Back to Front PageVOLUME 6, NUMBER 4

Readers Respond

The AAMC and several other national organizations have announced their support for new accrediting body for human research participant programs, a concept also recently endorsed by the Institute of Medicine. What impact will an accrediting effort have on clinical research?

In general, we support the concept as both logical and necessary. We do have two concerns. First, the accreditation process must be fair to both academic and nonacademic entities. We see risk that such a program, if not carefully designed, will become yet one more disincentive for industry to use academic centers for clinical trials. Second, the process must be properly funded. Programs must be able to recover new costs in gaining accreditation to sponsors, including government as well as industry.
Daniel Schuster, M.D.
Professor of Medicine and Radiology
Associate Dean of Clinical Research
Director, Center for Clinical Studies
Washington University School of Medicine

The impact on clinical research of an accreditation process will likely be the same as the effect LCME accreditation has had on medical education and other forms of accreditation have had on educational organizations. That impact has both a positive and negative side to it, but on balance I am in favor of accreditation in those areas where we already have experienced it. I am in favor of accreditation for clinical research, because the high variability in compliance with government regulations has left institutions at the mercy of a particular agency, and the net result has been a serious loss of public credibility in our enterprises. I think it is high time to step in with a well-designed accreditation process, leaving the government agency to focus upon serious compliance and other matters.
Roger Bulger, M.D.
President
Association of Academic Health Centers

This is a subject whose time has come. With all the focus on clinical trials outside medical schools and the possible and known instances of fraud, there should be at least an organization that tests the knowledge of human study researchers in much the same way that the Public Health Service has decreed for Responsible Conduct of Research policy.
J. Stanley Smith, M.D.
Director, Clinical Trials Office
Pennsylvania State University

The various proposals on IRB accreditation being debated are heavily weighted toward training and improving the IRB review/approval process. These are important issues, and adoption of an accreditation system for human research protection will undoubtedly have a positive impact on the process of achieving approval for human research and improve the protection of human subjects. The proposed accrediting schemes do not, however, address the complicated process of designing and conducting clinical research, and, thus, other than improving human subject protections, will not significantly impact the clinical research process per se.
Leonard P. Paplauskas
Associate Vice President for Research
Administration
University of Connecticut Health Center

Why should research programs involving human participants in medicine be treated differently than similar research programs in other fields, none of which (to my knowledge) require such accreditation? It accomplishes nothing, but will create plenty of jobs and paperwork for somebody. The big research institutions, which would no doubt receive accreditation, have been some of the biggest offenders when it comes to research ethics and human subjects protections violations. Accreditation won't solve this problem.
Daryle Gardner-Bonneau, Ph.D.
Principal, Bonneau and Associates

Success of this concept will depend upon the nature of the relationship established between the accrediting body and research programs. Accreditation implies a responsibility for developing procedures for mentorship, benevolent oversight, and mutual respect. If the climate established promotes suspicion, blame, or hectoring, the opportunity for positive outcomes will be lost. The accrediting body has to serve many constituents, including the research subject and the political establishment, but it also must gain the trust of the research community and its sponsoring institutions.
Charles Moldow, M.D.
Senior Associate Dean for Research
and Administration
University of Minnesota Medical School

For academic institutions that receive federal funds, there are already mechanisms to ensure that clinical research participants are treated appropriately. I suspect that more stringent accreditation of such institutions will yield few, if any, additional benefits while dramatically increasing administrative costs. Protection of patients would be most enhanced by accreditation of other independent investigators including free-standing facilities engaged in nonfederally funded pharmaceutical research. However, these facilities would seem less likely to seek accreditation unless it were mandated by the FDA and/or other sponsoring agencies.
Laura Fochtmann, M.D.
State University of New York at Stony Brook

Next month's question:
Should there be systems in place to educate residents and students about appropriate interaction with pharmaceutical companies? If so, what should they be?

Please send your responses (75 words or fewer) to rmuir@aamc.org or fax to (202) 828-1123. Responses must be received by June 13 for consideration, and may be edited for length and clarity. Also, please include your title, institution, and any academic degrees. Select answers will be printed in the July edition of the AAMC Reporter.

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11 June 2001