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. 2021 Jul;43(4):20-26.
doi: 10.1002/eahr.500096.

An Argument for Reinterpreting the Benign Behavioral Intervention Exemption

Ian Tully  1
Affiliations

An Argument for Reinterpreting the Benign Behavioral Intervention Exemption

Ian Tully. Ethics Hum Res. 2021 Jul.

Abstract

Recent changes to the Common Rule have helped reduce regulatory burden on researchers conducting minimal risk research. However, in this paper, I propose a way of minimizing burden further within the existing confines of the current regulations. I focus my discussion on the newly created "benign behavioral interventions" category of exempt research, arguing that this exemption from the federal regulations governing research with human subjects should be more expansively interpreted by the Secretary's Advisory Committee on Human Research Protections (SACHRP) than is currently the case. Specifically, I argue against the restriction, advocated by SACHRP, that the exemption exclude "physical (bodily) tasks" unless they are "incidental to the behavioral intervention." This restriction, I argue, is problematically vague and does no significant moral work. Acceptance of my proposed reinterpretation of "benign behavioral interventions" would, I hope, result in a significant reduction in regulatory burden for minimal risk research.

Keywords: Common Rule; IRB; exempt research; human research ethics; institutional review board; regulatory burden; research oversight.

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References

    1. Shweder, R. A., and R. E. Nisbett, “Long-Sought Research Deregulation Is upon Us. Don't Squander the Moment,” Chronicle of Higher Education 63, no. 28 (2017): A44.
    1. Protection of Human Subjects, 45 C.F.R. 46 (2018). As I'll explain later, “no regulatory oversight at all” is a bit misleading: many institutions require the submission of “exempt applications” so that their IRBs can make a formal determination that the proposed research is indeed exempt from further oversight. Moreover, the revised statute includes a provision for so-called limited review, which I'll also explain later. One major benefit of an exempt determination, however, is that exempt research does not require a consent document, which can be a huge timesaver.
    1. Infectious Diseases Society of America, “Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts,” Clinical Infectious Diseases 49, no. 3 (2009): 328-35.
    1. Protection of Human Subjects, 45 C.F.R. 46.104(3ii) (2018).
    1. Ibid.

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