Stanford Report, March 22, 2006

Human research protection program wins accrediting group's highest rating

BY RUTHANN RICHTER

After a rigorous review, Stanford has won full accreditation from the Association for the Accreditation of Human Research Protection Programs, considered the gold standard for participant safety in research trials.

To obtain the association's stamp of approval, an organization must show that it has comprehensive safeguards to protect human subjects and ensure integrity in its research program. The group's standards are more stringent than federal law in that they apply to all research programs—whether federally sponsored or not—and require additional protections, such as conflict-of-interest rules and community education.

The AAHRPP found that Stanford passed with distinction in three regards: its written plan describing the protection of research participants, its policy and procedure for recognizing and managing organizational conflicts of interests and the education of its investigators, IRB members and staff.

Stanford is one of 35 organizations to be recognized by AAHRPP and one of three academic institutions on the West Coast with full accreditation. Another 365 organizations now are seeking accreditation, according to the independent, nonprofit agency. The national program, which is voluntary, was founded in 2001 by a number of groups, including the Association of American Medical Colleges and Public Responsibility in Medicine and Research.

"Everyone who has gone through this review is impressed with AAHRPP's quality," said Arthur Bienenstock, PhD, vice provost and dean of research and graduate policy. "If the accrediting process is subscribed to by all the relevant institutions, then we will gain assurance that human research participants in this country are appropriately protected."

Stanford began the intensive process over a year ago and submitted 2,300 pages of material to the AAHRPP in September. The university then hosted a team of on-site reviewers in December, who spent four days interviewing faculty, students and administrators. The review included studies done not only at the university, but at Stanford Hospital & Clinics, Lucile Packard Children's Hospital, the Veterans Affairs Palo Alto Health Care System and the Palo Alto Institute for Research and Education.

The reviewers looked at every aspect of human research, including the process of obtaining informed consent, special protections for children, outreach to participants and how Stanford deals with problems that might arise during research studies, said Kathy McClelland, the university's research compliance director, who led the effort.

"It's a very thorough process, and I think it certainly takes huge institutional commitment, which Stanford has," McClelland said. "The commitment came from the very top."

Ann Arvin, MD, associate dean of research, said the reviewers have paid particular attention to whether an institution has a culture that values participant safety and has people at all levels who are fully aware of the requirements.

"The AAHRPP review provided an objective and critical evaluation of our processes to protect human subjects and of how we communicate with people involved in human subject research," said Arvin, the Lucile Salter Packard Professor of Pediatrics and Microbiology & Immunology. "We felt we had an excellent program but it is always extremely valuable to have an outside assessment. So we're delighted they found our program to be as robust and thorough as we thought it was."

Stanford has one of the largest biomedical research programs in the country, with more than 4,000 active studies in humans. Some 75 percent of these studies are conducted at the School of Medicine, which had a sponsored-research budget of $352 million in 2005. The medical school is No. 1 in the nation in research dollars per investigator.

Arvin said the review process was a valuable learning experience for the advisory panel members who helped prepare for and participated in the site visit. "As with any review, we had an opportunity to think about our processes, and we made improvements that built on the solid foundation of safeguards for human subject research that we had."

Bienenstock noted that the process also alerted him to the need to add staff and space to oversee the growing number of research studies at Stanford.