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October 2004
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Increasing Number of Schools Seek AAHRPP "Gold Seal"

Photo fo Marjorie Speers, Ph.D.

Marjorie Speers, Ph.D., AAHRPP Executive Director

By Suria Santana

Three years after its formation, the Association for the Accreditation of Human Research Protection Programs is hard at work. In just five months AAHRPP, which is involved in the accreditation of institutions that conduct human subjects’ research, more than doubled the number of accredited organizations. Between April and August of 2004, it accredited eight institutions.

“We weren’t sure how an institution of such complexity as ours would fare in this process,” said Theodore Cicero, M.D., vice chancellor for research and professor of neurobiology at Washington University School of Medicine. The university received accreditation last August, after nine months of intensive self-study and documentation.

AAHRPP uses a voluntary, peer-driven educational model that includes site visits and a set of rigorous performance standards and outcome measures. Institutions seeking accreditation complete a self-assessment that requires comprehensive information concerning the type of research they conduct and their policies governing the protection of research participants. Surveyors examine all of the information provided by applicant institutions and conduct site visits.

On average, it takes institutions from nine to 12 months to complete a self-assessment, according to Marjorie Speers, Ph.D., AAHRPP’s executive director.

“Seeking accreditation is a good mechanism to improve a program and receive recognition for it,” Dr. Speers said.

Since 2003, AAHRPP has accredited 14 institutions, including the University of Minnesota, the University of Iowa, Cedars-Sinai Medical Center and Washington University in St. Louis. Even though the organization has accredited a relatively small number of institutions, AAHRPP has received close to 200 commitments from programs seeking accreditation, according to Dr. Speers.

In an age of growing public suspicion of the research establishment, institutions seek to have the “gold seal” of groups like AAHRPP to raise confidence in human subjects’ research and ensure a consistent standard among the country’s research programs.

“The process is intense, there is no question, but we found the effort to be very helpful in focusing our attention on the overall research program and the integration of its different components,” said Moira Keane, director of the research subjects protection program at the University of Minnesota. Having to document and articulate the various aspects of her institution’s research programs was a very useful exercise that helped strengthen each of their components, she added.

Dr. Cicero cited a pressing reason why more universities should seek the AAHRPP’s seal of approval.

“It is important that medical schools and universities get into the business of accrediting their human research programs given the recent spate of concern by congressmen about conflicts of interest issues and the adequate protection of human subjects,” he said.

If the academic medicine community does not take an active stance in self-policing, the public might decide that federal regulations are the best way to ensure human subjects protection, Dr. Cicero fears.

“If we don’t do this voluntarily we’ll end up with a one-size-fits-all system imposed on us,” he said.

Considering institutions’ individual cultures and organizational structures such a system would not be in the best interest of human subjects and individual research programs.

Despite concerns, some in the research community are still a little hesitant to embark upon such a laborious effort.

“Some people are very apprehensive about the work that [the accreditation process] would entail, and I think they may not be quite certain if in the end it will be worthwhile,” Dr. Cicero said. In addition, universities usually employ a “wait-and-see” approach to new efforts such as AAHRPP’s, so many might just be waiting until more of their colleagues jump in.

Judging from conversations with colleagues, Keane said that other academicians believe the burden of internal and external review that precedes accreditation is well worth it. Officials at institutions who are preparing an application for accreditation indicated the process would benefit their programs.

“It’s always a bit of a challenge to start down in a new path like this, and accreditation in a lot of venues is not highly regarded,” Keane said. “But most of us believe that this is a great way to demonstrate that we have good, solid research programs.”

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