Oklahoma Medical Research Foundation (OMRF) is a private, not-for-profit institution that is composed of 44 principal investigators (PI) and over 500 total employees. OMRF has operated an Institutional Review Board (IRB) since inception of these boards in the early 1970s. At present the OMRF IRB has over 100 active protocols arising from the work of about one-half of the PIs on the faculty. The protocols range from simple blood drawing from normal volunteers to placebo-controlled, multi-armed pharmacology trials as well as studies of the genetics of complex diseases. At present three nationwide, NIH-funded disease registries or repositories are included among these ongoing protocols. This proposal will enhance the supervision by the OMRF IRB with three specific aims. First, an interactive web-based education module will be established to ensure that all PIs, IRB members and staff, and other appropriate personnel maintain knowledge of, and comply with, relevant ethical principles, relevant Federal Regulations, OHRP guidance, other applicable guidance, state and local laws, and institutional policies for the protection of human subjects in research. This will include both commercially available educational modules as well as locally developed educational tools that are specific to the institution's needs. Although funded by OMRF, access to this module will be shared by the PIs, IRB members and staff and other appropriate personnel at another private, not-for-profit institution here in Oklahoma City. Operated by a group of Catholic orders known as SSMOK doing business as St. Anthony Hospital, this institution has 1700 employees including about a dozen research investigators. The St. Anthony IRB has approximately 30 active protocols. As a further aspect of this aim, equipment will be purchased to enhance the present technology in OMRF's Wileman Learning Center in order to present interactive educational seminars and meetings available only through teleconferencing. These activities will be available to St. Anthony personnel and, with available space, other interested institutions.
Other aims i nclude (a) developing existing software to monitor and track IRB activities such as approval of consent forms used in multiple institutions and/or multi-center trials, (b) strengthening other activities such as initial, continuing and expedited reviews, adverse events, and study compliance, and (c) revising online forms used to request IRB review and approval.
