Email this pageInstitutional Review Board
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The Institutional Review Board (IRB) is responsible for protecting the rights and welfare of the human subjects who participate in clinical research trials at Guthrie. The IRB ensures that all trials comply with the regulations of the U.S. Food and Drug Administration (FDA), Office for Human Research Protections (OHRP) of the US Department of Health and Human Services, state and local laws, and Guthrie Healthcare System policies.
The IRB consists of a diverse group of physicians, professionals and community members who serve as voting members. The GHS Board of Directors appoints the IRB chairman and each member. Ferrol Lee, M.D., Guthrie Clinic chief of endocrinology and chairman of the Department of Medicine, serves as chairman of the IRB and Elaine Wall is the IRB coordinator.
The IRB meets monthly to review and discuss clinical research studies that a physician or staff member would like to conduct within the Guthrie Healthcare System. Before the investigator may begin the study, it must be presented to and approved by the IRB.
To propose a clinical research study, download and complete the IRB Application for Review of Research Involving Human Subjects. At least one month before the IRB meeting applicants must submit two complete applications (including protocol, consent form and Investigator’s Brochure) to the IRB office for initial review. After initial review the applicant will be notified of any necessary revisions. Fourteen revised applications must be submitted to the IRB Office two weeks prior to the IRB meeting. All applications should be submitted to Elaine Wall, IRB coordinator, Guthrie Foundation.
After the study has been approved, the investigator must keep the IRB informed of any changes in the study or adverse events. The IRB reviews and monitors each study until it is completed or closed.
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Ferrol Lee, M.D., MBA, FACP, chairman Michael Georgetson, M.D., vice chairman Surya Narayanan, M.D. Linda Jayne Harvey Taylor, Ph.D. Robert J. Landy, Esq. David Martin, D.Min, BCC Sally Bennett, R.N. |
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