Bioethics Blogs

My NPRM Comments

Perhaps 2016 will be the year when OHRP makes good on its 2007 promise to “give more guidance on how to make the decision on what is research and what is not,” in the form of a promulgated revision to the Common Rule. If so, Happy New Year, OHRP!

Wth these hopes, I have submitted my own comments on the NPRM. I have posted a copy of the PDF I submitted, and below is a web version with links.

Zachary M. Schrag. Comments on Notice of Proposed Rulemaking: 
Federal Policy for the Protection of Human Subjects. 1 January 2016

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. However, I wish to draw attention to some of the limits of the proposals, particularly in the areas of due process protections, empirical research, and revision in light of experience.

The Common Rule should adhere to statutory law

  • HHS and other regulatory agencies lack the authority to regulate research in the humanities and social sciences

The NPRM cites as its statutory authority 42 U.S.C. 289, which applies to “biomedical or behavioral research involving human subjects,” and does not mention social science or research in the humanities. As the NPRM acknowledges, “some of the commenters [on the ANPRM] recommended that the definition of research be focused more explicitly by being limited to ‘biomedical and behavioral research,’ in accordance with the statutory provision underlying the Common Rule.” But it makes no effort to focus the definition or to explain why the drafters felt comfortable ignoring this part of the statute.

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.