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DEMOCRACY AND INFORMED CONSENT

By

Tamayo Okamoto

A DISSERTATION

Submitted
Michigan State University
in partiaI fquiIIment of the requirements
for the degree of

DOCTOR OF PHILOSOPHY

Department of PhiIosoohy

1990

ABSTRACT
DEMOCRACY AND INFORMED CONSENT
BY

Tamayo Okamoto

Two aims of this dissertation are; (1) to describe the
American experience of informed consent. to 'the Japanese
audience whose medica'l practice, despite its successes in
health care, is feudal in terms of physician-patient interac-
tion, and (2) to make an appraisaI of informed consent as a
part of the theory of participatory democracy.

Informed consent is a medica] practice that requires a
physician to discIose necessary information to a patient and
obtain consent from the Iatter with regard to her proposaI of
a diagnostic or treatment procedureu Consent makes sense onIy
when it is the resu'lt of understanding and vquntariness.
So, the reaI message of informed consent is its democratic
nature, namer patient’s participation in medica‘l decisionmak-
ing against traditional medicine where a physician has been
the soIe decisionmaker.

In the first chapter I discuss Japanese medicaI practice
that needs informed consent. The second chapter deaIs with
the American history of informed consent and compares the
IegaI doctrine and ethicaI idea of informed consent. The
third chapter attempts a phi‘losophicaI reconstruction of
informed consent. It deaIs with the conversation modeI of

informed consent suggested by Jay Katz and the spectrum of

Tamayo Okamoto
understanding from the informational level through the
hermeneutical level to the shared decisionmaking stage. The
legal doctrine concerns mainly informational understanding.
Hermeneutical understanding attains ethical goal of com-
monality in the fusion of horizons (Gadamer). Democratic
understanding is directed to the solution of problems by way
of common understanding and shared decisionmaking (Habermas).
Informed consent should mean shared decisionmaking realized
only in the conversation model instead of indifferent,medicine
that informational understanding implies or of hermeneutical
medicine where decisionmaking is still in the physician’s
hands. Consistent claims throughout the dissertation address
the efficacy of language use in mutual communication and the
idea of participation. The final chapter deals with
participatory democracy in which social policies as well as
ethical norms are placed in the open, the practice of informed
consent being no exception. Our final discussion concerns
social conditions that could make informed consent work. It

includes proposals for public policy for informed consent.

ACKNOWLEDGMENTS

I thank the members of my committee, Professors Bruce
Miller, Richard Peterson, Albert Cafagna and Donald Koch, and
Professor Karin Wurst, for their many useful comments and
suggestions. I feel especially indebted to Professors Miller
and Peterson for their kind guidance during the writing of
this dissertation. My deepest gratitude is due to my husband,
Mitsuo Okamoto, without whose moral and material support, my
study at Michigan State University would not have been

possible.

iv

TABLE OF CONTENTS

INTRODUCTION .............. 1
CHAPTER I THE SILENT MEDICINE OF JAPAN .... ...... 9
1. Conflictual medical relationship ............ 9
2. The German legacy ............ 23
3. Responses to informed consent ............ 30
CHAPTER II INFORMED CONSENT: THEORY AND PRACTICE ... 42
1. American history of informed consent ........ 42
2. Informed consent legislation ............... 62
3. Practice of informed consent ............... 7O
4. From the legal doctrine to ethical principle . 77
CHAPTER III UNDERSTANDING .......................... 90
1. The conversation model of informed consent ... 91
2. Informational understanding ................ 100
3. Hermeneutical understanding ................ 107
4. Democratic understanding ..... ............... 123

CHAPTER IV DEMOCRACY, AUTHORITY, PUBLIC POLICY

...... 140

1. Participatory democracy ............. ....... 140

2. Informed consent, authority, discretion ...... 152

3. Obstacles for democratic medicine . ........... 158

4. Proposals for democratic medicine . ..... ....... 162
CONCLUSION ............. 168

INTRODUCTION

The main topic of this thesis is informed consent. To

thematize informed consent at this time may not be a very
interesting project for contemporary issues in medical ethics
and professional ethics in the United States. Informed
consent has been discussed for more than three decades now.
It is already eight years since the President’s Commission’s
report on medical decisionmaking appeared. With so much
literature available on this subject, there seems little more
to say. Yet I want to undertake two tasks concerning this
particular subject.

One is directed to the state of medical practice in my
home country, Japan, where medical ethics has emerged only
recently as a discipline. The physician-patient relationship
in Japan is similar to what seems to have existed in the
United States several decades ago. When I left my country
eight years ago in 1982 I had left behind a series of unhappy
encounters with physicians. One physician was simply mute,
another smoked in front of me though I was an asthma patient,
still another started arranging a tonsillectomy for my small
son without consulting me. I was one of those birthing

mothers to whom an episiotomy was administered without my

2

knowledge, and this generated considerable silent resentment.
I was also taken into the famous non-disclosure plot on
terminal cancer cases. Looking back, I realize that I was a
passive, dependent, ignorant, and unreflective patient. Most
of the physicians I saw were not only unwilling to communicate
with patients but also lacked awareness that they were dealing
with persons. ‘The study of informed consent in medical ethics
here in the United States has taught me that the physician has
a duty to inform and obtain consent from the patient and, more
importantly, that the patient should and can be an autonomous
decisionmaker. These were totally foreign things for the
ongoing medical relationship in Japan until quite recently.
As a sign of improvement there is now a new move to officially
introduce the idea of informed consent. So, while the study
of informed consent may be outmoded in the United States, a
correct exposition of the idea is a needed and timely project
for Japanese physicians and patients.

This study has also persuaded me that the most important
message of informed consent is that it is a part of the theory
of democracy, and that the physician’s authoritarian posture
and the patient’s dependent attitude are inappropriate to
citizens in any society where democracy is the declared way
of life. The study of informed consent has relevance not only
for medical practice in a Far-Eastern country but also for
reflection on the overall scheme of democracy, which is the

only option to take for a global community which we can

envisage in the next century. Viewed in such a perspective,
informed consent has yet to find a secure place in philosophi-
cal, ethical discussions of democracy. The relationship
between physician and patient seems the last one to be demo-
cratized. The imbalance of knowledge and power between
physicians and patients is too easily taken for granted. A
medical relationship is the prime locus where paternalism is
justified because of alleged incapacity, irrationality or
immaturity of one party. Even in the United States the intro-
duction of the idea of informed consent has not transformed
every physician into a less authoritarian, open-minded care-
provider, and every patient into a mature, independent
decisionmaker. In the Western tradition individual selfhood
may well be instilled in the socialization process. But when
it comes to medical treatment, most people still want to take
a child-like role in front of a physician. It seems that
there is a need for establishing an autonomous self who can
make a rational decision in a medical context. It is time to
secure a place for informed consent in a theory of democracy,
and present it in the curriculum for educating a democratic
citizen.

So my second task in this treatise is to place the idea
of informed consent in a proper place. I want to do it by
seeking a linkage between the autonomous subject and communal
orientation in the concept of understanding which finds its

expression in communication with one another. To thematize

4

understanding is also appropriate from the standpoint of the
study of the elements involved in informed consent. For
informed consent to be realized, it is said that at least two
conditions have to be met, namely, understanding and volun-
tariness. Because voluntariness is (or should be) based on
understanding, the discussion of understanding covers the
issue of intentionality. It also has a strong connection with
reflection and judgment.

My claims in this treatise are : (1) that a higher level
understanding not only validates consent-giving but demands
a truly democratic interaction without domination in a medical
context; (2) that it is necessary and possible to make the
physician-patient relationship as democratic as possible; and
(3) that informed consent, when fully implemented, is the only
institution to realize that sort of relationship. The
following is the main scheme of this thesis on informed
consent. In my discussion I owe much to medical ethics
literature that appeared in the United States in recent years.
I am indebted especially to Jay Katz’s characterization of
traditional medical practice as silent. medicine and his
proposal of the conversation model as the only feasible one
to realize informed consent in an ideal manner. I have also
found JUrgen Habermas enormously helpful for delineating the
spectrum of understanding, thereby providing a new perspective
on medical relationships. In the first chapter, I will

discuss the problems of Japanese medical practice which lacks

5

the idea of informed consent. Although Japan’s public health
care policy has greatly attained the goal of eliminating
diseases, it attacked them without paying attention to the
patients; silent, paternalistic medicine has long been
operative. One origin of the present practice is traced to
the official introduction of German medicine in the last
century; German idealism was also instrumental in the
formation of Japanese political ideology which supported and
justified the pre-war authoritarian structure which is still
an undercurrent.of undemocratic relationships and basic social
structure. IiNill then focus on how the medical establishment
has approached the problems of medical ethics in recent years
and discuss the problematics found in the new report of
hearings of the JapaneserMedical Association (JMA) on informed
consent.

The second chapter concerns the theory and practice of
informed consent that has been developed in the United States.
The main focus is the contrast between the legal nature and
the ethical requirement of informed consent. I will discuss
the meaning and the limitation of the legal doctrine of
informed consent, and touch upon the actual practice which
falls far short of an ethical, democratic ideal. It will be
shown that the ethical idea of informed consent is closely
connected with hermeneutical understanding, but also with
democratic understanding of self, others, community and

objective knowledge.

6

In the third chapter the main focus is the conversation
model and the concept of understanding in the context of
informed consent. To understand information disclosed is the
first step to be fulfilled in the procedure of informed
consent” Understanding involves more than making sense of the
given, objectively confirmable information within a certain
context. Understanding is viewed in a certain spectrum. The
most elementary type deals with objective knowledge. The
second is hermeneutical. Since medical practice in iden—
tification and cure of a disease involves human beings as
agents whose mental operation is the prime cause of actions,
understanding should involve a hermeneutical approach which
tries to derive meanings from the human actions. The her-
meneutical approach counteracts the al l-objectifying, physica-
listic approach in medicine. However, the limitation of the
approach lies in the tendency to keep the status quo intact,
and not to reform the vertical relationship of physician and
patient in a fundamental way. The third level has to do with
democratic decisionmaking. The conversation model of informed
consent proposed by Jay Katz incorporates the latter two
phases of understanding. But there are variations of the
conversation model. Hermeneutical conversation does not
necessarily aim at democratic decisionmaking. A democratic
conversation model encompasses features of all three levels,
namely, objectivistic, hermeneutical and shared-decisional

understanding. Habermas’ communication theory will be

7
evaluated as promising to endorse the democratic medical
relationship that Katz’s conversation model addressed.

In the final chapter I will discuss the basic
understanding of the theory of participatory democracy in
which informed consent will be placed. First, the legacy that
Rousseau started will be reviewed. Then, the theory and
practice of informed consent will be evaluated as something
to be discussed and employed as binding in a democratic forum.
It will be argued that the traditional authority of the
medical profession should be exposed, demystified and reevalu-
ated. To make medicine as democratic as possible, I will
discuss a proposal for public education about the implemen-
tation of informed consent.

Some important features in medical care, such as the
issues of gender difference and economic justice, have to be
mostly left out of my consideration. The specific problematic
in the medical relationship is here taken as gender-neutral.
I also have to assume that there is no grave injustice about
accessibility to medical care. But, since implementing
informed consent in an ideal mode can be costly in a capita-
list society, some economic consideration has to enter my
discussion. Medicine should to a large extent be socialized.
That means the right to medical care should be a part of
subsistence rights which a democratic society is expected to
guarantee. But even when distributive justice is realized,

it is possible that a medical relationship remains gravely

8
undemocratic. Socialized medicine could be concomitant with
paternalism of the state, unless it is a product of truly
democratic procedures. The discussion of informed consent
will not lose its significance in a society where basic needs

are taken care of.

CHAPTER I THE SILENT MEDICINE OF JAPAN

The theme of this chapter is medical practice in Japan,
which is about to face the official introduction of informed
consent. A correct conception of informed consent has never
been more needed than now because of the growing interests of
the general public in better medical practice and because of
the responses of the medical establishment expressed in their
reports and statements. In the first section I will mention
issues of the physician-patient relationship and focus on a
recent lawsuit and the judicial handling of the case. The
description of the issues will present a contrast, or rather
a serious contradiction, within an advanced capitalist and
highly (although unbalancedly) technological society which,
despite its outward democratic appearance, operates largely
on traditional principles of social and human relationships
that are clearly undemocratic. There is no serious shortage .
of medical care, but the lack of democratic interaction in
medicine needs attention as it is the cause of much unspoken
discontent and mistrust toward the medical profession. The
second section will deal with the German legacy of Japanese
medical practice and philosophical attempt to endorse this

heritage which has hindered a full democratization of ways of

10
life in society. I will discuss two representative theories
of society and human relationships which can be contrasted
with Western participatory democratic_ideas. In the third
section I*will discuss the attitudes of the medical establish-
ment toward the issue of democratizing medical practice in
Japan. It will be suggested that although the concept of a
patient’s giving consent upon appropriate information may not
be a difficult one for the Japanese to accept, the concept of
a patient’s participation in decisionmaking in medical matters
would be too radical for both physicians and patients. If
presented sugar-coated to suit the Japanese taste, however,
informed consent will lose its liberating power as a demo—

cratic idea.

1. Conflictual medical relationship

0n the external level Japan is on a par with other major
industrial forces in the world equipped with the state
apparatus of parliamentary democracy. The Japanese constitu-
tion is called the "Peace Constitution“ because} war is
renounced forever and various individual rights are guaran-
teed. In public health care Japan is one of the most develo-
ped countries. Statistically, the Japanese enjoy the greatest
longevity and the lowest infant mortality rates in the world.
After the postwar introduction of American medicine, efforts
were made to eliminate diseases such as tuberculosis and to

deal with high infant mortality. The death rates per 100,000

11
population have decreased from 1,087 in 1950 to 615 in 1987.
Japan was so quick to provide kidney dialysis machines that
no serious problem of allocating limited resources has
existed. A correspondent for The New England Journal of Medicine
reports that ”Japan has more CAT scanners per capita than the
United States" (Iglehart, p.1166).

All the same there is much mistrust and dissatisfaction
among patients with the medical profession. The charge of
'reckless medicine’ is made against the practice of those who
exploit medicine for their own personal interests. Physician
overcharges (to the insuranceiagencies) for the reimbursements
for their services, and large-scale tax evasion, have been
social problems for quite a while. Patients are puzzled by
the enormous amount of prescribed drugs which do not seem
necessary. A close link between the physicians (who can both
prescribe and dispense drugs) andflthe pharmaceutical companies
seems to be immoral rather than just indiscreet. A visit to
a physician’s office is described in a popular saying, "Three
hours’ waiting, three minutes’ consultation" which is actually
routine, especially at an out-patient office of a large
hospital. The author of a Japanese book titled Reasons Why
Doctors Are No Longer Respected was himself a physician. He
blames Japan’s reimbursement system for physicians’ uncon-
cerned behaviors. He is not the only one who says that the
system based on fee-for-service and universal insurance is an

incentive for more patients to visit doctor’s offices even for

12
trifling reasons and for physicians to dolonly calculable ser-
vices such as testings and dispensing of drugs (Nagai, p.27).
Physicians justifiably claim that their effort to spend more
time in the initial consultation is not duly rewarded. 0n the
other hand it was the physicians who were mainly responsible
for making medical practice very lucrative and expanding their
power and authority through accumulated wealth. Physicians,
who deplore that medicine has transformed itself from the art
of jen (humanity), which used to be its ideal, to the art of
arithmetic, where business or economics plays an important
role, think that the solution to the problem will come from
the recovery of medical practice which used to be operative
on the basis of the age-old principle of jen. This was
actually the suggestion made recently by the present president
of the Japanese Medical Association (JMA) (Haneda). Advanced
technology and changes in clinical management has transformed
traditional medicine into a less humane, less personal one.
Surely the nature of the relationships should be adjusted to
a new medical practice which did not exist a few decades ago.
But the solution for the problem is not found in the retrieval
of an old ethic. Unlike those well-meaning physicians who
suggest such a measure, one can justifiably point to a
hitherto unheeded truism that patients can have a say about
the treatment of their own problems. Further, instead of
silent medicine, there seems to be something good about having

a conversation between physician and patient and allowing the

13

patient to transform from a passive, dependent beneficiary to
an independent decisionmaker who can participate in medical
decisionmaking. But such transformation would be impossible
while physicians want to keep exercising their paternalistic
authority, and reject patient’s active participation. The
idea of informed consent should pose a serious challenge to
the traditional physician-patient relationship. 0n the other
hand, it is also very likely that the idea will not be taken
all that seriously in order for the relationship to change
fundamentallyu One may expect the judiciary, as the protector
of constitutional rights, to acknowledge patients’ right to
self-determination. But it has not happened yet.

To illustrate this point I would like to cite one recent
incident of a law suit filed by the family of a patient who
had never been told by the physicians that she had a gall-
bladder cancer. In this case (Mak/no vs. The Second Nagoya Red
Cross Hospital), even the family members were kept ignorant of
the diagnosis. Initially her hospitalization had been urged
in order to treat her gallstones. Apparently the patient
thought she could ignore the gallstones, so she went ahead to
make a scheduled sight-seeing trip abroad. The patient was
a nurse at a different hospital, and her doctors at the Red
Cross Hospital were not aware of that. She died a few months
later from cancer. Japanese civil law (not medical law) dic-
tates that when an invasive measure is going to be exercised

there are duties to explain it and to seek consent from the

14
person to whom the act is done (Kato, p.101ff). But since
such a duty was not observed, the deceased patient’s family
sued the hospital for the failure to explain which caused the
patient’s misjudgment of her own problem and her decision to
forgo the recommended treatment (which was not for her

disease, however). The court rejected her husband’s suit

against the hospital for compensation (AsahiShhnbun,5/29/89).
According to Hanrei (Case Law) Times (No. 699, 8/15/89),
the Nagoya District Court gave the following justification for
the verdict: (1) To disclose the exact name of the disease is
a part of the physician’s duties in the clinical contract, but
it is within the discretion of the physician, who must con-
sider the possible effect of the disclosure, to decide to whom
and when the disclosure is to be made and what and how much
should be disclosed while trying not to violate the patient’s
right to self-determination. (2) The patient’s physician had
not reached the final diagnosis of gallbladder cancer,
therefore the plaintiff’s charge, which was based on the
assumption of such a diagnosis, was inappropriate. (3) It is
not customary in our country to disclose cancer to the
patient, and there is no duty to explain a possibility of
cancer to the patient after the results of tests which were
done only in the out-patient clinic. (4) The physician’s
explanation that.itpwas a serious case of gallstones which had
to be removed was appropriate as the method of trying to

persuade the patient of the need for hospitalization. (5) In

15
cases of cancer with poor prognosis, explanation to the family
of the patient is necessary, but it was appropriate for the
physician to intend to do so only after further examination.
(6) The patient cancelled her own hospitalization and failed
to visit the hospital again; therefore, the physician had no
duty to take further measures.

The court makes reference to the patient’s right to self—
determination, without appearing to take this right seriously.
No definition of the right is given, nor are any conditions
for the implementation of the right specified. iApparently the
court does not intend to commit itself to, or establish a
legal precedent about, this specific right. The opinion
betrays the court’s ambivalence and involves a contradiction.
If one takes the patient’s right to self-determination
seriously, one cannot give nearly absolute priority to a
physician’s discretion to withhold information without
justifiable reasons. The patient was not incompetent by any
means. By.justifying the withholding of information which was
crucially important.to her decision about treatment, the court
flatly denied the patient her right to self-determination.
This case concerns the patient’s refusal of treatment based
on a false belief she formed upon the false or incomplete
information given by the physician. It was the accomplishment
of the American judiciary system and medical ethics to
recognize that.a.decision made upon false or incomplete infor-

mation is not authentic or legitimate. It implies that in

16
this case causation could beiestablished between the deceptive
information and the patient’s silent decision for no treat-
ment. Accordingly, if damage resulted, the provision of
inadequate information should be blameworthy. Clearly, in the
United States, physicians in similar situations could well be

held liable for deficient disclosure about the diagnosis and

the nature of the proposed procedure. But such causation was
not acknowledged by the Japanese court, which apparently
intended to protect the physician’s interests instead of the
patient’s right to autonomous decisionmaking which would be
possible only on appropriate information. The court’s
allusion to the patient’s right contradicts its intention to
give priority to physician discretion, which was acknowledged
unconditionally. In this context there was no conflict
between the value of patient autonomy and physician’s commit-
ment to health care. The former simply did not exist. Since
the patient was abandoned to death in ignorance, the latter
did not exist either. Silent medicine took a toll of a
patient’s life and the act was justified by the judiciary.
In the silent interaction many people simply do not
realize that they are involved in morally questionable and
irredeemable deceptions to themselves and others. The
physician has a prima facie justification for remaining silent
about the disclosure of a difficult case. They say that such
a disclosure would discourage the patient and deprive her of

the spirit to live. It is hard to disprove the validity of

17
this assumption. There are actually cases where a patient,
after finding out her grim prognosis, suddenly weakened and
died. But it would be equally hard to disprove that the
patient, once informed of her medical condition, might ap-
preciate the information and try to spend the rest of life in
her own unique manner. A good, caring physician would not
allow his patient to fall into self-destruction in ignorance.
In the above-cited lawsuit case, it cannot be said that the
woman had a chance to survive with medical intervention;
nonetheless it is evident that the physician deprived her of
the right to know about her own demise and to prepare for
that. We can argue that the Japanese people’s constitutional
right to choice should include their participation in medical
decisionmaking as well. But so far the judiciary has not
given such an interpretation. Another violation of patients’
rights concerns treatment options, which, even when they exist,
are simply not explained to the patient. This happens often
with breast cancer patients. Women who underwent a radical
mastectomy used to agonize silently but begin to express their
grudge bitterly after they hear that there were in many cases
alternatives. But the practice of concealing diagnosis and
treatment options still goes on. If the physician is ready
to display treatment options including non-treatment, she
would have to clarify the nature of the disease. That first-
step is often omitted. If a case is an incurable cancer and

no treatment is useful, the physician may still perform an

18

operation, however useless or palliative it is, just to
pretend that everything is fine and that the patient will get
well after the operation only if she does not lose hope for
recovery. In the good old days the patient could remain in
blissful ignorance believing that she had an efficient, trust-
worthy physician who knew her physical condition better than
anybody else, including herself. But those days are gone and
what we have now is a setting in which it is hard for us to
engender trustful relationships with each other. In the case
at issue it is ironic that the patient was a nurse and her
physician did not know that. Either the doctor was not inte-
rested in her life or she hid her occupation from him for some
reason. It was not a relationship of trust from the outset.
From her professional experiences and from what the doctor
told her about the disease she apparently conjectured that her
gallstones could be negligible at least for the time being.
Failure to get correct information about diagnosis, even if
it was tentative, was detrimental to her, and to great numbers
of other patients. But it seems that both physicians and
patients can have good relationships as morally equal persons
if we consider what constitutes a conflictual interaction and
what it takes to build a trustful, democratic relationship
which is helpful for good care.

In the general public’s impression Japanese physicians
do not seem to care to speak to, or ask questions of, or

listen to, patients’ stories, or have a meaningful

19

conversation with them. They seem to be very slow in realiz-
ing that in an ordinary clinical situation the silence of
health-care professionals can lead to an ineffective treatment
of the patient’s problem. Patients are also very slow to
realize that the fact that a patient is kept ignorant about
herself and is treated like a small child is the cause of many
unexpressed discontents. There are at least two sorts of
physicians’ silence. In a society, where not much attention
is given to verbal communication, it is not easy to distin-
guish paternalistic silence from silence of a different nature
which results from a physician’s indifference to his profes-
sional duty and is especially prevalent in clinical situations
between strangers.

Physicians’ paternalistic silence and patients’ acqui-
escence have a couple of explanations. One is the Japanese
people’s view of language use. Spoken Japanese sentences
often omit pronouns of both subject and object, yet are taken
to be understood by the listener. Speech acts are often
incomplete, ambiguous and context-relative. Indirect metapho-
rical expressions are favored over direct realistic expres-
sions. In the process of understanding, internal subjec-
tification is more important than objectification as a means
for intersubjective understanding. Accordingly language per
se does not carry much significance as a way of mutual
communication. The Japanese tend to think that they can unify

different opinions simply because they can count on racial

20

homogeneity that they believe to exist. Instead of attempt-
ing to arrive at agreement in an open argumentative form, they
believe in the efficacy of symbolic gestures, back-stage
dealings and ’belly’ talks. Accordingly the Japanese people
are often seen as poor in conversation and discussion at
meetings and conferences. In medical relationships physicians
are least expected to talk in terms of explaining what is
going on. Lest they get cold shoulders from physicians who
are unwilling to talk, the patients are scared to ask ques-
tions. We will find out later that both physicians and
patients have to learn how to express themselves and communi-
cate with each other efficiently from the belief that language
was made for mutual communication.

Language use»is one of various features that,characterize
human interactions in Japan. One predominant explanation for
paternalistic silence is the hierarchical and authoritarian
structure that the language use reflects in all phases of
Japanese society. In medical relationships patients are
treated like small children who are not supposed to claim
rights to decisionmaking. They are taught to be obedient and
thankful to whoever nurture them. Indebtedness to authority
and duty to defer thereto have been main moral precepts since
feudal ages. People often feel uneasy with rights-talk
despite the assurances of the constitution, which was after
all a gift from the United States. The idea of a patient’s

self-determination sounds repugnant. to both patients and

21

physicians. Moreover, patients feel they owe medical profes-
sion their overall state of medical well-being. When most of
the citizens identify themselves as the members of the middle
class (even though their standard of living is much lower than
that of the people of other advanced countries), and when they
feel that basic needs in terms of medical care are somehow
taken care of, they think that they owe many of the medical
benefits to the efforts of the medical profession and to
public health policy. Surely the medical profession has done
a remarkable job, but the lay people’s unreflected indebted-
ness seems to perpetuate the inappropriate silent acquiescence
to medical authority, and the lack of motivation to demand
their due rights.

Moreover, one cannot ignore the role that one’s family
plays in medical care. Cultural anthropological studies tell
how patients are indulged or spoiled in a close-knit tradi-
tional family system in which sickness or disease of an in-
dividual regarded as a family incident. One could even say
medical paternalism may be only a part of the scheme of the
family’s dealing with a sick family member. Non-disclosure
is a joint plot of the physician and family members. The
number of nuclear families and single households is increasing
so this description may not apply to all cases, but the weight
of traditional family system can explain why most patients
still want to be totally dependent on the family-centered care

system so that even an otherwise intellectual person may

22
refuse to know her own disease and leave everything to others
without realizing that to be treated like an infant is not
what a mature person should want.
Recently there have emerged many symposiums and publica-
tions on medical ethics (Kajikawa). This phenomenon has ap-

parently been the result of influence by information and

literature flowing from the United States. :rc has called
people’s attention to a great discrepancy between contemporary
medical practice and traditional mentality in Japan. Con-
cerned citizens begin to realize the serious gap between ethos
and advanced technology that perpetuates problematic medical
relationships. We may be facing a promising transformation
of medical relationship, but it is also the case in Japan that
things foreign are readily introduced but rarely taken
seriously enough toi change people’s fundamental mindset.
Democracy is not yet rooted in the Japanese soil. In the
following section I‘will discuss the modern history of medical
education and the system of ethics that endorsed the practice
in which patients have been excluded from decisionmaking

process .

2. The German legacy

Medicine practiced in contemporary Japan is not very
different from that in the United States. Mainstream medicine
is Western-style, but the structure of the medical establish-

ment, of the medical educational system, and the mode of

23

physician-patient interaction is to an important extent the
product of the model of German medicine that was adopted by
the government after the breakdown of feudalism in the late
19th century. I

During the opening years of the Meiji Era (1868 - 1911),
the mainstream of Western medicine in Japan was British
medicine. William Willis, the physician to the British
Minister to Japan, impressed the new Japanese government
officials with the excellence of British medicine while being
actively engaged in practicing surgery and teaching at the
newly founded medical school in Tokyo (Sugaya, p.27). British
influence gave way to Prussian because the two individuals who
were in charge of planning a new medical reform policy
determined that German medicine was superior to all others.
Their reasoning was as follows: (1) Dutch medicine was only
the translation of German and French medicines; (2) luxurious
French medicine did not suit the financial state of new Japan;
(3) British medicine was inadequate because of the British
contempt for Japanese people, and (4) American medicine was
too new and offered nothing for Japanese to learn from. What-
ever their official justification of the rejection of other
possibilities, their decision seemed inevitable. The Meiji
government leaders already had a great liking for the Prussian
system of constitutional monarchy. They had also found German
military, economic, legal and educational systems suitable for

emulation. Thus the Meiji Government officially invited

24
physicians from Prussia to teach at the national medical
schools, thereby starting an influential tradition of German-
style medicine in Japan. Significantly, Erwin B612, one of
the early German medical professors hired by the Japanese
Government, cautioned in his diary against the influx of the
American ideas of democracy and freedom (8312, p.92).

An important consequence of the introduction of German
medicine was the strengthening of the authoritarian structure
in medical education and in the over-all medical institution
of the countryu The overpowering status of the ’ordentlicher’
professor, especially in medicine, had its model in German
medical education. Each department, with a chairperson who
exercised absolute power at its top, built a high wall around
it and its inner tight-knit hierarchical structure. As a
consequence there was, and still persists, a lack of coopera-
tion among different clinical divisions in hospitals and
medical schools.

German medical terms are still used in the Japanese
clinical worhd. Words such as 'Karute’(<die Karte=chart),
’Kuranke’(<der Kranke=patient), Pulusu’(<der Puls=pulse) and
'Mesu’(<Messer=scalpel) are only a few of them. Patient
charts were written in German until recently. The practice
of medical paternalism and secrecy was enhanced by this
German-writing in the clinical context and symbolized non-
accessibility from the patient. Patients have taken for

granted the non-disclosure of information in diagnosis and

25

prognosis of their diseases. Nowadays charts are often
written in English and even Japanese but they are still
inaccessible to ordinary Japanese patients. Even if the
patient understands the foreign language used in the chart,
physicians protect secrecy by using technical terms which are
unintelligible even to intellectuals. Communication through
the use of an easily understood language has never been at-
tempted. Physicians simply have not been taught in medical
school to communicate meaningfully with patients. They are
easily annoyed by patients who want to ask them questions.

The social status of an ordinary physician was formally
established in 1906 by the enforcement of the Medical Prac-
titioner’s Law which recognized only the graduates of medical
schools as physicians (Sugaya, p.77). This meant that only
the practitioners of Western medicine and not doctors of Kampo
(traditional, oriental medicine) were allowed to remain in
the mainstream of Japanese medicine. Only those who are
educated at the now 80 Western-style medical schools are
entitled to take medical license examinations. Kampo is still
widely practiced, but only a few percent of physicians employ
the method together with scientific medicine which has been
blamed for its excessive use of tests and chemicals. An
organization of private practice physicians was gradually
formed and came to be called the Japan Medical Association in
1923. It became an enormous power center and has often been

involved in conflicts with other social powers.

26
German influence is still perceivable and often dominant.
After all, German ideas were accepted because they were in
harmony with the traditional political ideologies based on
Neo-Confucianism and Shintoism which justified the authorita-
rian rule with the emperor at the top. Against American

individualism the Japanese mental system operates on collec-

tivism due partly to its own political and intellectual
tradition and also partly to the German influence. Under such
a mindset people are born not as individuals but instead into
the relationships of the family only as members of a communal
unit. In feudal days Neo-Confucianism served as the ideology
of the individual having a fixed role and relationship within
a family or community. Democratic principles dictate that
individuals jointly decide on their own future project. By
contrast, in the Orient the concept of self has rarely been
given due consideration. "Annihilate your self to serve to
the public (country, corporate body, feudal lord, emperor)"
has been one of the most important slogans demanded of the
people throughout the recent centuries. The private self was
posited opposite to, and only to be subsumed by, the public
which was the transcendent authority posited by the mandate
of heaven, according to the tradition handed over from the
ancient Chinese tradition.

Two most influential modern Japanese thinkers, Kitaro
Nishida (1870 -1945) and Tetsuro Watsuji (1889 - 1960) ex-

pounded systems of thought which endorsed and supported the

27

above-mentioned traditional political ideology. Nishida was
a professor of philosophy at the University of Kyoto while
Watsuji was a professor of ethics at the University of Tokyo.
As pioneers in medicine, technology and social, humanistic
sciences with a number of influential scholars, both univer-
sities have been the academic centers of Japan. In his most
famous A Study of Good, while referring to James, Berkeley and
Hegel, Nishida develops a heavily idealistic philosophical
system in which the ultimate reality is realized in the
intellectual intuition where there is no distinction between
subject and object, intellect and will. The experience of
this reality is something that you have to attain yourself and
that cannot be expressed in language. Consciousness, reason,
spirit are all features of this ultimate, subjective, unchang-
ing unity which can be called God, who is in turn the basis
of other-love in an ethical context. A good action is the
realization of the individual self which is actually a part
of the commonality which is in turn the universe. Our real
self is identified with the substance of the universe.
Individuality is "the self-determination of the general” that
is God. There is no absolute evil because the ultimate
reality is Good. Evil arises only from contradictions within
the system of reality.

This eclectic system of Hegelian, Judaeo-Christian, Zen
Buddhist and Neo-Confucianist thought was popular among those

who had been exposed to German idealism. For many young

28

philosophers, Nishida synthesized those thoughts to form a
'uniquely’ Japanese system of epistemology, metaphysics, and
ethics. But as ethics this only exhorted meditation in order
for one to be unified with the essence of the universe or at
most religious fellowship with others. Nishida’s “self-
determination" was by no means a principle for autonomous
action. It was Watsuji who propounded the system of ultimate
reality which was political and which took the form of the
state in which alone individuals could realize themselves.

Watsuji studied in Germany and incorporated Hegelian
ideas into his grandiose system of ethical thought. His
ethics was based on the idea that ethics (rhnfi) means studies
of rln (=relationship). In his influential book Ethics as the
Study of Ningen (=human being) he noticed the term nlngen
(ninzhuman, gen=inbetween, relation) refers exactly to the
relation between humans rather than to an individual human in
Western thinking. Ningen is rendered as man, human or
anthropos in the Western languages which, according to Watsuji ,
means no more than an atomistic being and does not reveal the
true meaning of being human. Humans can by no means subsist
without having relations with other humans, so the nature of
this being is unable to be represented in the way it is
rendered in a Western language. For Watsuji ethics is not a
study of subjective, individual moral sense or the like, but
the study of the social order of human relationship. He uses

Hegelian and Buddhist language in characterizing humans as the

29

self-negation of the Absolute Negation, or the community as
the living totality in which alone individuals can have mean-
ingful existence. He emphasizes that usual relationships are
by no means complete unless subsumed in the real totality
which could be found only in certain higher-order orga-
nization. The state is the ultimate organic totality in which
alone individual freedom can subsist. The nation is prior to
its individual members (the opposite idea. of Rousseauan
democracy) and is itself the ethical totality. ‘The most ideal
polity would be absolute monarchy. From this standpoint
Watsuji defended the cause of Japan’s nationalism and sup-
ported its war efforts for imperialist expansionism. Even in
the postwar years Watsuji remained at the top of the scholarly
hierarchy in the study of ethics, and some of his disciples
were strong advocates of emperor worship and imperial tradi-
tion.

One can readily see that this sort of philosophical
orientation was in opposition to the democratic constitution
which was to be implanted in the postwar days. Individual
autonomy or self-determination was something which did not
belong to this way of looking at human relationship. This
basic intellectual, political orientation has not changed
drastically since the prewar days. This is one reason why the
same political party has remained in power and has established
conservative national policies in every division of society,

especially in education. It is true that private institutions

30
are less authoritarian and more democratic than public
institutions, but that is not always true. The president of
the JMA from 1957 to 1982 was a graduate of Keio Medical
School which was founded by an egalitarian pioneer educator
of the early Meiji Period. A man of anti-establishment vein
Dr. Takemi was always involved in confrontation with the
bureaucrats of the Ministry of Health and Welfare (MHW). On
the other hand he displayed quite an authoritarian, anti-
democratic personality by monopolizing all the decisionmaking
powers in the institution. During his reign nothing was done
to rectify the physician-patient relationship or help promote
patient autonomy. He did virtually nothing to respond to the
revised Helsinki Declaration although the revision was made
in the World Medical Association’s Tokyo Conference in 1975
over which he presided. What he did was to strengthen the
authority of the medical profession against the state power
and the resistance from lay people. ‘The JMA lacked motivation
to reconsider its own morality and reconstruct medical

relationships on democratic ethical principles.

3. Responses to informed consent

For a long time in history Japanese physicians have
believed that the ethic of fan sufficed to keep medical art
in good shape. But with regard to the quality of medical art,
members of the medical community have been uncritical to each

other’s work; as an American observer remarked, there “are no

31

formal mechanisms for reviewing the quality of medical care
in any setting" (Iglehart, Part Two, p.1168). The Medical
Morality Council of the MHW is mainly concerned with tax fraud
or other types of criminal conduct by physicians. Immoral
doctors are suspended or deprived of licenses in accordance
with the findings of the council. But our real concern is to
democratize medical practice so as to put an end to the
tradition of medical silence and get the patient involved in
decisionmaking. Having a reasonable code of professional
ethics would be a first step to self-improvement. However,
the Japanese medical profession does not have a code com-
parable to the code of ethics of the American Medical Associa-
tion (AMA) which has been revised a number of times over a
long period. In an effort to consider medical ethics, the JMA
set up in 1965 a task force within its organization. This,
however, was dissolved two years later after sponsoring a
series of lectures given by prominent scholars (Fuse, p.205).

On the part of the state administration, the Health
Policy Bureau of the MHW organized a study group on bioethics
which brought together prominent figures from various fields
such as law, medicine, philosophy and business. This study
group has met several times since April, 1983. In 1985 they
issued a report titled Considering Life and Ethics which deals with
the physician-patient relationship, particularly the issue of
informed consent. The participants do admit the importance

of the idea of a patient’s rights to self-determination but

32

at the same time they express scepticism toward the actual
implementation of the principle of informed consent. Their
justification for this scepticism is based upon their view
that an average patient is unable to understand or judge the
state of his illness and treatment. Apparently they do not
realize that disclosure is vital to the principle of informed
consent. These intellectual dignitaries believe in the
integrity of medical profession, but not in the integrity of
each patient, and still advocate the benevolence model of the
physician-patient relationship. In this report there is no
reference to a need for drawing an ethical code based on pa-
tient autonomy. They seem to think that physician’s benevo-
lence and patient autonomy are inherently contradictory.

By now most of the nation’s 80 medical schools have
ethics committees (AsahiShhnbun,12/30/86). Their main agenda
focuses on the definition of brain death and the regulation
of organ transplantation. It is characteristic of these
committees that their membership includes high executives of
the medical schools who are also physicians and that they do

not recruit many people from outside the campus or from other

disciplines. All but one are closed to public or media
(Saito). Secrecy and exclusiveness are still their common
denominators.

These situations reflect the general atmosphere surround-
ing the Japanese medical establishment, which is far fromiopen

and democratic. The Japan Bar Association, on the other hand,

33

held a symposium on brain death and organ transplantation in
1986 at its Annual Convention for Human Rights. From their
report it is evident that their position is to enlighten the
public and to call for the development of a consensus among
the people on these issues. In their 1980 declaration about
experimentation on human subjects, they asserted the impor-
tance of a principle comparable to informed consent. In 1984,
a nation-wide lawyers’ group issued a "Patients’ Bill of
Rights" which stressed the patient’s right to information.
However, it is not known how seriously this statement has been
taken. In the United States the “Patient’s Bill of Rights"
was declared by the American Hospital Association in 1972 so
that we are always reminded of our rights as patients entering
a hospital, but there has been no such move in Japan.

From the physicians’ world there has been some move to
improve the situation. In early 1988 a new initiative was
taken by the National Federation of Insurance Physicians
Organizations to which less than a quarter of Japanese
physicians belong (Okamoto, p.68). They issued a manifesto
of their basic posture about medical care. According to the
reported draft of the manifesto, they were determined: (1) to
make an effort to develop a humane relationship between
physicians and patients, paying attention to the care of a
total person; (2) to strive for better coordination among
physicians and among different divisions of medicine; (3) to

play a more positive role in community health care; (4) to

34

work harder in continuing education so that patients can have
access to the most advanced medical expertise; (5) to promote
dialogue with patients in order to know better the patients’
wishes and to offer what is needed to help them realize their
way of life; (6) to keep the medical record strictly confiden-
tial except for therapeutic needs or medical development; (7)
to avoid unethical conduct; (8) to be alert to dangers of
advanced technology; (9) to promote social welfare; (10) to
learn from history, to oppose all peace-threatening moves and
to acknowledge that it is a physician’s responsibility to
prevent nuclear war and eliminate nuclear weapons.

This is a great advance over their traditional pater-
nalistic posture. Not only do they realize the importance of
dealing with a patient as a total person, they also admit the
need for a meaningful conversation. From my_point of view,
however, this manifesto still falls short of being aware of
the importance of the value of patient autonomy which is vital
to good medical care. Also it fails to attend to the need of
reforming the insurance system itself} Some physiciansioppose
the implementation of informed consent mainly because it is
simply impracticable under the present system of insurance
reimbursement. The health insurance system does not pay for
the physician’s consultation session with the patient.
However much effort is expended for the conversation it is not
rewarded monetarilyu One plausible remedy, then, is to reform

the insurance system and to acknowledge the physician’s effort

35

to implement informed consent. For that purpose, however,
informed consent has to be officially introduced. I cite a
case of one recent exemplary physician who withdrew from the
insurance system and started a private practice in which he
hoped he could spend enough time with each patient (Mizuno).
In that manner, however, he was able to see no more than five
patients each day and had a hard time making both ends meet
every month. If the Japanese people, both lay and profes-
sional, decide that medical decisionmaking is mutual, it will
be necessary to reshuffle the whole system to accommodate the
idea of informed consent, and to reform the reimbursement
system. Informed consent is something which enlightened
patients should demand of their physicians. In that sense the
future of informed consent depends on the education of both
patients and medical students.

Finally, let us take a look at the recent statement made
by the JMA Council with regard to informed consent. Since
1985 the JMA held meetings on bioethics with experts from
different fields in its Bioethics Council but they focused on
brain death and organ transplantation on which they issued a
final report in January, 1988 (AsahiShimbun,1/13/88). Critics
pointed out that the JMA had never disclosed to the public the
actual processes of their deliberations on these issues. What
they did was to try to legalize organ transplantation without
any ethical code. After working on the issue of brain death,

the Council then took up informed consent and issued a report

36
early this year (Journal of the JMA, February 15, 1990). This
time the record of the procedure has been made public.

In this report informed consent is translated as setsumei
to dooi which means "explanation and consent“. There is so far
no fixed standard translation for the English term 'informed
consent’ which is neatly concise in its own right. It is
indeed a difficult one to translate into an equally concise
phrase. An attempted translation can end up long and ex-
planatory, spelling out something like "consent made upon
being informed”. One suggested translation, nattoku dooi, in
much shorter wording means something like "understood consent”
but it is not very appropriate because dooi means consent,
while nattoku is something that should be a part of consent so
that it sounds redundant and cannot represent the important
content of the original version, namely, "voluntary consent
given only upon the understanding of the appropriate informa-
tion provided". The JMA version is not appropriate either,
because it dichotomizes the agents and the actions and thereby
lessens the poignant implication of the patient’s decision-
making. Informed consent surely involves two parties but this
translation suggests two separate unilateral actions which may
not adequately interact with each other.

The JMA Council report gives a long—overdue credit to
informed consent. It acknowledges that the idea of informed
consent needs to be introduced to improve the quality of

medical care and physician-patient relationship. It calls

37

for physician’s awareness of the duty to explain and obtain
patient’s consent. It also calls for physician’s new ap-
proaches to ’Mundtherapie’ which, according to the writer of
the report, was operative in traditional medicine. ‘The report
says the Mundtherapie should go hand in hand with consent-
obtaining effort. It also advises physician’s openness, which
would open up the patient’s heart "to talk everything“. It
goes further to call for reform in the insurance system to
facilitate longer consultation session.

It was indeed an epoch-making event that the JMA’s
council issued a report which recommended the introduction of
informed consent into Japanese medical practice. However, we
also must note that the report wants to stress that the
American model of informed consent cannot be imported as it
is into Japanese medical practice because of the latter’s
historical background and the different ways of human inter-
action in both countries. So the writer emphasizes that
physician and patient are in no way equal in terms of knowl-
edge, and the former should exercise leadership in persuading
patients to the physician’s choice even if there are alterna—
tive treatments. A patient is reminded that she can express
her wishes, but cannot give positive instructions to the
physician. Apparently patient’s waiver and physician’s
discretion are considered as rules, instead of exceptions.
After all, the report does not address:a general audience, but

only physicians. It tends to underscore physician discretion

38

and naturally to be inattentive to patients’ needs to be
informed and participate in decisionmaking process. The
translation 'explanation and consent’ does not successfully
send a message about the need and importance of real consent-
giving, and of having appropriate information before decision-
making as a recogniton of concerned citizens in a democratic
society.

The report also endorses the thesis that since there is
neither an explicit legal precedent nor a judicial tendency
to introduce the idea of informed consent, a formal introduc-
tion may be made as an ethical imperative which can also have
valid claim of constitutionality, rather than as a legal
doctrine as was the case in the United States. Surely it does
not seem likely that in Japan informed consent will first get
employed by the judges, but rather by legal, scholars and
philosophers, and then physicians and hospital associations.
However, having heard that said by the medical profession, I
have a nfisgiving about the practicality of the suggestion.
I am especially concerned about the silence of the JMA to the
courts, especially the Supreme Court, which have often failed
to play the role of the protector of rights guaranteed by the
Constitution. In this report the JMA council almost endorses
the two Supreme Court rulings in 1981 and 1988 that limited
physician’s duty of explanation. Patient’s autonomy and right
to self-determination in this context seem to be no more than

a gift bestowed with a paternalistic largess. As in the

39
judiciary opinion cited in the first section, autonomy or the
right to self-determination is only cursorily mentioned. With
this in mind it does not seem to me that Japanese medicine is
going to be democratized in a near future unless there is

legal protection of patients’ rights.

In this chapter I have discussed the conflictual rela-
tionship between physician and patient in a society equipped
with parliamentary democracy and capitalist market economy.
I have pointed out the deficient relationship between the
physician and patient as the result of the vertical structure
that the medical profession has constructed in the modern age
with the use of German idealism and philosophical endorsement.
A partial remedy can come from the introduction of informed
consent. The idea of informed consent can point out to the
people the fact that their self-indulgently passive, child-
like role as patients has partially contributed to their
plight, and can also direct their attention to their unneces-
sarily subservient relationship to the physicians. Although
a suggestion that informed consent should be introduced in
Japanese medical practice as an ethical imperative is plau-
sible, the importance of having a legal endorsement cannot be
ignored. So there is a good reason to turn to the American
experience. I am now going to study the theory and the actual
practice of informed consent in the United States where the

idea was legally formed and ethically developed.

40

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FELDMAN, Eric. 1985. "Medical Ethics the Japanese Way“ in
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41

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OHNUKI-TIERNEY, Emiko. 1984. Illness and Culture in Contemporary
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Cambridge University Press.

OKAMOTO, Naomasa, et al . ed. 1988. Iryo, Igaku Kenkyu ni okeru
Rlnri no Shomondai (Ethical Problems in
Medical Care and Medical Science). Tokyo:

Tokyo Igaku-sha.

OKUYAMA, Kenji. 1970. Nlhon no Iryo(Medical System of Japan).
Tokyo: Shin Nihon Shuppan-sha.

SAITO, Takao & KAGA, Otohiko. 1990. "Dialogue -- Significance
and Practice of an Ethics Committee“ , Sekai
(The World), March.

SONODA , Kyoi chi . 1988 . Health and Illness In Changing Japanese Society.
Tokyo: University of Tokyo Press.

STESLICKE, William E. 1972. "Doctors, Patients, and Govern-
ment in Modern Japan“, Asian Survey. Vol.
12, No. 11.

SUGAYA, Akira. 1981. Nihon no Byoin (A Japanese Hospital).
Tokyo: Chuo Koron-sha. -

TSUNETA-YANO MEMORIAL SOCIETY. 1988. Nippon -- A Charted Survey
ofJapan, 1987/88. Tokyo: Kokusisha.

UEMURA, Ken’ichi. 1987."Kore dewa Byokiwa naoranai"(0isease
won’t be Cured in this Way). Chuo Koran.
Feb.

USHIBA, Daizo. 1978. “Medical Education in Japan", Social
Science 3 Medicine. Vol. 12A.

CHAPTER II INFORMED CONSENT: THEORY AND PRACTICE

The theme of this chapter is informed consent as it has
been legally introduced, ethically supported, and medically
practiced in the United States. The history of informed
consent will tell us that the path it has so far trod is far
from a smooth, easy or clear-cut one, even from its start on
the judiciary scene. But the study of the history and the
American experience of informed consent is necessary for those
who want to turn to it for guidance, whatever the experience
is, since informed consent based on the way of life in a
democratic society is the only viable alternative to a tradi-
tional medical relationship. Another reason for this chapter
was indicated in the end of the first chapter. The legal
birth of informed consent. in the United States will be
reevaluated. In this chapter, the history, theory and
practice of informed consent in the United States will be ex-
amined. .After that, the elements involved in informed consent
will be reviewed. All through the discussion I will pay
attention to the difference between the legal doctrine and the
ethical idea of informed consent, as that distinction has a
bearing on the medical practice which faces the introduction

of informed consent.

42

43

1. American history of informed consent

Informed consent first appeared in the American juris-
diction with regard to medical malpractice suits. Ethical,
philosophical and legal discussions followed it during the
past thirty years largely to endorse and promote the initia-
tive that the courts took. Thus, although informed consent
should be regarded as an ethical principle where there is no
established law, its origin in common law and later develop-
ment in courts and legislature deserves careful attention and
reappraisal.

The idea of informed consent in its present form had not
been recognized until the American courts pondered on it and
made a series of memorable judgments on compensation for the
plight of patients who suffered from harm done by physicians.
A great credit should be given to the judiciary of this
society for initiating the movement for informed consent and
stimulating heated discussion in legal, philosophical, and
ethical circles. To turn our eyes back to the Oriental
country we featured in the first chapter, we find that a newly
published Japanese book with the title Infoomudo Konsento
(Informed Consent, Mizuno) ignores this origin and maintains
that the origin of informed consent dates back to the Narnberg
Code of 1946 and more recently to the Helsinki Declaration of
1964 (later revised in 1975 and 1983). However, these codes

were primarily meant to regulate clinical experimentation

44

involving human subjects administered for biomedical, cli-
nicalresearch. The motivation was of course attributed to the
Nazi atrocity. I am not sure how the author can explain the
origin of informed consent in therapeUtical context without
reference to what happened in the American courts. The judges
could have had the Nazi’s inhumane deeds in mind, and
therefore regarded the NUrnberg Code as a guiding principle,
but the Helsinki Declaration did not play the role of a
precedent because the appearance of the idea of informed
consent in 1957 came chronologically prior to the Helsinki
Declaration. As stated before, a similarly negligent stance
is taken by the report of the JMA Council on informed consent.
It does mention the legal origin of informed consent in the
United States, but unduly dismisses the importance of its
birth and place in common law and indicates that the only
option to be taken in Japan would be in the use of an ethical
doctrine in an uniquely Japanese way. However, I think their
stance is wrong because belittling the origin means the denial
of the significance of democratic values to be reflected in
medical relationships. The historical origin of the idea of
informed consent can go back to the birth of democracy in
modern Western history which, as many Japanese intellectuals
seem to think, is incompatible with the ’unique’ Japanese way
of thinking. I hope that all the advocates of informed
consent will realize that this idea is a part of the theory

of democracy, and democratic values have to be either

45

protected by the constitution or common law.

Before I start I would like to acknowledge the following
books as my main references. The initials in the parenthesis
indicate the symbols used in this and subsequent chapters for
the citation of the sources, namely, (P) for President’s
Commission’s Making Health Care Decisions (1982); (K) for Jay
Katz’s The Silent World ofDoctor and Patient (1984); (L) for Charles
W. Lidz et al’s Informed Consent (1984); (F) for Ruth R. Faden &
Tom L. Beauchamp’s A History and Theory of Informed Consent (1986);
(A) for Paul S. Appelbaum et al ’s Informed Consent -- Legal Theory
and Clinical Practice (1987). Some of them cite empirical studies
which find out how well, or rather how poorly, informed
consent has been practiced in the actual medical interactions
between physicians and patients. But these books are similar
to each other in the motivation of writing, namely, tolendorse
and propagate the cause of informed consent in medicine. They
all intend to show that informed consent is an ethical
imperative which arose from the advocacy of patient autonomy
and to give moral support to the legal doctrine. I have not
drawn from unsympathetic views of informed consent because
they typically base their arguments on the inadequate~practice
of the idea when, in fact, necessary conditions for its
implementation are far from being satisfied.

The legal doctrine of informed consent can be expressed
in terms of legal requirements imposed on physicians, namely,

"the dual obligations to inform patients and to obtain their

46

consent“ (K, xiv). The doctrine is derived ”from the common
law and includes the entire body of law dealing with the
general obligation to obtain informed consent, specific
requirements by which to meet these obligations, and the
exceptions to both” (F, p.25). To put it in another way, “It
is from the collected opinions of appellate courts that the
legal requirements for informed consent are derived, and from
which the legal doctrine of informed consent has been developed
by scholars, as an embodiment of the idea of informed consent"
(A, p.15). The distinction of the legal doctrine from the
idea of informed consent is attributed to Katz. My thesis
also accepts the distinction which presumes that some of the
discussions developed in a Legal context could not have arisen
in a strictly ethical consideration. ‘The reason is, the legal
doctrine arose in malpractice lawsuits filed by the patients
who had been harmed or wronged by physicians. Common law and
statutes of informed consent were formulated either to protect
patients or physicians. Physicians may also suffer from some
egocentric patients whotwant to take advantage of the former’s
unintended, unavoidable mistakes. 'Thus, some of the laws were
made by the legislators urged by those physicians. ’But the
original intent of the legal doctrine of informed consent was
intended for the rescue of patients. Patients’ suffering was
far greater than the physicians’ and could not have been
stopped without legal help. So the discussion of the legal

doctrine focuses on the identity of the medical damage caused

47

by medical intervention.

On the other hand, the ethical theory which was developed
to endorse the legal doctrine apparently has one objective,
namely, toimake it eventually possible to»eliminate the neces-
sity of such lawsuits, that means, both parties take respon—
sibility for what they do. Thus, if the ethical theory had
been introduced first and practiced well, then the lively
legal discussions in the United States courts and law.journals
would have been mostly irrelevant. After all, the ethical
theory of informed consent arose only after the incentive was
given by prominent legal opinions, although the judges’ sense
of justice is owed to the democratic theory of modern ethics
which emphasized autonomy or self-determination of rational
subjects. The American judges have made tremendous contribu-
tions to the ethical awareness of patient autonomy or right
to self-determination in medical decisionmaking process. But
the difference between the legal doctrine and the ethical
ideas lies mainly in that the former takes note of the
objective, external conditions for medical decisionmaking when
damages occur, while the latter pays attention to the sig-
nificance of individual, autonomous subject’s rationally
making her own decision. Material causation is a key word in
the legal doctrine, while understanding is one important
concept in the ethical idea of informed consent.

In the legal doctrine, informed consent refers to the

physician’s duties to disclose to, and to obtain consent, from

48

the patient about a proposed treatment. The focus is on the
physician’s duties and responsibilities and not directly on
the patient’s need for autonomous decisionmaking. The courts
and physicians could have kept paternalistic medicine and
patient’s status intact. But in the United States the demo-
cratic principle at work in the history of political decisi-
onmaking was invoked, if not fully, in questioning the
traditionally vertical relationship. The courts which
deliberated on the causation of a patient’s plight apparently
identified as the ultimate cause or reason the inferior status
of the patient whose own health was at issue, yet who had no
say about the treatment of her medical problem. In an actual
legal inquiry, the causation of materialized harm is sought
in whether and how much disclosure was made. Consent might
have been sought cursorily without information about the
procedure. It was a medical custom in the West even prior to
this century to seek consent of the patient before surgery
took place (A, p.36). But uninformed consent had no sub-
stantial value.

Consent became informed more than three decades ago in
1957 when the term informed consent was first used in the
court ruling in the case of Salgo v. Leland Stanford Jr. University
Board of Trustees. ”Justice Bray of the California Court of
Appeals introduced it in a brief paragraph at the end of his
opinion..."(K, p.60). In the forehistory to the 1957 intro-

duction of informed consent, the consent requirement.in common

49

law could somehow protect "patients from unwanted inter-
ferences with their bodily integrity" (A, p.44). In Pratt v.
Davis (1905) the physician with the intention to cure epilepsy
removed the patient’s uterus and ovaries without telling her
about the nature of the operation. The court rejected the
defendant’s claim that the patient was not worthy of expla-
nation, and acknowledged the patient’s right to refuse,
namely, the physician was prohibited from violating "the
bodily integrity of his patient” without permission. What was
blamed here was the physician’s failure of informing and of
obtaining consent from the patient. But since the physician
was afraid of the patient’s refusal and the fear was somehow
taken as justifiable, the violation of consent requirement.was
the main issue. The Schloendorff v. The Society of New York Hospital
(1914) case is remembered for Justice Cardozo’s famous
statement: "Every human being of adult years and sound mind
has a right to determine what shall be done with his own body;
and a surgeon who performs an operation without his patient’s
consent commits an assault, for which he is liable in damages-
" (K, p.51). Mrs. Schloendorff’s surgeon had removed her
fibroid tumor despite her explicit refusal of any operation.
She had only permitted an examination under ether; It was not
a.case of "negligence” but the one of ”assault" or “trespass”.
But this remarkable verdict provided out no specification
about one of the most important conditions to implement self-

determination, namely, the necessity of having necessary and

50

sufficient information before making a right decision. Katz
writes, ”Courts tended to be as oblivious as physicians to the
idea that inadequate disclosure made meaningful consent
impossible and thus constituted an interference with patients’
liberty" (K, p.52). The idea that disclosure and consent
should come hand in hand was to be realized much later. Even
in mid-1950 an auto mechanic who had lost the ability to move
his fingers due to a faulty operation which might have been
unnecessary lost his case because he had given consent, but
the consent had apparently been based on a deceitful informa-
tion (K, p.53). Risks and alternatives of treatment (at least
no surgery, in this case) were not disclosed. Few realized
that consent—giving was only nominal if made on faulty
information without reference to risks and alternatives, and
such an act had little to do with a free, conscious act of
self-determination presumably permitted to the patient. Katz
suggests that if there was no genuine consent due t0>misinfor-
mation or misrepresentation, then the laws of fraud and
battery could or should have protected the wronged patients.
It took years for people to recognize the necessary connection
between disclosure and consent, understanding and decision-
making, existence of options and the act of choice.

After a transthoracic aotography, Martin Salgo suffered
paralysis of the legs (A, 39). In his lawsuit for redress of
the injury he claimed that "the physicians negligently had

failed to warn him of the risks of paralysis inherent in the

51

procedure” (K, p.61). According to Katz the term informed
consent which was used in Salgo in 1957 for the first time was
not Justice Bray’s invention. Katz discovered that it had
been taken from the amicus curiae brief submitted by the
American College of Surgeons to the California Court of
Appeals (K, p.60). The pivotal passage that contains the
introduction of this doctrine goes as follows.
“A physician violates his duty to his patient and sub-
jects himself to liability if he withholds any facts
which are necessary to form the basis of an intelligent
consent by the patient to the proposed treatment, and
physician may not minimize knowing dangers in order to
induce his patient’s consent; but patient’s mental and
emotional condition is important, and discussing the
element of risk a certain amount of discretion must be
employed consistent with the full disclosure of facts
necessary to an informed consent" (317 P. 2d 170).
The passage epitomizes the ongoing dilemma that the opinion
generated. In the first part we see the unmistakable ac-
knowledgment of the requirement of disseminating necessary
information to the patient. The underlying idea is that only
an informed person could make a free decision. The opinion
even says that a physician is liable if he withholds ”any
facts“. In the second part, which Katz says is “a most

ambiguous sentence,‘ where the term informed consent appears
for the first time in the history of medical jurisprudence,
we see already the curtailment of the application of the
doctrine. The extent of disclosure is within the physician’s
'discretion’ with regard to the disclosure of risks. One can

tell instantly that the ideas of full-scale disclosure and

professional discretion easily conflict with each other.

52
Indeed they are "reconcilable only in the kingdom of dreams“
(K, p.63).

Nonetheless, "Salgo initiated a process that eventually
could force medicine to abandon its feudal practices" (K,
p.65), because it brought in for the first time the combina-
tion of information and consent into the medical decision-
making. It marked ”the transition from simple to informed
consent“ (A, p.38). And that meant also the change in the
meaning of consent. Simple consent could be given mechani-
cally without adequate information, understanding, delibera-
tion, or conscious act of choice. It could even be given
under duress, coercion or anesthesia. Informed consent is
totally different in spirit from simple consent. It presup-
poses rational understanding of information and competency to
deliberate and make autonomous choice. On the one hand, it
was evaluated as the response to the decisionmaking need and
ability of the patient. On the other, the new physician’s
duty to disclose was, according to Katz, due to the recogni-
tion of the age of technological interventions which could
result in grave, unremediable damage and which, therefore,
required a new arrangement such as informed consent. But the
doctrine of informed consent was going to be applied to
conventional treatment procedures as well, so the significance
of the transition, namely from simple to informed consent, was
enormous. Unfortunately it was not the case that all later
courts followed suit with regard to the physician’s duty of

53

disclosure. "One court even imposed liability upon a
physician for mental anguish caused by information that he
disclosed to the patient about her condition and its proper
treatment" (A, p.39) and that happened in 1958. From the
outset the history of informed consent was to be a difficult
one.

The next important case, Natanson v. Kline (1960, 350 F. 2d
1093) in the Kansas Supreme Court, was seminal in the sense
that ”Justice Schroeder’s opinion established the law on
disclosure and consent for the next 12 years in almost all
jurisdictions that considered the matter" (K, p.65). Mrs.
Natanson received severe injuries from cobalt radiation
therapy administered after a mastectomy. She had given
consent to the treatment but had not been advised as to the
possible harms that such a therapy might incur. She sued her
radiologist for negligence and failure to give necessary
information. Justice Schroeder’s opinion expresses the basic
orientation of Anglo-American law that is based on the
"premise of thorough-going self-determination. It follows
that each man is considered to be master of his own body, and
he may, if he be of sound mind, expressly prohibit the
performance of life-saving surgery, or other medical treat-
ment" (1104). Justice Schroeder further says: "A doctor might
well believe that an operation or form of treatment is
desirable or necessary but the law does not permit him to

substitute his own judgment for that of the patient by any

54

form of artifice or deception" (ibid). This seems to be a
statement powerfully endorsing patient autonomy and the
patient’s right to refusal of _a treatment or procedure
proposed by the doctor. It is stated that the physician’s
"own judgment" should not override the patient’s decision
about treatment. For that purpose the doctor is not allowed
to mislead or deceive the patient by giving insufficient
information. As far as we read this passage the physician who
misguides the patient is subject to legal liability. Further-
more Natanson required disclosure not only of risks but "of the
nature of the ailment, the nature of the proposed treatment,
the probability of success, or of alternatives and perhaps the
risks of unfortunate results and unforeseen conditions within
the body" (1106). "These requirements ...are now the bedrock
elements of the information that the informed consent cases
and statutes require physicians to provide to patients" (A,
p.41).

As to the extent of disclosure the judge invoked "the
professional standard of care and the therapeutic privilege
to withhold information" stating that the "duty of the
physician to disclose is limited to those disclosures
which a reasonable medical practitioner would make under the
same or similar circumstances" (1106). A reasonable physician
is expected to abide by "the standard of what is customary and
usual in the profession“ (A, p.41). The consequence of impos-

ing the professional standard was, however, the placing of a

55

new burden on the patient who had to prove against what was
customary and usual within the medical profession. Katz and
other advocates of patient autonomy think that under this re-
quirement a patient would have difficulty finding physicians
who would be willing to speak against their colleagues,
especially on possible risks and treatment options.

This case was an example of a negligence case instead of
a battery case. It was assumed that, after all, the physician
would not try to intentionally harm the patient and Mrs.
Natanson had consented to the proposed therapy. That her
consent was given was taken as an evidence for the physician’s
freedom from liability to»a battery charge. ‘That insufficient
or deficient information does not constitute a valid consent
or that consent given upon faulty information should be void
did not come up in the lower court deliberation, simply
because it was presented as a negligence case. What negli-
gence is depends upon a definition. A physician could be
negligent in performing a medical procedure and harm a
patient. She could also be negligent in recognizing informed
consent and fail to give necessary and sufficient information
to patient. In this case the physicians thought negligence
was "defined as a violation of the duty to use due and proper
care” (1098). But the plaintiff took it as violation of ”a
duty to advise" of the fact that the proposed treatment
involved risk or danger (1099). Thus the defendants were not

termed liable for negligence in the lower court. The

56

physician’s withholding of information could be taken as
acting out of good intentions to place the best interests of
the patient first and out of the consideration that the dis-
closure might direct the patient to refuse the necessary
treatment. But if there was no valid consent, then the case
should have been one of battery.

The Kansas Supreme Court ordered a retrial, but it was
also balancing physician discretion and the requirement of
full disclosure. The court was reasoning that it was permis-
sible to withhold some information if the patient had the pos-
sibility to refuse the treatment proposal. Katz says that
the choice of negligence over battery "places additional
burdens on patients by requiring proof that they would have
refused the proposed treatment if they had been fully in-
formed" (K, p.69). The application "of the negligence theory
of liability, with this causation requirement, has the
potential to limit severely the patient’s recovery of damages-

.“ (F, p.131). However, if we take Katz’s real intention
to be the application of battery law which would award
dignitary injury or "insult to the personhood of the patient”
(A, p.133), it may not yield much compensation in terms of
monetary amount when patient’autonomy is valued less than it
deserves.

At any rate the Natanson court became the legal precedent
of requiring disclosure with the professional practice

standard in the negligence theory of liability. The

57

discussions of the legal doctrine of informed consent started
to center around the standard of disclosure and the causation
between the nature of disclosure and the patient’s consent or
refusal of treatment. These are the legal discussions. They
talk of the causation between the consent or refusal which
'materialized’ the actual damage. Legally, especially in the
negligence case, the physician’s mismanagement or unskill-
fulness is not exactly the issue. The logical consequence of
the argument was to find out whether the damage was 'caused’
by the patient’s consent. But prior consent could not really
refer to the adverse consequence which was to be caused by the
physician’s mismanagement rather than by the patient’s consent
given on faulty information. Such a legal argument sounds
far-fetched from our common-sensical approach and surely does
not belong to the ethical theory of informed consent.
Ethically speaking, regardless of the actual damage (that
means, even if a harm was not materialized), the withholding
of adequate information is questionable in itself, unless a
specific situation dictates that physician’s discretion or
therapeutic privilege is justifiable. In other words, physi-
cian’s unreflected {exerciser of ’discretion’ or authority
should be questioned regardless of its consequence. In
ethical theory, it is simply the case that consent can be
validated only by sufficient disclosure of knowledge, its
understanding, and voluntariness in the action of choice. In

the legal causation theory this sort of consideration is

58

simply missing, and the act of consent tends to receive an
inappropriate status only connected with the consequence of
the act. Justice Schroeder’s justification of physician
discretion went so far as to endorse the non-disclosure of
cancer to the patient. He wrote: “There is probably a
privilege, on therapeutic grounds, to withhold the specific
diagnosis where the disclosure of cancer or some other dreaded
disease would seriously jeopardize the recovery of an un-
stable, temperamental or severely depressed patient" (1103).
Such a legal endorsement could help preserve a custom which
is ethically problematic, because it is hard to determine the
psychological state of the patient and also a deception of
this sort could lead to a series of deceptions, or preclude
a treatment procedure proposed on reasonable grounds. One
cannot propose a treatment unless one discloses its nature
and purpose. But as for the cancer disclosure, a recent
survey shows that the majority of physicians disclose and the
majority of patients appreciate the disclosure. Despite some
of these conservative features, however, the Natanson court
should be remembered for its emphasis of the importance of
informed consent.

The Canterbury v. Spence case of 1972 (464 F. 2d 772) was
“the next and last landmark informed consent decision“ (K,
p.71). The plaintiff sued his surgeon for his failure to tell
him the (one percent) risk of paralysis after a laminectomy.

The following is a passage from Judge Robinson’s Opinion which

59

advocated the physician’s duty of disclosure for informed
consent:

“True consent to what happens to one’s self is the

informed exercise of a choice, .and that entails an

opportunity to evaluate knowledgeably the options avail-
able and the risks attendant upon each. The average
patient has little or no understanding of the medical
arts, and ordinarily has only his physician to whom he
can look for enlightenment with which to reach an
intelligent decision. From these almost axiomatic
considerations springs the need, and in turn the re-
quirement, of a reasonable divulgence by physician to

patient to make such a decision possible” (780).

Judge Robinson makes it clear that possible risks and treat-
ment alternatives should be disclosed so that the information
is material for making a specific treatment decision. He
says, ”The topics importantly demanding a communication of
information are the inherent and potential hazards of the
proposed treatment, the alternatives to that treatment, if
any, and the results likely if the patient remains untreated"
(787).

With regard to the extent of disclosure, Judge Robinson
brought in the standard of a reasonable patient instead of a
physician’s professional standard. The transition from the
older standard to the new one was a ”bold move" (K, p.74).
The judge specified that the permissible extent would be
decided by considering what a reasonable person would want.
It was called a patient-oriented standard. It was also called
a legal standard because it was to be set by law (785) or

"imposed by courts rather than by medical custom" (A, p.44).

According to this rule, “the physician is required to disclose

60

all information about a proposed treatment that a reasonable
person in the patient’s circumstances would find material to
a decision either to undergo or forego treatment" (A, p.45).
In this sense it was an objective standard (787). The
patient-oriented standard of disclosure had been formulated
by Waltz and Scheuneman in a legal journal in 1970. This
standard seemingly freed the plaintiff from finding an expert
witness to speak against the defendant-physician and the
defended custom of medical practice. Justice Robinson stated,
"Experts are unnecessary..." (792). He stressed patient’s
informational needs again and again.

However, as an objective standard Justice Robinson’s
patient-oriented standard made no reference to the specific
individual plaintiff-patient and her values and needs.
Although the opinion advocated the patient’s self-determina-
tion, the objective standard did not address the principle
which is based on the assumption that each individual is
significantly different, with different needs and wishes.
Thus this court advocated both a reasonable-person-as-patient
standard and therapeutic privilege which could easily conflict
with each other. Patient’s real wishes and physician’s
discretionary considerations can remain parallel phenomena not
easily to be reconciled without an appropriate medium of
mutual communication.

Katz wishes that the court would have addressed the need

for physician to initiate interaction in the form of conver-

61

sation so that both parties could understand each other to
make guess-games unnecessary. Needless to say, this is an
advice made from an ethical point of view. Medical jurispru-
dence apparently has serious limits to the implementation of
the idea of informed consent, even though courts such as
Canterbury took seriously the different standards of dis-
closure. Unfortunately, the court’s adoption of the reasona-
ble person standard did not help much the promotion of patient
autonomy. Nonetheless, ”about half the courts" adopted the
objective patient—oriented standard between 1972 and 1978, but
the tendency has declined gradually and moved in the opposite
direction (A, p.45). In the retrial Canterbury was reversed
(K, p.80).

A subjective patient-oriented standard was presented in
McPherson v. Ellis in 1982 (287 S.E. 2nd 892) but the case was
later overturned. Justice Mitchell of Supreme Court of North
Carolina wrote that a particular individual’s "supposedly
inviolable right to decide for himself what is to be done with
his body is made subject to a standard set by others" if an
objective standard is employed. Indeed a subjective standard
is most appropriate for the ethical idea of informed consent
and most feasible when physicians actively engage in conver-
sation with a particular patient” Still the courts should not
reject it in the legal doctrine, sinceuin a world of strangers
it is the patient and not her physician who knows better that

an untoward outcome might befall on her because of her own

62

past history which may not be known to her physician without
an active interaction. This applies especially to a surgeon,
radiologist or anaesthesiologist. Discussion with the patient
should include even a remote possibility of a serious harm.
But since the courts have not been sympathetic to the subjec-
tive standard, it is clear that what is called the conversa-
tion model of informed consent remains only an ethical
requirement without legal endorsement. There have been no
remarkable major court rulings since Canterbury and a couple
of other important cases in 1972. One notable case was Truman
v.7homas(1980) in which the court reaffirmed that the risks
of no treatment should have been included in the disclosure
of risks, even against the patient’s wishes. This means that
the right to treatment refusal should also be informed (F,
p.138).

To compare the early history of informed consent in the
United States with that in Japan where the courts have not
taken the initiative in acknowledging a patient’s right to
self-determination, one has to say that, although the U. S.
courts were ambivalent about the conflict between patient
autonomy and physician discretion, they have been far advanced
in taking the patient’s right seriously; The judicial
initiative was followed by legislative move to incorporate
informed consent into statutory lawn I*would like now to take

a look how informed consent was treated by law-makers.

63

2. Informed consent legislation

Although the legal doctrine of informed consent has never
been formulated in a uniform way, it is commonly thought that
informed consent refers to the physician’s duties (1) to make
disclosure to, and (2) to obtain consent from, the patient.
From the reverse point of view it refers to the patient’s
right to self-determination, however limited it is. It was
stated earlier that there had already existed a consent
principle before the age of informed consent” With the advent
of the legal doctrine of informed consent, the element of
making disclosure became the pivotal point in the physician-
patient relationship. Legislative effort following the
judicial presentation of informed consent focused on the
issues of disclosure.

However, the statutory approach to informed consent was
mainly concerned with limiting the physician’s duty rather
than expanding patient’s right. Meisel and Kabnick’s research
in 1980 (hereafter, M&K) on legislation of informed consent
tells that, although prior to 1974 "informed consentldeveloped
entirely within the domain of the judiciary", between 1975 and
1977, twenty-four states enacted informed consent legislation
of some kind. The number rose to 30 by 1982 (F, p.139).
Their study compares the enacted statutes with common law
precedents in the jurisdiction, if any. They write that this
sudden move had to do with the "medical malpractice crisis“

of 1974-76 which was strongly felt by physicians. The legis-

64

lative move was to respond to their outcries and to deal with
the crisis. Thus the legislators tended to be motivated by
the desire to curtail patient’s recovery in their lawsuits and
protect physicians’s privileges rather than patient’s rights.
This fact still gives an impression to the rest of the world
that informed consent in the United States was developed
mainly to protect physicians instead of patients. Many of the
states cited in the research report have both statutory law
and case law that do not exactly correspond toleach other with
regard to the requirement of standard and content of dis-
closure, and so on. Incidentally, Michigan has only common
law regulating informed consent cases, and therefore is not
included in the study.

With regard to the standard of disclosure which is "the
standard by which the adequacy of the physician’s disclosure
is‘measured” (M&K, p.421), fourteen jurisdictions out of
twenty-four adopted professional standard. Two. states
(Pennsylvania and Washington) employed patient-oriented
standard. Eight were silent. At common law, eleven states
had professional standard, while seven had lay standard and ‘
six had no standard. From common law to statutory law there
was an increase of three state statutes employing the profes-
sional standard and a decrease of five using lay standard.
That means, five states dropped the patient—oriented standard

which their common law had established.

65

The professional standard has two kinds, those with and
those without a ”locality rule“. The standard with a locality
rule refers to the custom established or advocated by the
local medical community. This means the extent to which a
reasonably prudent physician would disclose by the profes-
sional custom in the community. As we saw in case law, this
poses hardship to the suing patient because she would have
difficulty finding supporters and witnesses among the local
medical community. Out of the fourteen statutes which employ
professional standard, only five are without locality rule,
while the locality rule proviso had only two advocates at
common law. In the two states where they employ a patient
standard, the physician was required to disclose the amount
of information that. a reasonable person "would consider
material to the decision whether or not to undergo treatment
or diagnosis" (M&K, p.423). As a whole the researchers do not
think there was a great change in consequence of the legisla-
tion. The legislative intention was to make plaintiff’s
recovery more difficult. Meisel and Kabnick comment: "what
changes were made in standards of disclosure have, on balance,
been mildly favorable to physicians”(M&K, p.426).

With regard to the content of information disclosed,
there is no discussion of the adequacy of information about
the nature of the disease or the exact diagnosis. Presumably,
the disclosure of that sort is taken for granted. The focus

is rather on the nature of a particular treatment or procedure

66

proposed by the physician. Since the legislation concerns the
civil litigation calling for compensation for an injury
incurred from the procedure, the disclosure should first be
whether the procedure is diagnostic or therapeutic, invasive
or not, whether anesthesia is necessary, how long it would
take, and so on. Fourteen statutes require this disclosure
while ten are silent. At common law twelve required it, so
there is an increase of two statutes about the requirement of
disclosure of the nature of the procedure at issue.

"The disclosure of the risks of the proposed procedure
is one of the two most important elements of disclosure” with
the information of treatment alternatives being the other
(MaK, p.429). Twenty-two states out of the twenty-four
included the requirement of risk disclosure. Some statutes
had specified lists of risks to be disclosed. The report
cites the cases of Texas and Hawaii where they had detailed

lists of risks to which, however, M&K comment: ...we view
such a statutory scheme, which the extent of the required dis-
closure depends upon a predetermined list of procedures and
their risks, as implicitly characterizing the doctor-patient
relationship as mechanical rather than human" (M&K, p.430).
The authors claim that this move would pave the way to a
computer’s taking over the intermediary role in the relation-
ship with the job of disclosing the risks as well as diagnos-

ing. Meisel later reiterates the same fear in A, p. 53. When

there are no predetermined lists, then standard of«disclosure,

67

professional or lay, is invoked. It is taken for granted that
common, remote, minor risks do not have to be disclosed. The
disclosure of alternative treatment, if any, is a requirement
only in the eleven statutes, although as MaK say it is
indispensable, and should be, together with no treatment, one
of the important topics in the physician-patient conversation.
"Failure to require disclosure of alternatives shows either
that the legislatures were unaware of its importance to
informed consent theory or that their goal was, in fact, to
make recovery more difficult" (M&K, p.435).

Far less states, namely only four, require theldisclosure
of benefits of the proposed procedure. But this requirement
may be equally important as the risk disclosure requirement,
especially when the procedure is diagnostic rather than
therapeutic. If Japan had a statute or case law requiring the
disclosure of diagnostic or therapeutic benefits, then the
physician’s failure to meet the requirement in Makino vs. Second
Nagoya Red Cross Hospital would have been a basis for a judgment
for the patient.

Another element which has some impact on this Japanese
case is the consideration of causation. There are two kinds
of causation cases: injury causation and decision causation.
The first is a case to establish the necessary connection
between the physician’s treatment and the actual injury the
patient incurred. The above case falls under the decision

causation. ‘The plaintiffs claimed that the physician’s

68

failure to disclose the nature of disease gave the patient a
false belief that she could forego the proposed treatment or
diagnostic procedure, and this guided her to make a fatal
decision to refuse the physician’s recommendation. In other
cases patients could claim that if properly informed they
would have refused the proposed treatment and could have
avoided unfortunate consequence. To prove decision causation
there is an objective test and a subjective test. Nine
statutes employ the objective test "under which 'a reasonably
prudent person in the patient’s position would not have
undergone the treatment or diagnosis if he had been fully
informed....’“ (MaK, p.440). Two statutes adopt a subjective
test "under which 'the plaintiff must prove that if he had
been informed of the material risk, he would not have con-
sented to the procedure...” (ibid). At common law five
adopted objective test and five subjective test. The objec-
tive test tended to be favorable to physicians and detrimental
to patient autonomy, while the subjective test was considered
unfavorable to physicians and just the opposite to patients.
MaK propose an alternative test which they call "a material-
factor test“ under which the patient would have to demonstrate
that the information withheld was material to the decision-
making process“ (MaK, p.441). In this approach the patient
does not have to answer a hypothetical question to prove she
would have made a different deCision if the disclosure were

complete. At any rate the message is that any physician

69

should take seriously the causation between the information
she imparts, or fails to convey, and the response of the
patient.

There are four exceptions to the requirement of obtain-
ing informed consent, namely, emergency, incompetency, waiver
and therapeutic privilege. Among them the last one is most
problematic. At common law, fifteen states recognized
therapeutic privilege, while nine statutes did that. Thera-
peutic privilege is understood to be exercised when there is
a fear that certain disclosure might harm the patient so that
the physician refrains from giving the unfavorable news. The
fear is taken to be a justifiable reason for non-disclosure
under paternalistic considerations. But ethically speaking,
if there is no substantial disclosure, then there should be
no valid consent. By giving false information, the physician
could still obtain consent to her proposed procedure and avoid
legal liability, so the exception by therapeutic privilege is
not necessarily concerned about consent-seeking duty. Rather,
it is exercised from the paternalistic reason not to psycholo-
gically harm the patient. The authors of this article
conclude that the legislative efforts tol make patient’s
recovery more difficult did not attain their purpose greatly,
because the therapeutic privilege did not increase the
recognition on the statutory level. On the other hand, it
seems that physicians could use the incompetency exception

and claim that the failure to inform was due to presumable

70

lack of capacity to understand, which may not easy to prove.

Assessments of the statutory law of informed consent by
the writers of the books cited so far tend to be under-
standably negative. They lament that the doctrine has not
effectively overturned the long-time tradition of paternal-
istic practice. One of them writes: ”The legal doctrine of
informed consent and the much-trumpeted legal right of self-
determination have not had and are not likely ever to have a
direct and deep impact on the daily routines of the physician-
patient relationship" (F, p.141). They base their judgment
on the judicial setback and empirical studies of physician-
patient interactions in various clinical settings. I would

now like to take a look at a couple of these field works.

3. Practice of informed consent

Despite the above-mentioned limitations, judicial and
legislative statements have somehow directed our attention to
the right of patients which had long been ignored or sup-
pressed. Once a wrong is done, perhaps there is no other
remedy for the damage than judicially or legislatively
declaring that it was a grave violation of the patient’s right
to information and choice. I have to repeat my assertion that
the U. S. courts have made a tremendous contribution to
advancing patient autonomy by trying to rectify the inferior
status of patient. However, for our need to know or under-

stand our rights as citizens of a democratic society, the

71

courts’ enlightening posture did not attract enough attention,
as the judges’ opinions were not easily accessible to the
general public. We need to have our rights and responsibi-
lities clearly defined and spelled out in the form of a bill
of rights or a professional moral code. In that sense the
Patient’s Bill of Rights published by the American Hospital
Association in 1973 was phenomenal. It may be the case that
the declaration was more compelling for the physicians than
case law decisions established at a remote courthouse. Faden
et al comment: ”For perhaps the first time in any influential
document of medical ethics, the physician was compelled, by
claim of right, to incorporate patients in the decisionmaking
process and to recognize their right. to» make the final
authoritative decision" (F, p.94).

As for a professional ethical code, the first code of
the American Medical Association (AMA) was made in 1847 (more
than a hundred fifty years ago) and was to be revised four
times until the most recent revision in 1980. It was largely
based on paternalistic principles. Nonetheless, it was better
than nothing, as there was something to be revised or restruc-
tured or reconsidered. The 1980 "AMA Principles of Medical
Ethics" is very short (250 words) and does not reflect much
of the recent development. of medical ethics except for
stating, "A physician shall respect the rights of patients. .
and "A physician shall make relevant information available to

patients...“ (K, p.23). However, the principle of informed

72

consent was addressed in the "Current.Opinions of the Judicial
Council" of the AMA issued in 1981.

In the following, I would like to cite some of the
empirical research done on the clinical scene with regard to
the practice of informed consent. In the report of research
done in an abdominal surgery clinic and a cardiovascular
clinic of a university hospital (where the physicians were all
residents and interns), Lidz and Meisel present the legal
model of informed consent (it is, however, an ethical model):
a patient is informed, understands the information, makes a
decision about the proposed treatment and then gives a volun-
tary consent to the procedure (P, Vol.2, p.317ff). In
actuality, however, it was rare to see such an ideal model
realized, instead they found that "informed consent is largely
absent from the clinic; it is almost exclusively a creature
of law“ (p.320). For most of the physicians informed consent
is “synonymous with having the patient sign a consent form"
(p.328). In the hospital policy, it was officially stated
that informed consent was required for "all invasive surgery,
any procedure using an anesthetic, experimental proCedures,
and any ’non-surgical procedures which the chief of the
department has determined involve more than a slight risk of
harm’" (p.328). On the surgery ward, major diagnostic tests
such as cardiac catheterizations, exercise stress tests, and
’electrophysiological studies’ needed to get informed consent.

They involved more or less risk so there were some refusals

73

from patients but they ended up being persuaded into going
through the proposed procedures anyway. In some cases a
fiduciary relationship was formed so the patients left the
final decision to the physicians. Minor diagnostic procedu-
res which included "X-rays, CAT scans, blood tests, urine
tests, ultra-sound tests, EEGs, EKGs, letc.“ (p.333) were
regarded as routine and thought to require no patient consent.
Also, medication decisions were exclusively made by physicia-
ns. However, the researchers point out that medication
decisions and also the ’routine’ procedures might involve
serious harms that the patients should not ignore.

The survey shows that most substantial decisions were
made by physicians. Consent forms were often signed mechan-
ically regardless of patient understanding so that the
physician’s immunity from legal liability was guaranteed. As
for autonomy and understanding, their studies showed that
"outpatients were more autonomous and understood and par-
ticipated more than inpatients did" (p.343). The inpatients
tended to feel helpless and subdued in their sick role. In
other words “passive dependency" was ”the normatively expected
behavior pattern" of the inpatients (p.347). Another variable
that made a difference to the degree of participation in
decisionmaking was the nature of the disorder, namely chronic
vs. acute diseases. Patients on renal dialysis were found
most knowledgeable and active participants in decisional

interactions. On the other hand, acute patients with acute

74

diseases were only concerned with quick removal of their
problems, and tended to be passive to doctors’ instructions
without questioning about any alternative diagnoses or
treatment procedures, if any. Often not enough information
was given. One extreme case was reported in which the
physician was doing everything to obtain consent from an
apparently incompetent patient (p.375). The researchers com-
mented that the doctor’s act of "obtaining consent might have
compromised the quality of care”. Perhaps the physician was
too mindful of his risk of legal liability to pursue his
primary responsibility to attend to the needs of the patient.
This is a case in which the requirement of informed consent
went against its own purpose.

In this report on mostly cardiac and surgical cases, we
find one similar behavior which may be a sign of deep concern
but also of a false belief on the part of the family members.
A cardiac patient’s daughter refused the researcher’s inter-
view request because she did not want her father to know of
his heart attack history which might upset him badly; the
observer’s own impression was otherwise. At least in the
report there is no case where a physician intentionally
withheld information lest it harm the patient.

Another belief that controls the physician-patient
interaction has to do with the uncertainty of medical knowl-
edge. The report writers address this issue. The type of

information that physicians feel uneasy to convey to the

75

patients is that a particular diagnosis, prognosis or treat-
ment procedure is not absolutely certain. And according to
the reporters, this is the information that should be imparted
because it has to do with decisionmaking about treatment
(p.377). But in this case again, what is required is the
patient’s maturity to know and think about treatment options
with different uncertainties and to choose one on her own or
make a joint decisionmaking with her physician.

As stated before, routine care and medications are given
often without explanation or patient consent. Surgical
procedures are explained but usually one particular “medically
preferable treatment" is presented or recommended so the
patient does not really have a choice. Most likely the
procedures recommended have been determined already by the
medical establishment and tested by individual physicians.
The decision then usually concerns as to whether one accepts
it or not. The research shows that most patients are simply
acquiescent to the doctor’s recommendations.

The report refers to the role of the consent form. As
elsewhere nurses are assigned to get the consent form signed.
In most of the cases the prepared forms do not give any
detailed explanation about the treatment procedure for which
consent is sought. So there sometimes could occur a good deal
of conversation between the nurse and the patient. But this
situation does not strictly comply with the spirit of the idea

of informed consent. Informed consent assumes that

76

explanation and disclosure precedes the act of decisionmaking.
Serious conversation taking place right before the signing
implies that either prior explanation was not satisfactory or
the patient did not understand the content conveyed, although
a bit of conversation is better than nothing when there was
no prior mutual understanding between physician and patient.

A consent form could be signed without any understanding in

an extreme case. Even an incompetent person can write his
name on a form. One might do it as well when coerced or
forced, or just to please the physicians and nurses. The

findings by Litz et al. show that most physicians regarded the
act of obtaining a signed consent form as a cumbersome
rituality. For them the permission form that patients sign
at the time of admission to a clinic entrusts the physician
to proceed with her decisions, and to which she can expect
cooperation from the patient. In this sense the practice of
obtaining informed consent does not live up to the original
intent of the legal doctrine much less to the ethical prin-
ciples that the doctrine invoked. In the conclusion of their
report Litz et al. remark:
(1) "Disclosure" does not typically occur. Rather
patients learn various bits of information, some relev-
ant to decisionmaking, some not, from doctors’ and
nurses’ efforts to obtain compliance and from “situ-
ational etiquette".
(2) ”Decisions" are not made by patients. “Recommen-
dations" are made by doctors to patients.
(3) ”Consent" does not exist. Instead what we find is
"acquiescence," the absence of ”objection," or occa-
sionally a "veto“ (p.401).

So the researchers claim that no meaningful decisionmaking

77

takes place in an actual clinical context. Other research
done at psychiatric clinics and a research ward testifies a
similar conclusion (in L).

This is a discouraging picture for those who want to
learn from the American experience. Nonetheless, such ex-
perience cannot spoil the significance of the introduction of
informed concept in the recent history of medical practice.
The plausible reason for the apparent failure of the implemen-
tation of informed consent in the actual practice is simply
that neither physicians nor patients are aware of, or ready
to accept, the full significance of this institution in its
legal and ethical senses. They are simply not prepared to
exercise the practice which was introduced in the last three
decades. In the final section of this chapter I would like
to review the elements that are involved in the ethical
principle of informed consent which both (physicians and

patients should recognize and adhere to.

4. From the legal doctrine to ethical principle

The legal doctrine as such is not an ideal form to be
presented as an ethical principle to citizens in a democratic
society. If informed consent is practiced poorly, it is
because physicians only concern themselves with pro-forma
satisfaction of the legal requirement. In this section I
would like to summarize the major difference between the legal

doctrine and the ethical principle of informed consent. This

78

discussion will lead to the next chapter dealing with an ideal
human interaction to which the one between physician and
patient should not be an exception.

As has been shown in the previous part of this chapter,
informed consent was legally invoked to save patients who had
suffered from damages caused by medical intervention. The
courts which upheld the importance of informed consent
recognized the patient’s status as a consent-giver. Judges
such as Justice Robinson of the Canterbury case stressed
patient’s informational needs. But the doctrine centers
around physician’s duties to inform and obtain consent from
the patient in order for the physician to be free from legal
liability when damage is done to the patient, and not exactly
on the enhancement of patient autonomy, much less on the need
for shared decisionmaking.

The major elements of the legal doctrine of informed
consent are information, explanation or disclosure given by
physician on the one hand, and consent or refusal by patient
to the physician’s proposal on the other. The judge’s task
is to evaluate the existence and the nature of disclosure upon
which the patient was supposed to give consent to the proposed
procedure. A common formulation of the standards of dis-
closure of the legal doctrine includes four elements, namely,
(1) nature of the procedure, (2) risks, (3) alternatives or
options, (4) benefits (A, pp.41-57). Deficient disclosure as

such is not legally culpable if no harm is done. These items

79

are weighed in accordance with either the objective profes-
sional standard (with or without locality proviso) or
objective reasonable patient standard. We saw that a
subjective, individual patient standard was not acceptable as
a legal standard. Disclosure of treatment options may be
neglected in law most problematically from the standpoint of
an ethical view. 'No treatment’ is a viable alternative which
the patient may not be aware of unless informed, and if
informed consent should be exercised ethically optimally the
patient needs to be informed of any other treatment alterna-
tives which would satisfy her specific needs. There may be
safer, less costlier procedures elsewhere, but often profes-
sional custom, pressure of time, and ignorance on both sides
determine a treatment option. Disclosure of possible benefits
of the recommended procedure may look self-evident and
unimportant, but in some cases _.its failure may invite the
patient’s refusal of the proposed procedure for no good
reason. In many case laws and statutes, these are the things
which should be disclosed, but they are not always dealt with
as necessary items in disclosure. The problem is that they
cannot be adequately presented in a uniform, objective manner
that a hypothetical, reasonable person would want” After all,
the different.standards specified in theidoctrine are "derived
from the requirements of the litigation process. They are
devised not to aid physicians in performing their legal duty

to inform patients, but to instruct juries in deciding in

80

retrospect whether or not a particular defendant-physician had
adequately informed the patient-plaintiff" (A, 49).

Exceptions to the requirement of informed consent also
belongs to the legal consideration. They are often uniformly
specified under the conditions of emergency, incompetency,
waiver and therapeutic privilege. These are the conditions
that can free the physicians from legal liability. So the
consideration of the exceptions is also for protecting
physicians. As has been already stated, the most problematic
is the last condition. The first three can have standards to
test their objectivity, but the last one is often based on the
physician’s subjective paternalistic justification which could
be quite irrational. Physicians can exercise paternalism when
they somehow judge the effort to seek informed consent as not
in the interest of the patient. Perhaps this proviso is
legitimate and necessary as long as most patients are still
in the stage of being dependent, non-decisionmakers, but it
is subject to abuse and manipulation. In order for the
patient to be exempted from the exercise of the physician’s
therapeutic privilege, she has to learn how to be treated as
a responsible, independent adult who can claim an equal share
in medical decisionmaking. Perhaps she has to know first the
value of being an autonomous decisionmaker.

The legal requirement is a retrospective consideration,
and in the consideration of preventing harm or liability, the

doctrine is indifferent to the proper status of patients, and

81

to the mode of physician and patient interaction. The legal
doctrine of informed consent centers around the physicians’
duties» Corresponding to the duties are the patients’ rights.
The courts which gave birth to and supported the legal
doctrine of informed consent did acknowledge the patients’
rights of autonomous decisionmaking. What is radically
different about.the legal requirement.of informed consent from
the traditional style of medical interaction is the newly
acknowledged status of the patient as the informed consent-
giver. But consent-giving is all that the patient’s right is
about according to the legal doctrine. What exists between
physician and patient may be a one-way traffic in terms of
communication. The patient can be only a receiver of informa-
tion, and a formal consent-giver. The legal doctrine cannot
give justice to a fully autonomous person as_a patient. It
is indifferent on whether the patient deliberates, under-
stands, or voluntarily gives consent to the physician’s
proposal. It is indifferent to what good can be done when a
person is regarded as capable of considering, making judgments
about, and consenting to, the treatment proposed by the physi-
cian. Regarding the patient as an autonomous, rational
decisionmaker should enhance the self-respect of the patient
who may otherwise feel overly helpless and depressed by her
illness. It is better to be treated as an independent, mature
person whose needs and desires are given due attention rather

than as an ignorant, dependent invalid who needs care but not

82

respect, or even as a mere consent-giver. The legal doctrine

does not concern this sort of thing.

Even if informed consent presupposes the acknowledgment f

of the patient as an autonomous person whose illness is at

issue, neither courts nor legislatures pay attention to g

n
l

i

(

whether the person as the recipient of information understands}!

and deliberates.on what is informed. .Justice Robinson writes:{
"In duty-to-disclose cases, the focus of attention is more
properly upon the nature and content of the physician’s
divulgence than the patient’s understanding or consent" (464
F.2d 772, 780, n.15). Since understanding involves a lot of
things, as we will see in the next chapter, and it may be hard
to measure the level and quality of understanding, it is
understandable that the legal section wants to avoid requiring
understanding of the patient, even at its most rudimentary
level. Nonetheless, understanding should be a crucial concept
in the transformation of informed consent from the legal
doctrine to an ethical requirement, because this is the mental
operation directly connected to making a rational judgment and
a conscious decision. I do not know how one can make sense
of giving consent unless one presupposes understanding in the
act of giving consents One should remember that consent forms
can be signed under duress or without understanding. There-
fore, consent-giving can be substantial only when under-
standing in its proper mode takes place. You cannot expect

instant understanding by anybody from a brief encounter as a

83

stranger to the other party. So understanding necessitates
the existence of conversation.

The elements that the field researchers cited in the
previous section had in mind at the start of their study were
as follows: 1. Disclosure»of information concerning the treat-
ment. 2. Competency of the patient whose consent is soli-
cited. 3. Understanding of what is disclosed. 4. Volun-
tariness in decisionmaking without coercion. 5. Decision made
either to accept or refuse (L, p.22). These are in fact the
items that are to be enumerated in an ethical theory of
informed consent, and not found in the legal doctrine. The
original motivation for the doctrine was the acknowledgment
of patient autonomy, but the subsequent legal discussions
tended to compromise it in favor of more physician discretion.
Thus, when the above-mentioned conditions wereenumerated, the
researchers were hastily expecting to see the realization of
the ethical requirements. That means, failure to meet one or
two of the items is not legally liable. Rather they should
have said that the failure of any one of them was ethically
questionable. To meet just the legal requirement is simply
different from the ethical considerations. And the re-
searchers should have realized that neither physicians nor
patients were ready to realize the spirit of informed consent.
They had not been adequately educated to experience a democra-
tic encounter with each other. I think of not just education

at medical school or, in case of patients, education at lower

84

levels of school. We learn things through experiences. Both
parties observed in the research lacked experiences. Just to
be reminded of the existence of patient’s rights before one
enters hospital is simply not enough to act as an independent
decisionmaker. Democratic experience takes time, but we have
to start somewhere.

In the book written by Appelbaum et al an important
distinction is made, namely, between the event model and the
process model. 1W1 a legal setting informed consent is
represented as the event model because it is in a most
superficial respect the matter of actual, temporal happening
of signing an informed consent form. The event model is
applicable when informed consent is dealt with formally, and
in a legally dictated way. The event of signing a consent
form and the act of authorizing can take place only as a
matter of formality. In Faden et al’s book there is a clear
claim that concerns the characterization of the nature of
informed consent as "an autonomous authorization by a patient"
(F, p.3). Authorization could mean that it is a temporary act
and the matter of unilateral decision without the existence
of mutual interaction. Legally there is no real requirement
or guarantee to break the silence that characterized tradi-
tional medicine. The event model which focuses only on the
aspect of authorization or consent-giving does not reflect the
participatory process of decisionmaking which’takes place over

time during a series of interactions between two parties. So

85

if one conceives the act of authorization as an event as in
(F), then it can be placed under the event model, to which the
authors may object because they also discuss physician-patient
communication extensively. The representation of informed
consent simply as authorization is not appropriate. Converse-
ly, the process model represents the ethical ideal of informed
consent which can be realized during a series of interactions,
explanations, questions and answers, where modifications of
previous beliefs and needs, and the development of new ideas,
may take place.

The ethical idea of informed consent is an ideal which
can be realized only when understanding takes place on a
higher level than just the level of understanding in a simple
mode. Real understanding which is related to decisionmaking
can be attained only in conversation. In conversation it is
likely that the topic of standards of disclosure does not
arise in the physician’s mind. An ethically plausible
standard has to take account of specific needs, values and
desires of each individual participant in a democratic
interaction. It would be irrelevant to talk about a profes-
sional standard or a reasonable person standard when the
specific person’s needs and desires are known through conver-
sation, except when external social pressure dictates that
both parties have to employ a less than satisfactory option.
But that kind of compromise should be made clear after the

effort for mutual discussion is explored. In the ideal model

86

where autonomy and care nicely interact, there would be no
need for therapeutic privilege and physician discretion.
There is an ethical imperative for the physician to respect
the patient’s wishes and desires, and for the patient to be
aware of her own capacity and right to be an independent,
decisionmaker, responsive to the physician’s care-giving
effort. So physician’s duties to disclose and obtain consent
are not all that informed consent is about. Informed consent
is expected to promote and encourage the values of autonomy
and health, or a la Katz, liberty and custody. From the
standpoint of a physician, these values mean the requirements
of respect for the patient as a person (from a deontological
reason) and effective cure of illness (from a utilitarian
reason). Traditional medicine was solely concerned with the
latter value whereas the extreme form which—puts exclusive
value on patient autonomy is feared to be medicine without
cars. So the two requirements have to be well balanced.
Nobody wants a purely paternalistic medicine or atomistic,
contractarian, computerized medicine. We want to strike the
balance, namely, we want both autonomy and humane care. This
is very demanding for physicians, and also for patients who
cannot anymore rest contented with their dependent, childlike
role. The goal may be attained through the exercise of
informed consent in an ethically appropriate way.

However, it may be another story to demand that a patient

be a participant in the medical decisionmaking process. This

87
last qualification, namely, the patient as a shared decision-
maker (shared, because the image of an absolutely autonomous,
solitary decisionmaker is irrelevant to the patient) is not
always embraced by all informed consent advocates. It is an
ethically developed theory of informed consent which not only
pays attention to the enhanced status of patient as a consent-
giver, but wants to make informed consent a joint project
between physician and patient. There is a big gap from the
stage of a passive consent-giver to the one of a shared
decisionmaker. For informed consent to be implemented in a
democratic society requires more than meeting only legal
requirements, or «even ethical requirements, for separate
decisionmaking. Shared decisionmaking imposes further tasks
for physicians and patients. Physicians should understand
themselves before they can understand patients. In fact,
understanding oneself and each other will be a*vital condition
for democratic interaction. Above all patients should
appreciate the value of participation in medical decisionmak-

ing.

We have traced in this chapter the history, theory and
practice of informed consent in the United States. That
informed consent was born in the judiciary in the United
States should not be taken lightly. In many cases the courts
have proved to be the protector of the rights of patients.

We have also noticed the significant difference between the

88

legal doctrine and the ethical theory of informed consent.
Some of the elements in the legal doctrine do not show up in
the ethical requirement of informed consent. The legal
doctrine cannot deal with understanding, patient autonomy or
democratic decisionmaking. Ethically speaking, consent given
negligently or involuntarily does not make sense. Courts and
legislatures seem just to focus on the appropriateness of
disclosure. But correct disclosure is meaningless when not
understood correctly. Only in conversation can physicians
come up with a right prognosis and treatment proposal, and
then a possible misunderstanding can be rectified. Conversa-
tion can enhance mutual understanding. The logical conse-
quence of our discussion is in the next chapter’s concentra-

tion on conversation and understanding.

REFERENCES:

ANNAS, George J. 1989. The Rights of Patients, 2nd ed. Carbondale,
IL: Southern Illinois University Press.

APPELBAUM, Paul 9., LIDZ, Charles W., MEISEL, Alan. 1987.
Informed Consent -- Legal Theory and Clinical
Practice. New York: Oxford University Press.

BEAUCHAMP, Tom L. 8. FADEN, Ruth. 1986. A History and Theory of
Informed Consent. Oxford: Oxford University
Press.

GOLDSTEIN, Joseph. 1975. "For Harold Lasswell: Some Reflec-
tions on Human Dignity, Entrapment,
Informed Consent, and the Plea Bargain",
The Yale Law Journal. Vol. 84, No. 4.

KATZ, Jay. 1977. "Informed Consent -- A Fairy Tale? Law’s
Vision", University of Pittsburgh Law Review.
Vol. 39, No. 2.

KATZ , Jay . 1984 . The Silent World of Doctor and Patient. New York:

89
The Free Press.

MEISEL, Alan 8 KABNICK, Lisa D. 1980. "Informed Consent to
Medical Treatment: An Analysis of Recent

Legislation", University of Pittsburgh Law
Review. Vol. 41, No. 3.

MIZUNO, Hajime. 1990. Infoomudo Konsento (Informed Consent).
Tokyo: Chuo Koron-sha.

PRESIDENT’S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN

MEDICINE AND BIOMEDICAL AND BEHAVIORAL RESEARCH, 1982.
Making Health Care Decisions -- The Ethical and
Legal Implications of Informed Consent In the
Patient-Practitioner Relationship, Vol. 1, 2 and
3.

WALTZ, Jon R. & SCHEUNEMAN, Thomas. 1969. "Informed Consent

to Therapy", Northwestern University Law
Review. Vol. 64, No. 5.

CHAPTER III UNDERSTANDING

This chapter concerns the conversation model of informed
consent which is evaluated against three kinds of under-
standing. Understanding refers not just to the patient under-
standing of the disclosed information but more importantly
also to the physician’s and patient’s self and mutual under-
standing. A patient’s understanding of disclosure as such
belongs to the first type. Understanding, when directed to
objective knowledge, requires only making sense of cognitively
confirmable information operative in inductive or deductive
logic. Information flow takes place in one way. Understand-
ing is not satisfied with that kind of information when it is
directed to things pertaining to human volition, conscious-
ness, desires, and needs. Enter hermeneutics which indicates
that a dialogical or conversational mode is the only ap-
propriate approach in such an inquiry. Gadamer will show us
how it works. Participants in conversation are engaged in
reciprocal interchange of ideas which would be indispensable
for good physician-patient relationship. Purely pursued, this
kind of interaction may yield no decisionmaking result, that
means; it may not be able to have a decisive bearing on

informed consent if this latter refers specifically to

90

91
physician-patient joint decisionmaking. Democratically
reflective understanding is invoked in the operation of
informed consent. A democratic institution presupposes the
existence»of both autonomous individuals.and their dialogical,
conversational relationships. Since informed consent has to
do also with objective understanding, it encompasses all three
phases of understanding. Understanding on the second and
third phases reminds us of the need for the conversation
model. Conversation which the physician initiates would
enable the patient to understand the situation he is in and
participate in the joint decisionmaking process. Understand-
ing and conversation are mutually complementary. Katz is an
advocate of the conversation model which aims at shared
decisionmaking. Gadamer champions hermeneutic insights in
human interaction. Habermas is concerned with a decision-
oriented modality of communal relationships. My discussion

will center around the works of these people.

1. The conversation model of informed consent

Jay Katz in his seminal The Silent World of Doctor and Patient
(1984) documents the history of silence of the medical
interaction between physician and patient. Katz characterizes
the long tradition of medical practice as that of silence in
terms of information and decisionmaking. Physicians tend to
be silent all the way through the. medical interaction.

Needless to say silence has little to do with inefficiency.

92

Silent medicine can do a remarkable job. Also, there are
physicians who are by nature taciturn but very skillful and
devoted. Silence has also exceptions. Some physicians are
friendly and skillful in initiating conversation in a positive
way. They listen well and can get a good diagnosis. But
traditionally, physicians most typically never invited
patients into conversations pertaining to treatment decisions.
They took the sole burden of decisionmaking. Overall,
physicians have been silent, and have not even asked many
questions. Katz points out that nowhere in the Hippocratic
Oath are physicians advised to talk about diagnosis or
prognosis with the patients. The need for having a conversa-
tion with their patients rarely came into the mind of physi-
cians. The main and sole purpose of medical practice has been
the effective healing of sickness. Katz reveals that medical
history is scant in documenting physicians’ willingness to
talk with patients.

There is a traditional justification for silent medicine.
The tradition was made in the early days of medical history
that characterizes physicians as those who by divine blessing
receive special, esoteric knowledge which is not to be shared
by the general public. The Hippocratic Oath (to the Greek
gods of medicine) starts with the physician’s expression of
appreciation for the teachers who imparted the exclusive
knowledge; he then promises to transmit it to his own sons and

those of his teachers and some disciples "but to none others".

93

People outside of the selected group are left ignorant of
medical knowledge. Indeed it is amazing to realize how
ignorant we still are about our own body and illnesses. At
school we never learn anything substantial about physiology
or etiology. We recall from our discussion in the first
chapter that physicians in Japan recorded diagnoses and
prognoses in German (nowadays often in English) so that
patients can never find out truth about their cases. Our
ignorance seems as if it were systematically planned, imposed
and controlled. Physicians’ silence perpetuates our ig-
norance. Both physicians and patients lack a common language
for communicatjcwn Medical terminology is too complicated and
recondite. Physicians can anytime ’persuade’ or ’outwit’
patients by the magic of technical terms. When frustrated by
professional medicine, some people start their own search for
truth looking over books and documents, and finally get fairly
well informed about medicine as well as how it is actually
practiced. But otherwise patients remain as ignorant and
powerless as ever’ in contrast toi medical professionals’
outstanding expertise and authority. If medicine wants to
preserve its privileged tradition, silence will remain as its
trademark. Physicians decide everything and patients just
obey their ’orders’.

In individual cases against the demand for more open
medicine, physicians are ready with a paternalistic reason to

be silent. Silence is exercised in cases of grim prognosis,

94
placebo—giving, treatment alternatives, detailed information
about proposed treatment, and treatment against the patient’s
expressed wishes. One paradox here is.even when patients are
formally granted rights to know and to exercise autonomy, they
are left ignorant like children not knowing how to exercise
their rights. According to Katz, also at work is the complex
phenomena of 'transference’ and ’countertransference’ between
physician and patient. Patients bring in “an over-evaluation
of the physician as an omnipotent healer" while physicians
bring an “under-evaluation of the patient as a competent
adult" (Katz, p.142). And unconsciously physicians blame
patients for causing reactions in them. Physicians’ counter—
transference is deeply ingrained in their professional

attitudes which, Katz says, ...include the need to appear
authoritative, the importance of hiding uncertainties from
patients, the need to view patients as incompetent to par—
ticipate in decision making, and the belief that patients’
welfare depends on patient’s trusting doctors’ capacities to
know what is in patients’ best interests" (p.150).

Katz’s prescription against the phenomena is active
conversation between physicians and patients. He also
believes that some general principles could be spelled out
"based on an understanding of the psychology of physicians and
patients and on notions about proper professional conduct with

respect to decision making" (p.153). Without conversation,

physicians’ promise of benefitting patients upon a belief that

95

they know best not only patients’ physical needs but also
their values and wishes will be largely unfulfilled. But in
conversation, ”misconceptions, confusion, fears, and ignorance
can be clarified" (p.162). Further, conversations will enable
both parties to clarify false transference, reduce irrationa-
lity, and understand each other’s needs and assumptions. The
ultimate goal of Katz’s conversation model is a shared
decisionmaking about treatment options. One of the reasons
why medical decisions should not be placed solely on physi-
cians’ shoulders and has to be shared by physician and
patient, is because of the uncertainty of medical knowledge,
the stochastic nature of the consequence of technological
application, and the fallibility of medical authority. Since
there is no absolute certainty about medical science, the
physician needs to talk about it and share the decisional
aUthority about treatment options, and the responsibility to
accept the consequences, unless it is caused by the physici-
an’s lack of skills. Katz says conversation "unites physi-
cians and patients in common vulnerabilities" (p.121).

If the conversation model as it is proposed by Katz were
followed, then there would be no need to consider of excep-
tions to informed consent requirements of the legal doctrine
that we discussed in the second chapter. Indeed, Katz’s
scenarhp is not to posit two different types of people or
groups of people apart fromleach other in adversarial position

and give the one party a chance to exclude the other from

96

entering into a conversational relationship for whatever
reasons. Instead, he sees to it that mutual trust can be
engendered in having meaningful conversation which physician
starts and which results in shared rational decisionmaking
about good care. Unlike so many other physicians Katz is a
staunch advocate of patient autonomy as well as of shared
decisionmaking. He thinks consent-giving should be part of
a shared enterprise of arriving at a mutually favorable
agreement. He proposes this model as the only viable condi-
tion to bring about the situation where informed consent can
meaningfully take place. Katz’s model is clearly an example
of the process model against the event model, and no other
modality can be relevant and placed under this category.

Nonetheless, this proposal can sound unpractical. There
is a clear limitation of time. In a three-minute consultation
session, the physician may do no more than confirm his nurse’s
record of the patient’s complaints. To make good‘of the
situation, a compromise has to be made. Howard Brody points
out that in a primary care unit the physician cannot spend
enough time with one patient to carry out the conversation
model to the satisfaction of both parties (Brody, p.5). As
a compromise for mainly accommodating the legal requirement,
Brody suggests that in presenting risks and benefits of
treatment options, a reasonable patient standard should be
employed instead of the physician’s community or professional

standard. He calls it the transparency standard because the

97

physician tries to make her thinking about her treatment
proposal transparent to the patient. The transparency
standard requires some time to apply itself, so it can be
employed when a three-minute consultation period is expanded
to more than several minutes. This approach is based on the
premise of near impossibility of conversation or personal
interaction between physician and patient. A more idealistic
standard, namely, an individual patient standard is only
attainable on the premise of the existence of extensive
conversation. So the transparency approach does not aim at
the objective of patient participation in shared decision-
making and perhaps is not very different from just informa-
tional, objectivist approach in the sense that informational
flow is one-sided and patients are not required to be trans-
parent. However, the approach can be applicable to two other
phases of understanding and modes of interaction, since its
advocacy of open-mindedness of physicians is treasured by all
conversationalists, either hermeneutical or communal decision-
oriented. To clarify my point, I would like to turn my focus
on the spectrum of understanding and the modality of inter-
action.

Understanding is one of the features in the ethical idea
of informed consent which does not have an adequate place in
the legal doctrine. Physicians are not legally required to
make sure that the patient has understood the disclosed

information. Understanding is one aspect of the physician-

98

patient conversation which the ethical theory of informed
consent would mandate. Whether a patient understands what her
physician tells her affects her decisionmaking, so that
understanding is not only an epistemological issue but an
ethical issue as well. Lack of understanding could make both
information and consent meaningless. One cannot possibly make
a right judgment and decision on faulty information or poor
understanding of correct information. As we saw in the
previous chapter, consent can be given without understanding,
but a valid consent should not just be informed but under-
stood.

Our ethical assumption is clearly that consent or
authorization or decisionmaking can be validated only by
understanding and voluntariness. So even in cases where
understanding is not legally required, it is still necessary
to confirm that understanding takes place. "Patients’ common
reluctance to ask questions or admit of confusion means that
physicians must take the initiative in exploring patients’
understanding" (A, p.170). "It is evident that an adequate
decisionmaking process must include continual monitoring of
patients’ understanding" (A, p.171). When understanding has
to be weighed, the only plausible solution would be to employ
the conversation mode of interaction where the existence of
or lack of understanding routinely gets surfaced, monitored
and rectified. However, patient’s understanding of what is

disclosed may be more complex than we think. My claim is that

99
what is called patient’s understanding of disclosure already
should presuppose adequate self-understanding and under-
standing of the meaning of medical treatment, practice and
relationship. Medical understanding involves many things
including physician’s and patient’s self-understanding, their
mutual understanding, physician’s understanding of patient’
stories and patient’s understanding of physician’s expla-
nation. One may even say that.a patient’s genuine understand-
ing of disclosed information can take place in light of
understanding in all these contexts. If an agreement, or
joint decisionmaking is involved, understanding will be
related to practical judgment and actions. So there is a
spectrum of understanding, each phase of which has a cor-
responding mode of interaction. I call the simple mode of
understanding of objective knowledge, "informational under-
standing". The second level is hermeneutical, because the
object of understanding is now values, desires, and meanings
of human actions that scientific inquiry cannot handle. The
third one is communal, action-oriented understanding which I
could call democratic understanding. The categorization of
understanding in this way is owed to hermeneutics and critical
theory of social science. First of all, I will focus on the
simplest form of understanding which faces information
objectively acquired, handled and transmitted. Understanding
in the legal doctrine, and in usual discussions of informed

consent, does not extend much beyond this level.

100

2. Informational understanding

In the most rudimentary usage, understanding is equi-
valent to comprehending the content of disclosed information,
and something that can be certified by objective method, by
testing or experimenting with the help of logico-mathematical
inferences. This usage of the word understanding in the
modern times is explicated by Kant in his critique of pure
reason. For Kant, understanding is primarily the epistemolo-
gical faculty which "enables us to flflnk'theiobject of sensible
intuition" (Kant, p.93). Only through sensibility (intuition)
and the understanding we can know anything aposterlori. In the
understanding we think the sensibly given object by means of
concepts, both apriori and aposterlori. Understanding is also an
act that the faculty of the understanding exercises. We can
understand and know something when its manifold sensible data,
what Kant calls its representations, are synthesized in ai
concept. "Knowledge is AessentiallyU a whole in which
representations stand compared and connected" (Kant, p.130).
Causation is one of the pure concepts of understanding
(categories) which enable us to make sense of our experience
cyf a physical object and legitimately derive general rules
working in nature. The act of understanding is directed to
the world of phenomena, the world ruled by laws of nature.
This world of sensible objects is intelligible through the

faculty of understanding. With this thesis of understanding

101

Kant claimed that he endorsed the foundation of legitimate
scientific knowledge. Empiricists utilized his thesis and
attributed the basis of their scientific inference to this
faculty of understanding. Logical empiricists of our century
derived their verification principle from this tradition. In
this context understanding understands the causal network of
nature utilizing inductive and deductive inferences. The
basic principle of modern science, namely, "to (explain,
predict and control" is rooted in this foundation. Nowadays
explanation, instead of understanding, is the term used to
describe a natural scientist’s primary objective with regard
to the physical constitution, event, and phenomenon of the
object according to the logical empiricist’s philosophy of
science. Thus, in this stage, understanding means the act of
scientific and intellectual grasping of the object, and
phenomenon, expressed in causal terms. It has to do with
mental operations which take place in epistemological acqui-
sition and transmission of objective knowledge. Theories of
objective knowledge can be value-laden, and some sort of
interpretation (even to the point of arbitrariness) can be
involved, but the objectivist scientists tend to believe that
intersubjectivity among scientists can be obtained by the
understanding of objective knowledge about physical nature.

This may seem too theoretical to have anything to doiwith
a patient’s understanding and comprehension of medical

information. But there is an analogy between scientific

102
understanding and patient’s understanding of disclosed
information. In the legal doctrine of informed consent, one
of the judges’ main concerns was to find a connection between
objectively determined standard of disclosure about risks,
benefits and options on one hand, and the patient’s consent
or refusal on the other. When a physician informs and obtains
consent on the premise that information is understood, the
information concerns factual, objective truth about a specific
medical problem. IDi acquiring objective knowledge about a
certain illness, physician may use various methods to find out
what bothers the patient, what would be anleffective treatment
for the problem, and so forth. In the attempt to understand
the nature of the specific illness, scientific medicine
concerns mainly physiological causation. If a physician
believes that medicine is exhausted in finding out a causal
connection between certain physiological cause and a confirmed
event, and in hitting upon a most effective treatment of the
problem, the whole procedure may be done in a detached manner.
A radiologist who believes in diagnostic efficacy of a high-
tech machine often administers a procedure which may be
unnecessary and involve considerable risks in such a detached
manner. She seems to think that a sheet of paper describing
the risks will suffice to'meet the requirement of explanation.
To her a patient’s questioning of the procedure is a great
nuisance and a hindrance to a scientific, technological

success. In explaining scientific findings, the physician may

103
use only scientific terms which are not intended for patient
understanding, or may not even attempt to explain, because it
is useless to address a non-comprehending patient. Under-
standing on the part of the patient requires intelligence to
grasp and handle that sort of information, which may be given
in difficult language beyond comprehension.

Objectivity of scientific findings and their disclosure
can be valued and shared by common medical expertise and by
knowledgeable patients as well. In the event that democratic
medicine in a global, democratic community is realized,
knowledge and technology should be made commensurable with the
understanding of all competent laypersons and their relevance
to human life should be discussed by all the concerned
citizens” What is suspect in the ongoing practice of medicine
is the idea that objective, scientific knowledge can accord
physicians new expertise and authority with the result of
mystifying its possessors and distancing them even further
from lay people.

In the context of informed consent, in order for this
practice to make sense, the first step is to make sure that
the patient understands disclosed information. For ‘the
patient to understand the information the physician should be
aware of the patient’s degree of intellectual understanding.
It would be legitimate and desirable for the physician to
expect the patient to have some prior basic knowledge about

medical science so that the latter can have better

104

undertanding of the disclosure and relieve the physician of
the burden of explaining everything from scratch. If the
physician is caring enough to take patient’s understanding
seriously, he can identify the state of understanding by
asking the patient factual questions about the information
disclosed which require not just yes or no answers. To elicit
understanding, however, the physician should be careful not
to use technical terms that the patient would encounter for
the first time in his life. If physicians find difficulty
paraphrasing the information in accessible terms, then the
medical profession should start thinking seriously of educat-
ing not only physicians.tolbe more efficient in communication,
but also patients or future patients when they are still in
secondary schools.

Now this is the most rudimentary level of understanding
which is directed to objective knowledge. What is to be
understood here is a certain object whose truth is objec-
tively, cognitively obtained and confirmable. One may notice
that the information flows only one way and that there is no
substantial interaction to discuss the information between
the parties involved. So the knowledge disclosed does not
grow, get modified or corrected in the unilateral flow. In
a medical interaction, patients contribute little in the
process. Objectivist medicine heavily relies on tests and
instruments. By contrast, a good physician would make an

effort to find out about the patient’s problem by soliciting

105
information from the patient in order to make a right
diagnosis and prognosis.

In addition to this informational understanding, Faden
et al suggest that it is important that the patient under—
stands what he is doing, namely, that he is authorizing
something. (Recall it is what consent-giving means according
to (F)). There is a difference between the statement that
the patient understands what he has heard and the one that he
understands that what he is going to do is the act of authori-
zation. While the first refers to human cognition of the
object (objective knowledge) just.described, the latter refers
to an activity which reflects over its own activity. There
is a clear transition from the first to the next stage. When
one talks of understanding which should validate both informa-
tion and consent, it could not be just the Shared objective
knowledge that the rudimentary stage of understanding refers
tOu Rather understanding is used when our interest or concern
is directed to something deeper than the appearance an
observable object displays. When I say I understand someone
or something, I do not just mean that I place the person or
the thing in a causal network so that I grasp the object in
causal terms like how the object came to exist or appeals to
our senses, or the like. Instead the object is placed in a
meaning network in which, in the case of a person, intangible
relationships between my and his inner structure loom large,

such as value orientations, wishes, and desires. To make

106

sense of what I am doing is an operation of such an activity.
So when Faden et a1 claim that it is that kind of activity
which is supposed to validate or legitimize information and
consent, they mean understanding in this elevated sense.
Patient’s understanding is not just for the explanations of
physiological, etiological, therapeutical findings, but also
for the meanings of the proposal, the patient’s role and
mutual relationship with the physician. In case of medical
inquiry, such an intellectual operation is important when the
physician approaches the patient and listens carefully to her
story. A physician’s understanding no less than a patient’s
understanding should be relevant in order to make sense of the
physician-patient interaction and their joint decisionmaking.

Perhaps a physician’s understanding is what precedes his
effort to attain patient understanding. Physician understand-
ing is not just the understanding of causation of disease
which is verified by his scientific background knowledge and
methodology. Physician understanding is required when he is
concerned to give individualized medical care to a specific
individual person. Medical care should not be an assembly-
line process much less a temporary impersonal event. The
physician has to understand himself and the patient in the
elevated sense of the term. It is the task that a logico-
analytical, scientific approach is not helpful to fulfill.
The discipline of hermeneutics has provided a different

approach to understanding human actions and stories.

107

3. Hermeneutical understanding

Hermeneutics offers insights on the necessary connection
between conversation and understanding. The approach attempts
to look for the theory of truth about human existence and
interaction by focusing on dialogues among rational par-
ticipants. It offers a new perspective on illness phenomena
in a profound way which scientific medicine has not attained.
It requires conversation between physician and patient so that
medical inquiry into illness and understanding of it gets
substantial support from disclosed truth that conversation
uncovers. Its main expositor of this century is Hans-Georg
Gadamer (1900- ) who offers an important theory of interpreta-
tive understanding.

Hermeneutics was developed in the area of understanding
and interpreting art works and theological or legal texts.
Their main concern was not to explain the object in causal
terms but to dig out the hidden meanings of the object to be
interpreted. Gadamer in Truth and Method examines the history
of hermaneutics in the nineteenth century and contrasts his
method with the British empiricists’ way of approaching
physical nature and human nature. He suggests that gaining
objective knowledge is not all there is about understanding
anything at all. Such an approach, termed as natural scien-
tific or positivistic, may be applicable only to the purely

physical event or process. As we have seen, to look into the

108

physical causation of a thing suffices for understanding it
in its simplest mode; Epistemologically, however, the Kantian
understanding delimits the scope of the knowabLe or under-
standable object. The knowledge of illness causation is
limited in the sense that a satisfactory result cannot be
obtained by replicable, testable methods alone despite
scientific medicine’s promises. Hermeneutics directs our
attention to the fact that human events and conditions
including illness symptoms are not totally explainable in
scientific terms. The application of natural scientific
method, namely, the subsumption of an instance under a generic
occurrence seems perfectly legitimate in natural science but
becomes problematic in the field of human sciences, because
they involve consciousness, intentionality. and other psycho-
logical states which occur not in predictable, observable way.
In a medical context perhaps a stamping-out.of an epidemic can
be done in an objective, scientific way regardless of an in-
dividual patient’s background or intention which may be at
work in an individual sickening and healing process. Other-
wise, a physician can fail to ’understand’ her patient and
still succeed in curing her physically and emotionally only
in a lucky case.

Gadamer calls our attention to the fact that it was
Martin Heidegger (1889 - 1976), his mentor, who made a sig-
nificant turn in his Being and Time on the problem of under-

standing by showing that understanding is not just an act of

109

the human subject but rather it is "the mode of being“ of
human existence (Gadamer, xviii) in which it is now ontologi-
cally rooted. Heidegger shows that understanding is a
primordial feature of a human person to whom truth appears
when he is in a concernful circumspection toward environmental
totality, and in a solicitude toward other persons, instead
of a natural scientific interest and exercise of logical in-
ferences Understanding concerns what.a human person does, not
as a physiological being but as an intentional existence.

The method of understanding for Gadamer is a circular and
reciprocal movement which goes back and forth between subject
and object, between part and whole» One cannot understand the
object only taken as a separate being without the context it
is placed in. Contrariwise, the whole cannot be grasped
without looking into individual parts that censtitute it. In
this respect Heidegger pointed out earlier that a human
existence cannot be grasped unless by comprehending the
totality of the world in which he lives in terms of time and
space. Heidegger distinguishes an authentic understanding
which is circular from a common understanding which is used
in scientific or everyday context in which information flows
unilaterally. He would not apply the concept of authentic
understanding to the understanding of a partial event or state
separated from the whole. For him to understand something
authentically is to place that thing in thelentire perspective

and to derive the meaning of that being in relation to the

110
totality of beings. Heidegger’s Dasein is not something such
as the combination of soul and body, or as a political,
rational, risible animal or the like. Instead existence is
the person’s essence. He is thrown in existence (regardless
of his will) into this world and is only grasped as someone
in progress, not as a total, whole being. A person exists,
understands, wills, acts, projects oneself over possibilities,
and so on, in his unique way when he is situated in the life
world. This approach can be contrasted to the physician’s
understanding of physical causation of disease or to the
patient’s understanding of objective truth that is disclosed.
Instead, one may want to inquire into the possibility of the
physician’s and the patient’s self and mutual understanding
and of placing things in a proper perspective. And that
should make a difference to the purpose of their interaction.
This existence is hardly atomic, though it has to experience
its beginning and end all by itself. It is historical, partly
repeating the past experiences of the past people. Yet it is
also as if one carves one’s own future in one’s own way. So
there are two moments in the existence. We are conditioned
by the past history of human existence. We are historical
beings. Yet we understand and can plan our own course of
existence. Heidegger’s authentic understanding understands
that a human being is characterized both by historicity and

freedom.

111

A difference of Heidegger’s person from Gadamer’s is that
the former is an individual existence whose initial
interaction is not with other persons but with things in the
network of usability. For Gadamer an individual is not so
much a person who projects oneself in the future as the one
who brings in one’s unique past into the interaction with
other persons. In Gadamer’s words the cycle of the parts and
the whole ”is constantly expanding, in that the concept of the
whole is relative, and when it is placed in ever larger
contexts the understanding of the individual element is always
affected" (Gadamer, p.167). The hermeneutical approach
expects understanding to grow, expand and transform.

Heidegger and Gadamer are in accord with each other as
to the importance of language and conversation in the act of
understanding associated with the definition of truth. For
Heidegger truth is something Which can be talked about,
manifested, unhidden or disclosed through discourse (Heide-
gger, p.56). Truth is uncoveredness and also the state of
uncovering. Being false "amounts to deceiving in the sense
of covering up AverdeckenU" (p.57). When he is under the spell
of influences of others, public opinions or hearsays, the
person is in untruth. Things can be disclosed, and it is
simply good to be placed in the open. Discourse is ’equi-
primordial’ with understanding (p.203), which means, discourse
is also a fundamental constituent of being a human person.

In other words, understanding takes place in discourse in

112
which interactions between different persons is done in
language. "Dasein has language" (p.208). Silence could also
be part of the discourse, because a person could express
himself by being silent. Yet silence is not a genuine
characteristic of a person. "Man shows himself as the entity
which talks" (p.208).

For Gadamer language gets an even more important bearing
as the medium of hermeneutical experience. ”Language is the
middle ground in which understanding and agreement concerning
the object takes place between two people" (Gadamer, p.345).
Understanding is attained through the process of questions and
answers in conversation. Good questions can achieve openness
and insight. For Gadamer, not only the medium of under-
standing is linguistic. The characteristic of the herme-
neutical object is in fact linguistic. It is not just that
everything can be expressible in language, but that human
thought process and the ontological order of the world itself
are all embedded in linguistic activityu A commentator writes
that for Gadamer “language goes its own way because it answers
the immediate needs of its speakers and expresses what they
find most important...” (Weinsheimer, p.241). The hermeneuti-
cal emphasis of conversation through the use of language which
reveals hidden needs and desires of speakers has great
relevance to our discussion of the conversation model of

informed consent.

113

For Gadamer and unlike for Heidegger the act of under-
standing takes place most importantly between two persons.
“Understanding is primarily agreement or harmony with another
person. Men generally understand each other directly, ie they
are in dialogue until they reach agreement" (Gadamer, p.158).
Gadamer does not say that people can after all perfectly
understand each other. His goal of communication is more
modest than radical mutual penetration of each other.
Instead, understanding is "always understanding about some-
thing". So mutual understanding “means understanding each
other on a topic or the like“. But we still say two persons
understand each other; then that ”means that they understand
each other not only in this or that respect, but in all the
essential things that unite human beings". He also says,
"Understanding becomes a special task only when this natural
life in which each means and understands the same thing, is
disturbed" (ibid). When there is an apparent misunderstanding,
an effort to reach mutual understanding is made. In conversa-
tion, in the exchange of questions and answers, people will
realize the uniqueness or individuality of each other (p.159).

What happens in such an encounter is a “fusion of hori-
zons" that each participant has brought in. The fusion is a
condition of experience and to have a horizon (one’s own
clearly defined worldview or perspective) is a characteristic
<of'being a human person. One who has no horizon “does not see

far enough and hence overvalues what is nearest to him"

114
(p.269). And "...to have a horizon means not to be limited
to what is nearest, but to be able to see beyond it" (ibid.).
Conversation is to discover each other’s place of existence
and horizon, what the other thinks, wishes, needs, aspires.
Good conversation starts with openness and listening and
asking question. Asking questions means we admit the knowl-
edge of not knowing (Socratic method). In referring to the
Socratic dialogue Gadamer makes a distinction between genuine
and false discourse. Genuine discourse obtains between the
persons who want to know, understand and get insight from the
other. Whoever thinks he knows better does not even ask the
right questions. Whoever wants to prove her rightness,
instead of willingness to know, does not elaborate on what
should be asked. Indeed, asking the right kind of questions
is an index of the quality of conversation out of which
something positive comes. Discourse that is intended to
reveal something requires that that thing be opened up by the
question. Gadamer observes that in this context of question
and answer, truth and knowledge come to the fore. The things
that come to the fore are essentially undetermined. That is
why they are brought into the open. But the initial question
decides what is to be opened, discussed and decided. A false
question does not open up what is to be settled. "Knowledge
is dialectical from the ground LEM Only a person who has
questions can have knowledge" (p.328). But we cannot spell

out in advance what should be questioned. Only the awareness

115
of lack of knowledge induces one to ask questions, but it is
hard to know what we do not know. It “is so hard to obtain
an admission of ignorance" (p.329).

Gadamer’s theory uncovers features of conversation in
which Katz is interested as a model for informed consent. The
general principles which Katz suggested for initiating
physicians’ conversation with patients should include “Know
your ignorance. Be open. Ask good questions." These are
most basic, but abstract, guidelines applicable not only to
physician-patient relationship but also to any kind of
dialogical relationship. The principles should depend on how
you want your relationship to be. One ideal mode of medical
interaction is existential against the intellectual type of
Platonic dialogical relationship. Physician-patient
interaction is not just a salesman-customer, or'a colleague-
colleague relationship. On the contrary, both physician and
patient encounter each other on the deepest level-of our
existence; namely, in the experiences of bodily pains, of life
and death, where we get truly desperate, need support, and can
be deeply sympathetic. Here on this level we can be reflec-
tive on the meaning of mutual existence. One reflection might
lead to the awareness that physicians and we the ordinary
people are both beings who happen to live in the same period
of history and to share same or similar cultural tradition and
social experiences. From a wider perspective of history the

awareness of contemporaneous existence could arouse care for

116

the co-travelers, feelings of sympathy and solidarity. Thus
the physician-patient interaction could be regarded as an
existential encounter which is allowed only to us as contem-
poraries. Concern and care are extended in the others’ mode
of existence through the mediation of the presence of ill-
nesses, fears and anxieties. The meaning of illness ex-
perience is one thing that should be seriously talked out in
the dialogue between physician and patient. Both parties
cannot be resigned to their mutually fixed roles, but should
experience the fusion of horizons, that is, share the mutual
perspectives. But for this purpose both parties should be
mature, informative and understanding. Narrative medicine and
holistic approach can both be kins of hermeneutical medicine,
which is not just a possibility but rather a necessary
requirement of good health care. Indeed a therapeutic merit
can be accorded to hermeneutic medicine. A medical doctor
testifies that recent research has shown that "when patients
feel heard, they are not only more satisfied but healthier"
(The New York Times, 3/29/87).

I now turn to the ethical implication of Gadamer’s
hermeneutics. Heidegger did not talk too much of a tradition
(at least in his major work) but Gadamer wants to say that to
understand the other is to understand her from her cultural
heritage which might be alien to other people. In the human
interaction what happens is not just the fusion of different

horizons, but a birth of a new, common horizon. The fusion

117
of horizons is necessary because we are all different and the
difference has to come up to the surface once. But it is
necessary for another reason. That is, an ethical objective
of our interaction. After all, Heidegger’s main interest was
ontological whereas Gadamer specifically addresses one ethical
question, that is, the application of moral knowledge to make
a right judgment in a particular, concrete situation. For
Gadamer, application is part of understanding. Medical
insight has no meaning except in application and this ul-
timately cannot be understood in purely technical terms. If
you somehow gain moral knowledge, for example, that informed
consent is an ethical requirement, the knowledge is meaning-
less unless it can be applied to an actual medical relation-
ship. A moral person is not an objective observer but a
mature, rational decisionmaker who lets her moral knowledge
about a right conduct control her-action. Unlike accumulation
of technical skills, experience is not "sufficient for making
right moral decisions" (p.282). It is not impersonal, objec-
tive knowledge. Development of moral consciousness may be
done by education and custom to some extent, but we have to
remember that each concrete situation demands a different
application of the knowledge. In our context mechanical
application of the idea of informed consent does not work.
The terms "informed" and “consent" can be meaningful only when
the disclosed information and the act of consent-giving are

truly understood in the process of discussion and agreement.\

118

What is required of a physician as the initiator of meaning-
ful conversation is to be ready to utilize his moral intuition
and tries to ’see’ what should be doneimmediately. What
should be done would be to ask the patient right questions,
understand the patient’s hidden wishes, and to get her
involved in a conversation for making a right decision. In
such a situation, understanding shows itself in the form of
an 'understanding’ attitude. Understanding "appears in the
fact of concern, not about myself, but about the other person.
Thus it is a mode of moral judgment" (p.288). An under-
standing physician "united by a specific bond with" the
patient, ”thinks with the other and undergoes the situation
with him" (ibid.). Physician and patient encounter to make
a rational decision about treating a health problem. What is
intended in a dialogue between a physician and a patient is
not the complete and direct understanding of each other which
is neither possible nor necessary. Instead the goal is an
agreement between both parties about a specific topic, most
often about choosing a method of cure among alternatives.

The fusion of horizons that Gadamer emphasizes is an
insightful observation of an interaction of the persons with
different backgrounds and views of life. Unfortunately,
however, Gadamer regards the physician-patient conversation
as something different from usual relationship to which his
model can be applied. In Gadamer’s view the medical relation—

ship consists only in knowing the other party’s horizon and

119

not in generating a new horizon or "seeking agreement con-
cerning an object“ (p.270). Implicit in his observation is
that the physician-patient relationship is such a*wertical one
that no equal mutual interaction is relevant, that the disease
to be cured is something that the physician should be con-
cerned with and the patient has no say about, and that coming
to agreement does not seem to be the goal of this relation-
ship. Gadamer says, "Where a person is concerned with the
other as individuality, eg in a therapeutical conversation or
the examination of a man accused of a crime, this is not
really a situation in which two people are trying to under-
stand one another“ (p.347). After all, the above extrapola-
tion of Gadamer’s understanding model to a medical relation-
ship was mine. I suspect that Gadamer may still belong to the
old German mentality as far as the medical relationship is
concerned, in which the physician is depicted as the sole de-
cisionmaker and the patient just obeys his instructions. But
if we can claim that the physician-patient relationship should
be a hermeneutical one, then Gadamer’s scenario should also
be applied to the medical relationship as well, because the
real issue is how to conceive a fusion of horizons among those
who are not only different but unequal in their resources in
an important respect.

Indeed hermeneutical medicine should be medicine’s
immediate goal if it tries to get out of an impersonal, objec-

tifying orientation. This orientation is one in which

120
conversation does not take place. What is lost therein is not
only ethical but therapeutical. Hermeneutics has taught us
the importance of medicine dealing with a uniquely different
individual having different problems, needs and expectations.
However, Gadamer’s emphasis on tradition is both his strong
and weak points. He does suggest an important point with
regard to what it means to understand each other when each
comes from different tradition. People from different
cultural background often have different points of view about
health, sickness, care of the sick, death and the dead. Even
if the physician speaks the language of the alien patient, she
may not hit at the most appropriate cure for the patient
unless the physician gains some knowledge of their taboos,
customs and views, however peculiar they are“ Gadamer asserts
that there is nothing wrong about having prejudices (namely,
unique views) about morality and way of life insofar as they
are rooted in one’s legitimate tradition. Indeed some
prejudices are true and legitimate. For him prejudice is a
precondition for understanding. In our context we might want
to say that the awareness of one’s own bias and openness to
the cultural tradition of the other is one of the important
requirements of culturally conscientious physicians who
practice in a democratic society. Presumably medical anthro-
pology was born to respond to this requirement. This means
each tradition is taken more or less as authentic and respec-

table unless it greatly hinders the physician’s way of dealing

121
with the patient. This approach is commendable when there is
no particular reason to reject or ignore the tradition, and
there is some reason to believe that the patient’s belief in
the tradition may help the healing process. Faith in the
supremacy of modern science and technology tends to keep us
from listening to the wisdom that we have inherited from our
ancestors. So hermeneutic medicine directs our attention to
the existence of alternative approaches which have been his-
torically tested and verified. 11;can make suspect scientific
physicians’ rejection of traditional medicine as unscientific
and worthless without scientifically checking into the merits
and demerits of the cultural tradition. Scientism can become
very dogmatic in rejecting anything which belongs to the past
and is seemingly based on something other than scientific
causation and reasoning. One serious problem with hermeneutic
medicine, however, would be that physicians may be taken in
by the patient’s cultural tradition uncritically. One extreme
of traditionalism claims that. anything that has endured
historical vicissitudes is right and worth preserving. One
clainnout of this approach is the thesis of incommensurability
of different cultural traditions. And a cultural-anthropo-
logically conscientious physician may concern herself too much
with understanding the patient’s cultural heritage and meeting
the demands from the heritage bearer. A possible consequence
of this approach would bethat what the physician deals with

is not the patient but the tradition that the patient bears.

122

From the ethical point of view such cultural relativism only
helps endorse passive acceptanceeof a tradition simply because
it has been historically transmitted, when it may be ethically
problematic in ignoring personhood, autonomy, care for others
and other democratic values that have a bearing on all the
members of a future global community. A tradition often could
preserve serious discrimination as to sex, age, race, educa-
tion, walk of life, and so forth which can hinder participants
in a democratic interaction from conversing in common, free,
equal terms.

The greatest contribution of hermeneutical approach to
informed consent was to point out that understanding, not only
of disclosed information but also of the meanings of the par—
ticipants’ mutual roles and actions, has to precede the act
of consent-giving, that such understanding takes place only
in mutual conversation which the physician starts from her
concern in the patient, that in such a conversation something
like a fusion of perspectives takes place, and that only such
understanding as application can make mutual agreement
attained in the conversation meaningful. In the end, however,
Gadamer’s ethical stance in the matter of application became
suspect. What he has in mind may be age-old moral principles
which might not be democratic at all. Or we could also say
that the dogmatic use of such principles might fit quite
comfortably into conversation as Gadamer reconstructs it. So,

even when hermeneutical medicine is successful in obtaining

123
right diagnosis and prognosis, if tradition and authority
should be preserved intact, decisionmaking would still remain
solely in the hands of physiciansn (When hermeneutical
medicine is influenced only by tradition and authority, it is
not critical, free, and creative. The promised dialectical
development of dialogue may not meet the expectations and
needs of those involved. This sort of limitation of her-
meneutical understanding is pointed out by understanding of
a higher level which is possible in the presence of par-
ticipants with equal status and communicative ability for

shared, democratic decisionmaking.

4. Democratic understanding

Thus, although we get good insights from Gadamer about
the conversation model of the physician-patient relationship,
we still are not quite satisfied with his approach. It is
JUrgen Habermas who thinks of mutual understanding and the
conditions to attain that goal in terms of free and equal par-
ticipation. It is not just the patient’s understanding of
physiological, therapeutical information disclosed, nor just
the patient’s understanding of physician’s transparent
thinking, nor just the physician’s understanding of the
patient’s stories that make up the process of genuine under-
standing of a participant in a democratic decisionmaking
process. The attempted understanding is to take place in both

ways on the same topic at the same time for a clear purpose

124
of attaining agreement between the two parties. Habermas
writes:

"The goal of coming to an understanding...is to bring

about an agreement...that terminates in the intersubjec-

tive mutuality of reciprocal understanding, shared
knowledge, mutual trust, and accord with one another"

(Habermas, p.3).

The goal of communication is mutual understanding about
something. This much is not different from hermeneutical
understanding. For Gadamer the goal of understanding is
agreement and harmony; For Habermas, agreement and consensus.
Both seem to say the same thing about obtaining practical
truth through conversation. But there is a difference as to
what agreement is. Gadamer’s agreement seems to concern what
have already existed as horizons, prejudices, views of life.
Habermas is concerned rather with what should be done on the
premise of existing needs, conditions, and possibilities. The
basis of his argument is the critique of ideologies that may
constitute Gadamarian prejudices and traditions. Gadamer does
not address the feature of shared decisionmaking which is the
vital concern for both parties in terms of life and death
questions.

Habermas wants to show the efficacy of communicative
actions, and ultimately the possibility of gaining action and
decision-oriented understanding by proving the communicative
capacity' within speech acts that rational decisionmakers

exerciseu Habermas refers to the theories of ordinary langua-

ge philosophers concerning speech acts. His main concern does

125

not lie in linguistic analysis such as syntax, semantics or
empirical pragmatics of sentences of a language. Instead
Habermas tries to show what actually constitutes a communi-
cation act which leads to a mutual understanding between two
parties and which happens in any language of the world.

Habermas’ schema of universal pragmatics may be applied
to the physician-patient communication as follows. There are
three important elements in the structure of speech acts that
take place in a person-to-person relationship. The first
concerns the cognitive aspect of a proposition that happens
in the conversation. For example, the statements such as “I
have a headache" and "Your X-ray shows that there is a tumor
in the stomach“ have to be understood as true or corresponding
with reality in order to get the conversation going. The
second element of the speech act structure is the expression
of the speaker’s truthfulness. Implicitly or explicitly
expressed portions in the utterance of a sentence such as "I

sincerely think... betray the speaker’s inner subjectivity,

his truthfulness, transparency of his inner thought. Finally
there is the element of rightness in the speaker’s assertion
that fits for the communicative relationship. Sentences and

propositions are uttered often with illocutionary additions

such as "I have to tell you...', "I declare...', "I pre-

scribe... , “I advise you... , and "I promise you... . We may
note that Habermas does not deal with erotetic forms of

language, the way to ask questions, and imperatives, the way

126

to express commands. The three elements, namely, truth of
transmitted cognitive content, truthfulness of the speaker’s
intention, and rightness of speech act with regard to the par-
ticular intersubjective relation are the basic conditions for
successful communication that leads to mutual understanding.
In the intersubjective relationship what is expressed is that
a conversing person is involved in three worlds, his inner
subjective world, his outer objective world and his intersub-
jective world with other persons. Habermas presupposes human
capability to start an intersubjective relationship and that
language can bear the role of mediation to connect up the
three worlds. The triad represents three different values
that correspond with the spectrum of understanding, namely
objectivity, truthfulness and commonality. Habermas’s under-
standing covers all three dimensions. In the context of
informed consent, understanding understands objectivity of
information exchanged and expanded in conversation between
truthful participants for sharing decision and responsibility.

Habermas’ universal pragmatics is the analysis of a set
of speech acts that can result in a successful mutual under-
standing. There are a number of things in his thesis that are
suggestive for our discussion. First, speech acts are the
fundamental components for the act.of.attaining understanding.
Silence, gestures, facial expression, or sign language could
sometimes substitute linguistic expressions but they are all

only derivative and fall short of the effectiveness of speech

127
acts. With Habermas, one can be somewhat optimistic about the
efficacy of language use that can more or less represent the
objective state of the world and subjective intentionality.
In our context there may be doubt as to whether the same pain
language can be shared by both physician and patient, if the
physician has no experience of sickness herself. But if there
is to be mutual understanding, then the existence of shared
language has to be presupposed. Conversely if there is no
such thing as common language, then ultimate understanding
cannot be attained. One should be confident of one’s com-
municative competence as a participant in conversation and as
a psychologically and intellectually mature patient or physi-
cian. This competence is also something that has to be
cultivated and trained. Thus, education for physicians and
possible patients are equally important. Habermas’ scheme is
intended for all the members who make up a democratic society.
Sharing the same language, effective language use, and belief
in the efficacy of the language seem to be the first require-
ments for acquiring the competence. Secondly, speech acts
should or can be honest and transparent of the inner psycho-
logical states of the speaker. Trustworthiness of the
speakers is indispensable for good conversation and one of the
requirements in communicative competence. Understanding of
each other’s inner state is not the goal of conversation, but
the speaker’s readiness to be transparent is the sine qua non

for generating trustworthiness. Recall Brody’s transparency

128

standard of the legal doctrine of informed consent. Here,
however, transparency is required of both parties in the
conversation. Deception, self-deception and any other cover-
up of the speaker’s inner state are meant to be the giving up
of’ the (effort. to .attain mutual understanding. ‘Thirdly,
Habermas’ communication theory presupposes the existence of
communicative participants in conversation with equal status
and ability to communicate. Equality and care for others are
fundamental qualifications for participants in intersubjective
communication.

Given the conclusion about each person’s conversational
capacity, what makes most sense is to converse with each other
and find out the other’s thought process and hopefully arrive
at an agreement which would satisfy each other’s needs and
aspirationsn What should be shared in the medical interaction
are not only information on the nature, diagnosis, and
prognosis of the disease, risks and benefits of the treatment,
and possible alternatives, but also the image and under-
standing of the state of medical knowledge and technique,
especially of medical uncertainties, and acceptability of
considering one’s own values and desires in decisionmaking.
If there is an agreement, then the process is called shared
decisionmaking instead of solitary decisionmaking on either
side which may otherwise go parallel without interacting with
each other. The authorization model cited earlier is surely

an improvement over paternalism because it attends to the

129

patient’ decisionmaking right, but as such it may perpetuate
patient’s passive ,status, namely, of only accepting or
refusing the physician’s proposal. The conversation model
which goes beyond hermeneutical understanding calls for
patient’s contribution in the decisionmaking process on top
of physician’s honest disclosune of all needed information
gained through the interaction. The model therefore suggests
something very radical and innovative. It imposes new duties
both on the physician and the patient. ‘The physician’s duties
do not just concern disclosure and consent but the duty to
initiate conversation becomes the most important one. The
patient is equally obligated to respond to the physician’s
invitation and to be prepared to understand the physician’s
role and willingness to cooperate. Silence is no longer a
virtue. If you talk with, and understand, each other well,
and arrive at an agreement on a treatment option, then there
will be little room for resentment after the treatment is
done, unless the physician displays considerably poor quality
of care.

Habermas discusses an ideal interactive situation in
order to show that it is at least possible that such a thing
could hold if appropriate conditions are met. The conditions
are spelled out in the form of the communicative competency
of each participant. But even when competencies are latent
in them, still the ideal situation may not occur. That is

when Habermas comes up with consideration of the things that

130
place constraints on the realization of the situation. So the
discussion of the ideal interactive situation is helpful to
contrast it with the situation where conversation is con-
strained and no genuine understanding is achieved, which is
actually close to the case in our world.

For Habermas what has to be overcome is "systematically
distorted communication" (Habermas, p.120) in which deception
or manipulation of one party over the other by way of illusory
information takes place to generate "false consensus" or
agreement. This observation has a clear relevance to our
discussion of uninformed or misinformed consent. Also the
following are possible constraints placed on physician-patient
conversation. The first is stereotypical mutual images.
There is an age-old notion that the patient cannot be rational
in thinking so that she is not entitled to a rational conver-
sation. To label any patient irrational may be wrong. Pain,
fear and deprivation of mobility may be upsetting the patient
but not necessarily limiting totally her capacity for rational
thinking and decisionmaking.

On this matter, Katz makes an interesting observation.
He says that the basis for possible mutual understanding is
not mutual rational competence but something opposite may be
the case (K, p.120). Katz distinguishes between autonomy as
decisionmaking right and psychological autonomy as the
capacity to make decisions. Instead of trying to prove the

validity of psychological autonomy which could in turn

131
validate the patient’s claim to have decisionmaking right, he
embarks on a discussion from Freudian psychoanalysis of the
influence of unconscious and irrational motivations. But he
does not apply these motivations to ferm a deterministic
principle of psychological law. Rather he tries to show that
not only patients but also physicians are affected by these
processes. The result of this finding is that you no longer
can claim that physicians’ belief, especially of benefitting
the patient, which is used for justifying the control over the
patient, is more rational than a patient’s alleged irrational
mindset under the influence of illness or injury. Instead of
proving the patient’ capacity to make rational decisions Katz
disproves the rational-irrational distinction and the physi-
cian’s alleged monopoly of rationality: Reflection and choice
both work in the decisionmaking, and the process is not nece-
ssarily rational or conscious. A physician’s judgment is not
necessarily predominantly rational, while patient’s judgement
is not necessarily predominantly irrational. Patients could
be on a par with physicians in terms of irrationality. A
physician’s proposal or recommendation of one particular
treatment option is often influenced by her subjective
inclination, belief, or value preference when there are so
many uncertainties about medical science and there is no
definitive consensus about the treatment, one example being

breast cancer treatment.

132

How could one make sense of these opposite suggestions?
Habermas seems to suggest that both physicians and patients
are on a par with each other in terms of rationality whereas
Katz says it is the case in terms of irrationality. I do not
think these two thinkers present a difficulty for each other
by making seemingly opposite observations. Katz says that
both could be irrational not in qualitatively different ways.
Habermas would not disagree with Katz’s thesis because that
seems to be the case with the status quo of the physician-
patient interaction when in fact some physicians claim that
rationality is only with them and not with their patients.
On the other hand, Habermas talks of an ideal situation when
mutual understanding can take place, when both parties can
engage on perfectly rational terms. Katz wants to say that
the seeming lack of rationality with the patient cannot be an
excuse for the physician to refuse conversation. Both could
be irrational in a similar degree, but it is required of the
physician to initiate the conversation which may clarify the
problems and find a solution. It is Katz’s strategy to
discourage physicians from withdrawing from their conversa-
tional responsibility. Katz wants to say they should be
pressed to modify their self-understanding. But after all,
it is evident that Katz also believes in communicative com-
petence of all participants.

Since physicians have been historically the only deci-

sionmakers in medical affairs, they are the ones to realize

133

that patients have both informational and decisional needs.
The belief that a self-determination right does not belong to
patients is a great obstacle for mutual understanding.
Actually, those physicians who hold on to it would not admit
the need for mutual understanding or conversation. Conversely
negative attitude such as fear, blind trust, dependence, and
acquiescence make patients silent and vulnerable to coercion,
manipulation and impositicnm of‘ a physical, psychological
trauma by physicians. It sometimes happens that an unfor-
tunate encounter with a physician motivates the patient to be
self-reliant. But such a consequence cannot justify the
damage done. It is better that the damage did not happen at
all. If the lack of informed consent was responsible for it,
then the damage was definitely avoidable. Patients should be
transformed self-consciously to an independent decisionmaker
so that they can urge the reluctant physicians to be involved
in lively conversation. Another constraint is related to the
above two, that is the belief that patient are incapable of
conversation and understanding anyway because of inequality
of intellectual competence. In order to remove misunder-
standing, a patient has to be mentally prepared to have a
meaningful encounter with a physician. Education is again
needed to remove this obstacle.

However, the great obstacle for a good encounter would
be a socio-cultural environment in which both physician and

patient find themselves and which does not allow them to

134

engage in free discussions. The whole structure of the
medical profession tends to be hierarchical, authoritarian and
undemocratic. So the existing health care and insurance
systems may be the greatest hindrances for democratic interac-
tion. Also, hermeneutical understanding in Gadamer’s sense
fails to take a critical stance to the ongoing practice. The
communal decision-oriented understanding urges the partici-
pants in the conversation to critically discuss the situation.
Surely these are not actual topics to be discussed between
physician and patient in the present practice. But the
passive stance on both sides encourages the image of medicine
as a power center in capitalism instead of taking the role of
liberator of human suffering. ‘Together with these, the status
and authority of the medical profession and the validity of
informed consent are the topics that will be dealt with in the
next chapter, as something to be discussed in what Habermas
calls discursive will-formation in a democratic society.

In the rest of this chapter, I will summarize what is
gained from the above discussions of understanding. In the
medical relationship understanding is something that does not
limit itself to the area where the patient understands the
information disclosed. Both physician and patient could share
the basic understanding of the meanings of disease and death
which lie at the basis of human existence common to the
peoples in East and West. ‘The common denominator of a disease

is something which encroaches your body and hinders you from

135
pursuing your everyday activities, or from attaining a goal,
or from fulfilling your social responsibilities. Fever, pain,
loss of energy make you feel resentful, exasperated, and
desperate. The role of the physician is to help the patient
restore her physical and mental ability to function in soc-
iety. A physician is educated to tender a wound or sickness
of a fellow human who is unable to take care of oneself
properly. Sickness is not usually an isolated phenomenon.
Knowledge and understanding of the background of a sickness
should be important to find an appropriate cure. The superior
knowledge, however uncertain, that the physician possesses
about human biology and psychology should be used for freeing
human bondage from misunderstanding and nfisconception that
generate unnecessary fear and despair. Appropriate under-
standing should take place on the part of the physician about
his own role and the "organic nature and the complexity of
medical practice" (P, Vol.2, p.401). This requirement goes
further to the understanding of the historical, social,
economic situation of their mutual positions. What is
requested of a physician is a vision and mission to keep
enlightening the general public without taking advantage of
their ignorance. If there occurs a panic in the area of a
sudden epidemic or an incident of irrational ostracism.against
those who suffer from socially induced diseases, it is the
physicians who can enlighten the ignorant folks. Physicians

can be paternalistic in the face of such ignorance and

136
irrational beliefs. Indeed a physician’s proper understand-
ing of his own role is required before embarking on the pr-
oject of obtaining informed consent. However, the most
important part of a physician’s role is to recognize the
patient’s informational and decisional needs, and initiate
conversation to share decisionmaking and informational
authority. Moreover, what is important for both physicians
and patients is their belief in the effective use of language.
Successful communication and coming to understanding is
guaranteed by the language structure, if the speakers realize
what they are doing. Both parties are expected to have awa-
reness of communicative competence. The realization of com-
municative competence is the matter of education and traini-
ng. In this regard the way the Japanese people approach their
language is wrong and inappropriate for a democratic interac-
tion. Openness and truthfulness should and can be attained
through conscious speech actsn Without the awareness of these
features.of successful communication informed consent.will not

be realized in an ethically relevant way.

In this chapter, I have discussed the conversation model
of informed consent proposed by Jay Katz. It was shown that
the conversation model belonged to the process model against
the event model in which informed consent was supposed to
occur at a discrete moment. The process model on which

informed consent is considered as taking place in a certain

137
duration of time is an ethical requirement. Genuine under-
standing may not take place on the event model in which
informed consent can be only nominal. Understanding was
discussed in terms of a spectrum. Informational understanding
is used in natural scientific inquiry as well as in everyday
situations where natural causation or logical (both inductive
and deductive) inference is at issue. Hermeneutical under-
standing is at work when one wants to interpret the phenomena
or derive meanings from human activitiesn We learned from the
hermeneutical approach that human illness and its healing
process are not purely physical phenomena. Gadamer offered
insightful observations about an understanding relationship
but it turned out that he was too reliant on, and uncritical
of, tradition, so we turned to Habermas to gain better
understanding of our present situation and mutual understand-
ing to work together to solve medical problems. We saw Katz
and Habermas endorsing the conversation model which has joint
decisionmaking as the goal of interaction. Understanding is
connected with arriving at a good medical judgment and joint
decisionmaking. Understanding per se may not lead to a neces-
sary action at all, while a sound judgment should be the
result of a sound understanding. The ethical theory of
informed consent requires that understanding precede decision-
making. However, the physician-patient relationship is not
an isolated phenomenon from the main structure of society.

If the relationship is hierarchical, it is a mirror of the

138
society which has a hierarchical structure. Butleven when the
overall social structure is democratic, the physician-patient
relationship could remain vertical because of the traditional
authoritarian practice of the medical profession. Informed
consent requires that the participants in clinical decision-
making process keep equal status as decisionmakers at least
in matters that directly concern the patient’s value system,
even though both parties are unequal in expertise and social
influence. In the next chapter informed consent will be

examined as a part of a participatory democratic institution.

REFERENCES:

BRODY, Howard. 1989. "Transparency: Informed Consent in
Primary Care", Hastings Center Report, Vol.
19, No. 5.

GADAMER, Hans—Georg. 1975. Truth and Method. New York: The
Seabury Press.

HABERMAS, JUrgen. 1979. Communication and the Evolution of Society.
Boston: Beacon Press.

HABERMAS, JUrgen. 1990. Moral Consciousness and Communicative
Acficn.Cambridge, England: Polity Press

MCCARTHY, Thomas. 1978. The Critical Theory of JUrgen Habermas.
Cambridge, Mass.: The MIT Press.

HEIDEGGER, Martin. 1962. Being and Time. New York: Harper
& Row.

KANT, Immanuel. 1965. Critique of Pure Reason. New York: St.
Martin’s Press.

KATZ, Jay. 1984. The Silent World of Doctor and Patient. New
York: The Free Press.

KING, Lester S. 1982. Medical Thinking -- A Historical Preface.
Princeton, NJ: Princeton University Pre-
ss.

WEINSHEIMER, Joel C. 1985. Gadamer’s Hermeneutics --A Reading

139

of Truth and Method. New Haven, CT: Yale
University Press.

CHAPTER IV DEMOCRACY, AUTHORITY, PUBLIC POLICY

In this chapter I would like to deal with informed
consent from a broader perspective, namely, as a part of the
theory of participatory democracy. A. democratic theory
concerns a social structure that operates according to
democratic principles. The democratic principles include the
idea of participation in decisionmaking process to realize
communal values. Medical decisionmaking between physician and
patient should not be an exception. I will go on to examine
the issue of democratic justification of a social institution
such as informed consent as was suggested by Habermas. Along
this line of thought, authority of the medical profession and
the range of physician discretion will also be discussed. I
will also continue to discuss various constraints that
obstruct a democratic interaction. Finally some proposals
will be made on how informed consent can best be incorporated
in the mindset of the people and practiced in the physician-

patient relationship in an ongoing quasi-democratic society.
1. Participatory democracy

Informed consent as treated so far is a practice proper

to a democratic society. More specifically, it embodies the

140

141
values proper to participatory democracy. To understand both
some of the implications of informed consent and some of its
pre-conditions, it will be helpful to spell out the corres-
ponding notion of democracy. ‘There are two reasons to connect
democracy and informed consent, ethical and therapeutic.
First, autonomous or shared decisionmaking as democratic
practice should not be limited to political arena. Medical
relationship should also be democratic. Second, autonomy or
independence makes the patient stronger and more committed to
her own health. The first claim can be logical and necessary
conclusion from any proposition about participatory democracy.
There is no reason to exclude medical relationship from such
consideration. The second claim is neither logically derived
nor empirically conclusively verified. However, in the sense
that health can be one of the things that an enlightened
person can control, the second reason can also be the logical
conclusion from the analysis of the change of a person from
a dependent individual to an autonomous, democratic member of
society. The change is expected to take place in the self—
image of the profession and in the consciousness of the lay
people. Then, democratic medicine most likely fares better
than feudal medicine and also better than hermeneutic medicine
we discussed earlier in terms of healing the patient as a
whole person. Democratic medicine respects the patient as a
person who has or is going to have communicative competence,

rational decisionmaking ability, and readiness to take

142

responsibility for decisions made. Democratic medicine will
enhance her self-respect, personal dignity, independence, and
determination to carve her own future in her own way. The
first two chapters of this thesis recounted what has happened
in feudal or paternalistic medicine. For both ethical and
therapeutical reasons, patients deserve a democratic treatment
if they are in a democratic society, however formal it is.
The undemocratic status of patients reflects undemocratic
self-image of the medical profession and the professionals’
privileges in the medical decisionmaking process when the
matter at issue directly concerns the patients. So the most
plausible thing we can demand of the medical profession is
that it reconsider its own image and try to approximate itself
to'a democratic institution as much as possible, while we lay-
persons try to learn to be better participants in decision—
making in as many phases of life as possible. What we need
to do now is to get a boost from theories of democracy in
order to deal with the implementation of an institution which
is appropriate for a democratic society.

Among the theories of democracy, only the one of partici-
patory democracy has direct bearing on our inquiry because of
its respect for wishes and needs of each participant in a
decisionmaking arena. Democracy is an arrangement in which
equal, free, and rational agents assemble to discuss and
decide freely and openly things which are important for them.

We want to reject the idea that democracy starts and ends with

143

exercising voting rights to elect our representatives to of-
fices on local and national levels. Participation belongs to
the core idea of democratic theory. It is no doubt that the
ancient Athenian democracy was democracy as far as the
participating members were concerned. From our eyes it was
not a real democracy because the membership was limited to
certain strata of society. Their principle of discrimination
contradicts what we can call democratic values. However, in
the Athenian democracy we can find one salient feature that
is necessary for democracy, namely, the principle of direct
participation in a political decisionmaking process. Par-
ticipation itself may be a neutral concept as to the values
that are to be realized. We should say that direct participa-
tion to decide and realize the values that have universal
application is the only modality appropriate for autonomous
citizens. Participatory democracy pertains not only to the
decisionmaking procedure but also to the values to be real-
ized.

In The Social Contract Rousseau discusses two spheres in
which participation is decisive, namely, at the time of making
a contract of association to form a society and also at the
time of actual political decisionmaking. Rousseau thinks that
a society is formed because people want to get out of the
state of nature and decide to join together and cooperate to
found a community to protect themselves and solve various

problems of life. This act may be only hypothetical, but

144

Rousseau thinks that it should be the main idea of the
relation of society to its members. Unlike the feudal idea
of social constitution in a traditional society like Japan,
the Rousseauan theory tells that we are not just born in a
fixed form of society and supposed to passively accept our
fixed roles in it. Instead, society is something we mold by
ourselves and can change, if necessary. It is a truly radical
and revolutionary idea that we can form or change the society
which is usually thought to be given and unchangeable. The
idea of contract and the justification of revolution can be
traced to Hobbes and Locke, but it was Rousseau who was the
coherent advocate of participatory democracy. According to
Carole Pateman who wrote Participation and Democratic Theory in
1970, Rousseau was the first powerful theorist of participa-
tory democracy, as "his entire political theory hinges on the
individual participation of each citizen in political deci-
sionmaking" (Pateman, p.22). The agents in that situation are
presumed to be politically conscious and active. They are
ready to debate and make decisions on the matters that concern
their own life. They are the legislators of their own laws
and rules.

One of the strongest merits Pateman sees in Rousseau’s
theory is its educating effect on the part of the parti-
cipants. The agents are not perfectly autonomous persons from
the beginning who know what to do and what to choose to live

a good life in a society. Rather each individual is expected

145

to learn to be democratic by participating in democratic
procedures of various decisionmaking arenas in society.
Instead of being a rational, moral person from the outset, the
agent as a product of social, historical conditions becomes
a full-fledged citizen by learning what is required of her and
what she can do in terms of needs and desires in the specific
social context. The person eventually will realize the
limitation and possibility for self and mutual development
while actively taking part.in communal affairsn Participation
is preeminently a learning process for the participants. The
individual involved in the process will learn to be a socially
responsible person. Pateman maintains: "Once the partici-
patory system is established, and this is a point of major
importance, it becomes self-sustaining because the very
qualities that are required of individual citizens if the
system is to work successfully are those that the process of
participation itself develops and fosters; the more the
individual citizen participates the better able he is to do
so. The human results that accrue through the participatory
process provide an important justification for a participatory
system" (p.25).

We can then talk about something called democratic per-
sonality which is expected to be born out of each participant
in such processes. Openness, truthfulness and social concern
seem to constitute such a personality. Democratic perso-

nality-building takes place gradually in the process of taking

146
part in the intersubjective interaction. 1On the level of each
participant’s mental orientation, to be democratic means to
treat others as being equally capable of making communal
decisions and of acting responsibly according to the decisions
thus attained.

Rousseau does not suggest that any guiding principles
should be chosen in the original situation, but rather
presupposes that there are a couple of principles on which
society is to be constructed. They are the principles of
liberty and equality which are ”the greatest good of all"
(Rousseau, p.55) and not incompatible with each other.
Liberty does not exist without equality. By equality he does
not just think of political equality, but.of economic equality
as well. 'n: be economically stable and independent is an
indispensable condition to becoming a full-fledged citizen of
a society. According to Pateman, J. S. Mill was another
participatory democracy theorist who advocated the signifi-
cance of participation at a local government level and also
in industry (Pateman, p.33). Mill seems to have been sym-
pathetic to socialist causes except in the case of its centra-
lizing tendency. In our days there are people who believe
that perfect democracy will exist only in socialism (Cunni-
ngham). Since informed consent is greatly constrained by the
economic structure of society, it will be best realized in a
democratic society where economic equality is also attained.

The existing disparity in expertise and wealth between

147

physicians and patients poses a greatest challenge to the
democratization of the physician-patient relationship.

However, we may also pay attention to those advocates of
direct participatory democracy who want to dismiss the need
to establish basic principles such as equality and freedom in
the beginning. They also tend to ignore the meaning of the
original contract situation. Instead they want to emphasize
the process that participants undergo in gathering, talking,
debating and deciding. For Barber, who drew largely from John
Dewey and wrote Strong Democracy -- Participatory Politics foraNew Age
(1984), there is no political truth in the beginning. Rather
in the due course of participation people learn and recognize
their needs and their solutions. They come together to form
political consciousness, and to be able to make political
judgments through political discourse and activity. Barber
admits that not to have initial principles is rather an
uncertain business, but insists that political discourse
generates political truth about what should be done commu-
nally. He confirms this anti-foundationalist thesis in his
most recent book The Conquest of Politics (1988). Indeed, the
discussion of an original contractual situation, or the
confirmation of the basic principles of justice in the
beginning, may not be so important as the idea that we make
up a society in which we can have a say in the matters that
directly concerns us. On this view, participation will

generate the values to be realized. And this idea does not

148
contradict the Rousseauan view of participatory democracy as

is observed by Pateman. Still, one may say that Barber’s type

of democratic interaction also implicitly/presupposes thelcom:\_

FF,
-w ,4..—

fffiunicative competence of participants, and the three value
; ociggtations arising from the analysis of speech acts that ‘

Hgbermas #:Spells 99.13.13. In a medical context the value and

\.

Q..- "..--

meaning of healing a wound will be recognized and realized in
the participatory process of both physician and patient.
Underlying beliefs are the participants’ competence to
truthfully communicate, attain some sort of agreement and to
fulfill the agreed-upon agenda responsibly.

There is another important.feature»in participatory demo-

cratic theory, namely,fthe idea that the people’s voluntary

...—-
J‘JHM,

/’agreement or consensus is the only legitimating, justifying“

i or binding power to a contract, law or other social arrange-g
’ ment. 'The legitimacy or justification of the foundation of
a society or a social rule is derived ultimately from the
unanimous agreement of the participating agents. In the
theory of Rousseau there is a thesis that people are somewhat

"forced" into the participation. Everybody is lured into the

society to become freely active in a communal life. This is
the only time when a paternalistic principle works and makes

sense. The basic task of society remains to guarantee the

c,"

citizens’ political freedom as much as possible. fIt is the,

..o,_-

society where in principle people can freely get out or enter,—

A So their decisionmaking is uncoerced and free. (It is this

149

freely-made agreement or consensus that makes an authority
legitimate and binding. Other sources of power or authority
are illegitimate and void as far as the decisions about the
social arrangements are concerned. Rousseau says: "...since
force is not the source of right, conventions (=the original
contracts) remain as the basis of all lawful authority among
men" (Rousseau, p.11). Pateman does not specifically refer
to the question of legitimation or justification that par-
ticipation ensures, but only notes that.a collectively agreed-
upon decision is more easily accepted and realized by in-
dividuals. We will come back later to the issue of legitima-
tion of a social arrangement such as the practice of informed
consent, but this discussion of legitimation or justification
has an important bearing on the meaning of a consent-giving
activity. A well-understood, uncoerced, freely-given consent
is a product of participatory process of medical decision-
making. Only such an activity can be responsible and meaning-
ful.

What we learn from these discussions is that, if democra-
cy is to be worth its name, participation has to take place
in as many levels of society as possible in order that both
society and people become gradually democratic» ‘The character
or virtue of being democratic gains importance not only in the
talk of institutions but also of individual agents. Further,
the idea to assemble for intersubjective discourses is

motivated not.only by self-interests but.concern about.others.

150

Democracy admits no fundamentally hierarchical structures in
human relationship, and a democratic person is sensitive and
compassionate to the needs of the others, especially to those
who are underprivileged as the result of injustice imposed in
the past. The antithesis of democracy would be not simply
unjust power, but political apathy or indifference when the
world is still full of oppressive, negative elements for
mutual development. The antithesis of democratic interaction
is not simply hierarchical relationship, but unreasonable
relegation of decisionmaking power when one can be more
autonomous and independent.

For democracy to be alive, nothing is more important than
having regular meetings where people can assemble for poli-
tical discussions. Democracy as a social apparatus can be
maintained by these meetinQS‘where anybody can participate and
can be heard. It is important to keep conversation going in
the political arena, and no less important on other levels of
human interactions” ‘Through verbal interchange people’s
desires and needs are known and taken care of. Only openly
discussed and agreed-upon matters may have a legitimating
power. For all participatory theorists, democracy is a
process. It is through democratic process that both personal
self-realization and the search for political truth is
attempted and attained. AJthough a complete participatory
system may be impossible or at least not in view right now,

the virtue of being democratic is not something unattainable.

151

However, it is Rousseau himself who said in The Social
Contract, "Taking the term in its strict sense, there never has
existed, and never will exist, any true democracy“ (p.70), and
"If there were a nation of gods, it would be governed democ-
ratically. So perfect a government is unsuited to men" (p.7-
1). Rousseau was referring to constant "civil wars and agita-
tions” that could haunt the democratic state. It is not the
case that democracy can proceed automatically once its formal
procedure is established. It will encounter anti-democratic
wills or forces among the people. There are always people who
want to monopolize political, economic, and any other deci-
sional power of society. For some people domination over
other people never ceases to be the origin of the greatest
joy. There could also be other elements to break down
democracy. For Rousseau democracy presupposes ”many things
difficult to combine", namely, first, a very small state where
people assemble and know each other easily; secondly, a simple
tradition without complicated procedure to get consensus;
thirdly, over-all equality of status and property of the
people, and lastly "little or no luxury for...it corrupts both
the rich and the poor..." (p.70). As in Thomas More’s
’utopia’, there is much caution against the accumulation of
wealth, because it is a strong factor to divide the minds of
the people. In our days there are other goods the distri-
bution of which is the vital concern of the people, namely,

medicine, education and work opportunities. If there is no

152

way to arrive at an agreement, democracy will break down, but
if we are patient, there are ways to find breakthrough by way
of negotiation and compromise (Benjamin). Surely perfect
democracy has never existed, but it may be too early to give
up before we have ever seriously tried. After all, 'world-
wide perfect democracy’ (Cunningham) may not be impossible,
and if democracy is a process, what we are doing in terms of
making medical relationship as democratic as possible is
surely a step forward to the ideal.

Having sketched general features of participatory
democracy we can now in turn draw out some of its implications
for informed consent, including the implications for the

practice of the medical profession and the role of patients.

2. Informed consent, authority, discretion

The key word for this section in dealing with the
practices of the medical profession and the role of patients
is legitimation which was touched upon in our discussion of
participatory democracy. Habermas is more serious than other
participatory democratic theorists about the problem of
legitimation. For him, like others, the scheme of a demo-
cratic society, action-binding norms and needs to lead a
civilized life are not something imposed from above or by
inner pressure groups. They should instead be the results of
open discussions and argumentations among free and rational

citizens. Earlier, Habermas discussed communicative

153
competence of participants in ordinary conversation including
physician-patient dialogue. Now his theme is a higher-level
discourse which includes political decisionmaking. Habermas
calls it ’ discursive argumentations for will-formation’ and
believes that they are democratic processes resulting in
legitimizing the agreed-upon arrangements, institutions and
values. Only thus legitimized arrangement can have authority.
In such a discursive occasion, unlike in Kantian morality,
people need not suppress personal desires and interests. 'They
bring them to the discursive table and talk about them.
People’s needs, namely, generalizable interests, are the
objects of argumentation (Habermas, 1975, p.108). In such an
argumentation "no force except that of the better argument is
exercised". ”If ... a consensus about the recommendation to
accept a norm arises argumentatively..., then this consensus
expresses a 'rational will’". People will want to make
compromises in a wise manner because the end result is the
better understanding of each other. In Habermas’ scheme of
this procedure, both theoretical and practical matters are
objects of argumentation. Habermas’ theory of communicative
action serves as the basis for such a procedure. If the
social norms and needs are the subjects of argumentation, all
the political, economic, educational, and health care systems
and norms will be discussed. Meanings and legitimacy of
scientific and technological enterprises should also»be on the

agenda. Accordingly, informed consent would be one of the

154
items that are to be discussed in a discursive argumentation
in the "communication community” (p.105), because it is a norm
that should be legitimately imposed on citizens of a demo-
cratic community when they enter into a physician-patient
relationship.

In a society where people are content with a repre-
sentative form of government, leaving all the political
discussions to their surrogates, the importance of Rousseau’s
and Habermas’s proposals has slim chance to be heard. With
regard to our concern, namely, informed consent, it is the
government, the judiciary and the professional establishment
that decide the value of the institution. In the United
States the judiciary took the initiative and the medical
profession responded, if only very slowly. The whole proce-
dure looked like a normative structure given from above. We
only wish such a normative structure were more stable and
coherent” In this representative democracy, we are controlled
by ever-changing legislative and administrative policy-making
and judicial interpretations~ Yet, in the United States there
occurred something which came close to what Rousseau and
Habermas would have envisaged, which might turn out to be a
possible future course for Japan. I have in mind what has
happened to informed consent in the past decade. The main
idea was legal-paternalistically presented, but later it did
undergo some sort of public discursive argumentation. The

United States President’s Commission for the Study of Ethical

155

Problems in Medicine and Biomedical and Behavioral Research
placed the issue on public debate, though in a limited way in
the sense that the main participants were mostly expert
witnesses and in due course their debate was to be curtailed
by conservative political pressures (Benjamin, p.127).
Nonetheless, it was remarkable that so many different people
debated on difficult questions of medical and biomedical
decisionmaking for quite an extension of time and issued
reports on their discussions of various topics including
informed consent. They let the world know that these are the
things that should not be decided solely within a closed
circle of power holders“ With regard to informed consent they
agreed upon the feasibility and legitimacy of the institution
to be realized in a democratic way. So at least the legitima-
tion problem of this practice is not disputed in the United
States. For the rest of the world, where the Habermasean
ideal procedure is not easily implemented, the United States
has presented a model procedure to follow. What is left to
be done is to disseminate the conclusion of the democratic
discussions to the public.

Informed consent needs as one of preconditions for its
implementation the demystification of the medical profession.
If medical authority is intact and physician discretion is
absolute, they can be easily abused to the detriment of
ignorant, dependent patients. From the above discussion of

legitimation it is a logical conclusion that authority and

156
physician discretion can also be on the agenda of democratic
discursive argumentation either in academia or in political,
judiciary arena whenever the implementation of informed
consent or other democratic practices are questioned by the
medical profession.

But the traditional medical profession would regard this
kind of suggestion as an impossibility. Vested interests seem
to be strongly protected. Philosophical discussion on
authority tells us that authority is revealed in different
forms. Authority is sometimes categorized as epistemic and
executive authority (DeGeorge). As the possessor of medical
scientific knowledge and technique the physician is taken for
granted to have epistemic authority. Patients come to seek
help from her because of that sort of authority. But the
physician does not just display a special expertise on a
specific subject, but makes a medical judgment, and often
makes decision all by herself and act on that judgment. So
the physician’s authority is not just an epistemic one but an
executive one as well. However, the executive part of the
physician’s authority is derived not from the caliber of the
individual physician but ultimately from the medical estab-
lishment which supervises medical education, licenses physi-
cians and monopolizes medical knowledge and technique. What
is clear from the above discussions of democratic medicine is
that.a physician’s authority has certain important limitation,

not as an epistemic authority but as an executive authority.

157
The medical professional is not to execute her authority on
the patient without the latter’s consent if that patient is
competent and has not already waived his decisionmaking right.
That means, physicians should be more careful about exercising
their discretion. ‘The authority of the medical profession did
not come from the people as a free economic system can
sometimes be characterized (DeGeorge, p.175). Earlier in
history the medical profession was not recognized as having
the kind of authority that it now enjoys in any advanced
countries. The historical development of medical authority
is partly due to efforts on the part of the professionals, and
partly due to the economic condition of the capitalist,
technology-oriented society where medicine can be a private,
lucrative enterprise easily associated with drug and engineer—
ing industries. The traditional unwritten justification for
the medical profession is that medical practice is a God—given
mission to save life, heal wounds and remove pain of in-
digents, almost disregarding monetary remuneration. By
contrast, the present—day authority of physicians and the
medical profession largely lies in the economic factors of
medical practice. So much associated with power and wealth,
there is always a possibility for "despotism of the experts“
(A, p.28) in the medical profession. But if legitimacy of the
medical profession can ever also be put on the agenda of
people’s discursive argumentation, the whole institution can

perhaps cease to be authoritarian or despotic. Although I do

158
not see any such possibility in sight, it is encouraging to
think that conceptually there is such a possibility. We have
a right to urge medical professionals to accept the suggestion
that medical authority be placed more in the open, and that
they try to accommodate themselves to the realization of
democratic values.

To match such a partial relinquishment of authority on
the part of the physicians, what is required of patients is
that they do not abuse recently recognized rights to self-
determination while realizing that a curing process is a
democratic, cooperative enterprise. Enlightened patients
should not be a threat to physicians. Both side should be
open about what they know and what they do not know. Actually
in this process physicians are expected to relinquish partial-
ly their epistemic authority as well, in the sense that both
parties share the uncertainties of medical science“ We recall
that this is one of the reasons that Katz suggests the
institution of shared decisionmaking and shared authority.
In this scheme physicians are to let the patients shoulder
partly the burden of decisionmaking and of taking respon-
sibility in accepting any untoward consequence which is not

a result of the particular physician’s ineptitude.

3. Obstacles for democratic medicine
Having laid out these general considerations, we must

acknowledge constraints on realizing these democratic goals.

159
In doing so, we have to recognize the possibility that genuine
informed consent is not possible under existing social
conditions. On the other hand, we can try to see to what
extent some of its features can be realized.

The legal doctrine of informed consent is not the
embodiment of a democratic decisionmaking theory in the sense
that it does not presuppose the existence of conversation
which could allow both parties to empress their needs and
expectations and make sure of truthfulness and understanding
on either side. By contrast, the conversation model of
heightened understanding and shared decisionmaking is truly
democratic. The patient is an autonomous individual who has
informational and decisional needs to be fulfilled by an
understanding, democratic physician. Together they deal with
the common problem of curing the patient’s disease. They
exchange their thoughts and information, and arrive at a
rational decision about the most reasonable treatment option.
The process may take a dialectical route and the participants
may get to an unexpected end-result of conversation. Still,
the process is nothing other than democratic because of
sharedness in decisionmaking. The physician is not motivated
by her self-interest to promote medical business instead of
healing mission.

As has been stated in the previous chapter, preconditions
for the implementation of informed consent are largely

unfulfilled. For physicians, informed consent is a nuisance

160
because it requires to break up silence with the patient and
explain from ABC’s.of medical knowledge when the latter is
still ignorant and helpless. And their effort for communica-
tion is not duly rewarded. Under the present system it does
not matter if the consultation goes in a lively conversation
or in silence. The ongoing fee for service system discourages
conversation. So even in the United Sates, where informed
consent is officially endorsed by the profession, it has been
taken seriously only by a small number of physicians. Unless
physicians are monetarily endorsed for their conversational
effort the ideal situation may not happen at all, or if it
does, it will be only by an enormous sacrifice of conscien—
tious individual professionals. Ultimately it is social,
economic conditions that hinder a true democratic medicine.
In the United States enormous medical costs and a poor
insurance system make patients shy away from entering an
ordinary physician-patient relationship at all. One writer

comments: ...the possibility is that a patient’s choices in
the future will be overwhelmed by powerful economic and
structural forces. This makes it critical that patients
understand their situation and the rules of the doctor-patient
relationship, and that genuine informed consent for treatment
be obtained for reasons other than to comply with legal or
regulatory requirements, or to ensure against liability"

(Loren H. Roth in A, p.ix). Capitalist medicine has often

proved to be inhumane, and an individual patient finds herself

161

utterly powerless in the mess of medicine-business complex.
All one can say is that medicine should not be a part of
market economy, that medical education should be federally
subsidized, that private insurance shoUld be mostly replaced
by publicly-funded program, that pharmaceutical and medical
technology industry should be publicly controlled, that
hospitals should be publicly managed, and so on. While these
claims are reasonable, and most probably agreed upon by
democratically conscious, concerned citizens, they do not seem
to be realized in a near future as the decisionmaking of
social policies is controlled by various power holders. What
we can do is to remind people that the present medical care
system including insurance arrangement is the ultimate cause
of the situation in which informed consent cannot be adequate-
ly realized and invite them to take a close look at it and
change the situation first by serious argumentation nation-
wide.

Although we may not be able to rectify the overall
structure soon enough, what can be done immediately is that
physicians take more time conversing with patients, that
hospitals should reward the health care professionals for
their efforts to communicate well with patients, and that
every reimbursement system should pay attention to the style
of the clinical session. The success of the first item
ultimately depends on the modification of the self-understand-

ing of the medical profession as the sole authority of medical

162

matters. But physicians can start the move individually at
their own sacrifice and go on to pressure for the reform of
the system. They need to change the image of themselves who
seemingly want to take advantage of the ongoing system and
daily reproduce conveyor-belt medicine. However, it would be
far better if both physicians and patients can talk together
about the remuneration system, so that the demand for a reform
can be a joint effort.

In order for the movement for informed consent to be
successful, there should be a complete change in the mentality
of the profession. The final section will deal with some
proposals for creating the conditions for meaningful, if still

perhaps only partially realized, practiceiof informed consent.

4. Proposals for democratic medicine
As in all other similar situations, such as to alleviate

the social problems of crime, drug use, the AIDS epidemic, and

homelessness, the best and only solution proposed is found in

education. Toward the end of his seminal book Katz remarks:
“The radically different climate of physician-patient
decisionmaking that I envision cannot be implemented by
judicial, legislative, or administrative orders. At
best, such outside interventions can prod doctors; at
worst, they only substitute bureaucratic authority for
professional authority. Meaningful change can come about
only through medical education and the education of
patients" (K, p.229).

Laws and jurisdiction can rectify a wrong when it is done,

warn the physicians about how, retrospectively, they should

have behaved in order to avoid legal liability, and remind

163
them that patient’s right should also be respected. But the
legal doctrine does not deal with how best (in an ethically
ideal way) informed consent can be implemented. It is in
medical education where it is taught that informed consent is
a moral imperative for good medical practice, and that it will
lessen the physician’s decisionmaking burden. On the other
hand it would be ineffective for the physician to start
teaching the patient when the latter is engulfed by suffering
from a disease. Education is required of both future physi-
cian and patient-to-be at the earliest possible stage. One
American advocate of informed consent writes:
"Surveys of medical ethics teaching show that nearly all
medical schools had some form of medical ethics teaching-
-however abbreviated--by the mid-to-late 19705. There
are no data on how much teachers’ time is actually
devoted to informed consent, but this medical ethics
instruction--even if minimal--began to present to young
physicians the view that informed consent is not merely
a legal doctrine, but alsoia moral right of patients that
generates moral obligations for physicians" (F, p.95).
In the meanwhile enormous number of publications on bioethics
have appeared. Medical education at some medical schools
includes training for "decision-making competence” and skills
on ”how to converse" (Katz, p.152). This is exactly what is
lacking in Japanese medical education. While in the United
States people are discussing the need for conversation skills,
and of a curriculum incorporating humanities, medical schools
in Japan to my knowledge with a couple of exceptions, do not

offer any courses for educating humane and open-minded

democratic physicians.

164

Patient education is not an education to make an obedient
patient, or something done just to facilitate understanding
of disclosed information and decisionmaking within a clinical
context; the education I have in mind is given in school in
order to prepare people to become a patient who will not
suffer from deficient physician-patient relationships. In the
United States I would like to someday see the AMA and each
state medical society will help establish a course at the
secondary school level for health and patient education. When
students learn language, government, geography, science, they
should also learn basic facts about their own body and mental
mechanism and its care. Who would be a teacher of such
course? A retired physician or an experienced, registered
nurse would make a perfect candidate. And I hope to see
similar things happen in my country someday.

Katz’s conversation model requires that each person be
more interested in her own body and its management. Basic
knowledge of our body and psychology should be acquired. The
values and needs to become an autonomous individual, an
independent decisionmaker, a mature participant in discussions
with care-providers should also be discussed so that people
will be ready to start conversation with the physician, ask
questions, respond to physician’s readiness to help. That
kind of readiness will reduce the burden on physicians to
initiate conversation, and will teach the importance of being

a mature person for deciding things about her own body. The

165

course will include elementary exposition of physiology,
oncology, first-aid, statutes on medical matters such as the
determination of death, abortion, health insurance system,
what it means to refuse a proposed treatment. Each citizen
should know what statutes are available on deciding the matter
of life and death. Students should be involved in philosophi-
cal and sociological discussion of death and illness. Myths
and misconceptions of diseases, for example, that a cancer
disclosure is a death sentence, can be removed in education.
So while the mass media. may' be effectively utilized to
enlighten people with health information, formal education on
a physically and mentally healthy life should start at the
secondary school level.

With regard to informed consent, young students should
know about its existence. In the event they become patients
what they should know'in advance about legal requirements are:
(1) physicians have a duty to disclose information to them
about treatment, (2) patients have a legal right to make
decisions about treatment, (3) physicians cannot render
treatment without their consent when they are competent, and
(4) the right of decision includes a right to consent to or
refuse treatment (A, p.70). And the patients should also know
that they have a right to waiver. Waiver is of course a
matter of choice. Yet, it would be a more appropriate
behavior for an independent member of a democratic society not

to opt for a waiver. After adequate education, the patient

166
will know what she wants to know, what she does not under-
stand, and that she Will be responsible for a possible conse-
quence of her decision. More importantly, however, the
patient should know that shared decisionmaking is the best
possible way to deal with her problem and that it is done only

through good conversation with the physician.

This chapter started with a discussion of participatory
democracy which requires informed consent in medical practice
and ended with some proposals of public policy including
education for physicians and for patients for the implemen-
tation of democratic medicine. From the discussions of
Rousseau and other participatory theorists’ ideas, and Haber-

mas idea of legitimation, we derived a conclusion that the
institution of informed consent should be .an item on the
agenda for democratic argumentation. We also considered a
possibility that the authority of the medical profession and
the practice of physician’s discretion can also be placed in
the open, discussed and accepted perhaps with certain clearly
defined limitations. Education for patients is proposed to

make mature, independent, competent, autonomous and respon-

sible decisionmakers.

REFERENCES:

BARBER, Benjamin. 1984. Strong Democracy -- Participatory Politics for
a New Age. Berkeley, CA: University of
California Press.

BARBER, Benjamin. 1988. The Conquest of Politics. Princeton, NJ:

167
Princeton University Press.

BENJAMIN, Martin. 1990. Splitting the Difference -- Compromise and
Integrity in Ethics and Politics. Lawrence, KS:
University Press of Kansas.

CUNNINGHAM , Frank . 1987 . Democratic Theory and Socialism. Cambridge ,
England: Cambridge University Press.

DEGEORGE, Richard T. 1985. The Nature and Limits of Authority.
Lawrence, KA: University Press of Kansas.

ELY, John Hart. 1980. Democracy and Distrust -- A Theory of
Judicial Review. Cambridge, MA: Harvard
University Press.

HABERMAS, JUrgen. 1975. Legitimation Crisis. Boston: Beacon Press.

HABERMAS, JUrgen. 1979. Communication and the Evolution of Society.
Boston: Beacon Press.

HABERMAS, JUrgen. 1984. The Theory of Communicative Action, Vol. One,
Reason and the Rationalization of Society.
New York: Beacon Press

KATZ , Jay . 1986 . The Silent World of Doctor and Patient. New York:
The Free Press.

PATEMAN, Carole. 1970. Participation and Democratic Theory. Cambr-
idge: Cambridge University Press.

ROUSSEAU, Jean-Jacque. 1967. The Social Contract and Discourse on
the Origin of Inequality. Edited and with an
Introduction by Lester G. Crocker. New
York: Washington Square Press.

CONCLUSION

At the outset I stated two aims of this discussion of
informed consent. One was to address the issue of Japanese
medical practice which was in need of incorporating informed
consent. The other was the need of reconstructing informed
consent as a democratic theory. I started by describing the
Japanese situation and mentioned that informed consent was
beginning to be given serious consideration by the Japanese
medical establishment. I suggested that the hierarchical,
authoritarian nature of .Japanesee medical interaction had
something to do with the acceptance of German medicine in the
last century. It was also pointed out that the Japanese
language was poorly utilized for mutual understanding. I also
looked into representative philosophical systems that were
constructed to endorse the basic social structure and human
relationships. Those ethical, philosophical systems of
thought were undemocratic and allowed no room for decisional
autonomy, intellectual independence or individual integrity
of ordinary citizens. Although Japan has a democratic
constitution now, the judicial power of the state tends to
protect the power holders rather than the weak. As we saw,

the JMA’s new report on informed consent did not evaluate the

168

169
role that the United States courts have played in upholding
informed consent.

I then examined the American history of the legal
doctrine of informed consent in court decisions, in legisla-
tion, and in actual medical practice. We noticed a clear
difference between the legal doctrine and the ethical theory
of informed consent. One of the features that differentiated
them was the concept of understanding. Informed consent does
not make sense if it ignores the act of understanding of the
parties involved. The legal doctrine cannot refer to under-
standing partly because it is hard to be confirmed. Ethi-
cally, understanding is a demanding but necessary condition.
Understanding is not just exhausted by patient understanding
of the disclosed information. The way it is disclosed and
understood hinges.on the physician’s understanding of her role
and the patient’s understanding of what he is doing. These
and mutual fears and hopes must be placed in the open in the
fOTflIOf conversation. Jay Katz’s proposal of the conversation
model of informed consent was found most appealing and the
only one which could realize the ethical purpose of informed
consent. The conversation model of informed consent was
philosophically examined and reconstructed. The objectivist
approach of understanding implies a one-way relationship and
does not aim at mutual understanding. So a hermeneutical
approach was invoked. Gadamer provided needed insights about

understanding meanings and intentions.

170

But. Gadamer’s hermeneutics had limitations, such as
perpetuating traditional medical relationship, and failed to
give a perspective that could critically approach the object
area and change it for the better. So we drew from Habermas’
communicative action theory. He spelled out that the pos-
sibility of mutual understanding lied in the analysis of
speech act. Cnu‘intersubjectivity, our inner truthfulness and
objective truth are the elements of communication and
understanding. In everyday conversation and theoretical,
practical discourse these are presupposed and can constitute
domination-free interactjcwn Both physicians and patients are
expected to be competent but truthful speakers and free,
independent decisionmakers. They share decisional authority
and responsibility. They participate in decisionmaking
processes in society and are expected to be partners in
medical decisionmaking as well.

The nature of participatory democracy should be reflected
in informed consent. We learned from Rousseau and other
participatory theorists that to learn to be democratic is
(meaningful and can be done in the exercise of our autonomous
decisiomaking rights in our daily life. Habermas added to
that thesis that normative structures whose authority we have
taken for granted could be put on the agenda of discursive
will-formation. They should be discussed, recommended and
employed in public policy, including some legal endorsement.

Only those which withstand such procedure can have legitimacy

171

and binding power. We now know that neither physician’s
absolute authority nor informed consent.is to belenforced from
above. Silent acquiescence to authority is undemocratic.
Perhaps what we should do now is to tell the Japanese public
that informed consent is indispensable if they really want to
have good relationship with physicians, that they should not
tolerate the paternalistic arrangement of informed consent by
the medical profession, that they should urge a public debate
on this subject, and that they should push to have a uniform
law protecting patient’s rights and full implementation of
informed consent through public and medical education.

To reiterate, medical relationship should (and can) be
as democratic as possible. Ethical appraisal of informed
consent doubtlessly supports the status of a patient as one
who should be listened to and take part in a decisionmaking
process concerning her medical care. From the above discus-
sions one can conclude that informed consent is a part of
democratic theory and the practice of a good medicine in a
good society. Informed consent is a part of the theory of
participatory democracy, instead of other types of democracy.
Participatory democracy is the type of decisionmaking proce-
dure that all mature individuals should want to choose, not
only for the governmental institutions, but also for most of
their human relationships. Democracy is possible when there
are autonomous, independent decisionmakers who can and want

to decide on important things on their own and among

172
themselves, even when actual execution of the actions will be
done by others. Democracy is also a learning process for
hitherto naive people to become interested and engaged in
things that concern themselves and others. Informed consent
is a part of great many democratic practices that require par-
ticipation in decisionmaking. Although no perfect democracy
is in view, the most plausible proposal for implementing
democratic medicine would be to start educating people at
earliest.stagezto become autonomous and caring decisionmakers.
Policymakers can both be democratic and paternalistic (caring
against ignorant people’s wills) to create conditions for
producing democratic personalities and opportunities for
democratic interaction. Without them I do not know where the
process of democratization can start. I hope that this small
treatise can serve the purpose of directing the attention of
my country’s people to the importance of informed consent in

medical practice.

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