February 2, 2001

Daniel Federman, M.D., Chair
Committee on Assessing the System 
for Protecting Human Research Subjects
ATTN: Dr. Laura Lyman Rodriguez
Board on Health Sciences Policy
The National Academies
2101 Constitution Avenue, NW FO-3108
Washington, D.C. 20418

Dear Dr. Federman:

I am writing to comment on the draft accreditation standards being considered by the Committee on Assessing the System for Protecting Human Research Subjects.  The American Anthropological Association (AAA) is a member organization of the Consortium of Social Science Associations (COSSA) and supports the testimony presented by COSSA to the Committee by Dr. Felice Levine.  The AAA supports the testimony presented by the National Science Foundation to the Committee by Dr. Philip Rubin.  I would like to add a few comments to stress some of the points made in these testimonies and to address additional concerns. 

Firstly, the AAA supports the goal of promoting and protecting the health, safety and well being of human subjects in research.  Anthropology, the study of all aspects of humankind, is committed to respecting the dignity of all human beings.  Protecting human subjects in research has long been a concern of anthropology and the AAA.  For more than 30 years, the AAA has had formal ethical guidelines in place to educate anthropologists about the ethical obligations and challenges they face in research. 

The draft accreditation standards developed by PRIM&R propose changes in the IRB review process.  In addition to standardizing IRBs through an accreditation process, the draft standards propose certification of IRB members and investigators.  While the intent of these changes (more competent review and conduct of research) is good, the means raise concerns.  The draft standards reflect a, perhaps unintended, bias toward biomedical research in clinical settings.  Yet the impact of the proposed changes would affect a diversity of disciplines.  

We are concerned that the Committee, along with the National Bioethics Advisory Committee, and the Department of Health and Human Services Office for Human Subjects Protection are moving quickly to put into place an oversight system without thoughtful input or reflection by the diverse disciplines affected by the proposed changes.  While the rapidity of revising the oversight system may be to ensure that recent abuses to human subjects in high risk research do not happen again, the remedy may unintentionally harm the disciplines that conduct no to minimal risk research like the social and behavioral sciences.  We urge the Committee to deliberate longer in developing accreditation standards and make every effort to seek input from the diverse disciplines affected by the proposed standards.

The AAA supports the goal of educating IRB members and investigators as well as students who will be future investigators.  AAA's current Code of Ethics is an educational document, and AAA's Committee on Ethics is committed to educate members on the ethics of anthropological research.  Certification in the proposed standards is viewed as the means of demonstrating competence in the protection of human subjects.  We are concerned that certification standards and testing may serve the biomedical research community, and that social and behavioral science perspectives and concerns may be absent.  Further, it will be important to ensure that investigators and IRB members understand fully the ramifications of human subjects? protection and not merely be interested in passing a test to secure certification.

The draft standards refer to inclusion of nonscientists and community representatives on the IRB.  The establishment of institutional ties to the communities potentially under study is a worthy goal.  Yet the number of research proposals and diversity of disciplines will require technical expertise and representation by the various research fields to ensure appropriate and fair IRB review.  We recommend the inclusion of social and behavioral scientists on IRBs and/or the establishment of separate IRBs for social and behavioral science research.

Thank you for the opportunity to comment on the draft standards.  Please let me know if AAA may be of additional assistance.

       Sincerely yours,  

       Mary Margaret Overbey, Ph.D.
       Director of Government Relations