Jan. 31, 2000
OPRR approves VCU’s revised MPA
Immediate Re-Review of Previously Approved Studies Can Move Forward
Share this story
An MPA is the formal, written, binding agreement that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects. Approval of the MPA, which is granted by the OPRR, is necessary before investigators at an institution can conduct research with human subjects.
The MPA suspension, which occurred on Jan. 11, was in response to administrative deficiencies with the university’s Institutional Review Board, which monitors all research involving human subjects, and was not due to improper care of research participants or the exposure of subjects to a specific risk.
In a letter dated Jan. 31, the OPRR’s Michael A. Carome, M.D., wrote that "VCU has developed satisfactory corrective action plans that address each of the concerns and deficiencies documented in OPRR’s letters of Dec. 17, 1999 and Jan. 11, 2000. Furthermore, OPRR finds that VCU has either completed each required action stipulated in these letters, or provided an adequate explanation for why certain required actions could not be implemented yet."
Earlier in January, on Jan. 21, the OPRR granted VCU’s request to retain the authority to determine whether a study was exempt from IRB review, which means that such studies can resume immediately after that determination is made.
Now that the revised MPA also has been approved, Western IRB, an independent review board based in Olympia, Wash., will have the responsibility of approving or disapproving proposed studies involving human subjects. Western IRB also will re-review previously approved studies and assist VCU in revising the policies and procedures that govern human subjects research at the university. The review of new protocols and the re-review of previously approved protocols will take place concurrently.
The OPRR suspension of VCU’s MPA effectively suspended enrollment in research protocols involving human subjects at the university. The action also suspended all new research projects from being approved and initiated. Protocols involving previously enrolled subjects were allowed to continue only if it was shown to be in the best interest of the individual subjects. Enrollment of new patients into studies will not resume until Western IRB re-reviews and approves individual studies.
VCU’s IRB Task Force, created to address the OPRR’s concerns, will continue to oversee VCU’s corrective action plan, which includes a plan for educating and training the VCU IRB as well as all investigators involved in human subjects research. Successful completion of training will be required before investigators can submit new grant applications to the IRB. The training of both groups already has begun.
On Jan 19 and 20, Gary L. Chadwick, Pharm.D., M.P.H., a clinical associate professor of medical humanities at the University of Rochester and formerly with the FDA and the OPRR, conducted training sessions for IRB members on federal regulations for the protection of human subjects. The training covered the history of human subjects research and the federal regulatory system as well as ethical principles and federal regulations governing IRBs and human subjects research.
Subscribe to VCU News
Subscribe to VCU News at newsletter.vcu.edu and receive a selection of stories, videos, photos, news clips and event listings in your inbox.