A national accreditation group gave USC top marks this summer for the university’s program to protect those who volunteer to take part in research studies.

On June 26, the university announced that it received full accreditation from the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP). This voluntary accreditation process ensures that institutions that perform research on human subjects adhere to rigorous standards of accountability.

“USC is committed to the highest ethical standards, without exception, as it carries out state-of-the-art research involving human subjects,” said C. L. Max Nikias, USC's provost and senior vice president for academic affairs. “For this reason, our academic community can take great pride in this milestone.

“This is a relatively new accreditation process that requires a significant commitment of resources and time; however, we believe that every top research university should elect to undergo this process, so that the public can be assured that strong ethical guidelines are in place for all research that is performed by that institution.”

USC President Steven B. Sample paved the way for the creation of national standards that were consistent with USC's own code of ethics. As past chairman of the Association of American Universities, a consortium of North America's 63 leading research universities, and as co-chair of an AAU task force on research accountability, Sample advocated a voluntary, peer-driven research-accountability process. This led to the establishment of AAHRPP and its voluntary accreditation process.

In accrediting USC, AAHRPP praised the university's communication tools for human-subject research, which have been adopted by numerous other institutions nationally. The agency also commended USC's internal human-subjects educational programs for faculty, students and staff.

Randolph Hall, the vice provost for research advancement who oversees human subject research, gives much of the credit for USC’s successful bid for accreditation to the dedicated efforts of Susan Rose, executive director of the university’s Office for the Protection of Research Subjects (OPRS). “This has been an enormously detailed and time-consuming process, something that Susan has worked on for almost two years,” Hall said.

In addition to their education and communication efforts, Rose’s office implements the policies for the human subjects protection program and provides oversight to USC’s four Institutional Review Boards (IRB), which review faculty- and student-generated protocols for studies using human participants. The workload is heavy — currently, the IRBs have 2,936 active protocol submissions on file.

“At USC, we do a wide range of human subject research — from invasive medical trials that might involve surgery or new drug treatments to the other extreme, such as opinion surveys with individuals,” Hall said. “Our job is to ensure that all of the human research projects undertaken here are ethically sound and that participants understand any potential risks as well as possible benefits of the study.”

Hall also noted recent improvements the university has made to the project review process. Investigators now submit protocols electronically. The University Park Institutional Review Board has been revamped. And, the university has undergone a shift in philosophy. “Now, we focus on being more of a service operation than simply a policing unit. More of our effort goes into educating researchers about the guidelines,” Hall said.

Through the intensive accreditation process, organizations must be able to demonstrate that extensive safeguards are built into every level of their research operation. AAHRPP standards exceed federal regulations: The protections for research participants that the federal government requires only for federally sponsored or regulated research are extended to all research. AAHRPP requires additional protections, such as conflict-of-interest-rules and community education. Accreditation is maintained through annual reporting and a site review every three years.

The list of research institutions accredited by AAHRPP now includes 68 organizations. The list is comprised of organizations in the biomedical and behavioral and social sciences research fields, including community hospitals, teaching hospitals, independent review boards, research institutes, contract research organizations and universities. AAHRPP is currently working with nearly 400 organizations that are in the accreditation process.

For more information about AAHRPP accreditation, visit http://www.aahrpp.org