## 1. The requirement of informed consent



In English, "consent" has several meanings. In the
relevant sense, consent transactions have a distinct structure: agent
*A* consents to *B*'s *ph*-ing on
*A*, under a certain description of *ph*-ing,
whether or not the offer was initiated by *B*. For example, a
man may consent to a physician's touching the man's
testicles as part of a testicular cancer exam upon the
physician's suggestion (compare Kleinig 2010, 6-7).



Informed consent is shorthand for informed, voluntary, and
 decisionally-capacitated
 consent. Consent is considered fully informed when a capacitated (or
"competent") patient or research participant to whom full
disclosures have been made and who understands fully all that has been
disclosed consents voluntarily to treatment or participation on this
basis.



In its most important role in bioethics, informed consent is a
legitimacy requirement for certain actions. Inadequately informed
consent makes certain intrusions impermissible. Roughly, when a
sufficiently capacitated adult does not give sufficiently informed and
voluntary consent to intervention in her body or her private sphere,
then, at least when the intervention is substantial, not trivial, and
absent severe jeopardy for third parties, the intervention is
impermissible--even when it seeks to assist her, physicians
recommend it, third parties would benefit from it, and the patient
herself had repeatedly consented to it before expressing a change of
mind. When the antecedent is inapplicable--for instance, when the
patient lacks decision-making capacity--similarly spirited rules
apply, such as rules delegating consent "authority" to the
patient's
 advance directive
 or proxy.



While consent and informed consent are relevant to medical torts, to
distributive and proprietary medical claims, and to ideal (as opposed
to merely legitimate) doctor-patient relationships, this entry focuses
on informed consent in its central role as a legitimacy requirement
for medical intervention. Contemporary medical culture and central
human rights documents support something like this requirement. In the
U.S., where regulatory commitment to informed consent is especially
strong, federal funding for research usually requires review of
informed consent procedures, and the constitutional right to privacy
binds government to honor patients' refusal of care. Lack of
informed consent can be used to establish negligence (and hence
malpractice and torts), or battery and assault.



Since the 1970s, extensive bioethics writing focuses on how to define
and achieve "valid" consent--sufficiently
capacitated, informed, and voluntary consent--and the conditions,
especially in medical research, have become increasingly demanding.
The contrast between these post-informed consent expectations and an
earlier medical ethos is vivid in an excerpt of the Hippocratic Oath
(fifth century B.C.E.): "Conceal most things from the
patient... Give necessary orders with cheerfulness and
serenity... revealing nothing of the patient's future or
present condition." Present-day physicians like to think that
they treat their patients differently.



Section 2 discusses the potential justifications for the requirement
of informed consent. Sections 3-5 delineate its content with
greater detail. Sections 6-7 note potential waivers and
exceptions to the requirement. Sections 8-9 review its status
and its relations to consent requirements in other normative fields.
Section 10 concludes.


## 2. Why informed consent?



Plato attacks political democracy by drawing an analogy to the medical
arena: "When a man is ill... to the physician he must go,
and he who wants to be governed, to him who is able to govern"
(Plato *Republic*, VI 489B-C, 180). Nowadays it is common
to reject both Plato's anti-democratic politics and his medical
ethics. A central defense of political democracy against Plato's
attack rests on the
 Condorcet jury theorem,
 which underwrites the "wisdom of the masses." But why
reject Plato's medical ethics? In the medical arena there are no
masses, and yet the informed consent requirement gives a single
non-expert--the patient or the research participant--veto
power over some interventions, even against the will of many expert
physicians. Why *not* take Plato's, or
Hippocrates's, approach in the medical arena? Why require
informed consent, disallowing even a mass of medical experts to make
the final decision on matters that fall within their fields of
expertise--medical treatment and medical investigation? The main
arguments for informed consent revolve around:



> 
> 1. protection,
> 2. autonomy,
> 3. prevention of abusive conduct,
> 4. trust,
> 5. self-ownership,
> 6. non-domination, and
> 7. personal integrity.
> 
> 
> 


### 2.1 Protection



The simplest rationale for the informed consent requirement is that it
protects study participants' and patients' health and
welfare. It protects participants from investigators'
overzealous attempts to promote science and personal careers, even on
participants' backs, and it also protects regular patients from
neglectful clinicians or from overconfident, but often wrong,
 paternalistic
 ones. While many moral doctrines oppose harming study participants or
patients, bioethicists' expositions of this instrumental
rationale typically echo utilitarian philosopher
 John Stuart Mill,
 for whom "Over himself, over his own body and mind, the
individual is sovereign" (Mill 1990, 135; see also ch. 3). They
explain that patients and research participants are typically the best
judges of their own good and mind it far more than the doctor does,
even when the doctor is convinced that he or she acts in their best
interests (compare Mill 1990, e.g. 215). They add that doctors'
training scarcely prepares them to know patients' distinctive
non-medical interests.



However, insofar as the goal is to protect patients and trial
participants from harm, why honor informed consent requirements when
many physicians and patients--a Condorcet
"jury"--are fairly certain that a particular patient
or participant is not making a decision that furthers her own medical
interests? In clinical care, for example, patients' biases and
ignorance about medicine arguably tend to exceed those of physicians;
sometimes, patients refuse interventions that *everyone*
considers best for them--even family, friends, and these patients
themselves, before a change of heart. In the future, patients may
refuse interventions that highly-reliable algorithms predict patients
like them to be glad to have undergone. Indeed, some patients
knowingly jeopardize their own health in the name of religious or
moral commitments. This being the case, why is it important--as
it seems to many of us and as is enshrined in law--to honor the
requirement of informed consent? For example, why honor the
requirement when a fully capacitated Jehovah's Witness refuses a
blood transfusion on religious grounds? Why honor it when health is
not at stake, for example, in experiments on stored tissue? Finally,
specifically from a utilitarian standpoint, why honor the requirement
on occasions when it seems to set back collective health, for example,
when we cannot develop a new drug that would help many, because no one
is altruistic enough to consent to participate in its risky study?


### 2.2 Autonomy



The 1970s saw the ascent of a second rationale,
 autonomy,
 as the predominant justification of informed consent, through
influential work by Ruth Faden, Tom Beauchamp, James Childress, and a
U.S. President's Commission (Faden and Beauchamp 1986, 8;
National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research 1979, section b (1), 282-3; Beauchamp
and Childress 2008, ch. 4; Beauchamp 2010; see also President's
Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research 1982, 27; Feinberg 1986; Dworkin
1988, 111, 113; Buchanan and Brock 1989, 36ff.; Brock 1994,
31-2).



Philosophers of action usually understand autonomy as governance over
one's own agency--acting according to a law that one sets
for oneself. Likewise, for bioethicists Beauchamp and Childress,
"The autonomous individual acts freely in accordance with a
self-chosen plan, analogous to the way an independent government
manages its territories and establishes its policies" (Beauchamp
and Childress 2008, 99-100). As the authors emphasize (Beauchamp
and Childress 2008, 100-1), autonomy so understood differs from
autonomy as having the will that one wants to have (Frankfurt 1988).
It also differs from many other uses of "autonomy" in
bioethics and biolaw (Dworkin 1988, 101ff.)--so many as to prompt
some to question the force of autonomy-based justifications
(O'Neill 2003). However, initially, autonomy seems like a
promising ground for informed consent requirements. The rationale for
not transfusing a protesting, decisionally-capacitated Jehovah's
Witness even when forced transfusion would save the witness's
life is clearly not protection of her health. Instead, it may seem to
do with maintaining her self-rule on such momentous issues: a matter
of respect for an autonomous decision maker's refusal. And fully
informed consent usually assumes freedom from controlling interference
and from an inadequate understanding of the basic risks of the
intervention, components of fully autonomous choice as well (Beauchamp
and Childress 2008, 100-1).



While occasionally, the need for autonomous authorization of medical
intervention is considered "axiomatic" (Beauchamp 2010,
58), it is commonplace to defend autonomy on independent grounds. A
complete autonomy-based justification for the informed consent
requirement would explain both why personal autonomy, under a
plausible explication, matters--why it has high value or status,
at least in the health arena; and how honoring the informed consent
requirement engages with its value or status correctly.



Some attempt to justify autonomy on merely instrumental grounds,
suggesting, for example, that concordance between our care and our
values is often key to our continued satisfaction and cooperation with
assigned medical teams. Others add that autonomy is inherently good
for us. First, self-rule is central to a good life, perhaps because it
makes us less self-alienated and more worthy of praise for our
virtuous decisions. Second, autonomous choices promote our ultimate
goals, on the non-controversial assumption that medicine affects
non-technical and controversial matters of value and faith on which
physicians are not experts (say, a Jehovah's Witness's
faith), and the controversial assumption that these goals define how
well our lives go (President's Commission for the Study of
Ethical Problems in Medicine and Biomedical and Behavioral Research
1982; Dworkin 1988, 113).



However, these links between informed consent, autonomy, and the good
life are more tenuous than informed consent requirements are usually
assumed to be. In the Jehovah's Witness case, any medical good
that might come from promoting the patient's future cooperation
with assigned medical teams is irrelevant once refusal to accept
transfusion makes the patient's future life an impossibility. In
addition, according to the beliefs of some Jehovah's Witnesses,
what their religion says is that they must refuse transfusion, not
that undergoing forced transfusion would land them in hell or breach
their personal integrity. To impose transfusion on Jehovah's
Witnesses of that particular persuasion might not blight their lives,
yet it remains a clear breach of informed consent requirements.



Fully autonomous decision-making seems to be bad for us sometimes in
at least certain respects, say, when it involves tortuous
deliberations, makes us more accountable for embarrassing mistakes, or
invites social pressure to make certain choices (Dworkin 1988, ch. 5).
The cost of ensuring that a single decision is absolutely autonomous
may be a severe, permanent, or fatal health problem. This health
problem will usually affect well-being more than a small marginal
decrease of autonomy would--yet some informed consent
requirements apply. Indeed, on no theory of
 well-being--neither
 desire satisfaction, hedonic state, nor objective list--does it
seem to follow that either informed consent or autonomous choice
invariably makes a patient's life better (Buchanan and Brock
1989, ch. 1 SS4, esp. p. 40). And if they did, then it would be
absurd to claim, as proponents of the autonomy rationale do (Beauchamp
and Childress 2008, e.g. pp. 12, 14), that informed consent and the
principle of autonomy are distinct from, sometimes conflict with, and
often supersede, the principle of beneficence.



A different version of the autonomy rationale states, in the spirit of
 Immanuel Kant's
 ethics, that autonomy should command our awe and reverence, whether
or not it is good for us (Hill 1991, 43). The literature on informed
consent regularly cites Kant's Formula of Humanity (Kant 1996,
80 [4:429]) to establish that duties of
 respect
 for autonomy bind physicians (Beauchamp and Childress 2008, 63, 103;
Dworkin 1988, 110; Levine 1988, 96-7; Pellegrino and Thomasma
1993, 128). Alan Donagan's defense of the requirement of
informed consent illustrates this Kantian approach: "Recognition
of every human being as having a unique dignity as human, and as
therefore being an end in every relation in which others may morally
stand to him, entails that no human being may legitimately be
interfered with in pursuing his conception of his happiness in
whatever way seems best to him" (Donagan 1977, 31).



This version of the autonomy rationale is criticizeable as well. Kant
associated respect for persons with treating them only in ways that
they could possibly or rationally consent to, not with treating them
in ways that they have actually consented to--rationally,
voluntarily, or otherwise (Wertheimer 2014, 149). The notion of
autonomy as bioethicists understand it hardly resembles Kant's
notion of autonomy (O'Neill 2003). And while some contemporary
Kantians interpret autonomy as "our authority to determine our
own actions" (Buss 2016), many gross violations of informed
consent do not directly transgress that alleged authority. A surgeon
who exploits a patient's surgical anesthesia to force an
experimental intervention grossly violates informed consent by
affecting heavily the incognizant patient's body and life, but
less directly if at all by thwarting the patient's determination
of what actions to perform. During the violation, the anesthetized
patient was not performing any action. Likewise, informed consent
finds some interventions far more reprehensible than others, although
their impacts on our autonomous action and pursuits are similar.
Performing a testicular cancer exam without the patient's
informed consent is very problematic, and transgresses core informed
consent requirements. It is far harder to justify than looking
carefully at a skin mole on a patient's cheek from across a
clinic desk, in order to detect cancer, without the patient's
informed consent. Non-consensual facial scrutiny might not even
violate informed consent. The main difference seems to be in whether a
sensitive area of the patient's body is being touched and
scrutinized without the patient's consent, which can constitute
extreme battery; and not in the patient's exercise of agency,
say, in the number or nature of the patient's actions and plans
that are thereby blocked. It may be true that extreme battery
symbolizes extreme contempt towards the patient as a sovereign agent,
but here, at least, it does not involve greater interference with his
autonomy as characterized above.



Regardless of either the exact meaning of autonomy or the extent to
which autonomy is good for us, grounding informed consent in autonomy
turns out to be difficult. First, autonomous decision making over
*all* matters that heavily affect one's health is not
something to which any patient has a right. Organ waitlists, for
instance, can be perfectly legitimate even when some patients demand
in full voluntariness the next available organ and autonomously refuse
to wait in line. Just because receiving the organ would serve their
autonomous wills does not make it their right to obtain organs
designated to others ahead of them on the list without interference.
Admittedly, the autonomy rationale may here be conjoined with a
clarification as to which matters concerning patients' health
they have a right to determine. But for some that right would then be
the reason why their consent is required, when it is required
(McConnell 2018), potentially making any further reference to autonomy
redundant.



A second challenge to grounding informed consent requirements in
autonomy is that violating informed consent requirements can have
positive impact on autonomy. One example is when closing off an
option, in violation of informed consent, enables more important
freedoms. For instance, closing off patients' options for
voluntary euthanasia was said to increase their autonomy by freeing
them, as well as similar patients, from family pressure to use that
option (Velleman 1992); surely it may do so even when accomplished
through forced injection of an antidote or other violations of
informed consent.



A third challenge is that not all acts that are generally assumed to
violate informed consent seem contrary to autonomous decision-making.
Suppose that a sufficiently capacitated adult patient refuses a safe,
beneficial, and time-sensitive surgery to prevent a moderate
disability, due to a simple misunderstanding of medical facts. There
is no time to convince him of his mistake. Being uninformed, his
decision cannot count as autonomous. But present medical practices
surrounding informed consent continue to forbid, possibly for good
reasons, forcing care on such a patient--for example, strapping
him to the bed to deliver an operation. In such instances, the problem
with forced care cannot be simply violation of autonomy. Some have
argued in somewhat similar cases that forced care is legitimate,
because it would contravene "mere desire" not
"rational desire" (Savulescu 1994), and because "the
state has the right to prevent self-regarding harmful
conduct...*when...* that conduct is substantially
nonvoluntary..." (Feinberg 1986, 12). A different possible
conclusion is that present informed consent practices are sound, they
just rest on justifications other than respect for personal autonomy;
surely a "No" to an intervention in the body is often a
"No" even when the patient lacks the capacity or the
information to authorize an autonomous "Yes" (compare
Estlund 2007, 121-5; Gunderson 1990). A third possible
conclusion is that while what is wrong with forced care in this
setting is the violation of autonomy, what "autonomy"
means here is simply a domain over which one should remain sovereign
and have the final say, even if uninformed, incapacitated, and so
forth (Enoch 2017, 31-32). This, however, is not how
"autonomy" is used in bioethics.



As a final challenge to grounding informed consent in autonomy,
consider a patient who has been treated fairly and offered a simple
explanation of her treatment and the alternatives, which she could
comprehend if she tried; her failure to comprehend it and to choose
autonomously is the fruit of her own neglect. Can the physician or the
investigator really be blamed for the patient's consequent
non-autonomous choice (Sreenivasan 2003; Miller and Wertheimer 2010,
85, 95; Millum and Bromwich 2013)? In many areas of life in which
consent seems necessary, what matters is not so much the
"quality of choice," say, how autonomous it is, but
whether the person had been given the opportunity to make a choice of
that quality (Scanlon 1988). Advocates of the autonomy rationale may
respond in one of two ways. First, they may insist that when an
investigator did due diligence to help candidate participants
understand the significant risks of a study yet sees that they have
not been understood, she has a reason to explain again, or recruit
other candidates, precisely because the autonomy of study
participation matters; alternatively, they may insist that having been
given real opportunity to decide autonomously already counts as having
been given autonomy over the matter.


### 2.3 Preventing abusive conduct



An alternate rationale defends informed consent requirements as a
bulwark against such deontological offenses as assault, deceit,
coercion, and exploitation (Manson and O'Neill 2007, 75f.), or
fraud (Millum and Bromwich 2013). From this viewpoint, informed
consent requirements are instrumental against certain abusive acts,
not (only) against setbacks to health and welfare.



The abuse-prevention rationale may be unable to account for the full
extent of clinicians' informed consent duties. We have already
mentioned that physicians should make some effort to explain
information again if they discover that their patients misunderstand
crucial risks. Intuitively, this is so even if the patient was given
an excellent explanation, one that worked with similar patients and
which would rule out reasonable suspicion of deceit, exploitation, or
fraud, their patients misunderstand crucial risks should make some
effort to explain again. Given that abuse has already been ruled out,
the abuse-prevention rationale fails to account for this duty
(Beauchamp and Childress 2008, 118; compare Manson and O'Neill
2007, 82-3). That said, the abuse-prevention rationale in no way
rules out an account of that duty based on complementary rationales
for informed consent (Millum and Bromwich 2013, 218).



Another challenge for the abuse-prevention rationale is that it is
difficult to ground in the deontological morality that has been
invoked to motivate it. Typically understood as
 agent relative
 and moment relative, deontological morality may be unable to provide
strong reasons for preventing future deontological offenses,
especially by others. A truly deontological abuse-prevention rationale
would therefore leave little room for strong reasons to enforce
informed consent requirements on others, yet some informed consent
rights are surely legally enforceable by third parties later. It would
also hardly leave room for strong reasons against coercive medical
intervention when third parties perform the coercion; for example,
against extracting a live kidney from a consenting patient who
consents only due to her family's coercion, yet such reasons are
widely recognized. Any consequentialist variant on the
abuse-prevention rationale would usually need to focus on all bad
consequences, not just on abusive conduct and its downstream
consequences, and serious harm to someone's health would often
count as a worse consequence than someone's having been
deceived. 


### 2.4 Trust



In recent years, a number of philosophers have argued that
"Informed consent... is generally important [in part]
because it can make a distinctive contribution to the restoration of
trust" (O'Neill 2002, 145; see also Bok 1999, 11,
26-7, 63; Jackson 1994, 491; Kass et al 1996; Tannsjo
1999, 24). Their trust rationale is future-looking. It points out the
importance of ongoing societal trust in caretakers and medical
institutions, for example, as a precondition of ongoing compliance
with medical advice, registration for organ donor cards, and
participation in medical research. Since violations of informed
consent would jeopardize that trust, they are something to be avoided.
This rationale has the advantage of potentially demanding informed
consent even to certain low-risk and low-impact interventions. For
example, forced testicular exam may be medically "safe",
but, if discovered, could profoundly shake public trust in providers.
The rationale also addresses the special wrongness of outright lying
to patients (perhaps worse than non-lying deceit: Jackson 1991,
7-9)), say, to realize beneficial placebo effects. If
discovered, lying and battery could easily undermine public trust in
physicians.



The trust rationale is most plausible as a partial rationale. It faces
serious objections if it is taken as a comprehensive justification of
informed consent (Eyal 2014). For one thing, being forward-looking,
this rationale is vulnerable to the objection that, intuitively,
informed consent can remain necessary even when the public could never
find out that a core violation of the requirement took place. While
the requirement of informed consent might not obtain across the board,
it seems inappropriate to determine whether it obtains in a given
context based on e.g. how chemically traceable is the medication whose
forced administration is being considered, although that would affect
how much this act would jeopardize future public trust in physicians.
Another challenge to this version of the trust rationale is that
invasive interventions without a person's informed consent are
usually thought to wrong that person, not to wrong only the potential
future victims of a decline in public trust. A possible response would
be that the (only) reason why we consider informed consent to be the
immediate patient's right is that what is likeliest to inspire
public trust is unconditional commitment to one's immediate
patient's alleged consent rights.



A quite different version of trust rationale is backward-looking. This
version defends informed consent as an intrinsically important way to
honor the trust that the patient has placed in the physician, and as
part of the fiduciary role that the physician has undertaken (Joffe
and Truog 2010, 352ff.), perhaps a matter of virtuous trustworthiness
(Pellegrino and Thomasma 1993, 65-78). However, the
backward-looking version of the trust rationale has difficulty
explaining the need for informed consent outside pre-existing
caretaker-patient relationships. Forced bodily trespass, for example,
seems (not much less) wrong when it comes from complete strangers.


### 2.5 Self-ownership



Another rationale surrounds self-ownership: we are presumed to hold
proprietary rights over ourselves and our bodies, perhaps in line with
John Locke's idea that "every Man has a
 *Property*
 in his own *Person*" (Locke 1988, V. 27, 305).
Naturally, once an owner's consent is given, the alleged
proprietary prohibition on access and on direct impact is removed.
This rationale may better explain why we must normally grant our
permission, even for medical intervention that is safe, low-impact,
and clearly beneficial, and requires no agency on our part. Trespass
into a private sphere can be forbidden even when it involves mere
touching, and the owner is foolish or selfish to reject it (Archard
2008, 27f; Thomson 1990, ch. 8; Nozick 1986).



But an account based on self-ownership raises more questions than it
settles. Self-ownership may just *mean* that the individual
should be the final arbiter in the relevant sphere, and that seems
like a part of what informed consent requires--hardly an edifying
rationalization for requiring informed consent (compare Cohen 1995,
chs. 9-10). Alternatively, self-ownership may designate a more
circumscribed list of rights (Fried 2005; Archard 2008, 29-30),
but this list would also stand in need of a defense, and cannot by
itself count as adequate justification. A further challenge is that
the self-ownership rationale fails to clarify why touching sensitive
areas of the body without consent seems worse than touching less
sensitive areas without consent. Property violation is not usually a
matter of degree (compare Archard 2008, 30-1). Finally, the
self-ownership rationale fails to clarify why physicians must disclose
and ensure our comprehension of information prior to intervention,
something which proprietary rights seldom require. Indeed, the notion
of self-ownership could be used *against* coercing doctors to
give patients that information--because such coercion may violate
these physicians' self-ownership rights to interact as they
will.


### 2.6 Non-domination



Bioethicists rarely explore the value of
 non-domination
 as a rationale for informed consent, although this rationale is used
extensively in sexual ethics and political philosophy. The idea here
would be that no one should be under the arbitrary control of another
and that informed consent requirements help to prevent such arbitrary
control. One would argue that medicine is rife with potential to
become hierarchical, given the utter dependency of patients and
research participants on physicians (Levine 1988, 121-2), as
well as the knowledge gaps between them, especially in the
investigational context. Therefore, it is important to ensure that
patients and research participants retain a high degree of control
over what happens to them, and informed consent helps with this. This
rationale may shed light on the special importance of informed consent
to research participation--where the knowledge gap is greater,
and where there is a specific informed consent right to withdraw from
research at any point. Even if one has autonomously waived protection,
arbitrary control by others, without the protection of a consent
requirement, remains intolerable.



The non-domination rationale has difficulty explaining why physicians
and investigators who are closely monitored and cannot afford to
mistreat patients would also be obligated to let patients decide.
Arguably, some existing systems have ample institutional mechanisms in
place to prevent physicians and investigators from exercising
arbitrary control, even without informed consent requirements, and yet
commonsense recognizes such requirements.


### 2.7 Personal integrity



A final rationale for informed consent requirements is the need to
protect patients' sense of personal integrity. One reason
offered for keeping surrogate pregnancy contracts non-enforceable is
the need to maintain surrogate carriers' sense of personhood by
never coercively taking babies away (Radin 1983, e.g., 960). A similar
rationale may be thought to justify informed consent in general, and
to reflect our special relation to our bodies. As Gerald Dworkin put a
slightly different point, "one's body is irreplaceable and
inescapable. If my architect doesn't listen to me and this
results in a house I do not like, I can always move. I cannot move
from my body." (Dworkin 1988, 113). By one interpretation,
personal integrity underlies self-ownership norms. What it requires
is, in Ronald Dworkin's words, "a prophylactic line that
comes close to making the body inviolate" (Dworkin 1983, 39).
However, personal integrity may instead give rise to a normative
continuum, on which the outer line of the body is only one stop.
Touching someone's cheek without his informed consent is hardly
as bad as touching more sensitive areas of his body without his
informed consent. The continuum may also extend outside the body. As
Judith Thomson points out, it is a greater transgression to touch an
unwilling person's body than to touch his shoes, yet a small
transgression exists, even when he is not wearing them (Thomson 1990,
207-8). It also matters how and why these areas are touched.
Such continua may be thought to track the typical degree of injury to
personal integrity.



An account in terms of personal integrity would require more
specification. For example, what is the relation between this account
and the offense of battery? Would this account condemn the use of a
magic wand to treat an unwilling patient's ailments without
cutting his skin and so, perhaps without battery (Brock 1999, 529f)?
Would it also condemn threat of fines that coerces patients to move
their bodies in certain ways, even without touching them? Is the
account ultimately grounded in an *a priori* argument, in
evolutionary psychology (Wertheimer 2003, 113f.), in the typical
material harms from violations of bodily integrity, or in still other
considerations?


## 3. The idea of consent



Let us now review the different elements of fully free and informed
consent in some detail, starting with the notion of consent itself.
English admits of both psychological and behavioral senses of consent.
Psychologically, consent can designate "a state of mind of
acquiescence" (Westen 2003, 5), and "an act of
will--a subjective mental state..." (Hurd 1996, 121).
But the medical requirement of informed consent seems to include at
least some behavioral expression of consent (Kleinig 2010,
9-10), ranging from a patient's signature, to her
*not* protesting when a nurse approaches with a syringe
(so-called implicit or tacit consent). That said, the need for some
comprehension and voluntariness means that mental states also affect
when consent legitimizes medical intervention, perhaps supporting a
hybrid view of one sort (Miller and Wertheimer 2010, 84) or another
(Alexander 2014).



When emergency intervention is needed but normal consent cannot be
obtained, say, because the patient is unconscious and neither she nor
her family's specific preferences can be identified in time,
proponents of informed consent often justify intervention by invoking
a potentially different form of consent. They say that *presumed
consent* obtains, even if actual and express consent does not.
Presumed consent is also often invoked in order to legitimize a
general policy of harvesting organs from healthy deceased persons to
use in transplantation unless they explicitly indicated their
opposition, and a similar general policy of testing all incoming
patients for HIV except those who explicitly request not to be tested.
Such policies reverse the usual default assumptions about what is
permissible and place the onus on any individual who has reservations,
to "opt out." The underlying thought is that when opting
out remains easy, so-called presumed consent is perfectly consonant
with patient sovereignty (Sunstein and Thaler 2008).



Some authors oppose the terminology of presumed consent as a contrived
"myth" or "fiction" of actual consent (Harmon
1990; Brownsword 2004, 232-3; Beauchamp and Childress 2008, 107;
Dworkin 1988, 117). They concede that when a nurse approaches a
patient with a syringe, the patient's failure to protest
constitutes actual, albeit tacit, consent per convention. But they add
that it is fraudulent to presume consent when consent is not
explicitly given and no relevant convention specifies that silence
expresses consent.



This opposition seems to interpret "presumed consent"
ascriptions as meaning: *Presumably, the patient has given actual
(albeit tacit) consent*. The opponents seem right on point: it
goes too far to assume that, just because a patient fails to carry in
her pocket a directive forbidding care or organ harvesting in the
event of an emergency or death, she is consenting. However, on a
different interpretation, presumed consent ascriptions mean:
*Presumably, the patient would have consented to the intervention
if, under the current circumstances, she were
decisionally-capacitated*. A possible ground for such
counterfactual ascriptions is that there is no special information
that indicates that the patient would not consent, and most people
would consent. This interpretation seems to sidestep the
difficulty.



Of course, if opt-out organ procurement policies are justified, it is
not necessary that one justify them in terms of consent (presumed or
otherwise) as long as one is prepared to argue that sometimes, certain
values defeat individuals' consent rights. In the case of organs
from the deceased, the primary pull for making consent not refusal
into the default may well be the huge benefit to the organ recipient
and the far lower harm to the deceased. Together, these factors may
make high-quality informed consent less urgent.


## 4. Informed consent



Clinical trials are commonly anticipated by a formalized process in
which participants receive explanations of the purpose, methods,
risks, benefits, and alternatives to study participation, as well as
other matters, before they sign informed consent forms (Beauchamp and
Childress 2008, 129). Fairly similar processes exist in invasive care.
But what is the point of these processes? One of Plato's
characters mocks doctors who set aside time to keep sick patients
informed: "Foolish fellow, ... you are not healing the sick
man, but you are educating him; and he does not want to be made a
doctor, but to get well" (Plato *Laws*, IV.720a-c,
p. 413). Let us discuss two forms of transgression of the information
requirement: (1) lies, deceit, and merely-partial disclosure, and (2)
the patient's failure to comprehend well-presented information.
We shall then discuss (3) the content and (4) the cogency of the
information requirement.


### 4.1 Lies, deceit, and partial disclosure



Lies about pertinent matters are broadly assumed to violate the
informed consent requirement. So does non-lying deceit that
intentionally prompts a false impression, for example, complete
concealment of a potentially despairing prognosis, or its statement in
obscure Latin terms that the patient cannot understand, in order to
maintain the patient's hope and medical adherence. So does
non-lying deceit that is voluntary but unintentional, say an
explanation in obscure Latin terms meant only to impress the patient
but foreseen to hamper comprehension (Jackson 1991, 6). Interestingly,
ignorance of side effects that results purely from the early stage of
scientific inquiry into them is taken to permit informed consent and
autonomous decisionmaking (Millum and Bromwich 2013). A recent
question is how much certain mild forms of intentional
manipulation--for example, placing the hopeful news both at the
beginning and at the end of a prognostic report so as to make its
affect more hopeful--invalidate informed consent (Eyal 2016).



The intentional use of the placebo effect in clinical care, commonly a
deceitful means to help a patient feel better, is condemned by
prominent bioethicists in the name of informed consent (Bok 1999,
61ff.; Beauchamp and Childress 2008, 125). Other seeming breaches of
the information component of informed consent are somewhat more
popular with bioethicists. First, the well-established
"nocebo" effect is when the patient's expectation of
a negative outcome as a possibility generates corresponding symptoms
or exacerbates them. When a severe, unavoidable nocebo effect from
disclosure is predictable, most philosophical observers support
withholding certain information (Cohen 2014). In some cultures,
patients are averse to hearing about risks because they falsely
believe that the mention of remote risks makes those risks likelier to
materialize. While the expectation is false, it means that full
disclosure of these risks would meet with aversion, potential anxiety,
and fewer clinic visits, and many bioethicists permit partial
disclosure in such settings (Beauchamp and Childress 2008, 106).
Finally, so-called deceptive studies can begin while the participant
is waiting in the corridor for what she believes is an altogether
different experiment, precisely because full disclosure would foil the
investigation. Their deceitful nature notwithstanding, such studies
are ubiquitous in psychology and some bioethicists find forms of them
acceptable (but see condemnation in Bok 1995).


### 4.2 Comprehension problems



What is the point of the disclosure process? The Nuremberg Code can be
understood to answer that one point is that a research participant
should "have sufficient knowledge and comprehension of the
elements of the subject matter involved as to enable him to make an
understanding and enlightened decision." Clearly, mere
disclosure does not ensure that. Even when information is given in
plain terms in the participant's language, many participants
fail to appreciate statistical information about risks, or the fact
that in placebo controlled trials, they might not receive the
treatment under investigation, or the fact that trials aim to further
scientific knowledge and not necessarily their own medical good. The
result is that participants tend to overestimate the benefits of trial
participation and downplay its risks, part of a phenomenon called the
"therapeutic misconception" (Candilis and Lidz 2010;
Miller 2010, 382ff.; Beauchamp and Childress 2008, 129).



Many contemporary writers therefore emphasize that truly informed
consent requires much more than mere disclosure, and that the point of
disclosure, rather, is the comprehension potentially gained through
effective communication (Beauchamp and Childress 2008, 127ff; Manson
and O'Neill 2007, e.g., 184-5). Psychologists and health
literacy experts seek effective ways to improve comprehension among
patients and candidate study participants (Candilis and Lidz 2010).
And when a patient or a candidate participant is known to understand
the relevant information anyhow because she is a physician
specializing in the field, intuitively disclosure is unnecessary,
evidence that its point is comprehension and hence, perhaps,
autonomous decision-making (Beauchamp 2010, 57).



"However, a challenge arises in cases where disclosing all of the
very serious risks to candidates, results in forms that are so long as
to inhibit comprehension. When this happens, a preference for adequate
comprehension over adequate disclosure may suggest that we should
neglect to mention at least some major risks. If that seems misplaced,
there might be some point to adequate disclosure beyond its potential
contribution to the patient's or the study candidate's
adequate comprehension, such as greater transparency and
accountability.



When comprehension remains poor despite repeated efforts to elicit
comprehension, what should investigators do? Is enlistment in a trial
illegitimate, because no autonomous authorization took place (Faden
and Beauchamp 1986; Candilis and Lidz 2010)? Some philosophers respond
that it remains legitimate, because by giving candidates the
*opportunity* to issue autonomous authorization, investigators
do their parts (Sreenivasan 2003), avoid any potential fraud (Millum
and Bromwich 2013), and treat the candidates fairly (Miller and
Wertheimer 2010), conditions that they find sufficient for valid
consent. Indeed, even the permissibility of skipping disclosure when
the patient is a medical expert might be taken to indicate that part
of the point of informed consent is to prevent fraud, which is
impossible when the patient is easily capable of detecting fraud, and
not necessarily autonomous authorization.


### 4.3 Content



What information should be disclosed or comprehended? It is common to
emphasize that patients cannot possibly be "fully
informed" if that would include all facts, or all facts that are
material to physicians' decisions. For example, research
participants, who need to know the main risks of participation, do not
need to know much about the history of the disease. But how are we to
determine which facts patients and trial participants should be
informed about? Three legal standards exist: the professional
standard, the reasonable person standard, and the individual standard.




The *professional standard* mandates informing patients and
participants of those details that it is conventional for
professionals in the field to mention. Once predominant, this standard
has lost much of its traction with U.S. courts. Indeed, no
professional convention exists on this issue, and courts have opined
that patients should decide which information is pertinent to them.
The *reasonable person standard* mandates disclosing whatever
details a reasonable patient would find pertinent. Finally, the
*individual standard* mandates informing the patient or
participant of those details that she, as a determinate individual, in
keeping with her potentially unreasonable conception of the good,
would find pertinent if she were otherwise reasonable (Beauchamp and
Childress 2008, 122f.; Levine 1988, 104-5; Berg et al. 2001,
46-52). An argument against *requiring* the disclosure of
*any* risk is that neither advance disclosure nor risk
comprehension are necessary for the restoration of trust and for
deterring abuse of patients and trial participants; what is necessary
is only ready patient and trial participant access to the relevant
information in the event that abuse is suspected (Manson and
O'Neill 2007, 179ff.).



As with many other "standards" in medical ethics, the
question arises as to whether they are mere recommended procedures for
doctors, judges, and professional educators, or exhibit fundamental
moral principles.


### 4.4 Cogency



Whether being informed is cashed out in terms of disclosure or of
comprehension, and whichever standard is used, asking that patients or
study participants be even adequately informed is sometimes asking too
much. U.S. federal regulations waive the information requirement in
research for some studies that involve no more than a minimal risk. In
clinical care, many patients would rather not think about risks and
prognoses that would turn their stomachs and that they can do little
about. In some such contexts it seems cogent not to demand informing
in any form (see sections 6, 7 below). However, outright lies surely
remain forbidden even in such circumstances. A possible conclusion is
that informed consent encompasses several layers of requirement that
differ in their stringency.


## 5. Voluntary consent



When is consent sufficiently voluntary? Let us discuss three potential
barriers to voluntariness: (1) literal coercion, (2) "undue
inducement", and (3) "no choice" situations.


### 5.1 Coercion



Voluntary consent is usually thought incompatible with
 coercion,
 which philosophers define, roughly, as a threat to make someone
seriously worse off than she is or should be, unless she consents
(Wertheimer 1987). Nonetheless, the prevailing medical ethos tends to
treat more cases as cases of coercion than this philosophical
definition would suggest. A threat to cause even slight pain unless a
patient acquiesces would be taken to invalidate her consent. It would
do so even if the patient and the physician have common knowledge that
it would not make her seriously worse off and so, that it would not
amount to coercion. A threat to deny preventative intervention that is
not otherwise owed--which therefore rarely amounts to a threat to
make the patient worse off than she is or should be--unless the
patient consents to an intervention would also be frowned upon.



How much do "implicit threats" count as threats? Imagine a
practitioner who asks her own patient to participate in a study that
the practitioner runs, and the patient fears that care would suffer if
he declines, without the practitioner actually saying so. When the
patient's fear is well-founded, or even intentionally instilled
by the practitioner, the norm has been to consider consent invalid.
This clearly makes sense if what makes coercion problematic is
(unjust) curtailment of options. However, even when the fear is
unfounded and unintended, the hierarchy and the power inequality of
the physician-patient relationship are often still thought to make
such consent involuntary. The thought is that someone's options
count in this context as curtailed even when what curtails them is
uncertainty and the patient's own pessimism.


### 5.2 Undue inducement



Another category often said to undermine voluntariness is undue
inducement, a term of art meaning that something is being offered that
is alluring to the point that it clouds rational judgment, for
instance cash in hand or airline tickets in return for kidney donation
or risky study participation. Attention is fixated on the benefit,
disallowing proper consideration of risks. The thought here is not
that the offer is too good to decline rationally, but that, as in
deceit and hypnosis, proper reasoning and decision-making about it
becomes impossible, at least for some patient populations (Wilkinson
2003, 117-118). A common worry among bioethics practitioners,
undue inducement is less concerning to philosophers who have tried to
make sense of the notion (e.g. Wertheimer 2010).


### 5.3 "No choice" situations



In some areas of practical ethics, the lack of decent alternatives to
accepting a bad offer, a so-called "No choice" situation
(Wertheimer 1987, e.g., p. 13), is said to make us forced or compelled
to choose the offer (Cohen 1979), or to undermine voluntariness
otherwise. While in such cases, indecent alternatives remain in
principle open to us--the offer is not physically imposed on
us--the same could be said of most literal coercion. In
"your money or your life" situations, the option of dying
remains open in principle. Consider then a poor person who knows that
his only way to gain access to an expensive life-saving drug is to
participate in a risky or very unpleasant study where the drug is
provided free of charge. He is not, strictly speaking, coerced
(Hawkins 2008, 24-5), but some believe that his consent is
involuntary and the trial is unethical. None of the options available
to him are decent.



There is a problem with this claim. Its logic suggests that whenever a
sick, rich person has no decent alternative to taking a badly
unpleasant life-saving drug, there is no voluntary consent, and drug
delivery is illegitimate. Even when the nasty side effects remain far
better for her than her only alternative--to die of the
disease--she is not providing voluntary consent to take the drug,
and it is unethical to give it to her. Since the latter reasoning is
surely flawed, the former reasoning may be flawed as well.



Some have responded that the poor man's inability to give
voluntary consent to trial participation stems from injustice, not
natural disease, and that this makes a big difference. But surely
medical aid that saves consenting victims from the horrible results of
*injustice* and carries unpleasant side effects can remain
fully permissible. For example, following the 2010 earthquake in
Haiti, it was fully permissible for the U.S. military and its
physicians to perform consensual life-saving leg amputations. It was
permissible whether earthquake injuries were purely natural, partly
the result of non-U.S. injustice (local contractors' independent
neglect of safety rules), or partly the result of U.S.-perpetrated
injustice (long-standing U.S. meddling in Haitian politics at the
expense of accountability, including accountability for neglectful
construction projects).



Another way out is to say that consent is insufficiently voluntary
when the patient's options are unfairly curtailed by the offer
itself (Miller and Wertheimer 2010, 92, 97). "Your money or your
life" offers diminish our options, and that is why these offers
compromise our voluntariness. By contrast, the above-mentioned offers
to the poor trial candidate and to the rich patient do not curtail
options and they maintain voluntariness. However, imagine impoverished
potential study participants who lack alternative ways to obtain
life-saving drugs. Imagine further that the investigators offer them
these drugs whether or not they consent to participate, free of
charge. The intuition is that this free, unconditional offer increases
the voluntariness of these potential participants' decisions on
whether to participate, and it makes their invitation to participate
in the trial easier to defend ethically. The free offer keeps their
options open and thereby, commonsense suggests, renders their consent
more genuinely voluntary. Note, however, that the options that the
offer opens for them are *not* ones that the invitation to
participate would otherwise have curtailed.


## 6. Own-waivers of informed consent



When, if ever, is a person authorized to waive her informed consent
rights? Should participants who donate blood in a medical trial be
permitted to authorize its use in any future trial, without their
specific consent for each token (as U.S. federal regulations allow
them, since 2018, to do)? What about a patient or a candidate study
participant who asks to be spared tedious descriptions of her
different options, and would rather entrust the medical team, or her
village elder, with key decisions? What about someone who asks her
physician to lie to her, if he is willing, should her prognosis be
despairing? And what about a woman who would like to sell pregnancy
services with a fully enforceable contract to hand over the baby even
if she develops strong maternal feelings toward him or her and seeks
to revoke her consent?



In democratic politics, we delegate many decisions to representatives.
But we keep ourselves barred from signing away others, including the
decision to waive our voting rights altogether. The question as to
which decisions our institutions should allow patients to delegate to
third parties is complex and under-explored. Bioethicists usually
frown upon letting patients grant so-called *carte blanche*, or
general consent, to whatever the physician considers appropriate for
them (Dworkin 1988, e.g., 125-6). Instead, patients are usually
encouraged or compelled to make decisions on a more ongoing
basis--to give so-called specific consent (Kleinig 2010,
18)--although there are logical limits to how specific consent
can be (Manson and O'Neill 2007, 12).



The requirement of informed consent is often attacked on the ground
that many patients would rather have physicians make certain decisions
for them, and that such delegation often seems acceptable (Schneider
1998). One answer to the attack argues that informed consent is a
patient's right, not her duty (Beauchamp and Childress 2008,
105, 107), and that, since informed consent serves autonomy, it ought
to be autonomously waiveable (Beauchamp and Childress 2008, 106).
Indeed, autonomously signed advance directives that bind one's
future self can be perfectly consensual and autonomous. What we may
call "waiveable waivers" of informed consent rights
("Please spare me the full disclosure or decide in my name
unless I ask to resume full disclosure or active control") seem
relatively easy to accept and fairly consistent with autonomy.
However, we do impose some rights, which we consider inalienable, on
unwilling rights holders. The right not to become a slave is
inalienable, and the same may apply to some informed consent rights,
such as the right not to become a participant of a clinical trial that
one cannot exit.



An alternative answer to the attack is therefore that some informed
consent rights are waiveable (perhaps including many disclosure
rights), and others are non-waiveable (perhaps including the right to
revoke prior consent to bodily intrusion). Theory is needed in order
to tell which informed consent rights are waiveable and which are not.
(Is the alleged second-order right to *waive* informed consent
rights alienable?) Theory should also explore whether non-waiveable
consent requirements are consistent with patient autonomy, say,
because what such requirements impose is autonomous decision-making
(potentially out of *paternalistic* concern with protecting the
patient's autonomy).


## 7. Exceptions to informed consent



Even absent own-waivers, and despite absolutist statements of the
informed consent requirement, such as the Nuremberg Code, many
contemporary theorists agree that there are cases where informed
consent procedures are not necessary. The law, and many bioethicists,
recognize exceptions to informed consent requirements, such as lack of
decision-making capacity, or emergency circumstances where the
patient's wishes are unknown (Tannsjo 1999; Emanuel,
Wendler, and Grady 2000). That said, these exceptions serve the spirit
of informed consent; they can be plausibly woven into full statements
of the requirement (as proposed, for instance, in Dworkin 1988, 117),
and they question only its crudest, most absolutist statements. Other
exceptions seem harder to reconcile with full-blown commitment to
informed consent and its central justifications. Let us discuss,
specifically, the extent to which informed consent is needed in (1)
benign care and benign experiments, (2) certain risky experiments, and
(3) public health policy. We shall then present the general question,
(4) When is informed consent needed?


### 7.1 Benign interventions



The reality is that informed consent procedures are not legally
mandated for the lion's share of medical care, e.g. standard
blood draws, in contrast to more invasive interventions like surgery.
Indeed, form filling, mandatory disclosures, and so forth are
intuitively unnecessary for the former (Manson and O'Neill 2007,
81f). In medical research, United States federal regulations authorize
review boards to omit informed consent requirements on many occasions
when "research involves no more than minimal risk to the
participants", a provision expanded in 2018. Again, this seems
to make sense in many cases. A relatively safe and low-impact study
comparing two widely used drugs to ascertain which is best seems
morally permissible, even without a full-fledged informed consent
process (Truog et al. 1999).



Some authors have used such examples to downplay the need for informed
consent, criticizing what they call bioethicists'
"fixation" with informed consent (O'Neill 2002,
47-8; Brownsword 2004, 224). In response, some proponents of
informed consent insist that, in many of the alleged counter-examples,
something in the way of informed consent remains vital. In blood
draws, in particular, when the patient is shown the needle and
silently stretches her arm forward, she is said to give tacit or
non-verbal consent (Beauchamp and Childress 2008, 107; and see also
Manson and O'Neill 2007, 11). This particular response may be
insufficient. For example, when a busy nurse with many patients in
line realizes that a patient is very ignorant about a blood draw, such
that her tacit consent is uninformed, intuitively the nurse does
*not* owe the patient a long explanation of the risks from a
sanitized needle prick, which are remote and minor. 



To some, this may suggest that fully-fledged informed consent
requirements simply do not apply to highly benign interventions.
Surely the need to protect health and welfare, at least, through
informed consent procedures is lesser when that risk is negligible in
the first place. Interestingly, similar logic suggests that when an
intervention is not benign yet informed consent cannot improve upon
other protections, informed consent may be unnecessary. A possible
case in point is observational studies of anonymized electronic health
records, where the main risk comes from breach of data security and
confidentiality--a serious yet technical matter that few
individual patients could assess reliably--and thus informed
consent (on top of expert input and democratic decision making) might
be an ineffective, unhelpful protection.



Still, some elements of the requirement of informed consent must
remain in place, even in standard blood draws and other benign
interventions (Dickert et al. forthcoming). Physical duress against a
refusing patient and the intentional exploitation of a patient's
ignorance about blood draws both usually remain wrong. This may
suggest that informed consent bundles together several requirements
with different levels of stringency. Some are necessary in more
contexts than others. It may also be thought to substantiate other
theories on the ground for informed consent. For example, above we
mentioned the view that informed consent is necessary as a
preventative bulwark against coercive or fraudulent practices. But on
that view, any exception for benign interventions might be impossible,
since these interventions would be just as coercive or fraudulent as
invasive ones. Thus, if sometimes it is correct for benign studies not
to require informed consent, this calls this view into question. 


### 7.2 Some risky experiments



Advancing the field of emergency medicine requires medical
experimentation, including trials that compare different interventions
and that only sometimes serve the best interests of trial
participants. But, in emergency circumstances, it is often impossible
to obtain consent from the patient or her family in time. Many
physicians believe that, because the field of emergency medicine
simply cannot progress absent experimentation, there should be an
exception to informed consent requirements even for such risky trials,
and substitutes for informed consent should be sought (Fost 1998;
Dickert et al. forthcoming). Some elements of informed consent, such
as retrospective debriefing, remain relevant though (Dickert et al.
forthcoming), again suggesting a "bundled"
requirement.


### 7.3 Some public health policies



It is interesting that for public health interventions, whose impact
on human health can exceed that of clinical interventions, usually
little, if any, informed consent is mandated. Exposure to ads and
"nudges" that promote populations' health seems
legitimate to most of us even when the authority executing the
interventions discloses very little about these interventions, their
risks, their alternatives, and any real opportunities to avert them.
Changes to traffic regulations that affect accident rates on a grand
scale are not thought to demand the consent of each individual
citizen. Nor are such changes considered necessary when they are
experimental (despite Richter et al. 2001)--health policy trials may
require a very different approach to consent than clinical trials.




Differently put, even in the absence of public health emergencies
(which can warrant transgressions like forcing individuals to enter
quarantine), the widely accepted standard in public health seems more
intrusive than the one in clinical care. As further illustration, many
would agree that it is legitimate to implement smoke-free bar laws
that somewhat increase anti-smoking stigma, partly in order to goad
smokers to quit (and not only as measures to protect third parties
from second-hand smoke). But most would condemn a clinician who
deliberately boosts stigma to goad an individual patient to quit
smoking (e.g. mocking the stink), and might explain that such pressure
undermines the patient's freedom to decide whether to quit. Is
one of these arguably different approaches to informed consent right
and the other one, wrong? Or is informed consent morally required for
some interventions and not for others?


### 7.4 Informed consent--when?



An emerging picture is that the need for informed consent depends on
many variables. Just like being informed, the voluntariness of choices
comes in degrees (Beauchamp and Childress 2008, 101). Threats, for
example, control us to different degrees, depending on the degree of
harm being threatened (Beauchamp 2010, 70-1). The level of
voluntariness necessary for valid consent to medical intervention may
vary according to the type of intervention offered. So does the level
of decision-making capacity necessary for valid consent (Buchanan and
Brock 1989, ch. 1; Beauchamp 2010, 71). Robust informed consent that
requires a great deal of information, voluntariness, and decisional
capacity and is formalized and relatively non-waiveable, is necessary
sometimes, but not always. Roughly speaking, robust informed consent
(Joffe and Truog 2010, 358; Miller 2010, 391; Beauchamp and Childress
2008, 101; Beauchamp 2010, 70-1) tends to be necessary the more
risky the intervention, the more it is a high-impact (e.g. a
definitive "critical life choice": Archard 2008), the more
it is value-laden and controversial, the more private the area of the
body that the intervention directly affects, and the more conflicted
and unsupervised the practitioner. On other occasions, the need for
very robust informed consent, and indeed, for consent of any form, is
lesser (Miller 2010, 393). On those occasions, high financial or other
costs of robust consent procedures easily override that need.



Does the need for informed consent depend, among other variables, on
whether the consent is for research or for care? Currently, consent
procedures for research tend to be more demanding and more regulated
than consent procedures for equally intrusive treatment (Levine 1988,
127-30; Miller 2010, 381). Why? A standard account is that the
proper goal of research is to gather generalizable knowledge, and not
to help the individual, and that this different goal enhances the need
for protections like informed consent (Fried 1974). However, actual
goals often differ from proper goals. In reality, many researchers are
highly committed to promoting participants' health, and many
clinicians seek primarily financial gain, sometimes at patients'
expense. In addition, studies are reviewed independently for their
safety, making some so safe that (with or without consent) they impose
less risk than similar clinical care. Another rationale for the fewer
consent requirements in care is that the relationship between the
clinician and the patient is typically a fiduciary one whereas the
relationship between the investigator and the study participant is
scarcely fiduciary (Joffe and Truog 2010, 364). But this rationale
could easily work the other way around: assuming that the fiduciary
relationship is a ground for informed consent (Joffe and Truog 2010,
352ff.), the more fiduciary clinical relationship should demand more,
not less, by way of informed consent.



Let us return to the general picture of scalar need for informed
consent, which depends on many variables and generates different
requirements on different occasions. It also raises interesting
practical questions. First, who should decide when fully informed
consent is necessary (Joffe and Truog 2010, 361)? Might a crude,
one-size-fits-all requirement of informed consent serve most practical
purposes (Wertheimer 2014)? Perhaps a fair compromise is to use an
"intervention ladder" that defines broad categories of
intervention as more or less intrusive, then specifies broad
categories of circumstance that require especially robust consent in
some cases and only minimal consent in others (Nuffield Council on
Bioethics 2007, 41-3)? What seems, in any event, to emerge is
that the need for informed consent would be misrepresented as
fundamentally a single constraint or threshold. In this area, at
least, commonsense morality acknowledges that prescriptions'
strengths and characters vary, with multiple determinants.


## 8. The status of informed consent



When informed consent is required, what kind of requirement does it
represent? In particular, does it correlate to a natural right, to a
legal right, or to something else?



Bioethicists and human rights lawyers tend to assume that informed
consent is a natural right that generates a correlative objective
moral duty and, downstream, legal and institutional duties. Many
contemporary philosophers assume that consent has moral
"magic" that turns what would have been a wrongful action
into a right one, in an objective, moral sense (Hurd 1996). But some
of the aforementioned justifications for informed consent better
support other assumptions.



For example, the forward-looking trust rationale mentioned earlier can
be understood to mean that, morally, we should enshrine and then honor
legal (and cultural) informed consent requirements as a bulwark for
trust in medical practitioners. On that view, violating informed
consent requirements toward a patient does not necessarily violate
that patient's natural moral rights, only what *are* and
morally *should* remain everyone's legally protected
interests. 



In a further model, the uniform requirement of informed consent across
circumstances reflects our sheer epistemological problem telling in
advance the typical circumstances when it objectively applies from
relative exceptions on which it does not (Wertheimer 2014, about the
requirement in intervention research; see also Alexander 2014). In a
still further model, the informed consent requirement only appears to
apply homogeneously across circumstances in the eyes of agents who
have cultivated, as morally they should, a fruitful yet false belief
in the requirement's objectively homogeneous application (Eyal
2015). In a final model, the justified legal standing of informed
consent bolsters its moral standing (Miller and Wertheimer 2010,
82-3). 



One reason to take non-naturalistic approaches to the status of
informed consent seriously is that not all natural rights are legally
enforceable. Therefore, a moral informed consent right that is legally
enforceable (as that right is usually taken to be in at least some
institutional settings) may stand in need of additional moral
justification, even if a natural right has been established. That
additional, inescapable moral justification may then turn out to
justify informed consent regulations even absent natural informed
consent rights, say as trust-building measures. In particular, recall
that many bioethicists ground informed consent in duties to treat
rational, autonomous persons respectfully. Some such duties are
clearly non-enforceable. For example, the moral duty not to lie to
persons in breach of their autonomous decision-making is seldom
legitimately enforceable. It is not the business of third parties to
prevent me from disrespectfully and immorally lying to my friends.
Thus, additional justification would be needed, beyond simple appeal
to respect for autonomy, in order to establish an enforceable informed
consent requirement. That inescapable additional moral justification
may turn out, if successful, to justify informed consent regulations
and the surrounding ethos in full. It may do so even if the project of
grounding informed consent in autonomy, and all other attempts to
justify natural informed consent rights, founder.


## 9. Consent in other domains



For decades, bioethicists have discussed medical informed consent in
relative isolation from consent in political philosophy, contract
theory, and sexual ethics, where notions of consent are also pivotal.
This is finally changing, and it raises new technical and
philosophical questions about how to put these different discourses in
dialogue with each other. For instance, is what bioethicists call
"presumed consent" the same thing as what political
philosophers call "hypothetical consent"? Is what
bioethicists call "proxy consent" one with what lawyers
call "impersonal consent"? What bioethicists dub
"invalid consent" would often be described by contract law
experts as "lack of consent" (Beauchamp 2010, 56; Kleinig
2010, 13, 15).



This new development also raises substantive normative questions. For
example, imagine that the same basic principle underlies legitimate
political regimes and legitimate medical experimentation. It may
follow that either tacit consent to a political regime, which
 Lockean contract theorists
 often cite, cannot successfully legitimize political regimes; or that
tacit consent successfully legitimizes medical experimentation,
rendering long consent forms unnecessary. Likewise, imagine that the
same basic principle underlies the legitimate procurement of income
and that of organs for transplantation. Then perhaps either income
tax--without tax-payers' consent--is illegitimate
(Nozick 1986), or a "kidney tax" could be perfectly
legitimate (Fabre 2008, chs. 4-5). Either way, existing practice
in one of these domains would be misguided.



On a different approach, fundamentally different right-making
principles and rationales regarding consent apply in domains like
medicine, sex, and the marketplace, as might be indicated by the
variety of approaches to consent between these domains. For example,
in most commercial transactions, unlike in the medical sphere, there
are no legal requirements to disclose all relevant information and to
verify that it is understood (Miller and Wertheimer 2010, 80; Joffe
and Truog 2010, 351), perhaps indicating that fairness matters there
more than autonomous decision-making. Likewise, whereas once we
consent to sell a car or to support a political candidate (by signing
a contract or casting a vote) our consent is not retractable, invasive
medical intervention is usually considered illegitimate once a
previously consenting patient or research participant expresses a
change of mind--as though the point of consent in the medical
arena were not simply autonomous authorization but ongoing control
(compare Pateman 1990, 79 on the wrongness of forcing sexual
interaction even within otherwise consensual marital relations).
Finally, if A mishears B's consent to sex as refusal yet
proceeds with sexual advances, a third party who understands the full
picture has strong reasons to stop A's advances (*pace*
Alexander 2014, 105). But if a physician mishears a patient's
consent to medically beneficial treatment as refusal yet proceeds to
it, it is far less clear that a third party who understands the full
picture should thwart the treatment. The point of medical care is,
after all, not defeated by discordance of attitudes in quite the same
way that the point of sex is. One possible conclusion from this
variety is that the very point of requiring informed consent, and
hence what is fundamentally required and when, vary between
domains.


## 10. Conclusion: the core of informed consent



The turn of the 21st century has seen doubts surfacing about informed
consent, but that just makes the resilience of other parts of the
requirement all the more striking. Even purported critics usually
revise only the requirement's prevalent justifications and
interpretations in borderline areas, and leave a certain
"core" intact. Given how much philosophers usually
disagree, it is remarkable that, when a medical intervention is risky,
value-laden, high-impact, physically invasive, and/or medically
controversial, especially when a patient of sound mind explicitly
refuses the intervention, most of us would feel that only the most
dire costs would justify imposition of care. The grudging nature of
relative skeptics' acceptance of this core part of the
requirement only attests to its philosophical resilience.



In seeking justification for the requirement of informed consent, we
may therefore not have one task, but many. We need to justify this
powerful, relatively non-controversial core, as well as a weaker and
more questionable rim. It is possible that the core stems directly
from natural right, whereas the rim is merely instrumental or
conventional. It is also possible that they both rely on the same
ground, say, the value of autonomy, but touch on it in different
measures. Even if the core of the requirement of informed consent
commands high priority, other parts may turn out to be easily
overridable by competing values, including the value of advancing
scientific research.