The UCSF program to protect research participants has gained full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
UCSF is one of 33 institutions nationwide to hold this distinction and is the only West Coast university medical center to do so. Participation in the program by medical institutions is voluntary.
While the U.S. Department of Health and Human Services requires federally funded medical research centers to provide written assurance that all human research is in compliance with federal regulations and is guided by national ethical principles, the AAHRPP assessments are more rigorous and comprehensive.
AAHRPP reviews all programs involving research participants or their biological specimens- not only those that are federally funded -- and its assessment includes additional protections not required by the federal agency, such as community education and quality improvement activities.
The AAHRPP accreditation process took more than a year of preparation and several months of review, including evaluation of complex research protocols and related safety and privacy measures, as well as the caliber of training of investigators and the strength of the institution-wide commitment to human subjects' protection.
In the process, scrutiny was brought to bear on the effectiveness of interactions between various units needed to assure the best protection, such as the institution's investigational drug pharmacy program, clinical research centers, committee examining potential conflicts of interest, office overseeing sponsored research, and overall medical center organization.
More than 200 institutions are currently seeking accreditation in the four-year-old AAHRPP program.
UCSF is one of the largest biomedical research universities in the country, with about 3,600 active research protocols involving human subjects or biological specimens. These can range from federally funded clinical trials of new procedures, drugs or devices to genomics studies aimed at finding links between genetic makeup and specific disease vulnerabilities.
Many studies have contributed to improved treatments for cardiovascular and neurological diseases, cancer, children's diseases, HIV and other infectious diseases.
UCSF was the lead site for clinical trials demonstrating that the monoclonal antibody drug bevacizumab (trade name Avastin) improves the outcome and prolongs life in people with metastatic colon cancer. A series of UCSF studies has allowed doctors to determine the correct doses and delivery of new antiretroviral drugs for infants and children with HIV. Clinical studies have also helped determine the correct doses of drugs to treat HIV-infected pregnant women and to help suppress the transmission of the disease to their unborn infants.
In 2004 UCSF received more than $421 million to support research involving human participants or their medical data, about 80 percent from federal agencies.
"Full accreditation by the AAHRPP is considered the gold standard in assessing the caliber of an institution's program to protect research participants. I am particularly pleased that this recent recognition reflects UCSF's institution-wide commitment to the highest standards," said Eugene Washington, MD, UCSF executive vice chancellor.
"Research involving patients or their medical data provides the foundation for improving human health. Just as important as this long-term medical progress is the need to ensure that, moment to moment, we have the expertise and the programs to fully protect our research patients and their privacy and treat them ethically," he added.
AAHRPP was founded in 2001 as research institutions recognized the increasing need for clear, high standards of excellence beyond the written assurance program in place with the federal government.
UCSF is a leading university that consistently defines health care worldwide by conducting advanced biomedical research, educating graduate students in the life sciences, and providing complex patient care.