EVALUATION OF THE NIH HUMAN RESEARCH SUBJECTS PROTECTION PROGRAM:
FIRST IMPRESSIONS

Michael Gottesman

For ten days in December and January, NIH itself became a research subject. Our clinical research programs were evaluated by a site visit team from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) as part of a pilot program to develop and assess accreditation standards for human subjects research programs.

The evaluation team was chaired by Mark Brenner, vice president for research, Indiana University, Bloomington, and vice chancellor for research and graduate studies, Indiana University-Purdue University, Indianapolis, and included five other experts in human subjects protections, institutional officials who deal with clinical research, and a clinical investigator.

The visit afforded NIH the opportunity to receive a candid, confidential assessment of the effectiveness of our human subjects research program, and it enabled AAHRPP to begin to test out its accreditation and site-visit process.

The AAHRPP visitors sat in on the deliberations of 13 of 14 NIH Institutional Review Boards (IRBs; the NIEHS IRB will be evaluated separately). They interviewed senior officials, clinical directors, clinical investigators, and clinical research staff in the Institutes and in the Clinical Center and were impressed, they told us, by the frankness and cordiality of everyone they met at NIH.

They briefed NIH senior leadership and a combined group of Scientific Directors, Clinical Directors, and IRB chairs in separate sessions. Their preliminary report was comprehensive and thoughtful and will serve as a useful guide as we continue to work to improve our program to protect the patients in NIH clinical trials.

The AAHRPP team concluded that NIH has a vigorous and innovative clinical research program, with a strong culture of support for human subject research protections to which the NIH leadership and investigators are committed.

Because of the large number of IRBs at NIH, the visitors were able to evaluate a substantial number of clinical protocols in detail. They highlighted many best practices of individual NIH programs and were impressed overall by our standards for clinical research, training programs, and central policies and support activities, which enhance our human subjects research.

They liked the fact that IRB members are generally in close contact with investigators and therefore knowledgeable about their strengths and weaknesses and can make informed decisions about the risk of specific research activities in the NIH environment.

They also suggested ways we could clarify and codify our overall policy. Given the large number of IRBs, it is not surprising that they saw some inefficiencies and some variability in workload and staffing that need attention.

Some tips on how to avoid future problems in our program were presented at the briefings, but more will follow once AAHRPP has had a chance to review the findings and make formal recommendations.

I am grateful to our clinical investigators and to the staff involved in human subjects research protections for their facilitating of this site visit. As soon as we have a more complete evaluation, we will meet with you to decide how to capitalize on this evaluation and create an even better human subjects research protection program.

—Michael Gottesman

Deputy Director for Intramural Research

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