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New Accrediting Organization for Human Research Protection

by Marjorie Spears, Association for the Accreditation of Human Research Protection Programs, Inc.

The suspensions of assurances and federally funded research at major research institutions and the death of Jesse Gelsinger in September 1999 at the University of Pennsylvania was a wake-up call that something had gone wrong with the current oversight system for protecting human research participants. Two years later another death at the Johns Hopkins University School of Medicine prompted the Office for Human Research Protections (OHRP) to conduct a for-cause site visit that resulted surprisingly in the suspension of the university’s assurance and research in the medical school. Many asked how this could have happened at one of the best medical schools in the country—especially after two years of close scrutiny of research institutions and severe penalty for regulatory noncompliance by the federal government. The relevant issue is not why this happened at Johns Hopkins, but rather what can the research community do to prevent further shutdowns of research programs.

One response is the founding of the Association of the Accreditation for Human Research Protection Programs, Inc. (AAHRPP), a nonprofit organization that seeks to accredit organizations engaged in human research. Its founding members are the Association of American Medical Colleges (AAMC), Association of American Universities (AAU), Consortium of Social Science Associations (COSSA), Federation of American Societies for Experimental Biology (FASEB), National Association of State Universities and Land-Grant Colleges (NASULGC), National Health Council (NHC), and Public Responsibility in Medicine and Research (PRIM&R). COSSA, in particular, but also AAU and NASULGC were invited to be founding members to ensure that the interests and needs reflect those of the social sciences, humanities, and other non-medical types of research (e.g. business or engineering).

Since its inception, AAHRPP has involved social scientists. COSSA nominated three individuals to serve on the board of directors: Robert Hauck, Deputy Executive Director, American Political Science Association; Barbara Bailar, a retired statistician with a distinguished career at the National Opinion Research Center, University of Chicago; and Steven Smith, a lawyer who is the Dean of California Western School of Law. In addition, social scientists worked closely with AAHRPP when it developed its interim standards and are working on the final revisions.

When the interim standards and procedures are finalized, AAHRPP believes that its accreditation program will be beneficial to social scientists and their research activities. How could such an outcome possibly turn out to be true, especially given the insensitivities to the social sciences dating back to the promulgation of the Department of Health and Human Services (DHHS) regulations (45 CFR 46) in 1981?

First, accreditation by AAHRPP is voluntary. It is not required by the federal government. AAHRPP operates on the assumption that institutions seek accreditation because they are committed to protecting the rights and welfare of human research participants. They want to change their institutional culture and behavior, not merely comply with federal regulations. The voluntary nature of accreditation permits AAHRPP to use a set of standards that makes sense for all the research disciplines. It is our intention to use standards that are broad and flexible, and can be measured in ways that are appropriate for different types of research. For example, the evaluation of protections in a clinical trial is different from the evaluation of appropriate protections in a survey.

Further, because AAHRPP is not tied to the federal government, it offers the fullest confidentiality permitted by law to institutions on discussing their human research protection programs. Having the assurance that no AAHRPP representative will disclose any information to anyone other than the institution demonstrates AAHRPP’s commitment to working with institutions to improve their protection programs. Second, site visits will be conducted and accreditation decisions will be made by a group of individuals that includes expertise in the social sciences. Site visitors will represent IRBs, researchers, institutional officials, and the perspectives of participants in research. Researchers on site visit teams will be social scientists when universities without medical schools are visited, and researchers on site visit teams will include social scientists when universities with medical schools are visited. Following a visit, the site visit team will submit a report of its findings to AAHRPP’s Council on Accreditation that will be comprised of experienced site visitors, again including social scientists. Thus, site evaluations and accreditation decisions of human research protection programs for social research will be made by those who conduct and review social science research.

Accreditation is not a panacea that will cure the ills of the current oversight system, but it is a time-tested method for improving program quality. It offers several benefits that can directly affect researchers. It can demonstrate to the public and the federal government the commitment of research institutions to provide protections to research participants. Surely it is better than more regulation from the federal government that is more likely to stifle the research enterprise and add little to the protection of research participants. In addition, researchers can feel assured that when their institutions are accredited, their institutions are supporting research and providing the necessary infrastructure. For example, government inspections, when they do occur, should be less onerous and frequent. But, more importantly, researchers can be confident they are doing all the things they can to conduct ethical research. Over time, the public will come to rely upon the integrity that accreditation carries and be more willing to support research by enrolling in research at accredited institutions and to advocate for the use of public funds for research.

The success of AAHRPP’s accreditation program will depend in part on the involvement of social scientists. If you are interested in learning more about AAHRPP or in being involved with its accreditation program, please contact Dr. Marjorie Speers at mspeers@aahrpp.org.

Marjorie A. Speers, a psychologist, is Executive Director of the Association for the Accreditation of Human Research Protection Programs, Inc.