Episode 26: When is Informed Consent Unnecessary?

Image by Courtney Chrystal, J.D. candidate, Harvard Law School

In this episode of Proof Over Precedent, the fourth in a series on Ethics in the Law, host Jim Greiner talks again with IRB expert Shannon Sewards to discuss the complexities and criteria involved in obtaining waivers of informed consent within the realm of social science and legal research, comparing it to the regulations governing medical research. The two dive into an A2J Lab study on pretrial risk assessment tools to use as an example in determining the necessity of obtaining informed consent. When does protecting study participants take precedence, and when do critical research needs supersede those of participants?

Read the corresponding blog post.

Speakers:

• Shannon Sewards, Director of the Human Research Protection Program, Dartmouth Health; former Director, Harvard University Area IRB
• Jim Greiner, Honorable S. William Green Professor of Public Law at Harvard Law School; Faculty Director of the Access to Justice Lab at Harvard Law School

Resources mentioned:

• General Requirements for Informed Consent (45 C.F.R § 46.116)
• General Waiver or Alteration of Consent (45 C.F.R § 46.116(f)
• Office of Human Research Protection
• Common Rule (45 C.F.R § 46(a)

Related “Ethics in the Law” series episodes:

• Episode 8: Ethics in Research — IRBs and the Common Rule Explained
• Episode 10: What is Human Subjects Research in Law?
• Episode 14: Ethical Conundrums in Legal Research

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Proof Over Precedent cover art by Courtney Chrystal