The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort.
Get full access to this article
View all access options for this article.
References
1.
Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period, 82 Federal Register 28497, 28500-01 (final rule, June 19, 2018).
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, U.S. Department of Health, Education, and Welfare, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Bethesda MD: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978): 5-6.
5.
Federal Policy for the Protection of Human Subjects, 82 Federal Register 7149, 7265 (final rule, January 19, 2017).
6.
Id. at 7266.
7.
Id.
8.
Id. at 7264.
9.
See generally S.Stern, “R. v. Jones (1703): The Origins of the ‘Reasonable Person,’” in P.Handler, H.Martin, and I.Williams, eds., Landmark Cases in Criminal Law (Oxford, UK: Hart Publishing, 2017): at 59-79.
10.
O.Ben-Shahart and A.Porat, “Personalizing Negligence Law,”New York University Law Review91, no. 3 (2016): 627-688, 628 (reasonable person standard “requires people to behave in the prudent way that … the ordinary, typical member of the community observes”).
11.
A.Rose, “The ‘Reasonable Investor’ of Federal Securities Law: Insights from Tort Law's ‘Reasonable Person’ and Suggested Reforms,”Journal of Corporation Law43, no. 1 (2017): 77-118, at 104 (juries seen as competent to make general negligence determinations because personal experience allows them to apply realistic judgments to situations they are familiar with).
12.
See N.King, “The Reasonable Patient and the Healer,”Wake Forest Law Review50, no. 2 (2015): 343-361, at 346-347.
13.
J.Berg, P.Appelbaum, C.Lidz, and L.Parker, Informed Consent: Legal Theory and Clinical Practice (New York: Oxford University Press, 2d ed. 2001): 133.
14.
Id. at 46-47.
15.
Id. at 46-49.
16.
Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).
17.
Berget al., Informed Consent, supra note 13, at 49.
18.
See Berget al., Informed Consent, supra note 13, at 50; King, “The Reasonable Patient,” supra note 12, at 351-352.
19.
See King, “The Reasonable Patient,”supra note 12, at 353-54 (important ethical implication of reasonable person standard is not its impact in lawsuits, which look at cases retrospectively, but how it shapes what clinicians disclose in their interactions with patients).
20.
National Commission, Belmont Report, supra note 4, at 5.
21.
Id. at 5-6.
22.
Id. at 6.
23.
R.Veatch, “Three Theories of Informed Consent: Philosophical Foundations and Policy Implications,”Appendix II: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Bethesda MD: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978): 29.
24.
Id. at 32. The revised Common Rule's adoption of the reasonable person standard should not discourage researchers from supplying individual prospective subjects with the additional information they seek. Indeed, the Common Rule provision establishing the reasonable person standard directs researchers to give prospective subjects “an opportunity to discuss the study information” that is disclosed. Such discussions can open the door to additional questions from individuals with particular information needs. Federal Policy for the Protection of Human Subjects, 82 Federal Register 7149, 7265 (final rule, January 19, 2017).
25.
The consent jury would be composed of nonscientists considering study information presented by “expert advocates” arguing for and against disclosure of each anticipated study risk. The jury would then decide which risks should be disclosed to prospective subjects. See R.Levine, “The Nature and Definition of Informed Consent in Various Research Settings,”Appendix II: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Bethesda MD: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978): 20-21.
26.
This approach would involve assembling a group of layper-sons with backgrounds similar to those of prospective subjects, presenting them with a hypothetical protocol resembling a specific proposed study, then interviewing them to elicit their comments and questions about the protocol. N.Fost, “A Surrogate System for Informed Consent,”JAMA233, no. 7 (1975): 800-803.
27.
Veatch, “Three Theories of Informed Consent,”supra note 23, at 30-31. See also R. Veatch, “Human Experimentation Committees: Professional or Representative?” Hastings Center Report 5, no. 5 (1975): 31-40.
28.
L.Stark, Behind Closed Doors: IRBs and the Making of Ethical Research (Chicago: University of Chicago Press, 2012): 15.
29.
Id.
30.
Id. at 14. See also L.Odwazny and B.Berkman, “The ‘Reasonable Person’ Standard for Research Informed Consent,”American Journal of Bioethics17, no. 7 (2017): 49-51.
31.
C.Lidzet al., “The Participation of Community Members on Medical IRBs,”Journal of Empirical Research on Human Research Ethics7, no. 1 (2012): 1-8, 6; S. Sengupta and B. Lo, “The Role and Experiences of Nonaffiliated and Non-Scientist Members of Institutional Review Boards,” Academic Medicine 78, no. 2 (2003): 212-218.
32.
A.Cook, H.Hoas, and J.Joyner, “The Protector and the Protected: What Regulators and Researchers Can Learn from IRB Members and Subjects,”Narrative Inquiry in Bioethics3, no. 1 (2013): 51-65, 60.
33.
R.Dresser, “Personal Knowledge and Study Participation,”Journal of Medical Ethics40, no. 7 (2014): 471-474.
34.
Id. See also E.Anderson, “A Qualitative Study of Non-Affiliated, Non-Scientist Institutional Review Board Members,”Accountability in Research13, no. 2 (2006): 135-151.
35.
The controversy over the SUPPORT study is an example of problems with the existing approach to ascertaining what prospective subjects would want to know. Much of the debate involved researchers and bioethicists voicing competing claims about the risks that should have been disclosed to parents considering study participation. The claims relied on experts' assumptions about what should be disclosed to parents, rather than on information about what parents in similar situations would want to know. See B. Furlow, “SUPPORT Controversy's Lessons for Informed Consent,” Lancet Respiratory Medicine 3, no. 12 (2015): 928-929.
36.
Gearhart, “Reasonable Person,”supra note 2, at 3. See also J. Greenblum and R. Hubbard, “The Common Rule's ‘Reasonable Person’ Standard for Informed Consent,” Bioethics 33, no. 2 (2019): 274-277; J. Sugarman, “Examining Provisions Related to Consent in the Revised Common Rule,” American Journal of Bioethics 17, no. 7 (2017): 22-26.
37.
Rose, “‘Reasonable Investor’ of Federal Securities Law,”supra note 11, at 103.
38.
Berget al., Informed Consent, supra note 13, at 49.
39.
Odwazny and Berkman, “‘Reasonable Person’ Standard for Research,”supra note 30, at 50.
40.
See H.Lynch, E.Largent, and D.Zarin, “Reaping the Bounty of Publicly Available Clinical Trial Consent Forms, IRB: Ethics & Human Research39, no. 6 (2017): 10-15; C. Coleman, “Rationalizing Risk Assessment in Human Subject Research,” Arizona Law Review 46, no. 1 (2004): 1-51.
41.
Federal Policy for the Protection of Human Subjects, 82 Federal Register 7149, 7267 (final rule, January 19, 2017). See also Greenblum and Hubbard, supra note 36, at 4 (new regulatory requirement for centralized single IRBs will increase IRB members' awareness of other institutions' consent forms and guidelines).
42.
See for example Ben-Shahart and Porat, “Personalizing Negligence Law,”supra note 10 (courts considering negligence should be permitted to “subjectify” the standard of care, based on information available through advanced information tools).
43.
See A.Porat and L.Strahilevitz, “Personalizing Default Rules and Disclosure with Big Data,”Michigan Law Review112, no. 8 (2014): 1417-1478.
44.
A.MacLean, “Giving the Reasonable Patient a Voice: Information Disclosure and the Relevance of Empirical Evidence,”Medical Law International7, no. 1 (2005): 1-40. See also B. Main, A. McNair, and J. Blazeby, “Informed Consent and the Reasonable-Patient Standard,” Journal of the American Medical Association 316, no. 9 (2016): 952-953.
45.
R.Kostet al., “Assessing Research Participants' Perceptions of Their Research Experiences,”Clinical and Translational Science4, no. 6 (2011): 403-413, 409.
46.
R.Dresser, Silent Partners: Human Subjects and Research Ethics (Oxford: Oxford University Press, 2017).
47.
A.Wertheimer, “Non-Completion and Informed Consent,”Journal of Medical Ethics49, no. 2 (2014): 127-130.
48.
Cooket al., “Protector and Protected,”supra note 32, at 61.
49.
A.Motluk, “Diary of a Lab Rat,”New Scientist196, no. 2633 (2007): 38-41; K. Cox, “Enhancing Cancer Clinical Trial Management: Recommendations from a Qualitative Study of Trial Participants' Experiences,” Psycho-Oncology 9, no. 4 (2000): 314-322.
50.
A.Cook and H.Hoas, “Trading Places: What the Research Participant Can Tell the Investigator about Informed Consent,”Journal of Clinical and Research Bioethics2, no. 8 (2011): 1-7, 5.
51.
C.Behrendtet al., “What Do Our Patients Understand about Their Trial Participation? Assessing Patients' Understanding of Their Informed Consent Consultation about Randomized Clinical Trials,”Journal of Medical Ethics37, no. 2 (2011): 74-80, at 78.
52.
See M.Ederet al., “Improving Informed Consent: Suggestions from Parents of Children with Leukemia,”Pediatrics119, no. 4 (2007): e849-59; Y. Unguro, A. Sill, and N. Kamini, “Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent,” Pediatrics 125, no. 4 (2010): e876-83.
53.
For more on this topic, see Dresser, Silent Partners, supra note 46; R. Dresser, “Research Information for Reasonable People,” Hastings Center Report 48, no. 6 (2018): 3-4; R. Dresser, “Experimentation without Representation,” IRB: Ethics & Human Research 40, no. 4 (2018): 3-7.
