An Argument for Reinterpreting the Benign Behavioral Intervention Exemption

Author:

Tully Ian1

Affiliation:

1. Hecht‐Levi Postdoctoral Fellow in the Berman Institute for Bioethics at Johns Hopkins University

Publisher

Wiley

Subject

Health (social science)

Reference20 articles.

1. Long-Sought Research Deregulation Is upon Us. Don't Squander the Moment;Shweder R. A.;Chronicle of Higher Education,2017

2. 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.

3. Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts

4. Protection of Human Subjects 45 C.F.R. 46.104(3ii)(2018).

5. Ibid.

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