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Updated 10:00 AM June 8, 2009

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Forum aims to reduce regulatory burden in human research studies

Finding ways to trim the time and cost involved in complying with "red tape" without compromising the safety of participants in human research studies inspired a recent forum at the Ann Arbor campus.

"Reducing Regulatory Burden: Real Strategies for Real Change," co-hosted by the federal Office for Human Research Protections and U-M, drew more than 400 participants from across the country in mid-May.

The conference focused on novel approaches to Institutional Review Board (IRB) activities, proposed regulatory changes, and ways to use the flexibility within human research regulations as avenues to decreasing regulatory burdens for researchers and IRBs.

"This was a wonderful opportunity to demonstrate U-M's commitment to facilitating human research by showcasing our efforts to streamline regulatory burden," says Judy Nowack, associate vice president for research and director of the Human Research Protections Program.

One streamlining project being conducted at U-M allows two-year approval for some projects. The research must present minimal risk to subjects and not be federally funded. Projects governed by the detailed federal process must reapply for approval every year. The two-year approval cuts the workload for IRBs and for research teams without reducing subject safety, says Judith Birk, manager of the IRB Health and Behavioral Sciences.

Representatives from the Office for Human Research Protections, the National Institutes of Health, the U.S. Food and Drug Administration, the National Science Foundation, and the Secretary's Advisory Committee on Human Research Protections provided updates on the regulatory initiatives. Throughout the day, the agency representatives also participated in open forum discussions.

Participants represented all parties in human subjects research, including research investigators, clinical study coordinators, IRB members and staff, agency officials, public health officials, and patient advocates.

Presentations from the forum are available by going to

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