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NIH went under the microscope for ten days in December and January, when a team from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), evaluated clinical research programs as part of a pilot to develop an accreditation process for human subjects research.
AAHRPP is a nonprofit organization that offers accreditation to institutions engaged in research involving human participants. It was incorporated in April 2001 to ensure that scientific research can continue to grow and flourish under conditions in which the best interests of research participants will be protected.
“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,” said Dr. Michael Gottesman, deputy director for Intramural Research.
The accreditation process involves two steps: rigorous self-assessment, followed by a site visit from AAHRPP accreditors. The voluntary, peer-driven, and educationally focused accreditation process aims to foster a culture of conscience and responsibility within institutions seeking its services.
The team sat in on 13 NIH Institutional Review Board sessions and interviewed senior officials, clinical directors, including Clinical Center Director Dr. John Gallin, investigators, and research staffs of each Institute. The team also met with Clinical Center employees from the Pharmacy Department, Patient Representative Office, and Protocol Coordination Service Center.
Mark Brenner, vice president for research, Indiana University, Bloomington, and vice chancellor for research and graduate studies, Indiana University-Purdue University, chaired the evaluation team. Five other experts in human subjects protection, a clinical investigator and institutional officials who deal with clinical research, completed the team.
Highlights of individual practices within the Clinical Center, such as the standards for clinical research were recognized as being an enhancement to human subjects research.
“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,” said Dr. Gottesman.