IRB Inovation at a Private Research Foundation

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Oklahoma Medical Research Foundation (OMRF) is a private, not-for-profit institution that is composed of 44 principal investigators 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 two specific aims. First, the entire process of application, annual reporting and adverse event reporting will be made computer automated such that investigators will be able to submit data over the internet in a secure fashion and these data will be down loaded in a computerized tracking system. Second, the OMRF IRB will develop a resource by which investigators can securely, in a confidential manner, store and track human subjects enrolled in protocols. At present many of those involved in human research at OMRF are basic, laboratory-based scientists without a direct link to a hospital or clinic population. These investigators develop collaborative efforts with clinicians in order to collect samples from either normal or diseased subjects. However, the PIs are neither trained nor equipped to handle confidential clinical information that is obtained as part of most protocols. Therefore, the institution through the IRB will develop a centralized facility that will store, catalogue, and track information concerning human subjects.