Back to Front PageVOLUME 6, NUMBER 4

New Association to Accredit Human Research Protection Programs

By Barbara A. Gabriel

David Korn, M.D., had reservations at first. In general, universities are not eager to embrace yet another accreditation process. He knew from his years spent as dean of the Stanford University School of Medicine that seeking campus-wide or school accreditation is often a long, tedious, and expensive ordeal. But clearly something had to be done.

Institutions engaging in research involving human participants - especially academic medical centers - were under attack for lax supervision that had led to isolated cases with tragic consequences. The fact that institutional review boards (IRBs) are increasingly overworked and underfunded as well as the growing sense that ensuring the protection of human participants should be a responsibility shared by more than just IRBs made clear the need for a new system of oversight and guidance.

And so Dr. Korn, AAMC senior vice president for biomedical and health sciences research, began to talk to Public Responsibility in Medicine and Research (PRIM&R), an organization with which the AAMC had partnered to provide workshops and seminars on human research protections. PRIM&R had begun in 1999 to develop standards on human research protections for institutional programs with the goal of incorporating those standards into an accreditation process. The AAMC began discussions with PRIM&R about how it could help launch such an initiative. Thus the foundation for what was to become the Association for the Accreditation for Human Research Protection Programs (AAHRPP) was laid.

According to Sanford Chodosh, M.D., associate professor of medicine at the Boston University School of Medicine and president of PRIM&R, the newly incorporated nonprofit organization known as AAHRPP has the objective of developing an accreditation system for human research protection programs that is voluntary, peer-driven, and educational. The organization, whose efforts are aimed primarily but not exclusively at universities and academic medical centers, plans to start pilot testing its standards by late summer and be fully operational in January 2002.

Because the accreditation process is voluntary, Dr. Korn maintains that institutions will be motivated by their desire to raise the bar in human research protections instead of being held to a minimum threshold of mandatory requirements. And because AAHRPP is peer-driven, accreditors will be known to the people at the institution they are evaluating, helping to foster a "culture of compliance."

Finally, by addressing areas marked for improvement in a manner that provides education and guidance, AAHRPP puts to rest the image of surly, unforgiving inspectors armed with checklists. "By becoming the 'gold seal' signifying adherence to a high set of protection standards, AAHRPP will raise public confidence in human participants research and ensure consistency among the institutions conducting such research," Dr. Korn says.

By the time AAHRPP was incorporated in April 2001, PRIM&R and the AAMC had attracted five additional nonprofit founding members: the Association of American Universities, the Consortium of Social Science Associations (COSSA), the Federation of American Societies for Experimental Biology, the National Association of State Universities and Land Grant Colleges, and the National Health Council.

Dr. Chodosh explains that the new organization will be governed by a board of directors. The board, which will have total responsibility for overseeing the accreditation process, will be made up of 21 individuals, including representatives from member groups, associations and organizations concerned with human participants research, and five public representatives of patient advocacy organizations, ethnic minorities, and others. AAHRPP's members will have exclusive responsibility for the organization's corporate and fiscal health.

The accreditors will be people who, according to Dr. Korn, "have made careers out of working, teaching, and promoting human research protections." Dr. Chodosh says these people will be largely drawn from members of PRIM&R and the Applied Research Ethics National Association as well as the nonbiomedical research community represented by COSSA.

Dr. Chodosh explains that the accreditation process will begin when AAHRPP is approached by an institution. The institution will then be sent an application that requires comprehensive information concerning the type of research it conducts and its policies governing the protection of human participants. Site surveyors will examine all of the information provided by the institution and arrange a site visit.

"Accreditors will look for very specific details, such as protocols; they will interview IRB members, IRB chairs, research administrators, institutional officials, and investigators," Dr. Chodosh says. The resulting report will advise granting or denying accreditation or contain specific recommendations that AAHRPP will provide guidance on. Final decisions on accreditation will be made by the board of directors.

The new organization will initially be located in Rockville, Md., where it will share office space with the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), a nonprofit organization that promotes the humane treatment of animals in science through a voluntary accreditation program. AAHRPP is largely modeled on AAALAC's successful framework.

The value of accreditation was recently affirmed by the Institute of Medicine in its report "Preserving Public Trust: Accreditation and Human Research Participant Protection Programs." It confirmed that strengthening the system responsible for protecting participants in human research studies could be accomplished in part by the implementation of accrediting programs that certify that research entities meet certain performance standards.

"An accreditation process affords an opportunity for entities engaged in human research to demonstrate their commitment to responsible conduct of research and to achieve a standard of excellence that exceeds minimal regulatory requirements," says Greg Koski, M.D., Ph.D., director of the Office for Human Research Protections.

"In doing so, they send a message to their investigators and their participants, to their sponsors and their communities that demonstrates their commitment to ensuring that the research is done right," he continues. "This helps to not only preserve but actually build and reinforce the public's confidence and trust in the research endeavor to which we all look with hope for better, healthier, happier lives."

 

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11 June 2001