September 29, 2008
Michael A. Carome, M.D., Captain
U.S. Public Health Service
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Dear Dr. Carome:
On behalf of the American Historical Association, I thank the Office for Human Research Protections for inviting comments on “Implementation of Human Subjects Protection Training and Education Programs” [July 1, 2008 (Volume 73, Number 127)]. We write to express two specific concerns about the request. First, we are concerned that the proposed training program will reinforce the tendency to treat all research as if it was conducted in the experimental sciences. And our second concern is that the proposed training program would only cover what should be assessed by the review boards, and does not include room for discerning among different types of research methods.
As we have noted in past comments to OHRP (most recently on December 26, 2007), we are troubled about the inconsistent and uneven application of HHS policies to our discipline. With regard to the questions under section 1, about the implementation of current policies of training, we can only reiterate the reports from our members and staff noting the widely varied treatment of faculty in our field. It is not clear to us whether this is a problem inherent in the OHRP’s regulations or the training of the review board members and staff. Either way, it seems possible that the proposed training program could serve as a necessary remedy—potentially promoting some uniformity from institution to institution.
However, greater uniformity could also exacerbate the problems caused by the recent extension of review board coverage over methods remote from the experimental sciences. The Request in the Federal Register reinforces that concern, by describing proposed training methods for review board members using terms from the hard sciences, most notably when it asks (under 3d) “whether training should be tailored according to an individual’s role in the clinical research process.” The approaches and criteria of experimental sciences are generally inappropriate for the assessment of research in our discipline. If the OHRP mandates and designs education programs for board members and staff, it is imperative that some portion of the training include discernment about how to treat methods of research that are quite different from the experimental sciences in their methods and goals.
If OHRP proceeds to mandate a training program, we feel that it should include training that distinguishes between the experimental sciences and the humanities. To that extent, we are troubled that question 3b fails to suggest that the training and education recommendations or requirements may differ depending upon the subjects being reviewed, as well trainees work experience.
We endorse the approach developed by the Social and Behavioral Sciences Working Group on Human Research Protections of the National Human Research Protections Advisory Committee in the early 2000s. Rather than trying to impose a single curriculum on a wide range of scholarly disciplines, the working group prepared a separate list of readings for each discipline. Giving social researchers materials relevant to the ethical challenges they face, and eliminating irrelevant readings about medical and psychological experiments, will protect the rights and welfare of participants in research while fostering the mutual trust and respect sought by IRBs and investigators alike.
Finally, we note that in the experience of many of our members, institutional review boards rarely meet the requirement in 45 CFR 46.107 that the IRB will “include persons knowledgeable” in the areas under review. OHRP should make clear than an IRB whose members are unwilling to learn the methods and ethics of each discipline it reviews is not compliant with the Common Rule.
We continue to hope that OHRP will reissue its 2003 statement on oral history in clearer form, providing unambiguous exclusion of oral history from IRB jurisdiction on the grounds that it is does not meet the federal definition of generalizable research under the Common Rule. But until that time, we hope that OHRP will not impose a training regime that exacerbates the problems in disciplines such as ours.
We thank you for inviting comments on the proposed revisions, and are available for any further comments or clarifications of these remarks.
Sincerely,
Arnita A. Jones,
Executive Director