Issue 2

Winter 2003

Wright State Streamlines IRB Approval Process

Clinical investigators who conduct human subjects research at Wright State's affiliated teaching hospitals now have a more streamlined process for obtaining Institutional Review Board (IRB) approval.

The U.S. Office for Human Research Protections (OHRP) approved a new Federal-Wide Assurance filed by Wright State University. The approval is effective through April 30, 2005. The FWA is recognized by all federal departments and agencies that fund human subjects research.

Wright State's FWA references IRB authorization agreements with Children's Medical Center, Kettering Medical Center, Miami Valley Hospital, and Wright-Patterson AFB Medical Center. Wright State faculty who want to conduct human subjects research at one of these hospitals no longer need duplicate review and approval by Wright State's IRB, so long as no part of the research is also being conducted at a WSU facility. When a protocol is approved by the IRB at one of these hospitals, faculty investigators can simply send a copy of the protocol (including any consent forms) and approval to Wright State's Office of Research and Sponsored Programs (RSP).

Wright State continues to serve as the IRB of record for Dayton VA Medical Center, Good Samaritan Hospital, the Hipple Cancer Research Center, and the Dayton Area Oncology Program (DCOP). Faculty who conduct human subjects research at these affiliated institutions also need only one IRB review and approval from Wright State.

Before federal regulations were revised to accommodate the FWA, research institutions were required to file different assurances for single-site studies and multi-site collaborations. In most cases, one IRB was not allowed to defer to another IRB. From the investigator's perspective, the duplication of effort to satisfy multiple IRB's was "Byzantine," according to RSP director William Sellers.

"IRB's don't just review and approve human subjects research," he explains. "They also review and approve the format and content of all documents used in that research, especially the consent form that subjects sign. When changes were required in the forms as originally submitted (as they almost always are), the revised forms had to go back for re-review.

"Add to this mix a review by two different IRB's with two different schedules and procedures. One investigator described it as the 'ping-pong ball effect.'"

"This process improvement should help reduce the frustration factor for faculty initiating clinical research projects, without compromising the protection of human subjects and patients," says Margaret Dunn, M.D., associate dean for faculty and clinical affairs at the School of Medicine.

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