to the office of human research protections

So other people with a longer list of credentials than I have wrote far more articulate responses to the proposed changes in federal oversight for research involving human subjects that I wrote about last week. You can read two such responses at the American Historical Association blog and at historian and oral history advocate Zachary Schrag's Institutional Review Blog. If this is something that interests you, I highly recommend checking out their letters in full.

But since this is a blog dedicated to my own oral history project, I thought I would share my own response here. If a PDF is more convenient for you, I've made one available via DropBox.

LETTER SUBMITTED TO THE OFFICE OF HUMAN RESEARCH PROTECTIONS


Anna J. Cook
Assistant Reference Librarian
Massachusetts Historical Society
1154 Boylston St.
Boston, MA 02215

21 October 2011

Office of Human Research Protections
1101 Wootton Parkway
Suite 200
Rockville, MD 20852

To Whom it May Concern:

I am contacting you as special collections librarian and practicing historian with experience conducting oral historical research.

I am writing you today because of my concern over several aspects of the proposed changes to IRB oversight of research involving human subjects. Research “involving human subjects” encompasses much of humanities research, including historians, and many of us are concerned that the proposed changes could have the (perhaps unintended) consequence of irreparably thinning the rich body of primary source materials upon which we rely on for our scholarship – all in the name of curtailing “information risk.”

I am a member of the Oral History Association and the American Historical Association, and I hold a Master of Science in Library Science and a Master of Art in History. For my Master’s thesis I designed and conducted an oral history project documenting the founding of an off-campus study program in the mid-1970s, with the approval of the Institutional Review Board of Simmons College (Boston, Mass.). In designing my research project, I followed the best practices guidelines set forth by the Oral History Association. I was fortunate to work with an IRB panel familiar with the particular professional standards of oral historical work. As Zachary Schrag has documented, in his recent book Ethical Imperialism (Johns Hopkins, 2010), this is often not the case.

The interviewees whose stories I record all give explicit informed consent to participate in the research project. Integral to their consent is the understanding that their interviews would be made available for research in both recorded and transcript form when I deposit those interviews in an archival repository. Their names and identifying details are a necessary part of both their personal stories and the larger historical narrative which I am constructing about the off-campus study program which they established. In my profession, it is essential that the evidence upon which I base my historical claims be verifiable and accessible to future researchers. If I were required to obscure the details of a person’s identity or destroy the oral
historical interview following publication, my work would not be considered professionally acceptable in my field. Yet these are the type of requirements routinely made in the context of biomedical and social science research – which the IRB system justifiably oversees.

Your recommendation that HIPAA standards be applied more broadly highlights the danger of a “one size fits all” approach to protection of personal information. As a historian and librarian who works regularly with archival material containing intimate personal details, I have seen first-hand how application of HIPAA regulations to manuscript collections and archival records has stymied important historical research in the name of patient privacy – even when the individuals in question are generations behind us – at times, over a century deceased.

Historical research, and more specifically oral historical research, was never intended to fall under Institutional Review Board oversight. As both the AHA and the OHA have made clear, this is not an indication that the field is except from the rigorous demand of professional standards – but an acknowledgment that oral history already has its own principles and best practices that govern the conduct of oral histories in an ethically responsible way. Our standards are applied in fundamentally different ways than the scientific procedures and criteria administered by IRBs, and to explicitly exclude historical and oral historical research from the IRB mandate would be to correct the mis-application of IRB authority in a sphere where they are often ill-equipped to provide guidance.

I thank you for making it possible for the public to provide feedback on the suggested changes, and I urge you to listen to the recommendations of practitioners in the field who have a clear view to how these proposed changes can effect the practice of history for generations to come.

Sincerely,
Anna

Anna J. Cook, M.A., M.L.S.
Assistant Reference Librarian
Massachusetts Historical Society