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November 1, 2004

Health Center to Seek New Accreditation
for Human Subjects Research

With more than 300 researchers conducting nearly 600 studies, the Health Center has embarked on a process to apply for a new voluntary accreditation of its procedures to protect people who participate in its studies.

Accreditation by the Association for the Accreditation of Human Research Protection Programs “is a purely voluntary but highly prestigious accreditation,” says Dr. Richard Simon, director of the Health Center’s Human Subjects Protections Office. “Seeking it is a good mechanism to thoroughly evaluate all aspects of our program and to demonstrate to the public and to research sponsors that the program meets or exceeds the highest standards.”

The accreditation process entails a meticulous review of all policies and procedures related to the use of human subjects in research studies and clinical trials.

Thirteen institutions have received full accreditation from the AAHRPP since it was founded in 2001. The association’s goal is to ensure greater consistency of high standards for the protection of human research participants and ensure that scientific research can continue to grow and flourish.

The AAHRPP was founded by seven organizations representing the leadership of universities, medical schools, and teaching hospitals; biomedical, behavioral, and social scientists; and patient and disease advocacy organizations.

The accreditation process will look at five different areas, or domains, of the Health Center’s research program: the organization as a whole, the research review unit, the investigators, the sponsors, and the participants. Each of these domains is divided into standards and elements, each of which needs a written statement and policy to demonstrate compliance.

“It’s a mammoth undertaking that involves looking at all our policies and practices, dotting i’s and crossing t’s, and then making sure everyone is aware of those policies and adhering to them,” says Simon.

Deborah Gibb, administrative manager of the Human Subjects Protections Office, says, “A lot of the standards are steps we already take or procedures we already follow, but we do them intuitively. Now we have to spell out all the steps and procedures and document our compliance.”

For example, one of the domains includes detailed requirements for two committees of the Internal Review Board and qualifications for membership on the committees. “We have been doing it properly but we haven’t had all the supporting paperwork in place,” says Gibb. “Now we will focus on the paperwork.”

Adds Simon, “We can’t just say that all our research subjects are informed about their participation in a research study. We have to document their understanding of the purposes of the study and their awareness that they have the right to drop out at any time.”

A new education program will proactively reach out to all Health Center investigators involved with human research. All new hires at the Health Center who are involved in research on humans will be contacted soon after they arrive, so they can participate in an education/training program.

The accreditation process involves a self-assessment that requires comprehensive information concerning the type of research conducted at the Health Center and its policies governing the protection of research participants. Surveyors from the AAHRPP evaluate all the information and conduct a site visit that lasts up to a week and involves interviews with officials, administrators, staff, Internal Review Board members, researchers, and others.

The Health Center began the self-assessment part of the process about a year and a half ago. The site visit is expected to take place in the spring or summer.

Says Simon, “We believe the accreditation process will validate our program.”