Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.
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References
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Department of Homeland Securityet al., “Federal Policy for the Protection of Human Subjects,”Federal Register82, no. 12 (2017): 7149-7274. The DHHS Office of Human Research Protections orchestrated the revision process; the revisions themselves were jointly issued by all the Common Rule agencies. For a useful historical perspective, see A. M. Capron, “At Last! Aye, and There's the Rub,” American Journal of Bioethics 17, no. 7 (2017): 4-7.
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Department of Homeland Security et al., Id. at 7265.
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Department of Homeland Security et al., supra note 1, at 7211 (footnotes omitted).
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This history is described far more thoroughly and eloquently in A. M.Capron, “Where Did Informed Consent for Research Come From?”Journal of Law, Medicine & Ethics46, no. 1 (2018): 12-29. See also R. Dresser, “The Reasonable Person Standard for Research Disclosure: A Reasonable Addition to the Common Rule,” Journal of Law, Medicine & Ethics 47, no. 2 (2019): 194-202, for a perspective on the reasonable person standard that is complementary to and more complete than my own.
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See N. M. P.King, “The Reasonable Patient and the Healer,”Wake Forest Law Review50 (2015): 343-361.
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R.Dresser, Silent Partners: Human Subjects and Research Ethics (New York: Oxford University Press2017). See also S. A. Kraft et al., “Comprehension and Choice Under the Revised Common Rule: Improving Informed Consent by Offering Reasons Why Some Enroll in Research and Others Do Not,” American Journal of Bioethics 17, no. 7 (2017): 53-55, and J. Sugarman, “Examining Provisions Related to Consent in the Revised Common Rule,” American Journal of Bioethics 17, no. 7 (2017): 22-26.
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I've drawn this formulation from M. Powers and R. Faden's discussion of a range of justice theories in Social Justice: The Moral Foundations of Public Health and Health Policy (New York: Oxford University Press 2006), e.g., p. 191. The analogy is based on thinking about justice beyond questions of distribution, focusing instead on substantive determinations of what societies owe their members — and, in this context, on what information the research enterprise owes potential subjects as reasonable persons.
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P. S.Appelbaum, L. R.Roth, and C.Lidz, “The Therapeutic Misconception: Informed Consent in Psychiatric Research,”International Journal of Law and Psychiatry5, no. 3-4 (1982): 319-329; P. S. Appelbaum et al., “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,” Hastings Center Report 17, no. 2 (1987): 20-24; P. S. Appelbaum, “Commentary: Examining the Ethics of Human Subjects Research,” Kennedy Institute of Ethics Journal 6, no. 3 (1996): 283-287.
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Knowing what a particular hospital or practice would recommend outside the context of a comparative effectiveness trial is site-specific information that could be very useful to patients who are potential subjects, especially if the points of comparison are described. See, e.g., C.Feudtner, M.Schreiner, and J. D.Lantos, “Risks (and Benefits) in Comparative Effectiveness Research,”New England Journal of Medicine369, no. 10 (2013): 892-894. The differences between participating in comparative effectiveness research and receiving treatment outside the research context thus may not be measurable as changes in risks of harm, but they are readily describable nonetheless.
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J.Kimmelman, Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation (New York, NY: Cambridge University Press, 2009). Recent controversy about the so-called Chinese CRISPR babies has only reinforced the need to change that popular and dangerous view of research progress. See, e.g., two summaries of these claims and responses to it that provide an overview: S. Begley and A. Joseph, “The “CRISPR Shocker: How Genome Editing Scientist He Jiankui Rose from Obscurity to Stun the World,” STAT, Dec. 17, 2018, available at <https://www.statnews.com/2018/12/17/crispr-shocker-genome-editing-scientist-he-jiankui/> (last accessed December 26, 2018); E. Yong, “The CRISPR Baby Scandal Gets Worse by the Day,” The Atlantic, Dec. 4, 2018, available at <https://www.theatlantic.com/science/archive/2018/12/15-worrying-things-about-crispr-babies-scandal/577234/> (last accessed December 27, 2018).
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J.Wilbanks, “Design Issues in E-Consent,”Journal of Law, Medicine & Ethics46, no. 1 (2018): 110-118.
