Bioethics Blogs

Human Subjects Research “Vulnerability”

by J.S. Blumenthal-Barby, Ph.D., MA

Revisions are being suggested to the Federal Policy for the Protection of Human Subjects through the Notice of Proposed Rulemaking (NPRM). The changes being suggested are numerous (helpful summaries can be found here http://blogs.law.harvard.edu/billofhealth/2015/10/01/nprm-symposium-more-resources-now-from-ohrp/ and here http://blogs.law.harvard.edu/billofhealth/2015/09/30/nprm-symposium-resources-from-primr/). My aim is not to review those changes, but to point out a curious conceptualization of vulnerability affirmed in the NPRM.

Consider the following section (regarding conditions for IRB approval) of the original regulations:

46.111(b) – When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

In the NPRM, this section is proposed to stay the same, and another section is being modified slightly to be consistent with it (suggested modifications to that section are bold italicized):

Section__.107 IRB membership.

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice.

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.