April 2002
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AAHRPP: Advancing Human Protection in Research

By Marjorie Speers, Ph.D., Executive Director, Association for the Accreditation of Human Research Protection Programs, Inc.

I'm very pleased to report that the Association for the Accreditation of Human Research Protection Programs, Inc., or AAHRPP - the first organization with the specific purpose of accrediting human research protection programs - has moved swiftly over the last several months to establish itself.

We disseminated a set of draft standards and procedures for public review and comment. We tested those standards during several pilot site visits, including one for the intramural program at the National Institutes of Health. We installed a board of directors that has meaningful representation of all major stakeholders in the research process: researchers, administrators of both human participant protection programs and the parent institutions in which they reside, and the public - the five public members represent either research participants or consumer advocates. We revised the standards and procedures based on both public comment and the pilot site visits, and they were approved by the AAHRPP board.

What does this all mean? It means we have built a strong foundation for assisting the research community in continuously improving its efforts to protect the rights and welfare of research participants. This voluntary self- regulation by the research community, along with oversight by an accrediting body, is one of our best strategies for making research as safe as it possibly can be.

Here are the specific steps involved in AAHRPP accreditation:

1. An applicant organization completes a self-assessment, in which it reviews and modifies its human research protection program according to AAHRPP standards, ultimately submitting a program description to AAHRPP as part of the application.
2. AAHRPP site visitors conduct an on-site evaluation. Site visitor teams are made up of experts in human research protection, researchers, institutional officials, and members of the public.
3. The site visitors produce a report that is reviewed by AAHRPP's Council on Accreditation, which makes a determination regarding accreditation. The council's determination is then approved by the board of directors, and the organization is notified. If accredited, an organization's accreditation is valid for three years.
4. Between triennial visits, accredited organizations submit annual reports and AAHRPP notifies accredited organizations about new developments in regulations and best practices.
5. Renewal of accreditation involves a repeat of the self-assessment and the on-site evaluation.

AAHRPP's standards are broad and flexible so as to be meaningful to a full range of research types, from clinical and social science, to historical and business research. The standards can be applied in different settings, such as universities, hospitals, government agencies, and companies. The standards meet all regulatory requirements and, in some cases, exceed them.

AAHRPP recognizes that ensuring the safety and protection of research participants is not, and cannot, be the sole responsibility of IRBs. Therefore, entities seeking accreditation must meet standards in five different domains: organization, IRB, investigator, sponsor, and participant.

A notable characteristic of this new organization is that public representatives, in addition to other important stakeholders, have been at the table during each and every deliberation. The public has the most to gain or lose from accreditation; therefore, its representatives will continue to be involved in every step of the accreditation process.

It's well known that academic medical centers and other institutions that conduct clinical research are hard-pressed for resources to enhance their oversight activities. The National Institutes of Health recently recognized this need explicitly with the creation of the Human Subjects Research Enhancements Program, a much-needed, flexible initiative that will fund a wide variety of activities, all aimed at improving the protection of research participants. What we all share is the recognition that public confidence in the safety of research is shaken. To the extent that we can demonstrate our commitment to the safety and welfare of research participants - in AAHRPP's case, by recognizing that an institution has processes in place for continuously improving its human research program - the more likely we are to ensure that clinical research flourishes.

Academic medical centers have much to gain from AAHRPP accreditation. I encourage you to seek further information on our Web site, www.aahrpp.org, where an application is also available. I, or a member of my staff, would also be happy to discuss the accreditation process with you.

I look forward to working with you in reaching our collective goal: maintaining and growing a robust research enterprise, one that does its utmost to protect those who participate in it as volunteers.

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