Bioethics Blogs

My NPRM Response. Draft 1.

Though the deadline for commenting on the NPRM has been extended until January 6, I post here a draft of my comments in the hopes that they may help others craft theirs and send me feedback on mine.

Jerry Menikoff, M.D., J.D.

Office for Human Research Protections (OHRP)

Department of Health and Human Services

Dear Dr. Menikoff:

Thank you for the opportunity to comment on the September 8 notice of proposed rulemaking: Federal Policy for the Protection of Human Subjects, docket ID number HHS–OPHS–2015–0008.

I write these comments as the author of “How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965–1991,” Journal of Policy History 21 (2009): 3- 37, and Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 (Baltimore: Johns Hopkins University Press, 2010), and as the editor of the Institutional Review Blog, http://www.institutionalreviewblog.com, all of which were graciously cited in the NPRM.

Most recently, in November 2015, I participated as a panelist in the Chicago round of the workshops on “Revising and Expanding the Scope of the Common Rule,” sponsored by the CTSA Consortium Coordinating Center (C4). I also offered assistance to the drafters of the comments on the NPRM submitted by the National Coalition for History, and I endorse those comments.

In addition, I wish to offer the attached observations, which reflect only my views and may not represent those of historians’ organizations, George Mason University, or any other institution.

Comments on Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects

The proposed rule is designed “to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” So far as research in the social sciences and humanities is concerned, several of its provisions are likely to achieve these goals, so I applaud this effort and look forward to the final rule.

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.