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A
History
and
Theory
Y o rk Toronto
Petaling Jaya Singapore Hong Kong Tok yo
Nairobi Dar es Salaam Cape Town
Melbourne Auckland
Beirut Berlin Ibadan Nicosia
Copyr ight © 1986 by O xford U niversi ty Press, Inc .
Published by O xfo rd Univers i ty Press, Inc. , 200 M ad i so n A v enue ,
N ew York ,
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O xf o r d
is a regis tered t rademark o f Oxfo rd Univers i ty
Press
No part of
reproduced,
stored in a retrieval system, or transmitted, in any form or by any means ,
electronic, mechanical , photocopying, recording, or otherwise,
w i t ho u t the prior permiss ion of Oxford Univers i ty Press.
Library of Congress Cataloging in Publication
Data
Faden,
Ruth
R.
Bibl iography:
I.
Beauchamp,
ISBN
0-19-503686-7
342.44109
Printing (last digit) : 9 8 7 6 5 4 3 2 1
Printed in the United States of Am erica
on acid free paper
O ur primary goal in writ ing this boo k has
been
O ur
subject matter
is the or igin and nature of this concept . We therefore concentrate on
conceptual
under which
In
and
law. Fund am ental quest ions about info rm ed consent have
been
contr ibuted
on the
subject.
Moral philos op hy and law do no t exha ust, how ever, the perspectives
b rough t
to
examine
the origins and status of info rm ed co nsent in clinical m edicine (Chapter
3), in the law (C hapter 4), in research
involving
and how
theory
of
inform ed consent . We begin with the concept of autono m y. A n anal-
ysis o f
is
presented
(in
that serves
as the
basis for an analysis of the mean ing o f " informed consent" (in Chapter
8). Our
in Chapters 9 and 10, where we b ring perspectives
from
philoso-
phy
and
psychology
condi t ions
of a u ton om y a nd in formed consent .
Throughout this volume we address questions of public policy and
professional
ethics,
but
provide
an
analysis
of
the desirabil i ty of participation by patients or subjects in decisionmak-
ing,
nor do we ident i fy the condi t ions under which heal th care profes-
sionals and research investigators should obtain in fo rm ed consents . O ur
primary goals
Vll l PREFACE
discuss the nature o f informed consent , its condi t ions , and the ends it
serves,
be imposed.
to
practical
and
prac-
tices of inform ed consent requires an und ers tanding of the concept and
its
concerning
that about which we speak before reaching co nclusions about how things
ought
x
A C K N O W L E D G M E N T S
Many
erature
on
Sarah
V .
Bra km an, Kathy Buckley, Tim othy Hod ges, Sara Finne rty Kelly,
Donna Horak Mitsock,
Kennedy Inst i tute
executing
our
research objectives and ingenio us in devising new strategies of her o wn
design.
Library-Institute
Library), and the National Library of Medicine
(N.I .H.) .
Similarly, we
must
acknowledge the assistance of the keepers of the files and records
at the
American Psychological Asso-
ciation, and the Office of the D irector of N.I.H . Each helped us find data
that otherwise would have remained locked away.
Superb assistance was provided thro ugh our unive rsity offices, where
for
years
drafts
were
faithfully
prepared
in
an
endless flow of rewrit ing and proofing. We are indebted for this assis-
tance to Denise Brooks, Caren Kieswetter, Gwen Thomas, and M a r y
Ellen Timbol.
and our
project officer, Peter Clepper, for a grant [NLM -EP (K10 LM 0032-01,
01S1, 01S2)] which generously supported this wo rk . This
financial
assis-
and
Georgetown universit ies which facil i tated the writ ing of the final chap-
ters and their redraft ing. We a re sincerely grateful to those w ho made
these
Contents
PartI. F O U N D A T I O N S
1. Foundat ions in Moral Theory 3
Principles, Rules, and
Moral Principles and Legal Rights 24
Common
Part II. A HISTORY O F INFORM ED CONSENT
3. P ronouncemen t and Practice in Clinical M edicine 53
Problems of
Xll CONTENTS
Interpreting the History of Co nsent : Some Perils of the Project 53
Two Competing Historical Interpretations
Codes and Treatises from Hippocrates to the A MA 60
Ancient Medicine 61
Secrecy,
The
Arrival
of
1957-1972 88
The Development
Changed
100
Notes
101
4.
Consent
and the C ourts: The E m ergence of the Legal
Doctrine 114
Late Eighteenth-C entury England: The Slater Case
116
Battery
and
11 7
123
1957-1972:
Th e
Canterbury Case
Conclusion 140
Notes 143
5. The
The
Influential Scholarly Pub lications 157
Controversy over Cases 161
Psychology Gets a Code 167
Early
Discussions
of
Consent
and
Deception
171
17 2
Ethical Principles
in the
Conclusion 186
Notes 187
Research 200
from 1962-1974 201
FD A Policy Form ulat ion
202
NIH
of
Biomedical
and
of
Biomedical and Behavioral Research:
III. A THEORY OF INFORMED CONSENT
7. The Concept of A u to n o m y 235
A uto no m y and Inform ed Co nsent 235
Distinguishing Persons and Their Ac t ions 235
Degrees of Autonomous Action 237
Substantially Autonomous Actions
A ction 241
24 1
The Condition
o f
Authenticity
as
Ref lec tive Acceptance 263
Possible Reformulat ions o f the Authen ticity Co ndition 266
Conclusion 268
Notes 269
28 0
2
283
The
Nature
and
Degrees
Competence 28 8
Normative Funct ions o f the Concept o f Competence 290
Psychological Competence, Legitimate Authority,
Criteria of Substantial Un der standing 300
Understanding That
Standards
of
Understanding
and
Disclosure
305
The
Inadequacy
Communicat ion
and the
319
Problems o f In format ion O ver load, Stress, and Il lness 323
Co nfirmation of Sub stantial Understanding
326
Conclusion
329
Notes
330
Coercion
338
The
A
Subjective Criterion of Resis tibi l i ty 34 1
Coercive
Situations
344
Persuasion
346
The
C O N T E N T S X V
Manipulat ion 354
FOUNDATIONS
I
Foundations
in
rooted
in multiple disciplines and
social co ntex ts, inc lud ing those of the health profe ssions, law, the social
and behavioral sciences, and m oral philosophy. In recent years, th e most
influential
fields
have
been
law and moral philosophy ; the central prob-
lems of informed consent have been f ramed in their vocabularies. Yet
these disciplines, each with distinct methods and ob jectives, serve strik-
ingly different social and intellectual
functions.
chapters
of the
distinctive
forms
of
rea-
soning fo und in m ora l philosophy and law, in order that the history and
theory found
in the
may be
more easily
unders tood .
Although these tw o fo und ation al fram ewo rks are both in tricate and
controversial, the essences of the legal and the moral approaches to
informed
consent are not difficult to understand. The law has focused
almost exclusively on clinical rather than research contexts. From the
legal point of view, a phy sician has a duty bo th to inform patients and to
obtain th eir con sent. If a patient is inju red as a result of a failu re on the
part
causing
th e injury. This legal vision of informed consent is more focused on
financial compensation fo r un fo rtun ate medical outcomes than on either
the disclosure of information or the c onse nt of the pa tient in general.
For this reason, many have been suspicious about the adequacy of the
law as a vehicle for
defining
and
have increasingly come to regard the major issues as moral rather
than legal. From the moral point of view, informed consent has less to
do wit h the liability of pro fessio nals as agents of disclosure, and m or e to
do with the auton om ous choices o f patients and su bjects. In Chapters 7
and
8 we argue that, in one important sense of the term, an " informed
consent" is an autonomous authorization by a patient or subject. This
definition is mo re suited to d iscussion from the mo ral point of view th an
the legal point of view.
1
4
FOUNDATIONS
differences
between law and moral philosophy as follows: The law's approach
springs from
th e
physician,
who
holds
a
duty
and
who risks liability by failure to f u l f i l l the duty. Moral philosophy's
approach springs from a principle of respect fo r auton om y that focuses
on
the
patient
or
subject,
interpretation and comparison have proved
difficult,
scholarly controversies surround them. Indeed, it would be
fatuous
to
agreement
A ny
d efensible po sition will need an argued statemen t of its basic pr em -
ises.
A
statement
understood
as
and
their
relationships
will
before we turn directly to them, some background assumptions regard-
ing the
words "ethics,"
"morality," and
The word
"morali ty"
has meanings that extend beyond philosophical
contexts and professional codes of conduct. M orali ty is concerned with
practices
defining
usually
culture or institution from generation to generation, together with other
kinds
of customs and rules. Morality denotes a social institution, com-
posed of a set of standards pervasively acknowledged by the m em ber s of
the culture. In this
respect,
it has an objective, on go ing status as a bo dy
of action guides. Like political constitutions and natural languages,
morality exists prior to the acceptance (or rejection) of its rules and reg-
ulations by particular individuals. Its standards are usually abstract,
uncodified,
and applicable to behavior in ma ny diverse circum stances.
The terms "ethical theory" and "moral philosophy," by con trast, sug-
gest reflection on the institutio n of m or ality. These term s refer to
attem pts to introduce clarity, substance, and precision of argum ent into
the dom ain of mo rality. M oral philosophers seek to put mo ral beliefs and
social practices of morality into a more unified and defensible package
of action-guides by challenging presuppositions, assessing moral argu-
ments, and suggesting m od ifications in existin g beliefs. Their task often
FOUNDATIONS IN M O R A L TH E O R Y 5
centers
on
and
defe nded theories and principles, such as respect fo r au to no m y, distrib-
utive justice, equal treatment, human rights, beneficence,
nonmalefi-
cence, and u tility— som e of the principles com m on ly emp loyed in con-
temp orary m oral philosophy.
Despite these ro ugh distinctions, we shall use the terms
"moral"
and
"ethical"
as
synonymous ,
and
to
justified
Accordingly, mo ral philosophy offers principles for the development and
evaluation of
and the
like
derive
from
these pr inciples . ("Values" is a still more general term, and
one we shall rarely em plo y.) Such princ iples— the choice and analysis of
which are controversial— constitute the heart o f mo dern ethical theory .
They
o f
moral reasoning
employed so f requent ly in d iscussions of informed consent. Most of these
principles are already embedded in public morality and policies, but
only
in a vague and imprecise form. The job of ethical theory is to lend
precision without oversimplification. It should always b e remembered
that moral debate about a particular course of action or controversy is
often
rooted
applicable moral principles, but also in the interpretation of factual
information and in
physical, or
religious description
of a
situation .
Although
it is neither possible nor necessary to outline a full ethical
theory in this volum e, three moral principles releva nt to our subject mat-
te r need to be addressed and briefly analyzed: respect fo r au tonomy,
beneficence,
and
the
basis
and— when jo ined with jus t ice—they are
sufficiently
surrounding informed consent
form a
often
been
addressed in codes and
regu lation s specific to clinical and research con texts. These pres criptio ns
6 F O U N D A T I O N S
are composed of rules of conduct
directed
professional
problems,
pro fessional asso-
ciations or government agencies. There are two principal ways of con-
struing
ciples found
may be
for specific
contex ts but unrelated to ex ternally valid principles. A ltern ative ly, they
may
broader
accept thro ugho ut this
volum e— cod es and regulations can and should be evaluated in terms of
general ethical principles. Even if it could r igh tly be arg ued that codes
have
been
direct
principles, these codes
are
intended
to
serve
as
such a basis for critical analysis of moral codes, policies, and regula-
tions that traditionally have
In
using
mean
to
evade
or
because
t ion
informed
on rights language, as does the informed consent literature generally.
W e
principles. W e shall mainta in that for every duty
there
exists
at
least
one
Only
recently
has
the
h u ma n
rights, and only recently have rights come to play an im portant role in
public policy discussions, such as those
involving
Rights
are po wer ful assertions of claims that dem and respect and status,
and they occupy a prominent place in moral theory and political docu-
ments. If someone appeals to rights, a response is dem anded. We m ust
accept
valid, discredit
it by
countervailing consi-
derations, or acknowledge the right but show how it can be overridden
by
o f
moral rights is mo re p uzz ling. Some thinkers are skeptical of their valid-
ity; others find absurd the profusion o f rights and the
conflicts
resulting
from
o r
extended to many controversial arenas—rights to privacy, rights to
health care, rights
and
another's
duties?
A
plausible claim is that a right always entails the imp osition of a duty
on others either
state
vide such goods
other medical
care to
needy citi-
zens, then citizens can claim an entitlement or right to that care if they
meet
the
treated
as
entailing someone else's duty to abstain from interference with one's
intended course in life.
If
our treatm ent of the "correlativity thesis" is corr ect, little is distinc-
tive about rights
it
troversial in contemporary ethical theory whether rights are based on
duties, duties
based on
other,
we
have
tried
to circumvent this controversy by holding that the principles in a
moral system both impose duties and confer rights. We presume this
analysis
The
rights most central to our arguments, the right to make an autonomo us
choice and the right to perform autonomous actions,
will
the
autonomous
choices and actions of others and, in special relationships, correlative to
the
duty
to
and
Three Principles
f o r A u t o no m y
Respect
for
autonomy
in
the literature on info rm ed consen t, wh ere it is conceived as a principle
roo ted in the liberal Western tradition of the im portance of individua l
freedom and choice, both for po litical life and for personal development.
"Autonomy"
and
"respect
for
autonomy"
are
terms loosely associated
with several ideas, such as privacy , voluntar iness, self-ma stery, choosing
freely,
the freedom to choose, choosing one's own moral position, and
accepting responsibility
uncertainty, the concept of autonomy and its connection to informed
consent needs sustained analysis, which we provide in Chapters 7 and 8.
(self)
and nomos (rule or law) were joined to refer to polit-
ical
autonomy
has
come
to
refer
to
from
con-
been
can
emerge over th e precise analysis of autonomy if we move beyond th e
core idea that
autonomous
per-
son. O ur central interest, however, is in autonomous choice—or, more
generally, autonomous action. This d istinction is between (1) person s
who have the capacity to be independent and in control, and (2) the
actions that reflect
because
it m ight seem by d efinition that o nly autono-
mous persons act autonom ously. However, as we shall see in Chapters 7
and 8, the criteria o f autono mo us choices are not identical with th e cri-
teria of autono mo us persons. A uton om ou s persons can and do make non-
autonomous choices owing to temporary constraints such as ignorance
or co ercion. This is a m atter of significance for a theo ry of info rm ed con-
sent. It is no less important that some persons who are not autonomous
can
and do occasionally muster th e resources to make an autonomous
choice under circumstances calling for informed consents and refusals.
It is one thing to be autonomous, and another to be respected as auton-
omous. Many issues about consent concern failures to respect autonomy,
ranging
from
nonrecognition of a refusal of medical interventions. To respect an
autonomous agent is to recognize with due appreciation that person's
capacities and perspective, including his or her right to hold certain
views, to
respect
th e
au tonomous
treated
merely
as
means
or preven t a person's exercise of autono my .
The moral demand that we respect the autonomy of persons can be
formulated as a principle of
respect
for autonomy: Persons should be free
to choose and act witho ut controlling con straints imposed by others. The
principle provides the justificatory basis for the right to make autono-
mous
9
related
rights.
For
example,
informed
patients have the right to r efu se self-regard ing, life-sustain ing
medical interventions,
morally
principle
of
respect for auto no m y, several issues about the proper lim its of the obli-
gation
even
the primar y justification of consent requirem ents is controversial, as we
shall see in
demands
the
as to
rightfully
subjects when these choices conflict with other
values. If choices might endanger the public health, potentially harm a
fetus, or involve a scarce reso urce for whic h a patient canno t pay, it may
be
justifiable
to
on
some
competing
balancing the demands made by conflicting moral principles will be
addressed
later
in
this chap ter.
Many unsettled issues also surround the scope of the principle of
respect for
autonomy.
In
particular,
the
number
and
kinds
of
duties
it
entails are unresolved. For example, are duties o f disclosure derived
from
respect
principle?
linked directly to both autonomy and informed consent? (See pp.
39-43.)
that
a broad mo ral f rame wo rk adequate for the anal-
ysis
for
latter
alone will suffice as a basic principle.
W hereve r a mo ral right to privacy or the p rincip le of veracity is invo ked
in th e
treat it as either
reducible to or derivative from an autonomy right (although we do not
suggest that
th e
respect
pp.
27-28.)
Beneficence
The welfare of the patient is the goal of health care and also of what is
often
is
context and justification: Clinical therapies are aimed at the promotion
of health
as
the
celebrated
principle in the history of medical codes of ethics is the maxim pr im um
non nocere—"above all, do no harm"—commonly v iewed as the fun-
damental
thus demand ing the provision of benefit beyond mere avoidance
of harm.
The principle of beneficence includes the following four elements, all
linked
harm; (3) one
fourth
element may
no t, strictly speaking, be a d uty ; and so me have claimed that these ele-
ments should
the
fourth.
There
is a d efinite appeal to this hierarchical ordering internal to the
principle
exist
for
separating passive nonmaleficence (a so-called neg ative d uty to avoid
doing harm, as expressed in 1) and active beneficence (a so-called posi-
tive
duty
2-4). O rdinary mo ral dis-
course and m any philosophical system s suggest that negative duties not
to
to
ers.
9
For example, we do not consider it justifiable to kill a dying patient
in
patient's organs
the
duty
not to injur e a patient by abando nm ent seems to man y stronger than the
du ty
been
Despite the
in (1) may no t always outweigh those expressed in
(2-4).
For
example, the harm inflicted in (1) may be negligible or trivial, while the
harm to be
person's
life
there
asserting
tha t one principle m ust always ou tweigh the other.
F O U N D A T I O N S
IN
M O R A L TH E O R Y
11
In
concrete
cases,
the
least
prescribes
morphine for a patient in ex treme pain, is she providing a benefit (4) or
removing
a harm (3) or bo th? Sim ilarly, wh en the state prov ides certain
needed
m edical treatm ents to citizens, it can be argued that the state is
no t
only providing
and
removing
the
harms of illness and death (2 and 3). To avoid ru nnin g dow n a child play-
ing in the
do ing harm (1)— requires pos-
itive steps o f braking, turn ing, warning, and the like.
10
Such
mo ral demands that
sho uld ben-
efit and not injure others under a single principle of beneficence, taking
care
to
distinguish,
as
necessary,
between
strong
and
abstain
from
intentionally
injuring
others,
and to further the important and legitimate interests of others, largely
by
preventing
or
There are several problems with the principle, so understood. For
example,
to
it is
with minimal
personal risk
role
relations hips— in wh ich we are o bligated to act benef-
icently
even
ally
b ou n d to sacrifice time and financial resources fo r their children?
But
would
a
stranger
w hom duties
of beneficence are owed. Whose interests count, and whose count the
most?
The
principle
of
or subject-researcher relationship. Thus, the principle itself
leaves open the question as to whom one's beneficence should be
directed.
For
example,
(future patients, employers, the state, endangered parties, etc.), even if
the
Anothe r
fice and
a
kid-
ney for transplantation o r d onating bone m arrow . A s a result, som e phi-
losophers have argued that this form
o f
and
a moral ideal, but not a duty. From this perspective, the positive
bene-
are
position
The underlying problem is that actions such as sacrificing bod -
ily
parts
and
this
problem
by
12
The
scope
or
range
of
cided issue, and perhaps an undecidable one. Fortunately, our argu-
m ents do not d epend on its reso lution. That we are m orally obligated o n
some occasions
Beneficent
acts are dem anded by the ro les involved in fiduciary relation-
ships between health care pro fessionals and patients, lawye rs and clients,
researchers and subjects (at least in therapeutic research), bankers and
customers, and so on. For
example, physicians
injured, delirious, uncooperative
patients, sometimes at considerable risk both to themselves and to the
patient.
alleviation
of
disease
and
injury,
if
there
is a reasonable hope of cure. The har m s to be preven ted, remo ved,
or
considerations
to
subjects
parallel those in medicine—the cure, removal , or prevention o f pain,
suffering,
jects'
interests
are
less
at
th e
positive benefit
sou ght by the scientist is new know ledge. O ften (but not necessarily) this
knowledge is
d esired
because it is expected to contribute to the resolu-
t ion of important medical or social problem s. T herapeutic and nonther-
apeutic research thus
achieve.
there
harming the
m ay
legitimately present
increased potential for harms if they are balanced by a com mensura te
possibility
o f benefits to the subject.
Those engaged in both medical practice and research know that risks
of
FO UNDATIO NS IN MO RA L THE O RY 13
sician who professes to "do no harm" is not pledging never to cause
harm but rather to strive to create a positive balance of goods over
inflicted
enjoins:
"The
degree
o f risk to be taken should never exceed that deter-
mined
by the hum anitar ian impo rtance of the problem to be solved by
the experiment."
moral system: Beneficence assumes an obligation to weigh and balance
benefits against harm s, ben efits against alternative benefits, and harms
against alternative harms.
professionals and research investigators often disagree
over how to balance th e various factors, and there m ay be no objective
evidence that dictates one course rather than another.
14
In clinical con -
texts, this balancing can also present situations in which health care
professionals and
patients differ
their assessments
of the
profe ssional's
obligations. In so me cases, ben efit to another is involved— as, for exam-
ple, when a pregnant woman refuses a physician's recommendation of
fetal surgery. In other cases the refusal may be exclusively self-regard-
ing. So me health care p rofe ssion als will accept a patient 's refusal as
valid, whereas others are inclined to ignore the
fact
patient through a medical intervention.
This problem of wh ethe r to override the d ecisions of patients in order
to benefit them or preven t h arm to them is one d imen sion of the problem
of
medical paternalism, in which a parental-like decision by a profes-
sional
o verr ides an autonom ous decision of a patient. A lthough not cen-
tral to o ur co ncer ns, the issue of paternalism is at the core of m an y dis-
cussions of inform ed consent. M uch of the literature in the field focuses
on such fundamental moral questions
as
these discussio ns.
The issue of proper authority for d ecisionmaking is an implicit theme
thro ug ho ut this volum e. In health care, pro fessionals and patients alike
see the autho rity for some decisions as pro perly the patient 's and autho r-
ity
for
It is
widely agreed,
for example, that the choice of a birth control method is properly the
patient 's but that the decision to administer a sedative to a panicked
patient in an emergency room is properly the physician's. However,
many
cases in med icine exhibit no clear co nsensus about legitimate deci-
sionmaking
authority—for instance, who should decide which aggres-
sive therapy, if any, to administer to a cancer victim or whether to
prolong the lives of severely handicapped newborns by medical inter-
ventions? Similar disputes appear
research context—for example,
as to whether the researcher has the authority to use persons without
their knowledge
Decisions regard ing
legitimate autho rity—
patient, subject, or pro fessional— can turn decisively o n what will m ax-
imally prom ote the patient's or subject's w elfare. Standing beh ind the
position
that authority should rest with the patients o r subjects may be
the goal of benefiting patients and subjects by enabling them to make
the
of the
their own health. These arguments range from the simple contention
that making one's
decisions prom otes on e's psycho logical well-
being to the m ore con trov ersial observation that patients generally know
themselves
well eno ug h to be the best jud ges, ultim ately, of what is mo st
beneficial
for them . Similar argum ents are also used in research contexts
where
for
by
moral ,
legal, and c ultura l principles that define the te rms of social cooperation.
Beneficence and respect for
on the
been treated
in accordance with the p rinciple o f justic e if
treated
according to what is fair, due, or owed. For example, if equal political
rights are due all
information
to
which
a person has a right or entitlement based in justice is an injustice. It is
also an
are
not appeals to a distinctive principle of justice that is independent of
other principles such
in a broad and non specific
sense to refer to that which is generally justified, or in the circumstances
morally
tification. For example, articles on psychological research involving
deception often denounce the research as unjustly denying subjects
information
to
F O U N D A T I O N S IN M ORAL TH EORY 15
often
tur ns out that the con trol l ing m oral pr inciple in such a jud gm en t
is
less
autono m y. (The argum ent
could, o f course, involve appeal to both principles.) Similarly, propo-
nents
wou ld
possible
medical t reatment . Here the moral concern is one of benef icence ra ther
than just ice.
Many
com plaints of "injustice" in the in fo rm ed co nsen t l it-
erature can be l inked in this way to alleged vio lations of the princ iple of
respect
principle
beneficence.
However , not all issues of just ice in biomedical ethics can be entirely
accounted
ical
resources and the validity o f claim s to po ssess a right to health care
are staple examples of justice-based problems. A l though m ore difficult
to isolate, various problems that plague the l i terature o n in fo rmed con-
sent also seem justice-based. Fo r example, much o f the cont ro versy sur-
rounding the use of prisoners as subjects in research centers less on
wh ether pr isoners can give valid infor m ed co nsent in the coercive envi-
ronment of incarcerat ion than on whether just ice permits creat ion of a
ready poo l of hu m an vo lunteers out of the class of those incarcerated by
the
be
repeatedly
used. This quest ion turns on the just dist r ibut ion of the b u r de n of the
risks
in
society
and
thus
is
rather
than beneficen ce or respect for auto no m y. The issue
is whether this burd en could be w arranted even i f the pu bl ic welfare is
enhanced by the practice (a consid eration of ben efice nce in the form o f
public uti l i ty) and even if the prisoners are capable of giving, and do
give, a vo lun ta ry in fo rm ed consen t (a co nsideration o f
au tonomy) .
The
point of many analyses of research involving frequently used and vul-
nerable subjects
i s
to be
research subjects
o f
can be
mot i -
vated less
b y a
in fo rmed
including rules promoting increased disclosure in such areas as consent
to electrocon vulsive t reatm ent (ECT), have
been
over
the
fairness
harmful treat-
m e n t because o f administ rat ive convenience. They note that the advo-
cates o f
strict disclosure "sought
technique
to min imize the use of ECT by using premises o f equity and justice."
However , as so of ten o ccurs, the persons Lidz has in m ind were probably
m ot ivated by
respect
fo r au tonom y, bene f -
icence, an d just ice. Lidz and others descr ibe their o w n concerns in
FO UNDATIO NS IN M O R A L T H EO R Y 17
den or outweighed by competing moral demands. One's actual duty,
then, is determined by the
balance
man was
mo rtally ill in a hospital and required a m echanical respirator. A lthough
he had been
only
to
have
the
hospital staff reconnect it. The matter wound up in court. The patient
co ntend ed that the hospital and his physicians had an obligation to allow
him to
his
death.
His physicians and legal representatives of the state of Florida argued
that they
had a
A
Florida court then had to fix the actual duty of the hospital and physi-
cians. In a complicated balancing of the co nflicting obligations, the co urt
concluded that
to the
life.
Partially as a result of Ro ss's argum ents, moral philosophers have gen-
erally com e
rather,
as
stro ng prim a facie mo ral demand s that
may be
are
presented
by a com peting m oral principle. To call lying prim a facie wr o ng m eans
that
consideration prevails
in the
than mere
he nor any
losophy
has proved incapable of providing a solution to this problem of
weighing and balancing that im proves on R oss's approach. The metaphor
of "weight" has not proved am enable to precise analysis, and no one has
claimed to be able to arra nge all mo ral principles in a hierarchical ord er
that avoids conflicts.
thesis also applies to circumstances in which a single principle
directs us to two
equally attractive alternatives, only
which
can
be pur sued . Fo r exam ple, the principle of beneficence, w hen applied to
problems of disclosing info rm ation to patients,could require
both
disclo-
sure and no nd isclosu re; both options could lead to equally
beneficial,
18 FOUNDATIONS
albeit d i f f e r e n t outcomes. Whether
the
conflict
may not be a single right action in some
circumstances, because two or m o re mo rally acceptable actions may be
unavoidably in
circumstances.
W e assume thro ugh ou t this volum e that respect fo r autonom y is but a
prima facie principle, and that it there fo re has the same b u t only the same
prima facie claim
analysis pre-
supposes, as an inherent feature of the moral life, a pluralism of mo ral
principles equally weighted
accept
"equal
weight.")
Theref ore, we ho ld that the m oral principles of bene ficence and jus -
tice—as well as more particular role responsibilities such as providing
the
best
The
is not
standing of autonomy. Autonomy gives us respect, moral entit lement,
and pro tection against invasions by o thers. Few m atters of mo rals could
be mo re im po rtant. But we sho uld step back and ask, as D aniel Callahan
has put it, "what it
18
There
is an historical
and cultural oddity about giving a standing of overriding importance to
the
i tself—was
founded at least as much on the other principles we have
m entione d, and usually in a contex t of strong co m m itme nt to the public
welfare.
th e
moral value rather than
a moral value, weighting it to trump every other moral value, buys the
luxury
of autono m y at too high a price, and we wo uld
agree.
However,
depress
to the
A uton om y is almo st certainly
the most important value "discovered" in medical and r esearch ethics in
the
last
single mo st imp or tant m oral value
for
informed
co nsent and for the argu m ent in this boo k. The pertine nt point
is
that
evaluations h ave
inform ed consent.
This analysis of plural prim a facie duties applies to rights as we ll. It has
often been
funda-
are
absolute trumps. However,
decisive cou nterex am ples can be m o un ted against this thesis. For exam -
ple, it is sometimes proclaimed that the right to
life
FOU N DATION S IN M O RAL TH EORY 19
thesis is evidenced by common moral judgments about capital punish-
ment, international agreements about killing in war, and beliefs about
the justifiability of killing in self-defense. Most writers in ethics now
agree that we have an
ex ercisable right
is no t a
s u f f i i e n t moral justification
to
override
the
right.
The
right
to
the
right
to
give
an inform ed consent, or a paren t 's right to
decide
mately exercisable and
right
in
ing protracted controversy
balance with great discretion
the competing rights claims.
Numerous authors in biomedical and research ethics believe that if a
person is act ing autonomously and is the bearer of an autonomy right,
then
care.
Although
the
burden
of
be on
"weight"
of
more likely that
considerations will validly override demands to
respect au to no m y. Similarly, because some a uto no m y rights are less sig-
nificant
than others, the demands to protect those rights are less weighty
in
entrenched and
among principles and rights can
be. Ho wever, in our book these problems, including the aforem entioned
problem of paternalism, take a back seat to problems of conceptually
analyzing
info rm ed consent and establishing its relationship to the p rin-
ciple
enabling autonomous choice as the goal of informed consent require-
ments. However, we shall no t argue that either this goal or the under-
lying
principle of respect for autonomy always or even generally out-
weighs other moral duties
W e
enco unter m any unresolved moral problems about inform ed consent
in this volume. We must not expect too much in the way of final moral
solutions from
to
mo ral problems, but it does not supply mechanical solutions o r d efinitive
procedures
are its indispensable allies in applied contexts. However, this lack of
finality
is
no
reason
for
superior to
shall
1969), 130.
2. For some reflections on what Kant's views do and do not show, see Arthur Flem-
ming, "Using a Man as a Means,"
Ethics
88 (1978): 283-98.
3. See, for example, President's Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research,
Deciding to Forego Life-Sustaining
244ff ;
and,
Office,
4.
These
issues are treated in Tom L. Beauchamp and James F. Childress, Principles
of
esp.
Chaps.
3,7.
Chapter
a
right
of
privacy
nineteenth century
individuals
against intrusions into zones of private life through newspaper gossip or
telephone
wiretapping.
The
was
later broadened,
according to a theory of constitutional law, to protect not only against the exploitation
o f
f o rms
decisionmaking.
Analysis
of the moral right to privacy that builds on ordinary language meanings of
"privacy"
as well as on the several legal notions of privacy has led to a complex array
of
into a directly corresponding, but more neatly formulated, moral right.
Part of the
dif ferent
writers who attempt to
explicate privacy as at once (1) an independent moral right (one that does not overlap
with other well-established moral rights, such
as the
moral concept that basically accords with
the common law's concept of privacy, and (3) a notion that does not depart signifi-
cantly
f rom
ordinary language meanings of "privacy." It is doubtful that these three
conditions
single moral concept
Compare W.A. Parent, "Recent Work on the Concept of Privacy,"
American Phil-
osophica l
sons:
(March 1980):
and
Privacy," Ethics 89 (October 1978): 76-81 and "Privacy and Self-Incrimination,"
Ethics
Civil
Rights-
Civil Liberties Law Review 12 (1977): 233-96; A r thur Caplan, "On Privacy and Con-
fidentiality in Social Science
Issues in Social
Sc ience Research
to
Affairs 4 (Summer
James Rachels, "Why Privacy is
Important,"
4
Inform ed Co nsent," 66-71.
7. See Lud wig Ed elstein, "The Hippocratic O ath: Tex t, Translation, and Interpre-
tation," Supplements to the Bulletin of the His tory of
Medicine
timore:
The Johns Hopkins University Press, 1943); reprinted in Owsei Temkin and
C.
injunction is
Ethics ,
Inc., 1973), esp. 47.
9. Perhaps the most important philosophical statement of this position is found in
W.D. Ross,
(O xfo rd: Clarend on Press, 1930), 21 .
10. For a discussion of such problems, see Joel Feinberg, Harm to Other s : The
Moral Limits
o f
York:
Journal o f Phi losophy
72
(1975):
and
Affairs 5 (1976): 305ff.
11. A widely held view is that one has a duty of beneficen ce only if one can pre vent
harm to others at minimal risk to oneself and if one's action promises to be of sub-
stantial ben efit
formulated
as follows: X has a duty of beneficence toward Y only if each of the follow-
ing conditions is satisfied: (1) Y is at risk of significant loss or damage, (2) X's action
is
needed
to prev ent this loss or d amage, (3) X 's action w ou ld probably preven t this
loss or damage, (4) the benefit that Y will probably gain outw eighs any harm s that X
is
likely
to
suffer
indebted to
Er ic D'Arcy, H uman A c t s: An Essay in Their Moral Evaluation (Oxford:
Clarendon Press,
1963), 56-57.
Provision o f benefit beyond these conditions would be to act generously but
beyond the call of duty. O ur form ulation is only one plausible con strual of the general
duty
purposes
in
this volume.
Fo r
contrasting views, see Earl Shelp, "To Benefit and Respect Persons: A Challenge for
Beneficence in Health Care," A llen Buchan an, "Philosophical Fo und ations of
Benef-
icence," and Natalie Abrams, "Scope of Beneficence in Health Care," all in Earl
Shelp, ed.,
(Do rdrecht, Holland: D. Reidel Pub lishing
Co., 1982).
Publ ic Affairs 1 (1972): 229-43, and Practical Ethics (Cam-
bridge: C ambridge Un iversity Press, 1979),
168fF;
in Ethics
and
Michael
A .
Slote,
"The M orality of Wealth," in William A iken and H ugh LaFollette, eds., Wor ld Hun-
ger a nd Moral Obl igat ion (Englewood Cliffs, N .J.: Prentice-H all, In c., 1977), 125-47.
22
FOUNDATIONS
13.
Nuremberg
berg Military Tribunals
Washington, D.C.: U.S. Government Printing
Office, 1948-49).
14. A comprehensive treatment of this problem in the context of
research
(Baltimore: Urban
Informed Consent: A Study of Decisionmaking in Psy-
chiatry (New York:
17. Satz v. Perlmutter, 362
S.2d
160
(October 1984):
Foundations in Legal Theory
W e m aintained in Chapter 1 that m oral principles are to be unders tood
as
principles of duty and that these duties are correlative to rights.
Although no s t ructure of principles in law corresp on ds directly to mora l
principles, m ora l principles
are
expressed
and
enforced
by the law in the
form of rights and duties devised for the specific purposes of a legal
framework. In
criteria
often
similar
in the two disciplines.
In this chapter, we first exam ine various relationships between m oral
principles and legal righ ts and then turn to the so-called "legal do ctr ine
of
info rm ed con sent." Tw o areas of the law are relevant to this do ctrine.
They represent different legal traditions thro ugh which requirem ents
to
obtain inf orm ed consent can be defined . The first and mo st imp or tant for
the current legal do ctrine of info rm ed consent is tort law. A "tort" is a
civil
injury to one's person or property that is intentionally or negli-
gently inflicted
com-
pensated by, mo ney damages. Civil injuries can be contrasted with crim-
inal injuries, which
or by fines not
intended as com pensation but paid as penalties to the state. A t com m on
law, an u njustifiable failure to obtain inform ed consent is a tort . In this
chapter
we
examine
the
obligation
to
obtain consent.
The second relevant area is the legal right to privacy, a right embed-
ded in American consti tutional law. Privacy, like many constitutional
rights,
serves
state over individ uals'
lives. In many instances, harmful state intrusions on privacy can be
legally preve nted rathe r than m erely recom pensed . The right of privacy
has
been
applied to vario us kind s of m edical choices, includ ing treatm ent
refusal, but there is as yet no developed constitutional do ctrine of
"informed consent."
24
FOUNDATIONS
Legal
Rights
The law relies o n mo ral principles to d elineate rights and d uties in bo th
case law (judge-m ade law expressed in court decisions) and statuto ry law
(federal and state statutes and their acco m panying adm inistrative regu-
lations). The same correlativity of rights and duties appears in law as in
morality: If one person has a legal right and another the corresponding
duty , the latter may be held legally responsible, and so liable, fo r violat-
ing
the
by
failure
to
fulfill
the
duty.
In
law, m any factors besides com m on ly shared m oral principles influ-
ence theories of legal liability. A ltho ug h they may be loo sely spo ken of
as legal princ iples,
true
principles; they are a
set of paradigm s, con structs, and provisos uniqu e to law and the institu-
tions o f
law. Includ ed
practical issues arising from the use of case-by-case adjudication, and,
finally, the traditional division of law into different categories, w hich dif-
fer
influences
liability.
of
judg e-m ad e law that began in med ieval En gland — and , second, into law
derived from the Constitution and statutes that supplant or supplement
the common law. Although it has been substantially reconstructed by
statute, the legal doctrine of inform ed consent is essentially a c o m m o n
law development.
and
civil law, and civil law again into sub-categories, including to rt, pr o per ty,
and co ntract law. W ithin these bro ad com m on -law categories, legal
problems are classified according to
"causes
of
action,"
o f liability." These consist o f sets o f
"elements,"
each o f which m ust b e pleaded in court and proved t rue by a prepon-
derance of the evidence in ord er for the com plaining par ty to prevail.
In English and early A m erican law, the c ommon law causes of action
were rigid and formal. Every claimed wro ng had to be fit ted into one of
th e "writs" that laid out the proced ures and arg um ent for each cause of
action. Although modern common law is more flexible, the influence
of its history is still felt. The theory of liability under which a case is
pleaded
is vital not on ly in shaping the pro of of a case at trial but also in
determining
To
detach the law from this fundam ental s t ructure is impossible, even
within the purest legal analysis. The need to fit facts and principles into
a
if a
single mo ral principle—
such as respect for autono m y— und erl ies several
different
Informed consent
fo r
autonomy. However ,
in the legal con tex t, info rm ed consent is not precisely abo ut how best to
respect
auton om y or to enable auto no m ou s decisionm aking. Legal lan-
guage
is
and
duties
Thus,
in
case
is
couched
in
rights lang uag e— the patient 's right to self-determination— and the pri-
mary
concern
duties that devolve upon phy -
sicians
Common Law and the Legal Doctrine
A
legal
"doctrine"
is a bod y of legal theo ry applied to a particular topic.
Legal scholarship often
the
common
includes
the entire body of law dealing with the general obligation to obtain
informed
1
The legal d octrine derives in A m erican case law almost exclusively
from
the
contrasted with
th e
researcher-sub ject relatio nsh ip in research . The d iscussion in this chap-
ter,
together
w ith the history in Chapter 4, presents the fr am ewo rk of
informed
consent
of
informed consent in biom edical and social research is reviewed in Chap-
ters
the
legal
into
these topics is bey o nd the scope of our v olum e, although we ou tline
them below. We do not address the doctrine as a whole; instead, we
focus almost exclusively
of
informed consent in the law, wh ich is the scope and configuration of spe-
cific
case law. These requirements
are shaped b y the exigencies of transla ting mo rality into social practice
thr o ug h the adversary legal system and its theor ies o f liability.
The failure to obtain inform ed consent in situations where it is legally
required is a tort. The linking of info rm ed con sent to a financial rem edy
and the othe r constraints of civil law is crucial to un d ers tan d ing the legal
doctrine.
A
theory but through various doctrines of tort, property, and con-
tract law, protects
decision from certain kinds of interference by others. Legal require-
ments
of
namely, the protection from physical intrusions by others.
Within the physician-patient relationship, th e right of bod ily integrity
is
supplemented
by
what
and
physicians
are unequal in possession of info rm ation and pow er to c ontro l the cir-
cumstances
without consent.
The key issues in case law and legal litera ture on inf o rm ed consent can
be divided into four categories: choice of the theory of liability, disclo-
sure requirements, causation,
either
action
or
abstention
from
action.
is
liable
to
punishment (in the criminal law) or is obligated to make compensation
for th e
a
case is tried determines the civil (or the criminal) duty that must be ful-
filled. In recent
originally
developed
of
liability.
Cou rts in som e states still apply the battery theo ry ex clusively, and other
states that prim arily apply negligence law to info rm ed consent cases con-
tinue to use battery under some circumstances. A s a result, no
funda-
unified
legal theory und erlies all info rm ed consent cases. In
Chapter 4 we will discuss the historical development of the informed
consent doctrine
difficult
sent.
and the way informed consent is treated by each.
The choice between battery and negligence has been the focus o f
much
legal scholarship about the do ctrine of info rm ed consent. There is
reason
to
volume
of
distinction in legal theory.
Under battery theory the defendant is held liable for any intended
(i.e., not careless or accidental) action that results in physical contact—
contact for which the plaintiff has given no permission, express or
F O U N D A T I O N S IN LE GAL THE O RY 27
implied,
and
which
the
must
injury
result;
the
if
nei-
ther
is present, the plaintiffs recovery, if any , will be of a sm all sum . In
practical reality these damages
on the
source
of
liability.
The
carelessness
occurs in regard to some activity in which the defendant has a socially
or
to
take
behave reasonably towar d oth-
ers, and in jury is caused by f ailure to d ischarge the d uty . The injury mus t
be translatable into money damages or the
plaintiff
The foregoing descriptions seem to imply that battery and negligence
describe starkly different types
and negligence theories can be viewed as distinct but not
mutually
fuller
ories and their differences.
tional and legally unpermitted physical contact with ("touching" of)
another person. Because th e essential purpose of the battery theory of
liability
so-called dignitary interest—the individ-
ual's bodily integr i ty— no injury need result from violation of this inter -
est. Treatment without consent
the
complaint
is
lodged)
who
party who co mplained) has com m itted a "technical
battery"
plaintiff
need not even
be aware of the event at the tim e contact has taken place (fo r exam ple,
he or she may be anesthetized). The defendant may act in good faith,
without any desire to harm , perhaps in the m istaken belief that the plain-
tiff
has
consented,
or
even
in
such
4
court
do
all the
plaintiff
must
show to win in cou rt is that the def end ant intended a contact that a rea-
sonable person wo uld find offensive und er the circum stances, or one that
the defendant should have kno wn would be offensive to that particular
plaintiff.
5
defendant intended to cause physical or psychic harm.
To d efend against a charge o f battery, the d efend ant can show that the
plaintiff consen ted to the to uch ing, or that the p lain tif fs dissent could
28
FOUNDATIONS
not
have
been
anticipated.
In
to
many harm less contacts is assumed by the law because reasonable people
deem such contacts
knowledge
objects "unreasonably"
to
some accepted social contact such as social kissing, then an act by the
defendant such
general right
It is
well captured
by the
following passage from a 1914 case that became a po wer fu l rallying sym-
bol in the
of
adult
years and sound mind has a right to determine what shall be done with
his
own
body;
6
This right of self-determination
is th e legal equivalent of the moral principle of respect for autonom y
discussed
in
Chapter
1.
Patients
are
kno w that phy -
sicians m ust obtain con sent, and phy sicians are expected by law to kn o w
that patients
patient's permission m ay thus be
found
sonable person would have authorized
th e
procedure
if
asked.
The physician may be found to have committed battery if no consent
at all was
in
scope or kind from the one actually performed, or if the physician failed
to
inform
the
of the
patient,
whether by virtue of om ission of important information or b y misrepre-
sentation, then what appears to be a
"consent"
is
"vitiated"
dered
invalid.
9
The central issue for the battery cause of action is thus
whether an effective (or
given. Battery requires that consent
be based on an
procedure.
10
Negligence.
The
on
premises
differ-
ent from those of batter y. Negligence is, in effect, th e failure to use due
care; negligence is the tort of
un intended harmful
action or omission. It
is analyzable in terms of five essential elements: (1) a legally established
duty to the
plaintiff must exist;
(3) the plaintiff
causal rela-
tionship between the act or omission and the injury must b e proximate.
FOUNDATIONS IN LEGAL THEORY 29
Proximate causation (5) is a limitation on responsibility that can be
invoked in negligence cases in order to preclude liability for remote or
unforeseeable causation
o f injury.
The d uty breached by a neg ligent act or o m ission is based in a general
duty to
is
m easur ed in law by the standard of the reaso nable perso n, an imag inary
actor who rep resents the co m m un ity consensus of acceptable or appro-
priate behavior. This consensus establishes neither a standard of what
average persons do no r an aspirational ideal bey on d the reach of m ost
persons, but a
threshold below which the ord inary person m ay
no t fall without being found deficient und er the law. (See the discussion
of the reasonable person standard in the sections on Disclosure and
Causation,
pp.
32-33.)
Professional
negligence,
or
malpractice,
of
negli-
gence in w hich professional standards of care have been developed for
persons possessing or claiming to possess special knowledge or skill.
Medical malpractice is but one type of professional negligence. The phy-
sician
found
to have com m itted malpractice is held liable for violation of
a duty to exercise the requisite skill and care of the ordinary qualified
m em ber of the medical profession. Fellow pro fessionals represent the
peer
group, whose standards and testimony at trial are necessary to
establish
the
scope
of
there is a
of
due care to provide to patients an appropriate disclosure of information
before obtaining
same respect
as is careless p erfo rm ance of a surgical proced ure.
The informed consent action in negligence has five elements, corre-
sponding to the above five elements of general
negligence:
part
of the professional duty of due
care; (2) the physician breaches the du ty ; (3) there is an
injury
to the
patient that makes th e patient worse off (in financially measurable term s)
than
materialization of an undisclosed outcome or possible outcome (risk);
and (5) had the plaintiff been info rm ed of the o utcome o r risk, he or she
(o r a reasonable person ) wo uld not have consented. Un derlying (5) is the
crucial
offered
num ero us reasons for the con-
temporary trend toward negligence and away from b attery as the p re-
ferred theory
11
A
is
that
bat te ry—as the cruder and more drast ic theory—is useful only in lim -
ited
situations wher e the nature of the procedure has not
been
disclosed
at all or an action inte ntio nally exceeds the scope of the consen t. Som e
30
FOUNDATIONS
courts
see
physicians
as
inform
as intentionally
antisocial acts such as those typically found in assault and battery.
However, some legal commentators have argued that
the
battery
action, in recognizing the dignitary importance o f individual bodily
integrity and self-determination, is closer to the spirit of the informed
consent doctrine than is negligence, which has the
effect
several commentators have proposed
12
Disclosure
Requirements
that must
be disclosed to a patient are central to the legal doctrine of informed
consent
and
disagreements exist
regarding what must be disclosed about the nature and purpose of the
procedure,
its
benefits,
and
tive standard.
standard holds that both
the duty to disclose and the criteria of adequate disclosure, its topics and
scope, are
by the
customary practices
of a
professional com-
muni ty .
Proponents o f this standard argue that the physician is charged
professionally
with
the
responsibility
information
that
should
be
disclosed
and
from
this perspective a job belonging to physicians by virtue o f
their
profession
establishes th e standard o f care for disclosure, just as custom
establishes
the
standard
informed consent negligence cases, Natanson v. Kline the court held:
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.
14
performance
of
med-
F O U N D A T I O N S IN LE GAL THE O RY 31
The
A ll the co urts adopting the pr ofessio nal
practice
groups
to d eterm ine wh ether a physician has violated a du ty to disclose
the risk in question . The decision in a 1972 case in which rad iation ther-
apy for Hodgkin's disease led to paralysis provides a typical expression
of this standard: "Generally the du ty of the physician to inform and the
extent o f the info rm ation required should be established b y expert med -
ical testimo ny."
been
crit-
icized severely as a disclosure rule for inf or m ed consent law. It has
been
is
required
for
the establishment of such a standard. A second objection is that truly
negligent
care
might
be
perpetuated
if
offer
the same inferior info rm ation, whether thro ugh ignorance, as a
genuine con viction,
17
Another m ore fund am ental objection centers on a basic assum ption of
the medical practice standard—that physicians have sufficient expertise
to
and
disclosures are either harmless or beneficial for patients, this
conclusion is not m uch more adequately groun ded than the contrasting
hun che s of exp erienced physicians who appeal to anecdo tal evidence.
18
There
is some evidence to support the claim that because of the value
patients place o n info rm atio n, they w ou ld support a disclosure standard
requiring m o re d etailed inf o rm atio n than physicians typically give.
19
Related data suggest that phy sicians believe that the a dd itiona l
infor-
affect
their
norms
additional information is in fact harmful to patients.
Although
the
professional
that
it
the
protection
to the
medical
practice applies only to specifically med ical jud gm en ts and that,
ultimately,
decisions
ments, are
to
adopt
more adequately the patient's right of self-determination. T his standard
focuses o n the
alternatives, and consequences. The legal litmus test under this
standard for determ ining the exten t of disclosure is the "m

a history and theory of informed consent.pdf

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