EVALUATING THE INTRAMURAL HUMAN SUBJECTS PROTECTION PROGRAM:
THE BEGINNING OF A NEW ACCREDITATION PROCESS

Michael Gottesman

Clinical research at NIH is conducted under the eye of a complex oversight system that was formulated in response to legal and regulatory requirements and international ethical standards. The system reflects the strong belief of our scientific staff that research with human participants is a special partnership.

Research involving humans has come under increasing scrutiny in the past several years. The HHS Office for Human Research Protections has suspended clinical protocols at such institutions as Duke University in Durham, N.C., and the Johns Hopkins University School of Medicine in Baltimore for deficiencies in their institutional review boards (IRBs) and procedures to protect human subjects.

These events have generated some rethinking about how best to protect participants in clinical trials. We have accelerated efforts to develop an accreditation process for programs dedicated to the protection of human research subjects.

Institutional oversight of NIH intramural clinical research is my responsibility as deputy director for intramural research. Key roles are also played by the director of the Clinical Center, John Gallin; the scientific directors and clinical directors of the NIH institutes; NIH’s 14 IRBs; the Office of Human Subjects Research (OHSR) under the direction of Alan Sandler; and clinical investigators, research staff, and many others. The policies and procedures governing the human research program are found in the NIH Multiple Project Assurance and the Clinical Center’s Medical Administrative Series; in various other documents, such as Protomechanics; and on the OHSR’s and Clinical Center’s websites.

Although various components of the NIH program engage in ongoing self-evaluation, the program as a whole has never been systematically evaluated by outside experts—and until recently there has not been an organization qualified to conduct such an evaluation.

Now, however, a new, nonprofit organization called the Association for the Accreditation of Human Research Protection Programs (AAHRPP) has been established. It will offer voluntary evaluation and accreditation of human research protection programs based on a set of written performance standards. These standards address five domains: (1) the organization, (2) IRBs, (3) research investigators and research staff, (4) research sponsors, and (5) research subjects and participants.

AAHRPP has not yet begun its formal accreditation activities, but will start pilot site visits in December 2001. The NIH Intramural Research Program will be the first of three pilot sites for evaluation. This pilot visit, starting on December 10, will help NIH prepare for human subjects accreditation in the future and will also help AAHRPP test its draft performance standards and evaluation procedures.

The OHSR is preparing a pre–site visit application based on the AAHRPP’s draft standards. Copies of the application will be available to the intramural community well before the visit and OHSR will also prepare briefing materials specifically for IRBs, clinical directors, and others to highlight the areas of concern to the review team. This is an excellent opportunity for all members of the intramural community to brush up on their knowledge of human subjects research through our computer-based training course, with more specialized training for IRB members available at this website.

The AAHRPP site visitors will be interviewing the Clinical Center director, institute clinical directors, IRB chairs and members, principal investigators, and others, as well as me. They will visit various departments in the Clinical Center, observe IRB meetings, and review protocols and other relevant documents. They will also visit NIDA in Baltimore and NIEHS in Research Triangle Park, N.C. Their interviews and visits will be scheduled in advance, and individuals involved will have ample time to prepare. Their observations and conclusions will be submitted in a confidential report to the deputy director for intramural research.

I strongly believe that the NIH IRP has an excellent human research protection program, with knowledgeable and responsible investigators conducting cutting edge research in keeping with federal regulations and the NIH Multiple Project Assurance. Our program will become even better as Standards for Clinical Research within the NIH Intramural Program are fully implemented in all institutes.

As with all programs, however, there is room for improvement, and this pilot site visit—which is not to be confused with an FDA or other regulatory "for-cause" audit or inspection—should be viewed as a constructive, collegial exercise that will benefit both the NIH and AAHRPP. We seek the cooperation of the NIH community in welcoming these site visitors to our campus so that we can demonstrate the strengths of our program, learn how to improve it, and prepare for a formal accreditation visit in the future.

If you have any questions or would like more information about AAHRPP standards or any of NIH’s human protection policies, please call OHSR at 301-402-3444.

—Michael Gottesman
Deputy Director for Intramural Research

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