Abstract
The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account.
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Notes
Millum and Bromwich write that “the standard view of informed consent is mistaken [because the] view’s constitutive claim–that the contents of the disclosure and understanding requirement are identical–is false” (2021, 6); Sreenivasan writes that “the standard view of informed consent is mistaken…[its] most serious defect … is that it threatens to bring enrollment in many clinical trials to a near standoff” (2003); Manson and O’Neill write that “standard accounts of informed consent, standard arguments for requiring consent in clinical practice and standard ways of implementing consent requirements lead to intractable problems” (2007, vii).
As we explain below, S is in error about p if she falsely believes p. S suffers from suspending ignorance regarding p, if having considered whether p, she neither believes that p nor its negation.
While our argument applies both to consent to medical treatment and to participation in research, in what follows we often refer only to consent to treatment. Unless explicitly stated otherwise, the reader should understand such formulations as applicable also to consent to research.
While we focus here on the medical context, our account, like the standard account, has implications for many other contexts where concern for autonomy requires obtaining IC to forms of interaction.
For formulations of the standard account see Beauchamp and Childress (2001, 2009), and Faden and Beauchamp (1986). The account is still referred to as the “standard account”, even though several authors have recently rejected it, and it is not obvious that it underlies common judgments and practices. See, e.g., Dickert et al. (2017).
See, e.g., Beauchamp (2010).
See, e.g., Beauchamp and Childress (2001: 88).
Others who accept a knowledge requirement that is extensive in both senses noted above (knowledge that is extensive when compared to what is required by minimalist accounts of IC, and that in many medical contexts is much more extensive than the kind of knowledge typically possessed by the average patient) include Faden and Beauchamp (1986), Beauchamp (2010), Capron (2008), Wendler and Grady (2008). Dougherty provides some further examples of proponents of the requirement, which he labels a “comprehensive understanding” requirement (see Dougherty 2020, footnotes 5 and 6). Such an extensive knowledge requirement is also included in the most influential medical codes of ethics (requirement is also included in the most influential medical codes of ethics (World Medical Association’s (2013) WMA Declaration of Helsinki, Article 26; CIOMS (2016), guidelines 4 and 5), and the most influential legal IC rulings (Canterbury v. Spence 1972).
The standard account does not deny that IC’s disclosure requirement might also have other sources, e.g., in duties of beneficence and institutional considerations. Nonetheless, the primary basis of disclosure requirements is what patients need to know to be able to provide valid consent.
Note that there is more than one way of understanding what is supposed to be counterintuitive about this implication of the standard account. We discuss these different interpretations in Sect. 6.
As is standard, we take ignorance to be lack of knowledge. For an objection to this standard definition of ignorance, see Peels (2010). Peels’ objection, however, is irrelevant to the forms of ignorance discussed here. In any case, nothing substantial turns on our use of the term; anyone concerned about the identification of ignorance with lack of knowledge can substitute “lack of knowledge” wherever we use “ignorance”.
Thus, Sue can suspend judgment both on whether God exists and on whether the number of women serving in the Senate is an even number.
We refer to this form of ignorance as “deep ignorance” (following Peels 2014). For lack of space, we do not discuss here states of non-belief other than that of suspending ignorance.
To be clear, we do not deny that some very minimal knowledge is required for valid consent. This is why we add the qualifier “generally” above. Thus, according to some minimalists (Millum and Bromwich 2018), to give valid consent to a transformation of the normative boundaries between the parties, there are exactly three things that the profferer of consent must understand: (1) that she is giving consent; (2) how to exercise her right to give or refuse consent, and (3) how her consent would redraw the normative boundaries between the parties. They claim that such minimal knowledge is required for an act of consent to be intentional, and therefore for its validity. Our account is compatible with this claim. Obviously, this kind of knowledge demanded by the minimalist falls far short of the kind of knowledge required by the standard account. Note that our account nevertheless differs from this kind of minimalist account in that it makes further epistemic requirements, in terms of the avoidance of error.
Note that this explanation of why suspending ignorance does not invalidate consent does not seem to apply to other states of non-belief such as deep ignorance. The case of deep-ignorance raises further complications; for lack of space, we leave its discussion for elsewhere.
Care is needed here. In one sense it is true that we cannot take the fact that we are in error into account, but in another, it is false. For we can be aware of the fact that we are generally prone to error and take this fact into account. What is impossible is to have a false belief about a particular proposition while knowing that this particular belief is false. Arguably, what matters for the validity of consent is one’s ability to take one’s state of ignorance about particular propositions into account. If general knowledge about our fallibility were sufficient for the ability to validly consent, then a lesson in epistemology would suffice for patients to give valid consent to treatment. This seems wrong.
Note that we do not claim that any error about material facts invalidates a person’s consent. For example, a patient’s error about a material fact might not invalidate her consent, if her consent is not based on this error and she would make the same decision regardless of whether her error were corrected or not. To illustrate, consider a patient who consents to treatment A, while holding a false belief about some material fact relevant to treatment alternative B. If correcting the patient’s error about B would neither make a difference to his decision to consent to A, nor would justify any further deliberation on his part, then his error about B need not invalidate his consent. We are grateful to an anonymous reviewer for asking us to clarify this point.
We say that prima facie you should not proceed, because in certain circumstances validity of consent and permissibility can come apart. Sometimes, for instance, commitments have been made on the basis of a justified false belief that valid consent was obtained, and the harm caused by violating these commitments would be worse than that of acting without valid consent. In such cases, it might be permissible, and sometimes even obligatory, to proceed with an interaction in spite of the invalidity of consent.
All individuals considered in our examples are assumed to be competent adults.
The case is based on a well-known case presented, in a very different context, by Jackson (1991).
We are grateful to an anonymous reviewer for pressing us on this issue.
Beauchamp and Childress explicitly note that “[a] single false belief can invalidate a patient’s or subject’s consent” (2009, 130). However, they offer no explanation of why this false belief invalidates consent other than the claim that ignorance invalidates consent when it prevents patients and research-participants from knowing what they must know to have substantial autonomy. Thus what explains why a “single false belief invalidates a subject’s consent” is that “in some cases, a person’s lack of awareness of even a single risk or missing fact can deprive him of adequate understanding” (2009, 127).
Because there are forms of ignorance not considered here (see note 15), we cannot rule out the possibility that forms of ignorance other than error also undermine the validity of consent. The important point, however, is that not all forms of ignorance are problematic, and so knowledge of material facts is not required.
Because we haven’t examined forms of ignorance other than error and suspending ignorance, in considering these objections, we shall ignore other forms of ignorance, and compare the two types of accounts only with respect to their implications for error and suspending ignorance.
For a general epistemological discussion of the importance of such belief see Fricker (2006).
Thus, there is no reason to rule out the possibility that lack of disclosure often invalidates patients’ consent both for the reasons suggested by SIED, and for the kind of reasons suggested by Millum and Bromwich (2021).
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Acknowledgements
Research on this paper was generously funded by the Israel Science Foundation (Grant No. 650/18). Versions of this paper were presented at the Mancept Workshop on Autonomy, and at colloquia at the Hebrew University of Jerusalem, London Bioethics Colloquium, University of Haifa and at the Uehiro Centre for Practical Ethics at the University of Oxford. For helpful comments, we are grateful to the audiences at these meetings, and to Aliza Avraham, David Enoch, David Heyd, Annette Rid, Julian Savulescu, Saul Smilansky and Daniel Statman.
Funding
Research on this paper was generously funded by the Israel Science Foundation (Grant No. 650/18).
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Keren, A., Lev, O. Informed Consent, Error and Suspending Ignorance: Providing Knowledge or Preventing Error?. Ethic Theory Moral Prac 25, 351–368 (2022). https://doi.org/10.1007/s10677-022-10277-w
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DOI: https://doi.org/10.1007/s10677-022-10277-w