University Research Program Achieves Pre-Eminent Accreditation

June 28, 2007

The University of Rochester program that ensures the safety of people who participate in research has received the highest level of accreditation possible.

The Association for the Accreditation of Human Research Protection Programs (AAHRPP), based in Washington, D.C., announced that the University’s Human Subject Protection Program completed a two-year intensive process and received full accreditation. The University of Rochester had to demonstrate that extensive safeguards – exceeding federal regulations -- were built into every level of its research operation.

“All of our volunteers, including people who are ill and seeking to enroll in clinical trials and healthy individuals who participate in survey and interview research, can be assured that their rights and safety are protected in the fullest sense,” said Gary L. Chadwick, Pharm. D., M.P.H., associate provost and director of the Office for Human Subject Protection (OHSP) at the University of Rochester.

Rochester has been a national leader in developing oversight mechanisms for human volunteers who take part in research. Prior to the accreditation process, the University helped write the training manual that was recommended by the U.S. Secretary of Health and Human Services for physician investigators and research scientists. The OHSP also expanded its audit function five years ago, and improved education about the program to doctors, scientists, nurses, patients and other interested local residents.

However, the accreditation process demanded a rigorous self-assessment. It involved the review of hundreds of documents, an on-site visit by the accrediting body and AAHRPP interviews with the University and Medical Center leadership team, key researchers, study coordinators and Research Subjects Review Board (RSRB) members. The RSRB is the committee that reviews all research involving humans at the University to ensure ethical standards are met.

The gold-seal approval of the clinical trials process comes at an important time for the University of Rochester. In October 2006 the National Institutes of Health awarded the University $40 million for a new initiative that would harness medical breakthroughs and move them more quickly from scientists’ laboratories to the treatment stage. Plans call for the construction of a new building to house the Clinical and Translational Science Institute, which will increase the number of research studies launched at the URMC. From June 2005 to June 2006, the RSRB approved approximately 1,600 studies.

“People who participate in clinical research do so because of their altruistic interest in generating knowledge that will help others in the prevention, diagnosis and treatment of disease,” said David S. Guzick, M.D., Ph.D., dean, University of Rochester School of Medicine and Dentistry. “It is of utmost importance that we ensure this research is safe and conducted according to the highest ethical standards. We are pleased that AAHRPP has recognized our program for achieving its rigorous standards of human research practice.”

The AAHRPP process goes beyond federal regulations, as it reviews studies that are typically exempt from oversight by the Department of Health and Human Services and the Food and Drug Administration. The accrediting organization thoroughly scrutinizes the highest risk studies that involve patients diagnosed with cancer, heart disease or HIV/AIDS, for example, as well as behavioral studies involving healthy volunteers and clinical trials with people who agree to serve in control groups.

The AAHRPP is a nonprofit organization. This week it announced that it had accredited the largest number of institutions at one time in the history of the organization. The AAHRPP news release and a list of other accredited institutions can be found at this link: http://www.aahrpp.org/www.aspx?PageID=223

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