IRB Inovation at a Private Research Foundation

私人研究基金会的 IRB 创新

• 批准号: 6591618
• 负责人: Morris Reichlin
• 金额: $ 10万
• 依托单位: OKLAHOMA MEDICAL RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591618
• 关键词: Internet; computer data analysis; computer program /software; data collection; data management; health science research support; human data; information systems; medical records; sample collection

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.

俄克拉荷马州医学研究基金会（OMRF）是一家私营的非营利机构，由44名主要研究人员和500多名员工组成。自1970年代初机构审查委员会（IRB）成立以来，OMRF一直在运作这些委员会。目前，OMRF IRB有超过100个活跃的协议，这些协议是由大约一半的PI在教员中的工作产生的。这些方案包括从正常志愿者简单抽血到安慰剂对照、多臂药理学试验以及复杂疾病的遗传学研究。目前，三个全国性的，NIH资助的疾病登记处或储存库包括在这些正在进行的协议。这项建议将加强管理和资源基金内部审查委员会的监督，具体目标有两个。首先，申请、年度报告和不良事件报告的整个过程将实现计算机自动化，以便研究者能够以安全的方式通过互联网提交数据，这些数据将以 计算机化追踪系统其次，OMRF IRB将开发一种资源，研究者可以通过该资源以保密的方式安全地存储和跟踪方案中招募的人类受试者。目前，在OMRF参与人类研究的许多人都是基础的、以实验室为基础的科学家，与医院或诊所人口没有直接联系。这些研究人员与临床医生合作，从正常或患病受试者中收集样本。然而，PI既没有经过培训，也没有配备处理作为大多数方案一部分获得的机密临床信息的设备。因此，机构将通过IRB开发一个集中设施，用于存储、编目和跟踪有关人类受试者的信息。