Posted on September 22nd, 2015 by Blog Administrator
Anthropologists’ Input Needed! Proposed Federal Changes to the Common Rule (IRB Regulations) Are Finally Published and Await Public Comment
On Tuesday, September 8, 2015 the U.S. Department of Health and Human Services (HHS), along with several other federal agencies, published its long-awaited proposal for a dramatic overhaul of the federal regulations for the protection of human subjects (http://www.gpo.gov/fdsys/pkg/
FR-2015-09-08/pdf/2015-21756. pdf). Appearing in the Federal Register, this proposal takes the form of a “Notice of Proposed Rulemaking” or NPRM. Publication of an NPRM is a key stage in the process by which U.S. federal regulations are developed and implemented, during which federal agencies solicit public commentary from interested individuals and organizations. The comment period on this NPRM closes 5 pm, December 7, after which HHS administrators will begin the multi-year process of finalizing the new rules.
Anthropological research is heavily impacted by IRB regulations. This NPRM public commentary period is an opportunity for anthropologists to make our voices heard to persuade HHS to implement changes that acknowledge the intellectual value and ethical character of our discipline’s scholarship. In 2011, when HHS published an earlier version of these proposed changes for public comment, Rena Lederman (Princeton University) and Lise Dobrin (University of Virginia) authored the American Anthropological Association’s response, after soliciting advice and input from AAA sections and members. You can read that 2011 response here: http://www.aaanet.org/
Lederman and Dobrin have agreed to draft the AAA’s commentary on the NPRM as well, and they need your input for the comment to represent members’ concerns. You are encouraged to study the NPRM, a detailed and intricately argued document. Please send your analyses and reflections concerning its implications for anthropological work across all subfields directly to Lederman ([email protected]) and Dobrin ([email protected]), and/or to the AAA’s Ethics blog. Individual anthropologists and anthropological organizations may also send comments directly to HHS (information about how to do that is contained in the NPRM, p. 53933, at the Federal Register link above).
While anthropologists have been writing about the impacts of IRB regulations on ethnographic research ever since those regulations were introduced in the 1970s, this NPRM is brand new and there are no substantive anthropological responses as yet. While HHS has disseminated a summary highlighting what it construes as the NPRM’s most significant elements; and while other responses and analyses have begun to appear expressing the perspectives of IRB professional organizations, legal scholarship, and others, they do not directly address the needs of our discipline. Your contributions to the AAA Ethics blog and advice to Dobrin/Lederman (who will also post to the blog) will help right the balance.
Filed under: IRBs