AAA Commentary on Proposed Changes to the Common Rule

January 11, 2016

On the AAA’s behalf, Rena Lederman (Princeton University) and Lise Dobrin (University of Virginia) have submitted a commentary on a Notice of Proposed Rulemaking (NPRM) that seeks to dramatically overhaul the federal regulations for the protection of human subjects.

The AAA commentary:

• Emphasizes the need for the regulation to mention specifically anthropology’s core scholarly methodology, participant observation.
• Provides arguments for “exempting” or even “excluding” participant observation from the revised regulations.
• Points out that the ethical conduct of anthropological research requires sensitivity to context, which runs counter to the proposed rule’s insistence on adherence to a common set of privacy safeguards irrespective of the situation (including the wishes of the participants).
• Supports proposals that would allow greater flexibility in obtaining and documenting informed consent.
• Supports a proposal to treat human blood, tissue samples, and other biospecimens as aspects of persons that call for ethical protection, meaning that research on them would not be allowed to proceed without permission.

Read the full commentary (PDF).  

Excerpts of the AAA's comment have been posted to the AAA Ethics blog. 

Background:

In 2015, the U.S. Department of Health and Human Services (HHS), along with several other federal agencies, published a long-awaited proposal to dramatically overhaul the “Common Rule,” the federal regulations for the protection of human subjects. This NPRM has consequences for much anthropological research. (You can read the NPRM as it was published in the Federal Register here; you can also read a brief summary of its major proposals prepared by the federal Office for Human Research Protections here.)

When HHS published an earlier rule change proposal in 2011, Lederman and Dobrin authored the American Anthropological Association’s response, after soliciting advice and input from AAA sections and members. You can read the 2011 AAA response here.

A period of public comment on the new proposed changes closed on January 6, 2016. After again soliciting advice and input from the anthropological community, Lederman and Dobrin submitted the AAA’s commentary on this NPRM.

Anthropologists have not been well served by a regulatory framework that overlooks their core methodology. We hope that the positive suggestions made in the AAA’s NPRM commentary will influence HHS to make regulatory changes that better support anthropologists’ deep engagement with the ethical questions raised by their research.