IRB Inovation at a Private Research Foundation

俄克拉何马州医学研究基金会（OMRF）是一家私营的非营利性机构，由44名主要研究人员和500多名雇员组成。自1970年代初这些委员会成立以来，OMRF一直运作着一个机构审查委员会。目前，OMRF IRB有100多个活跃的协议，这些协议是由大约一半的学院pi的工作产生的。研究方案的范围从普通志愿者的简单抽血到安慰剂控制的多臂药理学试验以及复杂疾病的遗传学研究。目前，美国国立卫生研究院（nih）资助的三个全国性疾病登记处或储存库包括在这些正在进行的方案中。这项建议将加强OMRF内部审查委员会的监督，有两个具体目标。首先，申请、年度报告和不良事件报告的整个过程将由计算机自动化，以便调查人员能够以安全的方式在互联网上提交数据，这些数据将被下载

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.