Wednesday, July 15, 2009

AAHRPP Proposes Revised Standards

Robert Townsend, PhD, kindly alerted me to the Proposed Revised Accreditation Standards of the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The revisions are largely cosmetic, grouping many of the existing standards under new headings. As far as the review of social science and humanities research goes, I see no drastic departures from previous AAHRPP positions. This is a pity, since the standards need more substantive revision to meet the goals that AAHRPP has set for itself.

AAHRPP is accepting comments until July 30. My comment follows.

To the AAHRPP,

Thank you for the opportunity to comment on your proposed revised accreditation standards. If enforced, these standards would provide researchers with some protections against arbitrary actions by IRBs and human research protections staff. But they fail to look at the bigger picture and ask why so elaborate a structure is necessary to oversee areas of research with sparse record of doing wrong, or whose ethical challenges are too unpredictable to be spotted in advance by an ethics committee. Moreover, the standards fail to take seriously the suggestions of some of the most informed critics of the present structure.

Researchers in the social sciences and humanities have long complained that their work was being reviewed by committees that lacked the necessary expertise. I am therefore glad to see that Element II of the new standards requires that "the IRB or EC has and follows written policies and procedures requiring protocols or research plans to be reviewed by individuals with appropriate scientific or scholarly expertise . . . " It also insists that "the IRB or EC is comprised of members to permit appropriate representation at the meeting for the types of research under review, and this is reflected on the IRB or EC roster," a criterion currently violated by most IRBs that review ethnographic and humanities research.

I would like to suggest that Element II be strengthened by requiring IRBs and ECs to base their evaluations on documented benefits and risks. Many committees demand precautions against risks that are largely chimerical, such as the possibility that an interview will re-traumatize victims of earlier trauma. As noted in the March 2008 issue of the Journal of Empirical Research in Human Research Ethics, empirical study suggests that such people are much more likely to be benefited than harmed by interviews. AAHRPP should insist that IRBs and ECs keep current with such literature and base their judgments on its findings. AAHRPP should also prohibit IRBs and ECs from judging proposals on irrelevant criteria, such as the number of typographical errors in a proposal.

The standards also provide a measure of accountability. Element I.5 insists that "based on objective data, the Organization identifies strengths and weaknesses of the Human Research Protection Program, makes improvements, when necessary, and monitors the effectiveness of the improvements." It also provides that "the Organization has and follows written policies and procedures so that Researchers and Research Staff may bring forward to the Organization concerns or suggestions regarding the Human Research Protection Program, including the ethics review process." Again, many universities currently fail to meet these standards.

I would be more encouraged by these standards if AAHRPP would pledge to enforce them. I suggest that as part of its system of maintaining accreditation, AAHRPP establish a mechanism by which researchers can bring violations of these elements directly to the attention of the association. Researchers at accredited institutions should be guaranteed that AAHRPP will investigate their complaints.

More significantly, I am disappointed to see that the proposed standards reject two of the most prominent suggestions for taming overregulation put forward by IRB critics: allowing researchers to apply clearly worded exemptions to their own research, and limiting the application of federal rules to federally-funded research. AAHRPP promises policies and procedures based on "objective criteria and measurable outcomes." What objective criteria suggest that researchers cannot apply the exemptions, or that federal regulations are necessary for all research?

Prominent members of the IRB community, including a former director of OHRP, and current members of SACHRP, have conceded that overregulation and hyper-protectionism are problems that must be addressed. Restoring the exemptions of 45 CFR 46 to their original intent, and allowing institutions to experiment with ways to oversee non-federally-funded research, are among the most constructive suggestions put forward to address these problems. The proposed standards reject these proposals out of hand. In doing so, they fail to meet AAHRPP's professed ideal of performance-based policies.

Finally, while you have not sought comment on your current Accreditation Principles, let me express my hope that you will find some room in them for the promotion of academic freedom. A university or research center that fails to incorporate this ideal into its human research protection system cannot be faithful to its core mission.

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