Outside review under way of university’s safeguards for human research subjects
BY ADITI RISBUD
For years, researchers at Stanford have gone beyond state and federal requirements in their efforts to protect human research subjects. Now the university is seeking the "gold seal" of approval for the safeguards it has put in place.
The university has invited a team of experts from an outside agency to visit the campus in December and conduct a thorough review of its policies and practices involving scientific investigations with humans. The panel from the Association for the Accreditation of Human Research Protection Programs is part of a recent initiative by the group to provide accreditation to institutions that have adopted strong systems to protect the human participants in research studies.
The evaluation of the Human Research Protection Program at Stanford will have the reviewers covering a lot of territory. The program oversees not only studies at the university, but also those at Stanford Hospital & Clinics, Lucile Packard Children's Hospital, the Veterans Affairs Palo Alto Health Care System and Palo Alto Institute for Research and Education.
Arthur Bienenstock, PhD, vice provost and dean of research and graduate policy, heads up the Stanford program. He and associate dean of research Ann Arvin, MD, the Lucile Salter Packard Professor of Pediatrics, have been leading a committee that is preparing for the review. "We expect that the process of evaluation by this expert panel will help us to maintain the highest standards for our program," said Arvin.
The accreditation process is voluntary and was launched a few years ago, after AAHRPP was incorporated as a non-profit organization in Maryland. Following the on-site visit to Stanford, the AAHRP will conduct a council review and then notify the university of its accreditation status.
Stanford's application was sent to the AAHRPP in September, containing approximately 2,300 pages of documentation about the human research protection program. "They already know us before setting foot on campus," said program administrator Barbara Arnoldussen. "We are welcoming them. Stanford really wants to be at the cutting edge of how people are protected, and it is a great opportunity to show how comprehensive our program is."
The review will be led by Robin C. Ginn of Vanderbilt University. Other members of the review team are: Anne N. Hirshfield, PhD, George Washington University; David R. Segal, PhD, University of Maryland, and Jeffrey H. Silverstein, MD, Mount Sinai School of Medicine.
Stanford researchers and officials selected to speak with the site visitors will be notified in advance of the review; questions will focus on the mechanisms in place to protect research participants in both individual research programs and broader Stanford organizations.
The evaluation consists of five "domains" used by AAHRPP to grant accreditation of human research programs: organization (how responsibilities are met), research review unit (including institutional review boards), investigators (those who conduct the research), sponsored research (those who fund research) and participant outreach (the involvement of participants at every stage of research).
According to its Web site, AAHRPP "establishes a 'gold seal' signifying adherence to a rigorous set of human protection standards, helping to ensure consistency and uniformity among all institutions conducting biomedical, behavioral and social sciences research."
To date, AAHRPP has accredited 27 U.S. organizations. A Sept. 21 news release from the group reports that it aims to have completed the accreditation process for the nation's top academic research organizations in the next two to four years.
Founding members of the AAHRPP include the Association of American Medical Colleges, Association of American Universities, Consortium of Social Science Associations and Public Responsibility in Medicine and Research.
Aditi Risbud is a science-writing intern in the Office of Communication & Public Affairs at the School of Medicine.
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