There Oughta Be a Law: When Does(n’t) the U.S. Common Rule Apply?

Author:

Meyer Michelle N.

Abstract

Using mobile health (mHealth) research as an extended example, this article provides an overview of when the Common Rule “applies” to a variety of activities, what might be meant when one says that the Common Rule does or does not “apply,” the extent to which these different meanings of “apply” matter, and, when the Common Rule does apply (however that term is defined), how it applies.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference109 articles.

1. 25. See White House, “Administration Discussion Draft: Consumer Privacy Bill of Rights Act of 2015,” February 27, 2015, available at (last visited January 20, 2020). The criteria resemble the Common Rule’s criteria for waiving consent. See infra Part III.

2. The historical foundations of the research-practice distinction in bioethics

3. 24. Consumer Privacy Protection Act of 2015, S. 1158, 114th Cong.

4. 91. 45 C.F.R. §46.104(d)(8)(iv).

5. 42. Id., at 7-8.

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