November 5, 2004

Group validates human subjects protection efforts

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Group validates human subjects protection efforts

Vanderbilt University's program to protect human research participants was recently stamped with a seal of approval. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) awarded full accreditation to Vanderbilt, the 13th organization to achieve this status.

“I am very pleased that Vanderbilt has been recognized as one of the first major research intensive institutions to fulfill the substantial requirements necessary to obtain full AAHRPP accreditation,” said Jeffrey R. Balser, M.D., Ph.D., associate vice chancellor for Research.

“This accomplishment has been realized through the combined contributions of the Institutional Review Board (IRB) administrative staff led by Robin Ginn and Denise Roe, the dedication of substantial time and effort from our four IRB standing committees and through the acquisition of the necessary substantial resources from the University.”

AAHRPP accreditation is voluntary and includes a self-assessment process and on-site evaluation by peer reviewers. The process evaluates the entire program of human research participant protection, of which the IRB is the largest part, said Ginn, M.B.A., executive director of Research Informatics and Regulatory Affairs.

Ginn and Gordon R. Bernard, M.D., medical director of the IRB and assistant vice chancellor for Research, have directed a major overhaul of IRB operations since 1999. “We have completely revamped the human research protections program here at Vanderbilt, and this accreditation is proof of what we have accomplished,” Ginn said.

AAHRPP's premise, Ginn said, is that voluntary accreditation and oversight by an accrediting body is one of the best strategies for making research as safe as possible. Vanderbilt will submit annual reports and must be re-accredited every three years.

“AAHRPP accreditation shows regulatory agencies and the public that we maintain high ethical standards and we are committed to self-regulation and continuous quality improvement,” Ginn said. q

The accreditation may make research projects at Vanderbilt more attractive to potential human participants and to industry sponsors.