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Using Informed Consent to Save Trust Nir Eyal Feature article J Med Ethics: first published as 10.1136/medethics-2012-100490 on 8 December 2012. Downloaded from Using informed consent to save trust Nir Eyal Correspondence to ABSTRACT process of consent… run the risk of undermining… Dr Nir Eyal, Program in Ethics Increasingly, bioethicists defend informed consent as a trust.’6 Additional authors cite trust as a ground for and Health, Harvard University, safeguard for trust in caretakers and medical institutions. rigorous informed consent procedures in medical Boston, MA 02139, USA; 7–9 [email protected] This paper discusses an ‘ideal type’ of that move. What I trials. call the trust-promotion argument for informed consent The value of public trust has also been invoked Received 2 January 2012 states: against specific transgressions of informed consent. Revised 16 July 2012 1. Social trust, especially trust in caretakers and Sissela Bok’s early writing mobilises the risk to Accepted 1 November 2012 ‘ Published Online First medical institutions, is necessary so that, for example, public trust against policies of shading the truth (in 8 December 2012 people seek medical advice, comply with it, and deceptive psychological research), which are participate in medical research. opposed to what must remain informed consent;’ 2. Therefore, it is usually wrong to jeopardise that she expresses frustration that ‘advocates of decep- trust. tive research… rarely even take into account the 3. Coercion, deception, manipulation and other risk of damaging the climate of trust in which they violations of standard informed consent requirements have to operate.’10 The same concern for public seriously jeopardise that trust. trust underwrites her opposition to deceptive 4. Thus, standard informed consent requirements are placebo prescription: justified. fi This article describes the initial promise of this The trust of those patients who nd out they have been duped is lost, sometimes irretrievably. They argument, then identifies challenges to it. As I show, the may then lose confidence in physicians and in value of trust fails to account for some commonsense bona fide medications which they may need in the intuitions about informed consent. We should revise the future. They may obtain for themselves more argument, commonsense morality, or both. harmful drugs or attach their hopes to debilitating fad cures.11 New work continues to link informed consent THE TRUST-PROMOTION ARGUMENTFOR with trust,12 and this linkage seems to resonate INFORMED CONSENT with the wider community. In a focus group of As I understand the standard requirement of African-American Washington DC area residents on informed consent, it states, how to increase study enrolment in their community, roughly, [that] when a sufficiently capacitated adult does not give sufficiently informed and voluntary Several participants emphasized the need for full consent to intervention in her body or her private and honest disclosure of information before a http://jme.bmj.com/ sphere, then, at least when the intervention is sub- study begins… The group members suggested [a] stantial, not trivial, and absent severe jeopardy for key reason for informed consent: to help build a third parties, the intervention is impermissible.1 relationship of trust between researcher and participant.13 Commonsense morality includes additional spe- cifications, as to who counts as sufficiently capaci- Surprisingly, the link to trust is virtually absent tated, when consent is sufficiently informed, and so from most textbook discussions of the case for forth. This article explores how much the fully spe- informed consent. This article fills this lacuna by on October 1, 2021 by guest. Protected copyright. Editor’s choice Scan to access more cified standard requirement may rest on the need starting a more systematic assessment of that link. free content to protect public trust in the medical system. Some of the bioethicists mentioned above are Bioethicists increasingly invoke that need as a Kantian, some are consequentialist, and some are major ground for informed consent. In Autonomy practice-oriented without foundational commit- and Trust in Bioethics, Onora O’Neill writes, ments. Their views on informed consent and on its ‘Informed consent… is generally important (inter relation to trust differ in scope, detail, putative ▸ http://dx.doi.org/10.1136/ alia) because it can make a distinctive contribution urgency and otherwise. Rather than attempting medethics-2012-101206 to the restoration of trust.’2 O’Neill follows exegesis and examination of each authorâ s special ▸ http://dx.doi.org/10.1136/ Torbjörn Tännsjö, Jennifer Jackson and other way of linking informed consent and trust, I shall medethics-2012-101207 bioethicists who have cited the need to build and chart and then examine a simplified and straightfor- ▸ http://dx.doi.org/10.1136/ medethics-2012-101208 maintain trust as reason to demand informed ward way to link them. This abstraction seems to consent for clinical care.34In ‘Trust, The fragile me more fruitful. Physicists who explore movement foundation of contemporary biomedical research,’ also find it fruitful to abstract from moving objects’ Nancy Kass and colleagues defend informed colours, from friction and from other complicating consent to research participation similarly. They factors. The ideal type that I shall examine can be explain that ‘Maintaining public trust is absolutely called the trust-promotion argument for informed crucial to the research enterprise.’5 For Ruth Faden consent. It states: To cite: Eyal N. J Med and colleagues, ‘institutional review boards (IRBs) 1. Social trust, especially trust in caretakers and – Ethics 2014;40:437 444. and investigators that (do not pay) attention to the medical institutions, is necessary so that, for Eyal N. J Med Ethics 2014;40:437–444. doi:10.1136/medethics-2012-100490 437 Feature article J Med Ethics: first published as 10.1136/medethics-2012-100490 on 8 December 2012. Downloaded from example, people seek medical advice, comply with it and or in other channels, informed consent, trust and the good participate in medical research. effects of trust may be thought to be bound up. Indeed, patients 2. Therefore, it is usually wrong to jeopardise that trust. who rate physicians lower on participatory decision-making—a 3. Coercion, deception, manipulation and other violations of component of fully informed consent—are more likely to disen- standard informed consent requirements seriously jeopardise roll from a treatment practice over 1 year—perhaps reflecting that trust. diminished trust—leading to outcomes such as lower adherence 4. Thus, standard informed consent requirements are justified. to blood pressure treatment.25 26 Although non-utilitarians can certainly use the trust- To illustrate both how important trust in the medical system promotion argument, the argument is potentially utilitarian. It can be and how that trust may depend on informed consent, defends informed consent as an instrument to an important consider social good—trust in caretakers and medical institutions and, more broadly, social trust. The argument is different from African-American mistrust of the medical community in general backward-looking trust-based arguments, which defend and medical research in particular. The absence of trust has informed consent as an intrinsically valuable way to honour the emerged as a stumbling block in efforts to include 27 trust that the patient has placed in the doctor, or as an intrinsic- African-Americans in clinical research. – ally valuable expression of virtuous trustworthiness.14 18 Finally, the argument differs sharply from the argument that informed Low research participation among African-Americans prob- ’ consent is important because it is naïve to trust doctors to ably delimits doctors understanding of the impact of disease 27–30 decide for oneself. and medicine in that population. Similar mistrust partly 31 This article shows both the initial attraction and the chal- accounts for relative paucity of visits to doctors and dentists ; 30 lenges facing the trust-promotion argument. In its present form, for low adherence to medical advice ; for relatively low rates 32 33 I shall contend, the argument fails to ground the requirement of of organ and blood donation and availability ; and for low 34 35 informed consent as commonsense morality construes that rates of care withdrawal at the end of life. In a nutshell, dis- requirement. Either the argument or commonsense intuitions trust of the medical community is one factor setting back ’ require revision. African-Americans average health outcomes and quality of life. That distrust has deep roots and justifications, ranging from 36 THE INITIAL PROMISE OF THE ARGUMENT slavery through Tuskegee to continuing disparities. However The trust-promotion argument is an ‘ideal type’ that links trust understandable, it arguably affects many contemporary fi 36 to informed consent in a simple way, facilitating a systematic African-Americans more adversely than bene cially. Part of assessment of that link. The link merits assessment not only the promise of informed consent lies in the hope that it will because bioethicists make it, but for three additional reasons. warrant and save trust in medical institutions and in individual Trust matters a lot, especially in medical settings; informed caretakers. Visibly enforced informed consent practices signal to fi consent seems initially to protect it in several channels; and patients that they, and not doctors, will have the nal say; for alternate arguments for informed consent are currently in hot instance, that trial participation and clinic visits do not risk water. Let me elaborate. unwanted intervention. It is for such reasons that the above- ‘ The importance of trust goes far beyond the clinical setting. quoted study concludes, Most recently, the question has been Social capital literature often argues that ‘high-trust’ societies, raised of waiving consent for some areas of clinical investiga- … http://jme.bmj.com/ where mutual trust and trust in institutions flourish, tend to tion We advocate extreme caution in populations such as the …’27 have stronger economies and democracies than ‘low-trust’ ones.
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