront public health professionals and researchers. My discussion focuses on public health responsibility for certain social problems as well as how virtue of responsibility can point to what it means to act responsibly in public health (clinical trials). I have underscored the point that moral responsibility is neither contractual nor optional, yet innately other-regarding. As a cue to that, I presented responsibility in the context of virtue as a way of determining character ideal which lies beyond the range of self-interest.   The deep and dense literary corpus on responsibility that I reviewed include responsibility to fellow moral agents as being intrinsically and uniquely valuable; the obligation to be responsible for the other by Levinas; Gustafson lity as an ought; or Richard Niebuhr and Bernard  185  surprisingly, most of these viewpoints exhibit some trappings that relate with virtue ethics. Like virtue ethics, they all emphasize the acquisition of moral character  an attribute that harks back to Aristotle, Plato and even the more ancient African mystics (in Egypt and the Nubia region).   In effect, it is easy to see how responsibility as a virtue runs deep in this analysis. As a character trait or a disposition which is entrenched in its possessor, responsibility as a form of virtue, is a state of character by which persons are defined. I extend this /entities in the legal sense. And just as virtue can be cultivated and habituated in persons with flesh and blood, so too can it be embedded or inculcated in the formations of legal entities in ways that are action-guiding. As noted, the central question ithe pursuit of the good life for humans. Likewise, legal persons  corporations. Yes, if for legal entities is profit making, it ought to be within a social, not a self-centered context. I recognize that my position is unacceptable to those who think that corporate reiterate that corporations cannot have it both ways. In their public relations, corporate entities seek to be reliable and even trustworthy (to mention just two). Both concepts, just like responsibility, are moral appraisals or normative notions by which entities are judged or assessed in the space of social norms. As I have stated, both the good of the agent and the good of others, result  186  from the exercise of virtue.    Finally, for the chapter, and given that the 1996 drug experimentation with children by Pfizer provided the stimulus for this research, it is justified that I have paid close attention to address whether or not corporations have moral responsibility on top of the responsibility to generate revenue for their shareholders. I have demonstrated my opposition to the argument that shields corporations from social responsibility merely on the claim that profit-making trumps everything else. Just as companies cannot engage in such questionable practices as polluting the environment with toxic chemicals, producing unsafe and lethal products, or lying and deceiving in advertising, so too would biomedical corporations such as Pfizer be held to similar ethical standards when they conduct research with human subjects, and to do so with sensitivity to cultural norms. Next in Chapter 2, I examined the research ethics and as a concept that has endured since the dawn of experimentation, presenting a platform for analyses on a wide range of issues. That platform is probably more critical today than it has ever been. For instance, the 1996 clinical trials which followed severe meningitis and cholera outbreaks in Kano, a northern Nigerian city that involved huge ethical issues with the American pharmaceutical giant Pfizer, provide both the catalyst and a test case for this dissertation research. But I am quick to remark that the citing of this case does not only serve to illustrate the imposition of  187  the Euro-American autonomy-based philosophical principles on other cultures (particularly the African cultural milieu). It also points to the arrogant, ruthless expansion and exploitation of scientific and biotech markets; to the point that even the minimum that international research ethics principles demand was virtually unmet in the said clinical trials.   In consideration of this, I highlight the need for responsibility in clinical trials to be that character trait or ideal facilitating moral agents in their professional duty to serve the common good while recognizing multiculturalism. Hence, I totally communities, [it] can particularly be helpful to professionals in discerning appropriate ethical conduct in multicultural settings and inte327   Nonetheless, as far as the history of biomedical research goes, the importance of the value of persons and the protection of that value, have never been in question. I have argued that the intension for which the now familiar series of guidelines and codes for human subject protection ought to be strengthened more than ever before, not least of all due to the impacts of globalization.     I argue that when clinical trials (much of which are currently conceived in the Global North) involve other cultures (in the Global South, e.g., Africa, where many are often offshored to), there is need to frame and apply some additional                                                            327 The Counseling Psychologist, 24, 1:4-77  188  considerations. The status quo has not made provisions to properly articulate these considerations. As I have already enunciated, the philosophical/cultural significance of the person in the African setting differs markedly from the Euro-American perspective. I therefore see my suggestion to re-conceptualize responsibility from an understanding of the African perspective on selfhood as one way of addressing the issues and providing a path to head off philosophical, cultural and ideological tensions that have confronted, and will continue to confront us going forward.   Then in Chapter 3, I examined relevant aspects of the WHO-sponsored  Framework for Testing of Genetically Modified proposed to tackle the twin scourges of malaria and dengue fever. The most outstanding aspect of this public health tool for me remains the unprecedented clinical trial protocol that it recommends. For instance, responsibility in clinical trials covers a wide range of ethics and engagement, community enlightenment and authorization in a concentric relationship. From the core human research subjects, to their families, friends and the community. The outer spectrum recognizes individuals who do not typically fall within the definition of human subjects but who might be affected by the conduct of research, either because they reside near the research project site, or that their daily activities and/or livelihood, including economic interests, could be affected by the research activities; etc.     equally ground-breaking in the manner that  189  it plans for environmental safety. For instance, they suggest ways of channeling the experimental pathogens in a way that does not harm either environmental or human health (and admittedly, health of non-human animals too). These recommendations thus presaged the thrust for my reconceptualization project which I addressed in Chapter 4.   Finally, in Chapter 5, by bringing to bear its African philosophical dimension. The notion of personhood in African thought provides a perspective of what responsibility can mean as it applies to biomedical clinical trials with human subjects. Ultimately, this move boosts my argument to re-conceptualize responsibility in clinical trials. While opposing individualism (a Euro-American mantra), the African perspective stresses communitarianism. As such, responsibility for (and by) the individual can only make sense through the community in which he is rooted.     As I have observed, when communalist principle (personhood within the context of the community and his milieu) is applied to the public health sphere, the interconnectedness and interrelatedness of human persons with everything else in nature is easily discernible such that whatever happens to the individual happens to the community in which he belongs, and to the environment in which he is situated. The individual is integrally anchored in a mesh of relationships within the family,  190  physical, psychic, and spiritual existence  wellbeing or otherwise. By implication, if you are responsible for one, you are responsible for all (hence, I view it as a one-in-all or bio-eco-communalism, BEC, paradigm). Research ethics is right, just, proper, and culturally sensitive so long as it expresses respect for communal relationships in which people both identify with each other and exhibit solidarity with each other and with everything else in the environment.       Also, because of this communal disposition, it follows that almost every issue with the individual is correspondingly regarded as a communal affair, sometimes to wellbeing and having a role in the decisions regarding their treatment  a phenomenon that contrasts with the Euro-American proclivity to individual right to confidentiality. This comparative analysis should be a teaching moment for researchers, clinicians, bioethicists, students and academics as they confront the African perspectives on morality. In final analysis, responsibility in clinical trials is seen in terms of not only for the traditionally defined human subjects, it includes by extension responsibility for family members, friends, neighbors, immediate community, extended community, interest groups, the health and lives of non-human animals, and even the physical environment. It is a fallacy to think that humans can exist without the environment they live in. Ultimately, we ought to see beneficence, non-maleficence, justice and respect for the individual as beneficence,  191  non-maleficence, justice, and respect for the autonomy of everyone and everything around him (in varying degrees). In a sense, we are not just a part of nature, we are nature. In this way, the interconnectivity and inter-dependability, as well as the wholeness of reality are thus underscored, along with attendant socio-cultural, political, and economic ramifications.                       192  Figure 5: Study summary chart                 Goals Prominently position the African notion of the self in clinical trials context  Draw further attention to the problem with principlism in multicultural settings Stimulate interest and re-assess the failed assumptions of universal moral principles Develop a reliable framework of analysis Encourage African thinkers to do more promoting multiculturalist ethical values Urge for the reconciliation of bioethics and environmental ethics [holism]. Methods  Review of related literature (responsibility, clinical trials, selfhood)  Retrace medical events that foreshadowed ethical codes  Draw from WHO transgenic mosquitoes project  Content analysis. Integration of the Trifecta Themes  OUTCOME Responsibility  Formal/informal, normative or descriptive obligatory building block for order in all human systems  Collective, mutual & individual    As a virtue or a character trait, habituated over time  Moral, legal, social, mental accountability/ call to action  Obligation to be accountable for oneself, the other; intrinsically and uniquely valuable  Maximizing profits plus CSR   Clinical Trials  Respect, individual rights, etc. for human subjects  Pursuit of efficacy, transparency responsible sense of purpose, quality and consistency in testing  Community permission, public engagement/outreach & education  Biosafety, ethics of engagement, independent review boards, etc.   Prior, during & post-implementation surveillance  Human/environmental health  Tying research with societal ramifications    African Selfhood  Energy-radiating vital force above all other creations (plants, animals, minerals)  Exists within a hierarchy of forces above and below him  Fulfilment depends on support of other forces (deity, humans, spirits, plants, animals, minerals, etc.)  African self = communitarian; Euro-American self = autonomous, self-interested, propertied, personal goals, control, sensuous, status, etc.  African self = rational, conscious, free, cooperate wellbeing, etc.; made meaningful only centrifugally with the social environment; hence, BEC.   Re-conceptualized responsibility in clinical trials goes beyond the bare bones of principlism to concentrically connect interests of all stakeholders: human subjects, family, host community, distant communities, the environment, animals, minerals, etc.    193  5.8 STUDY LIMITATIONS/DIRECTIONS FOR FUTURE STUDIES  The focus of my research is clearly framed within the confines of redefining or reconfiguring responsibility in clinical trials with the understanding of selfhood in aspect of the subject area or conclusively settled every matter in this regard. My analysis here is meant to join forces with scholarly discussions that have been gathering steam on the topic of cultural diversity in global bioethics. Hence, I align with the momentum which is aimed at forging an appropriate rubric for practice particularly with reference to Africa. In the main, I have argued that the autonomy-based bioethical principles are too narrow and urged for a more comprehensive consideration for the self  the substrate of clinical trials and the larger bioethical project  using the African philosophical insight about self.    Here I identify a handful of topics that were either partly covered or not covered at all in my exegesis, and to which greater attention are required:  1. I urge for relentless energy to resist the wool over our collective eyes on the question of ethical universalism. Evidence are mounting that even the Euro-American stance on principlism does not capture enough, including the different European cultural structures.  The basic ethical principles may function as reflective guidelines and important values in European culture but they can no longer be assumed to be  194  universal everlasting ideas or transcendental truths.328 More objections to Beauchamp rality have continued to find it we could convincingly show accepts.329  2. Environmental health is the basis of human health. In fact, it is an axiom to say that the state of the natural world determines the state of everything residing in it. In the same token, environmental health ethics is ethics of healthcare or bioethics. There is a crying need to frame environmental discourses in ways that connect with public health discourses (or vis-à-vis) in order to provide more holistic understanding of issues. For instance, the clinical trials process can never be sufficiently made meaningful without reference to environmental ramifications (be they physical, social, or spiritual). Part of my analysis in Chapter 3 point to this self-evident fact but a lot more needs to be done. 3. In many African settings (rural and urban), traditional medicine has played significant role in the healthcare delivery since the emergence of time. More recently it has complemented the modern medical practice. But it is almost inconceivable to put in the same bucket list the modern form of clinical trial protocols along with traditional medicine practice. However, it would be worth the effort to elevate the notion of self in                                                            328 integrity and vulnerability  Towards a Medicine, Health Care and Philosophy, 5:235-244. 329 Cambridge Quarterly of Healthcare Ethics, 23, 1: 75-85. I also credit my colleague, Dan Beck for calling my attention to this information.  195  indigenous biomedical practice and discourse by researching it further. 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