News Release

July 17, 2006

Contact: Patrick S. Keefe, 860-679-2447
e-mail: keefe@nso.uchc.edu

Health Center Human Research Programs Accredited

Organization Works to Raise the Level of Protection for Research Participants

The University of Connecticut Health Center’s human research participants protection program has been awarded qualified accreditation by the Association for the Accreditation of Human Research Protection Programs, Inc. The Association is a nonprofit entity that works with organizations that conduct human research to raise the level of protection for research participants.

Accreditation means the Health Center’s program not only complies with federal regulations, but has reached performance standards that surpass the threshold of state and federal requirements.

“We’re pleased and gratified to have our program accredited,” said Richard Simon, M.D., director, Human Subjects Protection Office. “The importance of the credential lies in the process leading up to accreditation. The rigorous accreditation process led to many system-wide improvements that provide greater protection for research participants, that facilitate compliance with federal regulations and internal policies, and that ensure the integrity of the research data. Some examples of improvements that we have instituted include a research monitoring program that audits both the IRB review process and the way in which the research is being conducted, the development of a more extensive IRB application that now addresses issues such as conflict of interest management, obligations related to the use of an investigational agents, and protections for vulnerable populations, in greater detail. All of these issues are then factored into the IRB review and deliberation process.”

“Accreditation confirms that policies and safeguards are in place and observed in order to ensure participant safety, the most important factor in human subject research.”

One other academic institution, an international medical center, and a central Institutional Review Board were accredited by AAHRPP’s Council on Accreditation in the June meeting.

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 regulation in two ways: the protections for research participants that the federal government requires only for federally sponsored or regulated research are extended to all research and AAHRPP requires additional protections, such as conflict of interest rules and community education.

The Health Center’s accreditation adds to the growing list of research organizations already accredited by AAHRPP, which now includes 39 organizations with 106 entities. Specifically, 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, and universities. “All of these institutions are nationally and internationally recognized for their extensive research programs and their commitment to human research protection,” said Marjorie A. Speers, Ph.D., executive director, AAHRPP. AAHRPP is currently working with an additional 380 organizations that are in the accreditation process.

“We could not have achieved this accreditation without the support of the Health Center’s leadership, the cooperation of other Health Center areas such as, for example, the Office of Research and Sponsored Programs and the Office of Research Compliance, the professionalism and sincerity demonstrated by our faculty researchers and their staff, and the steadfast commitment of the members of the Institutional Review Board, Scientific Review Committee, Research Adverse Events Committee and the HSPO staff,” said Simon.

To learn more about AAHRPP accreditation, visit www.aahrpp.org.

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