Informed consent is currently treated as the core of bioethics. Inclinical practice, the doctrine of informed consent rose to dominanceduring the course of the 20th century. It replaced a medical ethosfounded on trust in physicians’ decisions, often on theassumption that “doctor knows best”, with an ethos thatsought to put patients in charge of their own care. In medicalresearch, the influential Nuremberg Code responded to the cruelty ofNazi experiments stipulating: “The voluntary consent of thehuman subject is absolutely essential”. But why should werequire informed consent, e.g. when it comes at a cost to theindividual’s health? What is the content, the scope, and thestatus of that requirement? How does informed consent in bioethics,the focus of the present entry, relate to consent in sexual ethics,business ethics, and political philosophy?

• 1. The requirement of informed consent
• 2. Why informed consent?
  • 2.1 Protection
  • 2.2 Autonomy
  • 2.3 Preventing abusive conduct
  • 2.4 Trust
  • 2.5 Self-ownership
  • 2.6 Non-domination
  • 2.7 Personal integrity
• 3. The idea of consent
• 4. Informed consent
  • 4.1 Lies, deceit, and partial disclosure
  • 4.2 Comprehension problems
  • 4.3 Content
  • 4.4 Proportionate stringency
• 5. Voluntary consent
  • 5.1 Coercion
  • 5.2 Undue inducement
  • 5.3 “No choice” situations
• 6. Own-waivers of informed consent
• 7. Exceptions to informed consent
  • 7.1 Benign interventions
  • 7.2 Some risky experiments
  • 7.3 Some public health policies
  • 7.4 Informed consent—when?
• 8. The status of informed consent
• 9. Consent in other domains
• 10. Conclusion: the core of informed consent
• Bibliography
• Academic Tools
• Other Internet Resources
• Related Entries

1. The requirement of informed consent

In English, “consent” has several meanings. In therelevant sense, consent transactions have a distinct structure: agentA consents toB’sφ­-ing onA, under a certain description ofφ­-ing,whether or not the offer was initiated byB. For example, aman may consent to a physician’s touching the man’stesticles as part of a testicular cancer exam upon thephysician’s suggestion (compare Kleinig 2010, 6–7).

Informed consent is shorthand for informed, voluntary, anddecisionally-capacitated consent. Consent is typically considered sufficiently informed when acapacitated (or “competent”) patient or researchparticipant to whom full disclosures have been made and whounderstands fully all that has been disclosed consents voluntarily totreatment or participation on this basis.

In its most important role in bioethics, informed consent is alegitimacy requirement for certain actions. Inadequately informedconsent makes certain intrusions impermissible. Roughly, when asufficiently capacitated adult does not give sufficiently informed andvoluntary consent to intervention in her body or her private sphere,then, at least when the intervention is substantial, not trivial, andabsent severe jeopardy for third parties, the intervention isimpermissible—even when it seeks to assist her, physiciansrecommend it, third parties would benefit from it, and the patientherself had repeatedly consented to it before expressing a change ofmind. When the antecedent is inapplicable—for instance, when thepatient lacks decision-making capacity—similarly spirited rulesapply, such as rules delegating consent authority to thepatient’sadvance directive or proxy.

While consent and informed consent are relevant to medical torts, todistributive and proprietary medical claims, and to ideal (as opposedto merely legitimate) doctor-patient relationships, this entry focuseson informed consent in its central role as a legitimacy requirementfor medical intervention. Contemporary medical culture and centralhuman rights documents support something like this requirement. In theU.S., where regulatory commitment to informed consent is especiallystrong, federal funding for research usually requires review ofinformed consent procedures, and the constitutional right to privacybinds government to honor patients’ refusal of care. Lack ofinformed consent can be used to establish negligence (and hencemalpractice and torts), or battery and assault.

Since the 1970s, extensive bioethics writing focuses on how to defineand achieve “valid” consent—sufficientlycapacitated, informed, and voluntary consent—and the conditions,especially in medical research, have become increasingly demanding inlater decades. The contrast between these post-informed consentexpectations and an earlier medical ethos is vivid in an excerpt ofthe Hippocratic Oath (fifth century B.C.E.): “Conceal mostthings from the patient… Give necessary orders withcheerfulness and serenity… revealing nothing of thepatient’s future or present condition.” Present-dayphysicians like to think that they treat their patients differently,but recent literature and regulatory reforms may be paddling back abit on the stringency, demandingness, and universality of informedconsent requirements, especially in research.

Section 2 discusses the potential justifications for the requirementof informed consent. Sections 3–5 delineate its content withgreater detail. Sections 6–7 note potential waivers andexceptions to the requirement. Sections 8–9 review its statusand 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 medicalarena: “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”(PlatoRepublic, VI 489B–C, 180). Nowadays it is commonto reject both Plato’s anti-democratic politics and his medicalethics. A central defense of political democracy against Plato’sattack rests on theCondorcet jury theorem, which underwrites the “wisdom of the masses.” But whyreject Plato’s medical ethics? In the medical arena there are nomasses, and yet the informed consent requirement gives a singlenon-expert—the patient or the research participant—vetopower over some interventions, even against the will of many expertphysicians. Whynot take Plato’s, orHippocrates’s, approach in the medical arena? Why requireinformed consent, disallowing even a mass of medical experts to makethe final decision on matters that fall within their fields ofexpertise—medical treatment and medical investigation? The mainarguments 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 itprotects study participants’ and patients’ health andwelfare. It protects participants from investigators’overzealous attempts to promote science and personal careers even onparticipants’ backs, and it also protects regular patients fromneglectful clinicians or from overconfident, but often wrong,paternalistic ones. While many moral doctrines oppose harming study participants orpatients, bioethicists’ expositions of this instrumentalrationale typically echo utilitarian philosopherJohn Stuart Mill, for whom “Over himself, over his own body and mind, theindividual is sovereign” (Mill 1990, 135; see also ch. 3). Theyexplain that patients and research participants are typically the bestjudges 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 bestinterests (compare Mill 1990, e.g. 215). They add that doctors’training scarcely prepares them to know patients’ distinctivenon-medical interests.

However, insofar as the goal is to protect patients and trialparticipants from harm, why honor informed consent requirements whenmany physicians and patients—a Condorcet“jury”—are fairly certain that a particular patientor participant is not making a decision that furthers her own medicalinterests? In clinical care, for example, patients’ biases andignorance about medicine arguably tend to exceed those of physicians;sometimes, patients refuse interventions thateveryoneconsiders best for them—even family, friends, and these patientsthemselves, before a change of heart. A family-oriented, supposedlyConfucian, alternative to Western individualized informed consentculture (Fan (ed.) 2015) vests decision power on patients’ carewith their families, which know them well and have the Condorcetadvantage of comprising several people not one. In the future,patients may refuse interventions that highly-reliable algorithms orlarge language models predict patients like them will be glad to haveundergone (compare Rid and Wendler 2010; Valdman 2010; Borg,Sinnott-Armstrong, and Conitzer 2024). Indeed, some patients knowinglyjeopardize their own health in the name of religious or moralcommitments. This being the case, why is it important—as itseems to many of us and as is enshrined in law—to honor therequirement of informed consent? For example, why honor therequirement when a fully capacitated Jehovah’s Witness refuses ablood transfusion on religious grounds, risking injury? Why honor itwhen health is not at stake, for example, in experiments on storedtissue? Finally, specifically from a utilitarian standpoint, why honorthe requirement on occasions when it seems to set back collectivehealth, for example, when we cannot develop a new drug that would helpmany, because no one is altruistic enough to consent to participate inits risky study?

2.2 Autonomy

The 1970s saw the ascent of a second rationale,autonomy, as the predominant justification of informed consent, throughinfluential work by Ruth Faden, Tom Beauchamp, James Childress, and aU.S. President’s Commission (Faden and Beauchamp 1986, 8;National Commission for the Protection of Human Subjects of Biomedicaland Behavioral Research 1979, section b (1), 282–3; Beauchampand Childress 2008, ch. 4; Beauchamp 2010; see also President’sCommission for the Study of Ethical Problems in Medicine andBiomedical and Behavioral Research 1982, 27; Feinberg 1986; Dworkin1988, 111, 113; Buchanan and Brock 1989, 36ff.; Brock 1994,31–2).

Philosophers of action usually understand autonomy as governance overone’s own agency—acting according to a law that one setsfor oneself. Likewise, for bioethicists Beauchamp and Childress,“The autonomous individual acts freely in accordance with aself-chosen plan, analogous to the way an independent governmentmanages its territories and establishes its policies” (Beauchampand Childress 2008, 99–100). As the authors emphasize (Beauchampand Childress 2008, 100–1), autonomy so understood differs fromautonomy as having the will that one wants to have (Frankfurt 1988).It also differs from many other uses of “autonomy” inbioethics and biolaw (Dworkin 1988, 101ff.)—so many as to promptsome to question the force of autonomy-based justifications(O’Neill 2003). However, initially, autonomy seems like apromising ground for informed consent requirements. The rationale fornot transfusing a protesting, decisionally-capacitated Jehovah’sWitness even when forced transfusion would save the witness’slife or limb is clearly not protection of her health. Instead, it mayseem to do with maintaining her self-rule on such momentous issues: amatter of respect for an autonomous decision maker’s refusal.And sufficiently informed consent usually assumes freedom fromcontrolling interference and from an inadequate understanding of thebasic risks of the intervention, additional components of fullyautonomous choice as well (Beauchamp and Childress 2008,100–1).

While occasionally, the need for autonomous authorization of medicalintervention is considered “axiomatic” (Beauchamp 2010,58), it is commonplace to defend autonomy on independent grounds. Acomplete autonomy-based justification for the informed consentrequirement would explain both why personal autonomy, under aplausible explication, matters—why it has high value or status,at least in the health arena; and how honoring the informed consentrequirement 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 ourvalues is often key to our continued satisfaction and cooperation withassigned medical teams. Others add that autonomy is inherently goodfor us. First, self-rule is central to a good life, perhaps because itmakes us less self-alienated and more worthy of praise for ourvirtuous decisions. Second, autonomous choices promote our ultimategoals. They allegedly do so because medicine affects non-technical andcontroversial matters of value and faith on which physicians lackexpertise (say, a Jehovah’s Witness’s faith), and thesegoals (as well as their independent pursuit: Pugh 2020, ch. 9) definehow well our lives go (President’s Commission for the Study ofEthical Problems in Medicine and Biomedical and Behavioral Research1982; Dworkin 1988, 113).

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

Fully autonomous decision-making is sometimes bad for us in at leastcertain respects, say, when it involves tortuous deliberations, makesus more accountable for embarrassing mistakes, or invites socialpressure to make certain choices (Dworkin 1988, ch. 5). The cost ofensuring that a single decision is absolutely autonomous may be asevere, permanent, or fatal health problem. This health problem willusually affect well-being more than a small marginal decrease in ourautonomy would—yet some informed consent requirements apply.Indeed, on no theory ofwell-being—neither desire satisfaction, hedonic state, nor objective list—does itseem to follow that either informed consent or autonomous choiceinvariably makes a patient’s life better (Buchanan and Brock1989, ch. 1 §4, esp. p. 40). And if they did, then it would bedifficult to claim, as proponents of the autonomy rationale do(Beauchamp and Childress 2008, e.g. pp. 12, 14), that informed consentand the principle of autonomy are distinct from, sometimes conflictwith, and often supersede, the principle of beneficence.

A different version of the autonomy rationale states, in the spirit ofImmanuel Kant’s ethics, that autonomy should command our awe and reverence, whetheror not it is good for us (Hill 1991, 43). The literature on informedconsent regularly cites Kant’s Formula of Humanity (Kant 1996,80 [4:429]) to establish that duties ofrespect for autonomy bind physicians (Beauchamp and Childress 2008, 63, 103;Dworkin 1988, 110; Levine 1988, 96–7; Pellegrino and Thomasma1993, 128). Alan Donagan’s defense of the requirement ofinformed consent illustrates this Kantian approach: “Recognitionof every human being as having a unique dignity as human, and astherefore being an end in every relation in which others may morallystand to him, entails that no human being may legitimately beinterfered with in pursuing his conception of his happiness inwhatever way seems best to him” (Donagan 1977, 31).

This version of the autonomy rationale is criticizable as well. Kantassociated respect for persons with treating them only in ways thatthey could possibly or rationally consent to, not with treating themin ways that they have actually consented to—rationally,voluntarily, or otherwise (Wertheimer 2014, 149). The notion ofautonomy as bioethicists understand it hardly resembles Kant’snotion of autonomy (O’Neill 2003). And while some contemporaryKantians interpret autonomy as “our authority to determine ourown actions” (Buss 2018), many gross violations of informedconsent do not directly transgress that alleged authority. A surgeonwho exploits a patient’s surgical anesthesia to force anexperimental intervention grossly violates informed consent byaffecting heavily the incognizant patient’s body and life, butless directly if at all by thwarting the patient’s determinationof what actions to perform. During the violation, the anesthetizedpatient was not performing any action. Likewise, informed consentfinds some interventions far more reprehensible than others, althoughtheir impacts on our autonomous action and pursuits are similar.Performing a testicular cancer exam without the patient’sinformed consent is a serious transgression, and transgresses coreinformed consent requirements. It is far harder to justify thanlooking carefully at a skin mole on a patient’s cheek fromacross a clinic desk, in order to detect cancer, without thepatient’s informed consent. Non-consensual facial scrutiny mightnot even violate informed consent. The main difference seems to be inwhether a sensitive area of the patient’s body is being touchedand scrutinized without the patient’s consent, which canconstitute extreme battery; and not in the patient’s exercise ofagency, say, in the number or nature of the patient’s actionsand plans that are thereby blocked. It may be true that extremebattery symbolizes extreme contempt towards the patient as a sovereignagent, but here, at least, it does not involve greater interferencewith his autonomy as characterized above (compare Mazor 2019).

Regardless of either the exact meaning of autonomy or the extent towhich autonomy is good for us, grounding informed consent in autonomyturns out to be difficult. First, autonomous decision making overall matters that heavily affect one’s health is notsomething to which any patient has a right. Organ waitlists, forinstance, can be perfectly legitimate even when some patients demandin full voluntariness the next available organ and autonomously refuseto wait in line. Just because receiving the organ would serve theirautonomous wills does not make it their right to obtain organsdesignated to others ahead of them on the list. Admittedly, theautonomy rationale may here be conjoined with a clarification as towhich matters concerning patients’ health they have a right todetermine. But for some that right would then be the reason why theirconsent is required, when it is required (McConnell 2018), potentiallymaking any further reference to autonomy redundant.

A second challenge to grounding informed consent requirements inautonomy is that violating informed consent requirements can havepositive impact on autonomy. One example is when closing off anoption, in violation of informed consent, enables more importantfreedoms. For instance, closing off patients’ options forvoluntary euthanasia was said to increase their autonomy by freeingthem, as well as similar patients, from family pressure to use thatoption (Velleman 1992); surely it may do so even when accomplishedthrough forced injection of an antidote or other violations ofinformed consent.

A third challenge is that not all acts that are generally assumed toviolate 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 moderatedisability, due to a simple misunderstanding of medical facts. Thereis no time to convince him of his mistake. Being uninformed, hisdecision cannot count as autonomous. But present medical practicessurrounding informed consent continue to forbid, possibly for goodreasons, forcing care on such a patient—for example, strappinghim to the bed to deliver an operation. In such instances, the problemwith forced care cannot be simply violation of autonomy. Some haveargued in somewhat similar cases that forced care is legitimate,because it would contravene “mere desire” not“rational desire” (Savulescu 1994), and because “thestate has the right to prevent self-regarding harmfulconduct…when… that conduct is substantiallynonvoluntary…” (Feinberg 1986, 12). A different possibleconclusion is that present informed consent practices are sound, theyjust 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 theinformation to authorize an autonomous “Yes” (compareEstlund 2007, 121–5; Gunderson 1990). A third possibleconclusion is that while what is wrong with forced care in thissetting is the violation of autonomy, what “autonomy”means here is simply a domain over which one should remain sovereignand have the final say, even if uninformed, incapacitated, and soforth (Enoch 2017, 31–32). This, however, would disallow appealto autonomy to clarify why certain actions fall inside that domainwhereas others are permitted despite the patient’s refusal.

As a final challenge to grounding informed consent in autonomy,consider a patient who has been treated fairly and offered a simpleexplanation of her treatment and the alternatives, which she couldcomprehend if she tried; her failure to comprehend it and to chooseautonomously is the fruit of her own neglect. Can the physician or theinvestigator really be blamed for the patient’s consequentnon-autonomous choice (Sreenivasan 2003; Miller and Wertheimer 2010,85, 95; Millum and Bromwich 2013)? In many areas of life in whichconsent seems necessary, what matters is not so much the“quality of choice,” say, how autonomous it is, butwhether the person had been given the opportunity to make a choice ofthat quality (Scanlon 1988). Advocates of the autonomy rationale mayrespond in one of two ways. First, they may insist that when aninvestigator did due diligence to help candidate participantsunderstand the significant risks of a study yet sees that they havenot been understood, she has a reason to explain again, or recruitother candidates, precisely because the autonomy of studyparticipation matters; alternatively, they may insist that having beengiven real opportunity to decide autonomously already counts as havingbeen given autonomy over the matter.

In recent decades, communitarian authors, includingcommunitarian-feminists, often endorse so-called “relational autonomy” in bioethics. However, that is usually taken toquestionstandard informed consent requirements.

2.3 Preventing abusive conduct

An alternate rationale defends informed consent requirements as abulwark against such deontological offenses as assault, deceit,coercion, and exploitation (Manson and O’Neill 2007, 75f.), orfraud (Millum and Bromwich 2013). From this viewpoint, informedconsent 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 fullextent of clinicians’ informed consent duties. We have alreadymentioned that physicians should make some effort to explaininformation again if they discover that their patients misunderstandcrucial risks. Intuitively, this is so even if the patient was givenan excellent explanation that worked with similar patients, ruling outreasonable suspicion of deceit, exploitation, or fraud. If theirpatients still misunderstand crucial risks, these doctors orresearchers should at least make some effort to re-explain (Keren andLev 2022). Given that abuse has already been ruled out, theabuse-prevention rationale fails to account for this duty (Beauchampand Childress 2008, 118; compare Manson and O’Neill 2007,82–3). That said, advocates of the abuse-prevention rationalecan explain that duty based on complementary rationales for informedconsent (Millum and Bromwich 2013, 218).

Another challenge for the abuse-prevention rationale is that it isdifficult to anchor in the deontological morality that is typicallyinvoked to motivate it. It is challenging foragent relative and moment relative deontological morality, which focuses on theagent’s contemporaneous action type and not on minimizingcertain actions in the world to provide strong reasons to preventfuture deontological offenses by others. For that reason, a trulydeontological abuse-prevention rationale might not recognize strongreasons to enforce informed consent requirements on others (Eyal 2022,II.2). Nevertheless, some informed consent rights are surely legallyenforceable by third parties. Such a rationale might also notrecognize strong reasons against coercive medical intervention whenthe coercion is performed by third parties only; for example, againstextracting a live kidney from a consenting patient who consents onlydue to her family’s coercion. But reasons against relying onsuch coerced consent are widely recognized.

As to consequentialist variants on the abuse-prevention rationale,they would usually need to focus on all bad consequences, not just onabusive conduct and its downstream consequences. Serious harm tosomeone’s health would typically count as a worse consequencethan 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 oftrust” (O’Neill 2002, 145; see also Bok 1999, 11,26–7, 63; Jackson 1994, 491; Kass et al 1996; Tännsjö1999, 24). Their trust rationale is future-looking. It points out theimportance of ongoing societal trust in caretakers and medicalinstitutions, for example, as a precondition of ongoing compliancewith medical advice, registration for organ donor cards, andparticipation in medical research. Since violations of informedconsent would jeopardize that trust, they are something to be avoided.This rationale has the advantage of potentially demanding informedconsent even to certain low-risk and low-impact interventions. Forexample, 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 lyingto patients (perhaps worse than non-lying deceit: Jackson 1991,7–9)), say, in order to realize beneficial placebo effects. Ifdiscovered, lying and battery could easily puncture public trust inphysicians.

The trust rationale is most plausible as a partial rationale. It facesserious objections if it is taken as a comprehensive justification ofinformed 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 neverfind out that a core violation of the requirement took place. Whilethe requirement of informed consent might not obtain across the board,it seems inappropriate to determine whether it obtains in a givencontext based on e.g. how chemically traceable is the medication whoseforced administration is being considered, although that would affecthow much this act would jeopardize future public trust in physicians.Another challenge to this version of the trust rationale is thatinvasive interventions without a person’s informed consent areusually thought to wrong that person, not to wrong only the potentialfuture victims of a decline in public trust.

A quite different version of trust rationale is backward-looking. Thisversion defends informed consent as an intrinsically important way tohonor the trust that the patient has placed in the physician, and aspart of the fiduciary role that the physician has undertaken (Joffeand Truog 2010, 352ff.), perhaps a matter of virtuous trustworthiness(Pellegrino and Thomasma 1993, 65–78). However, thebackward-looking version of the trust rationale has difficultyexplaining the need for informed consent outside pre-existingcaretaker-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 holdproprietary rights over ourselves and our bodies, perhaps in line withJohn Locke’s idea that “every Man has aProperty in his ownPerson” (Locke 1988, V. 27, 305).Naturally, once an owner’s consent is given, the allegedproprietary prohibition on access and on direct impact is removed.This rationale may better explain why we must normally grant ourpermission, even for medical intervention that is safe, low-impact,and clearly beneficial, and requires no agency on our part. Trespassinto a private sphere can be forbidden even when it involves meretouching, and the owner is foolish or selfish to reject it (Nozick1986; Thomson 1990, ch. 8; Archard 2008, 27f; Mazor 2019).

But an account based on self-ownership raises more questions than itsettles. Self-ownership may justmean that the individualshould be the final arbiter in the relevant sphere, and that seemslike a part of what informed consent requires—hardly an edifyingrationalization for requiring informed consent (compare Cohen 1995,chs. 9–10). Alternatively, self-ownership may designate a morecircumscribed list of rights (Fried 2005; Archard 2008, 29–30),but this list would also stand in need of a defense, and cannot byitself count as adequate justification. A further challenge is thatthe self-ownership rationale fails to clarify why touching sensitiveareas of the body without consent seems worse than touching lesssensitive areas without consent. Property violation is not usually amatter of degree (compare Archard 2008, 30–1). Finally, theself-ownership rationale fails to clarify why physicians must discloseand ensure our comprehension of information prior to intervention,something which proprietary rights seldom require. Indeed, the notionof self-ownership could be usedagainst coercing doctors togive patients that information—because such coercion may violatethese physicians’ self-ownership rights to interact as theywill.

2.6 Non-domination

Bioethicists rarely explore the value ofnon-domination as a rationale for informed consent, although this rationale is usedextensively in sexual ethics and political philosophy. The idea herewould be that no one should be under the arbitrary control of anotherand that informed consent requirements help to prevent such arbitrarycontrol. One would argue that medicine is rife with potential tobecome hierarchical, given the utter dependency of patients andresearch participants on physicians (Levine 1988, 121–2), aswell as the knowledge gaps between them, especially in theinvestigational context. Therefore, it is important to ensure thatpatients and research participants retain a high degree of controlover what happens to them, and informed consent helps with this. Thisrationale may shed light on the special importance of informed consentto research participation—where the knowledge gap is especiallyhigh. Indeed, there is a specific informed consent right to withdrawfrom research at any point–perhaps because even if one hasautonomously waived protection, arbitrary control by others, withoutthe protection of a consent requirement, would constitute domination(compare Pateman 1990, 79 on the wrongness of forcing sexualinteraction even within otherwise consensual maritalrelations–because rights to nondomination cannot be waived).Inasmuch as shared decisionmaking with patient groups can preventdomination, it is a natural complement to individual informed consent(Kestigian 2017, 11).

The non-domination rationale has difficulty explaining why physiciansand investigators who are closely monitored and cannot mistreatpatients with impunity would also be obligated to let patients decide.Arguably, some existing systems have ample institutional guardrails topredictably prevent physicians and investigators from exercisingarbitrary control, even without informed consent requirements, yetcommonsense insists on those requirements.

2.7 Personal integrity

A final rationale for informed consent requirements is the need toprotect patients’ sense of personal integrity. One reasonoffered for keeping surrogate pregnancy contracts non-enforceable isthe need to maintain surrogate carriers’ sense of personhood bynever coercively taking babies away (Radin 1983, e.g., 960). A similarrationale may be thought to justify informed consent in general, andto reflect our special relation to our bodies. As Gerald Dworkin put aslightly different point, “one’s body is irreplaceable andinescapable. If my architect doesn’t listen to me and thisresults in a house I do not like, I can always move. I cannot movefrom my body.” (Dworkin 1988, 113). By one interpretation,personal integrity underlies self-ownership norms. What it requiresis, in Ronald Dworkin’s words, “a prophylactic line thatcomes close to making the body inviolate” (Dworkin 1983, 39).However, personal integrity may instead give rise to a normativecontinuum, on which the outer line of the body is only one stop.Touching someone’s cheek without his informed consent is hardlyas bad as touching more sensitive areas of his body without hisinformed consent. The continuum may also extend outside the body. AsJudith Thomson pointed out, it is a greater transgression to touch anunwilling person’s body than to touch his shoes, yet a smalltransgression exists–even when he is not wearing them (Thomson1990, 207–8). It also matters how and why these areas aretouched. Such continua may be thought to track the typical degree ofinjury to personal integrity.

An account in terms of personal integrity would require morespecification. For example, what is the relation between this accountand the offense of battery? Would this account condemn the use of amagic wand to treat an unwilling patient’s ailments withoutcutting his skin and so, perhaps without battery (Brock 1999, 529f)?Would it also condemn threat of fines that coerces patients to movetheir bodies in certain ways, even without touching them? Is theaccount ultimately grounded in ana priori argument, inevolutionary psychology (Wertheimer 2003, 113f.), in non-idealrealities (Kukla 2021), in the typical material harms from violationsof bodily integrity, or in still other considerations?

3. The idea of consent

Let us now review the different elements of fully free and informedconsent in greater 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 ofacquiescence” (Westen 2003, 5), and “an act ofwill—a subjective mental state…” (Hurd 1996, 121).But the medical requirement of informed consent seems to include atleast some behavioral expression of consent (Kleinig 2010, 9–10;Dougherty 2021), ranging from a patient’s signature, to hernot protesting when a nurse approaches with a syringe(so-called implicit or tacit consent). That said, the need for somecomprehension and voluntariness means that mental states also affectwhen consent legitimizes medical intervention, perhaps supporting ahybrid view of one sort (Miller and Wertheimer 2010, 84) or another(Alexander 2014).

When emergency intervention is needed but normal consent cannot beobtained, say, because the patient is unconscious and neither she norher family’s specific preferences can be identified in time,proponents of informed consent often justify intervention by invokinga potentially different form of consent. They say thatpresumedconsent obtains, even if actual and express consent does not.Presumed consent is also often invoked in order to legitimize ageneral policy of harvesting organs from healthy deceased persons touse in transplantation unless they explicitly indicated theiropposition, and a similar general policy of testing all incomingpatients for HIV except those who explicitly request not to be tested.Such policies reverse the usual default assumptions about what ispermissible and place the onus on any individual who has reservations,to “opt out.” The underlying thought is that when optingout remains easy, so-called presumed consent is perfectly consonantwith patient sovereignty (Sunstein and Thaler 2008).

Some authors oppose the terminology of presumed consent as a contrived“myth” or “fiction” of actual consent (Harmon1990; Brownsword 2004, 232–3; Beauchamp and Childress 2008, 107;Dworkin 1988, 117). They concede that when a nurse approaches apatient with a syringe, the patient’s failure to protestconstitutes actual, albeit tacit, consent per convention. But they addthat it is fraudulent to presume consent when consent is notexplicitly given and no relevant convention specifies that silenceexpresses 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: itgoes too far to assume that, just because a patient fails to carry inher pocket a directive forbidding care or organ harvesting in theevent of an emergency or death, she is consenting. However, on adifferent interpretation, presumed consent ascriptions mean:Presumably, the patient would have consented to the interventionif, under the current circumstances, she weredecisionally-capacitated. A possible ground for suchcounterfactual ascriptions (often referred to as “hypotheticalconsent”) is that there is no special information that indicatesthat 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 isnot necessary that one justify them in terms of consent (presumed orotherwise) as long as one is prepared to argue that sometimes, certainvalues defeat individuals’ consent rights. In the case of organsfrom the deceased, the primary pull for making consent not refusalinto the default may well be the huge benefit to the organ recipientand the far lower harm to the deceased. Together, these factors maymake high-quality informed consent less urgent.

4. Informed consent

Clinical trials are commonly anticipated by a formalized process inwhich participants receive explanations of the purpose, methods,risks, benefits, and alternatives to study participation, as well asother matters, before they sign informed consent forms (Beauchamp andChildress 2008, 129). Fairly similar processes exist in invasive care.But what is the point of these processes? One of Plato’scharacters mocks doctors who set aside time to keep sick patientsinformed: “Foolish fellow, … you are not healing the sickman, but you are educating him; and he does not want to be made adoctor, but to get well” (PlatoLaws, IV.720a–c,p. 413). Let us discuss two forms of transgression of the informationrequirement: (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 theinformation requirement.

4.1 Lies, deceit, and partial disclosure

Lies about pertinent matters are broadly assumed to violate theinformed consent requirement. So does non-lying deceit thatintentionally prompts a false impression, for example, completeconcealment of a potentially despairing prognosis, or its statement inobscure Latin terms that the patient cannot understand, in order tomaintain the patient’s hope and medical adherence. So doesnon-lying deceit that is voluntary but unintentional, say anexplanation in obscure Latin terms meant only to impress the patientbut foreseen to hamper comprehension (Jackson 1991, 6). Interestingly,ignorance of side effects that results purely from the early stage ofscientific inquiry into them is taken to permit informed consent andautonomous decisionmaking (Millum and Bromwich 2013). A recentquestion is how much certain mild forms of intentionalmanipulation—for example, placing the hopeful news both at thebeginning and at the end of a prognostic report so as to make itsaffect more hopeful—invalidate informed consent (Eyal 2016).

The intentional use of the placebo effect in clinical care, commonly adeceitful means to help a patient feel better, is condemned byprominent bioethicists in the name of informed consent (Bok 1999,61ff.; Beauchamp and Childress 2008, 125). Other seeming breaches ofthe information component of informed consent are somewhat morepopular with bioethicists. First, the well-established“nocebo” effect is when the patient’s expectation ofa negative outcome as a possibility generates corresponding symptomsor exacerbates them. When a severe, unavoidable nocebo effect fromdisclosure is predictable, most philosophical observers supportwithholding certain information (Cohen 2014). In some cultures,patients are averse to hearing about risks because they falselybelieve that the mention of remote risks makes those risks likelier tomaterialize. While the expectation is false, it means that fulldisclosure of these risks would meet with aversion, potential anxiety,and fewer clinic visits, and many bioethicists permit partialdisclosure in such settings (Beauchamp and Childress 2008, 106).Finally, so-called deceptive studies can begin while the participantis waiting in the corridor for what she believes is an altogetherdifferent experiment, precisely because full disclosure would foil theinvestigation. Their deceitful nature notwithstanding, such studiesare ubiquitous in psychology and some bioethicists find forms of themacceptable (but see condemnation in Bok 1995).

4.2 Comprehension problems

What is the point of the disclosure process? The Nuremberg Code can beunderstood to answer that one point is that a research participantshould “have sufficient knowledge and comprehension of theelements of the subject matter involved as to enable him to make anunderstanding and enlightened decision.” Clearly, meredisclosure does not ensure that. Even when information is given inplain terms in the participant’s language, many participantsfail to appreciate statistical information about risks, or the factthat in placebo controlled trials, they might not receive thetreatment under investigation, or the fact that trials aim to furtherscientific knowledge and not necessarily their own medical good. Theresult is that participants tend to overestimate the benefits of trialparticipation 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 informedconsent requires much more than mere disclosure, and that the point ofdisclosure, rather, is the comprehension potentially gained througheffective communication (Beauchamp and Childress 2008, 127ff; Mansonand O’Neill 2007, e.g., 184–5). Psychologists and healthliteracy experts seek effective ways to improve comprehension amongpatients and candidate study participants (Candilis and Lidz 2010).And when a patient or a candidate participant is known to understandthe relevant information anyhow because she is a physicianspecializing 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 veryserious risks to candidates, results in forms that are so long as toinhibit comprehension. When this happens, a preference for adequatecomprehension over adequate disclosure may suggest that we shouldneglect to mention at least some major risks. If that seems misplaced,there might be some point to adequate disclosure beyond its potentialcontribution to the patient’s or the study candidate’sadequate comprehension, such as greater transparency andaccountability.

Sometimes, comprehension remains poor despite repeated efforts toelicit comprehension. That can happen because patients are not doingtheir parts to learn, because some pertinent risks are too complicatedto explain effectively, or because some experience and what they woulddo to us impossible to comprehend in advance, as in so-calledtransformative experiences,which produce radical change in what weknow or in who we are, especially with respect to personal values orcore preferences (Paul 2014). When that is the case, is clinicalintervention or enlistment in a trial illegitimate, because noautonomous authorization took place (Faden and Beauchamp 1986;Candilis and Lidz 2010)? Some philosophers respond that it remainslegitimate, because by giving candidates theopportunity toissue autonomous authorization, investigators do their parts(Sreenivasan 2003), avoid any potential fraud (Millum and Bromwich2013), and treat the candidates fairly (Miller and Wertheimer 2010),conditions that they find sufficient for valid consent. (Indeed, eventhe permissibility of skipping disclosure when the patient is amedical expert might be taken to indicate that part of the point ofinformed consent is to prevent fraud (not necessarily to ensureautonomous authorization); fraud is impossible when the patient caneasily detect the fraud.) A different response is that consent remainsvalid so long as the patient or the participant know that theircomprehension is poor and accordingly withhold judgement (Keren andLev 2022) or prefer treatment or study participation despite thatknowledge (Villiger 2024; Kious, Peterson, and McGuire 2024).

4.3 Content

What information should be disclosed or comprehended? It is common toemphasize that patients cannot possibly be “fullyinformed” if that would include all facts, or all facts that arematerial to physicians’ decisions. For example, researchparticipants, who need to know the main risks of participation, do notneed to know much about the history of the disease. But how are we todetermine which facts patients and trial participants should beinformed about? Three legal standards exist: the professionalstandard, the reasonable person standard, and the individualstandard.

Theprofessional standard mandates informing patients andparticipants of those details that it is conventional forprofessionals in the field to mention. Once predominant, this standardhas lost much of its traction with U.S., English, and Welsh courts.Indeed, no professional convention exists on this issue, and courtshave opined that patients should decide which information is pertinentto them. Thereasonable person standard mandates disclosingwhatever details a reasonable patient would find pertinent. Finally,theindividual standard mandates informing the patient orparticipant of those details that she, given her determinate andpotentially unreasonable conception of the good, would find pertinentif she were otherwise reasonable (Beauchamp and Childress 2008, 122f.;Levine 1988, 104–5; Berg et al. 2001, 46–52). An argumentagainst requiring the disclosure or comprehension ofany riskis that neither is necessary for the restoration of trust and fordeterring abuse of patients and trial participants; what is necessaryis only ready patient and trial participant access to the relevantinformation in the event that abuse is suspected (Manson andO’Neill 2007, 179ff.).

As with many other “standards” in medical ethics, thequestion arises as to whether they are mere recommended procedures fordoctors, judges, and professional educators, or exhibit fundamentalmoral principles.

4.4 Proportionate stringency

Whether being informed is cashed out in terms of disclosure or ofcomprehension, and whichever standard is used, asking that patients orstudy participants be even adequately informed is sometimes asking toomuch. U.S. federal regulations waive the information requirement inresearch for some studies that involve no more than a minimal risk(seeU.S. federal code 45 CFR 46.110). In clinical care, many patients would rather not think about risksand prognoses that would turn their stomachs and that they can dolittle about. The legal defense of therapeutic privilege can beavailable to doctors who had reasonable belief that full disclosure orfull comprehension would harm the patient physically orpsychologically. In some such contexts it seems cogent not to demandinforming in any form (see sections 6, 7 below). However, outrightlies surely remain forbidden even in such circumstances. A possibleconclusion is that informed consent encompasses several layers ofrequirements which differ in their stringency.

5. Voluntary consent

When is consent sufficiently voluntary? Let us discuss three potentialbarriers to voluntariness: (1) literal coercion, (2) “undueinducement”, and (3) “no choice” situations.

5.1 Coercion

Voluntary consent is usually thought incompatible withcoercion, which most philosophers define, roughly, as a threat to make someoneseriously worse off than she is or should be, unless she consents(Wertheimer 1987). Nonetheless, the prevailing medical ethos tends totreat more cases as cases of coercion than this philosophicaldefinition would suggest. For example, a threat to cause even slightpain unless a patient acquiesces would be taken to invalidate herconsent even when the patient and the physician know that it would notmake her seriously worse off and so, that it would not amount tocoercion.

How much do “implicit threats” count as threats? Imagine apractitioner who asks her own patient to participate in a study thatthe practitioner runs, and the patient fears that care would suffer ifhe declines, without the practitioner actually saying so. When thepatient’s fear is well-founded, or even intentionally instilledby 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 isunintended and not founded on the researcher’s specificbehavior, the remaining uncertainty, combined with the typical powerinequality of the physician-patient relationship, are often stillthought to make such consent involuntary, perhaps by keeping the fearrationally legitimate (Hempeler et al 2024).

5.2 Undue inducement

Another category often said to undermine voluntariness is undueinducement, a term of art meaning that something is being offered thatis alluring to the point that it clouds rational judgment, forinstance, allegedly, glittering cash in hand or airline tickets inreturn for kidney donation or risky study participation. Attention isfixated on the benefit, disallowing proper consideration of risks. Thethought here is not that the offer is too good to decline rationally,but that, as in deceit and hypnosis, proper reasoning anddecision-making about it becomes impossible, at least for some patientpopulations (Wilkinson 2003, 117–118). A common worry amongbioethics practitioners, undue inducement is less concerning tophilosophers who have tried to make sense of the notion, partlybecause these philosophers find that inability to reason properly issomewhat rarer than the worry assumes (Wertheimer 2010).

5.3 “No choice” situations

In some areas of practical ethics, the lack of decent alternatives toaccepting a bad offer, a so-called “no choice” situation(Wertheimer 1987, e.g., p. 13), is said to make us forced or compelledto choose the offer (Cohen 1979), or to undermine voluntariness orindependent decisionmaking otherwise (Millum & Garnett 2019).While in such cases, indecent alternatives remain in principle open tous—the offer is not physically forced—the same could besaid of paradigmatic cases of coercion. In “your money or yourlife” situations, the option of dying remains open to thevictim.

Consider then a poor person who knows that his only way to gain accessto an expensive life-saving drug is to participate in a risky or veryunpleasant study where the drug is provided free of charge. He is not,strictly speaking, coerced (Hawkins 2008, 24–5), but somebelieve that his consent is involuntary and that the trial isunethical, because none of the options available to him are decent.However, there is a problem with this claim too. On its logic,whenever a very sick rich person has no decent alternative to taking abadly unpleasant life-saving drug, there is no voluntary consent, anddrug delivery is illegitimate. Even when the nasty side effects remainfar better for her than her only alternative—to die of thedisease—she is not providing voluntary consent to take the drug,and it is unethical to give it to her. Since the latter reasoning issurely flawed, the former reasoning may be flawed as well.

Some have responded that the poor man’s inability to givevoluntary consent to trial participation stems from injustice, notnatural disease, and that this makes a big difference. But surelymedical aid that saves consenting victims from the horrible results ofinjustice and carries unpleasant side effects can remainfully permissible. For example, following the 2010 earthquake inHaiti, it was fully permissible for the U.S. military and itsphysicians to perform consensual life-saving leg amputations. It waspermissible whether earthquake injuries were purely natural, partlythe result of non-U.S. injustice (local contractors’ independentneglect of safety rules), or partly the result of U.S.-perpetratedinjustice (long-standing U.S. meddling in Haitian politics at theexpense of accountability, including accountability for neglectfulconstruction projects).

Another way out is to say that consent is insufficiently voluntaryonly when the patient’s options are unfairly curtailed by theoffer itself (Miller and Wertheimer 2010, 92, 97). The reason why“Your money or your life” curtails voluntariness is thatit curtails our options. By contrast, the above-mentioned offers tothe poor trial candidate and to the rich patient do not curtailoptions. They maintain voluntariness. However, one may insist that,while notcoercive, “no choice” situationssomewhat undermine voluntariness (Feinberg 1986, 233–244), thegood of independent decisionmaking (Millum & Garnett 2019), theappropriateness of the offer to participate (Bomann-Larse 2013,72ff.), or even the (likely overall) permissibility of intervention.Imagine impoverished potential study participants who lack alternativeways to obtain life-saving drugs. The investigators offer them thesedrugs whether or not they consent to participate, free of charge. Theintuition is that this free, unconditional offer increases thevoluntariness of these potential participants’ decisions onwhether to participate, and it makes their invitation to participatein a risky trial easier to defend ethically.

6. Own-waivers of informed consent

When, if ever, is a person authorized to waive her informed consentrights? Should participants who donate blood in a medical trial bepermitted to authorize its use in any future trial, without theirspecific consent for each token (as U.S. federal regulations allowthem, since 2018, to do)? What about a patient or a candidate studyparticipant who asks to be spared tedious descriptions of herdifferent options, and would rather entrust the medical team, or hervillage elder, with key decisions? What about someone who asks herphysician to lie to her, if he is willing, should her prognosis bedespairing? And what about a woman who would like to sell pregnancyservices with a fully enforceable contract to hand over the baby evenif she develops strong maternal feelings toward him or her and seeksto revoke her consent?

In democratic politics, we delegate many decisions to representatives.But we keep ourselves barred from signing away others, including thedecision to waive our voting rights altogether. The question as towhich decisions our institutions should allow patients to delegate tothird parties is complex and under-explored. Bioethicists usuallyfrown upon letting patients grant so-calledcarte blanche, orgeneral consent, to whatever the physician considers appropriate forthem (Dworkin 1988, e.g., 125–6). Instead, patients are usuallyencouraged or compelled to make decisions on a more ongoingbasis—to give so-called specific consent (Kleinig 2010,18)—although there are logical limits to how specific consentcan be (Manson and O’Neill 2007, 12).

The requirement of informed consent is often attacked on the groundthat many patients would rather have physicians make certain decisionsfor them, and that such delegation often seems acceptable (Schneider1998). One answer to the attack argues that informed consent is apatient’s right, not her duty (Beauchamp and Childress 2008,105, 107), and that, since informed consent serves autonomy, it oughtto be autonomously waiveable (Beauchamp and Childress 2008, 106).Indeed, autonomously signed advance directives that bind one’sfuture self can be perfectly consensual and autonomous. What we maycall “waiveable waivers” of informed consent rights(“Please spare me the full disclosure or decide in my nameunless I ask to resume full disclosure or active control”) seemrelatively easy to accept and fairly consistent with autonomy.However, we do impose some rights, which we consider inalienable, onunwilling rights holders. The right not to become a slave isinalienable, and the same may apply to some informed consent rights,such as the right not to become a participant of a clinical trial thatone cannot exit.

An alternative answer to the attack is therefore that some informedconsent rights are waiveable (perhaps including many disclosurerights), and others are non-waiveable (perhaps including the right torevoke prior consent to bodily intrusion). Theory is needed in orderto tell which informed consent rights are waiveable and which are not.(Is the alleged second-order right towaive informed consentrights alienable?) Theory should also explore whether non-waiveableconsent requirements are consistent with patient autonomy, say,because what such requirements impose is autonomous decision-making(potentially out ofpaternalistic concern with protecting thepatient’s autonomy). It should also characterize how much thewaiveability of informed consent should depend on the healthworker’s relative expertise on the subject matter (Brown2024).

7. Exceptions to informed consent

Even absent own-waivers, and despite absolutist statements of theinformed consent requirement, such as the Nuremberg Code, manycontemporary theorists agree that there are cases where informedconsent procedures are not necessary. The law, and many bioethicists,recognize exceptions to informed consent requirements, such as lack ofdecision-making capacity, or emergency circumstances where thepatient’s wishes are unknown (Tännsjö 1999; Emanuel,Wendler, and Grady 2000). That said, these exceptions serve the spiritof informed consent; they can be plausibly woven into full statementsof the requirement (as proposed, for instance, in Dworkin 1988, 117),and they question only its crudest, most absolutist statements. Otherexceptions seem harder to reconcile with full-blown commitment toinformed 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 necessary?

7.1 Benign interventions

The reality is that informed consent procedures (form filling,mandatory disclosures, and so forth) are not legally mandated for thelion’s share of medical care, e.g. standard blood draws, incontrast to more invasive interventions like surgery. Nor are theynecessary intuitively (Manson and O’Neill 2007, 81f). In medicalresearch, United States federal regulations authorize review boards toomit informed consent requirements on many occasions when“research involves no more than minimal risk to theparticipants”, a provision expanded in 2018. Likewise, arelatively safe and low-impact study comparing two widely used drugsto ascertain which is best seems morally permissible, even without afull-fledged informed consent process (Truog et al. 1999), and recentUS regulations waive consent requirements in many such cases (Propes,O’Rourke, and Morain 2024).

Some authors have used such examples to downplay the need for informedconsent, criticizing what they call bioethicists’“fixation” with informed consent (O’Neill 2002,47–8; Brownsword 2004, 224). In response, some proponents ofinformed consent insist that, in many of the alleged counter-examples,something in the way of informed consent remains vital. In blooddraws, in particular, when the patient is shown the needle andsilently stretches her arm forward, she is said to give tacit ornon-verbal consent (Beauchamp and Childress 2008, 107; and see alsoManson and O’Neill 2007, 11). This particular response may beinsufficient. For example, when a busy nurse with many patients inline realizes that a patient is very ignorant about a blood draw, suchthat her tacit consent is uninformed, intuitively the nurse doesnot owe the patient a long explanation of the risks from asanitized needle prick, which are remote and minor.

To some, this may suggest that fully-fledged informed consentrequirements simply do not apply to highly benign interventions.Surely the need to protect health and welfare, at least, throughinformed consent procedures is lesser when that risk is negligible inthe first place. Interestingly, similar logic suggests that when anintervention is not benign yet informed consent cannot improve uponother protections, informed consent may also be unnecessary. Apossible case in point is observational studies of anonymizedelectronic health records, where the main risk comes from breach ofdata security and confidentiality—a serious yet technical matterthat few individual patients could assess reliably—and thusinformed consent might be an ineffective, unhelpful protection. Whatis needed instead is legal and information technology solutions, aswell as democratic decision making on any remaining risk.

Still, some elements of the requirement of informed consent obtaineven in standard blood draws and other benign interventions (Dickertet al. 2017). Physical duress against a refusing patient and theintentional exploitation of a patient’s ignorance about blooddraws both usually remain wrong. This may suggest that informedconsent bundles together requirements of variable stringency, some ofwhich obtain apply only sometimes. An alternative account of theimpermissibility of duress even for benign blood draws is thatinformed consent is a bulwark against coercive or fraudulent medicalinterventions, risky or benign. However, the arguable permissibilityof some benign studies without informed consent calls this defenseinto question.

7.2 Some risky experiments

Advancing the field of emergency medicine requires medicalexperimentation, including trials that compare different interventionsand that only sometimes serve the best interests of trialparticipants. But in emergency circumstances, it is often impossibleto obtain consent from the patient or her family in time. Manyphysicians believe that because the field of emergency medicine simplycannot progress absent experimentation, there should be an exceptionto informed consent requirements for these trials, however risky, withsubstitutes for fully-fledged informed consent sought. That elementsof informed consent, such as retrospective debriefing, remainnecessary in such trials, again suggests a “bundled”requirement (Fost 1998; Dickert et al. 2017).

7.3 Some public health policies

Interestingly, that for public health interventions, whose impact onhuman health can exceed that of clinical interventions, usuallylittle, if any, informed consent is mandated. Exposure to ads and“nudges” that promote populations’ health seemslegitimate to most of us even when the authority executing theinterventions discloses very little about these interventions, theirrisks, their alternatives, and any real opportunities to avert them.Changes to traffic regulations that affect accident rates on a grandscale are not thought to demand the consent of each individualcitizen. Nor are such changes considered necessary when they areexperimental (despite Richter et al. 2001)--health policy trials mayrequire a very different approach to consent than clinical trials(Faden et al. 2013, Mackay and Chakrabarti 2019).

Differently put, even in the absence of public health emergencies(which can warrant transgressions like forced geographical isolation),the widely accepted standard in public health seems more intrusivethan the one in clinical care. As further illustration, many wouldagree that it is legitimate to implement smoke-free bar laws thatsomewhat increase anti-smoking stigma, partly in order to goad smokersto quit (and not only as measures to protect third parties fromsecond-hand smoke). But most would condemn a clinician whodeliberately boosts stigma to goad an individual patient to quitsmoking (e.g. mocking the stink), and might explain that such pressureundermines the patient’s freedom to decide whether to quit. Isone of these arguably different approaches to informed consent rightand the other one, wrong? Or is informed consent morally required forsome interventions and not for others?

7.4 Informed consent—when?

An emerging picture is that the need for informed consent depends onmany variables. Just like being informed, the voluntariness of choicescomes in degrees (Beauchamp and Childress 2008, 101). Threats, forexample, control us to different degrees, depending on the degree ofharm being threatened (Beauchamp 2010, 70–1). The level ofvoluntariness necessary for valid consent to medical intervention mayvary according to the type of intervention offered. So does the levelof decision-making capacity necessary for valid consent (Buchanan andBrock 1989, ch. 1; Beauchamp 2010, 71). Robust informed consent thatrequires a great deal of information, voluntariness, and decisionalcapacity and is formalized and relatively non-waiveable, is necessarysometimes, but not always. Roughly speaking, robust informed consent(Joffe and Truog 2010, 358; Miller 2010, 391; Beauchamp and Childress2008, 101; Beauchamp 2010, 70–1) tends to be necessary the morerisky the intervention, the more it is a high-impact (e.g. adefinitive “critical life choice”: Archard 2008), the moreit is value-laden and controversial, the more private the area of thebody that the intervention directly affects (Mazor 2019), and the moreconflicted and unsupervised the practitioner. On other occasions, theneed for very robust informed consent, and indeed, for consent of anyform, is lesser (Miller 2010, 393). On those occasions, high financialor other costs of robust consent procedures easily override thatneed.

Does the need for informed consent depend, among other variables, onwhether the consent is for research or for care? Currently, consentprocedures for research tend to be more demanding and more regulatedthan consent procedures for equally intrusive treatment (Levine 1988,127–30; Miller 2010, 381). Why? A standard account is that theproper goal of research is to gather generalizable knowledge, and notto help the individual, and that this different goal enhances the needfor protections like informed consent (Fried 1974). However, actualgoals often differ from proper goals. In reality, many researchers arehighly committed to promoting participants’ health, and manyclinicians seek primarily financial gain, sometimes at patients’expense. In addition, studies are reviewed independently for theirsafety, making some so safe that (with or without consent) they imposeless risk than similar clinical care. Another rationale for the fewerconsent requirements in care is that the relationship between theclinician and the patient is typically a fiduciary one whereas therelationship between the investigator and the study participant isscarcely fiduciary (Joffe and Truog 2010, 364). But this rationalecould easily work the other way around: assuming that the fiduciaryrelationship 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 informedconsent, which depends on many variables and generates differentrequirements on different occasions (Dickert et al. 2017). It alsoraises interesting practical questions. First, who should decide when(relatively exacting and burdensome) informed consent is necessary(Joffe and Truog 2010, 361)? Might a crude, one-size-fits-allrequirement of informed consent serve most practical purposes(Wertheimer 2014)? Perhaps a fair compromise is to use an“intervention ladder” that defines broad categories ofintervention as more or less intrusive, then specifies broadcategories of circumstance that require especially robust consent insome cases and only minimal consent in others (Nuffield Council onBioethics 2007, 41–3)? What seems, in any event, to emerge isthat the need for informed consent would be misrepresented asfundamentally a single constraint or threshold. In this area, atleast, 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 itrepresent? In particular, does it correlate to a natural right, to alegal right, or to something else?

Bioethicists and human rights lawyers tend to assume that informedconsent is a natural right that generates a correlative objectivemoral duty and, downstream, legal and institutional duties. Manycontemporary philosophers assume that consent has moral“magic” that turns what would have been a wrongful actioninto a right one, in an objective, moral sense (Hurd 1996). But someof the aforementioned justifications for informed consent bettersupport other assumptions.

For example, the forward-looking trust rationale mentioned earlier canbe understood to mean that, morally, we should enshrine and then honorlegal (and cultural) informed consent requirements to protect trust inmedical practitioners. On that view, violating informed consentrequirements toward a patient does not necessarily violate thatpatient’s natural moral rights, only whatare andmorallyshould remain everyone’s legally protectedinterests.

In a further model, the uniform requirement of informed consent acrosscircumstances reflects our sheer epistemological problem telling inadvance the typical circumstances when it objectively applies fromrelative exceptions on which it does not (Wertheimer 2014, about therequirement in intervention research; see also Alexander 2014). In astill further model, the informed consent requirement only appears toapply homogeneously across circumstances in the eyes of agents whohave cultivated, as morally they should, a fruitful yet false beliefin the requirement’s objectively homogeneous application (Eyal2015). In a final model, the justified legal standing of informedconsent bolsters its moral standing (Miller and Wertheimer 2010,82–3).

One reason to take non-naturalistic approaches to the status ofinformed consent seriously is that not all natural rights are legallyenforceable. Therefore, a moral informed consent right that is legallyenforceable (as that right is usually taken to be in at least someinstitutional settings) may stand in need of additional moraljustification, even if a natural right has been established. Thatadditional, inescapable moral justification may then turn out tojustify informed consent regulations even absent natural informedconsent rights, say as trust-building measures. In particular, recallthat many bioethicists ground informed consent in duties to treatrational, autonomous persons respectfully. Some such duties areclearly non-enforceable. For example, the moral duty not to lie tofriends, disrespectfully and in breach of their autonomousdecision-making, is seldom legitimately enforceable. Thus, additionaljustification would be needed, beyond simple appeal to respect forautonomy, in order to establish an enforceable informed consentrequirement. That inescapable additional moral justification may thenturn out, if successful, to justify informed consent regulations andthe surrounding ethos on its own. It may do so even if the project ofgrounding informed consent in autonomy, and all other attempts tojustify natural informed consent rights, founder.

9. Consent in other domains

For decades, bioethicists have discussed medical informed consent inrelative isolation from consent in political philosophy, contracttheory, and sexual ethics, where notions of consent are also pivotal.This is finally changing, and it raises new technical andphilosophical questions about how to put these different discourses indialogue with each other. For instance, is what bioethicists call“presumed consent” the same thing as what politicalphilosophers call “hypothetical consent”? Is whatbioethicists call “proxy consent” one with what lawyerscall “impersonal consent”? What bioethicists dub“invalid consent” would often be described by contract lawexperts as “lack of consent” (Beauchamp 2010, 56; Kleinig2010, 13, 15).

This new development also raises substantive normative questions. Forexample, imagine that the same basic principle underlies legitimatepolitical regimes and legitimate medical experimentation. It mayfollow that either tacit consent to a political regime, whichLockean contract theorists often cite, cannot successfully legitimize politicalregimes—because it would not suffice for most medical studies;or that tacit consent successfully legitimizes medicalexperimentation. Likewise, imagine that the same basic principleunderlies the redistributive agency’s legitimate procurement ofincome and that of organs for transplantation. Then perhaps eitherincome tax—without tax-payers’ consent—isillegitimate (Nozick 1986), or a “kidney tax” could beperfectly 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-makingprinciples and rationales regarding consent apply in domains likemedicine, sex, political life, and the marketplace, as might beindicated by the variety of approaches to consent between thesedomains. For example, in most commercial transactions, unlike in themedical sphere, there are no legal requirements to disclose allrelevant information and to verify that it is understood (Miller andWertheimer 2010, 80; Joffe and Truog 2010, 351), perhaps indicatingthat in commerce, fairness or the right to be spared exhaustingdisclosures (Chomanski and Lauwaert, forthcoming) generally mattermore than autonomous decision-making. Likewise, whereas once weconsent to sell a car or to support a political candidate (by signinga contract or casting a vote) our consent is not retractable, invasivemedical intervention is usually considered illegitimate once apreviously consenting patient or research participant expresses achange of mind—as though the point of consent in the medicalarena were not simply autonomous authorization but ongoing control.Finally, if A mishears B’s consent to sex as refusal yetproceeds with sexual advances, a third party who understands the fullpicture has strong reasons to stop A’s advances (paceAlexander 2014, 105). But if a physician mishears a patient’sconsent to medically beneficial treatment as refusal yet proceeds toit, it is far less clear that a third party who understands the fullpicture should thwart the treatment. The point of medical care is,after all, not defeated by discordance of attitudes in quite the sameway that the point of sex is. One possible conclusion from thisvariety is that the very point of requiring informed consent, andhence what is fundamentally required and when, vary betweendomains.

10. Conclusion: the core of informed consent

Recent decades have seen doubts surfacing about informed consent, butthat just makes the resilience of other parts of the requirement allthe more striking. Even purported critics usually revise only therequirement’s prevalent justifications and interpretations inborderline areas, and leave a certain “core” intact. Givenhow much philosophers usually disagree, it is remarkable that, when amedical intervention is risky, value-laden, high-impact, physicallyinvasive, and/or medically controversial, especially when a patient ofsound mind explicitly refuses the intervention, most of us would feelthat only the most dire costs would justify imposition of care. Thegrudging nature of relative skeptics’ acceptance of this corepart of the requirement only attests to its philosophicalresilience.

In seeking justification for the requirement of informed consent, wemay therefore not have one task, but many. We need to justify thispowerful, relatively non-controversial core, as well as a weaker andmore questionable rim. It is possible that the core stems directlyfrom natural right, whereas the rim is merely instrumental orconventional. It is also possible that they both rely on the sameground, say, the value of autonomy, but touch on it in differentmeasures. Even if the core of the requirement of informed consentcommands high priority, other parts may turn out to be easilyoverridable by competing values, including the value of advancingscientific research.

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Acknowledgments

For excellent comments, thanks are due to Jennifer Hawkins, as well asDan Brock RIP, Tom Dougherty, Steve Joffe, Neil Manson, Emma Ryman,Robert Truog, David Wendler, Daniel Viehoff, Alan Wertheimer RIP, DanWikler, and my students. Work on recent editions was supported byWellcome 208766/Z/17/Z.