Bioethics Blogs

Final Rule, three months later

It’s been three months since the announcement of the new Common Rule. Some reactions so far:

Shweder and Nisbett hope for vast deregulation

On March 12, Richard A. Shweder and Richard E. Nisbett published an essay in the Chronicle of Higher Education celebrating the new final rule:

in January the federal government opened the door for universities to deregulate vast portions of research in the social sciences, law, and the humanities. This long-sought and welcome reform of the regulations requiring administrative oversight of federally funded human-subject research on college campuses limits the scope of institutional review board, or IRB, management by exempting low-risk research with human subjects from the board’s review.

In particular, they wrote that “the overhauled policy … holds that exempted research activities should be excused from board review with no requirement of IRB approval of the exemption.”

[Richard A. Shweder and Richard E. Nisbett, “Long-Sought Research Deregulation Is Upon Us. Don’t Squander the MomentChronicle of Higher Education, March 12, 2017.

Meyer asks, what’s new?

On March 16, Michelle N. Meyer tweeted a GIF showing that several of the provisions cheered by Shweder and Nisbett have been part of the regulations for decades. Indeed, since 2009, OHRP has grudgingly acknowledged that the Common Rule allows researchers to make exemption determinations. The problem has been persuading universities to take advantage of these longstanding provisions.

On the other hand, Meyer notes that the liberation of oral history is new, and that the exemption for “benign behavioral interventions” is, in her terms, “new & awesome.”

(GIF re-posted here with Meyer’s permission.)

Comments posted to the Chronicle website made similar points.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.