Graham Deborah G., Pace Wilson, Kappus Jennifer, Holcomb Sherry, Galliher James M., Duclos Christine W., Bonham Aaron J.
The National Research Network, American Academy of Family Physicians (DGG, JK, JMG, AJB). Department of Family Medicine, University of Colorado Health Sciences Center (WP, SH, CWD).
Institutional review board (IRB) approval of research that involves the collection of medical error reports is a major challenge. The process includes issues of confidentiality, privacy, discoverability, informed consent, and Web site security. The challenges are more complex for multisite research. This paper describes the approaches taken by the American Academy of Family Physicians (AAFP) and the University of Colorado (CU) to address the challenges and barriers created by the IRB approval process for multisite patient safety research studies. Between 2001 and 2004, the AAFP and CU conducted several patient safety studies involving primary care practices in three practice-based research networks (PBRNs). The AAFP conducted two pilot studies in 18 primary care clinics in which error reports were submitted by physicians, staff, and patients. The AAFP sought approval from 15 different IRBs for these studies. CU conducted a 3-year project that collected medical errors from 38 primary care practices affiliated with seven separate IRBs. AAFP successfully obtained approval from all 15 IRBs. Several sites required approval from risk management and legal departments. CU obtained approval for the primary study from seven IRBs and two hospital research committees. Secondary studies required additional approvals. Overall, the two projects had a high level of success in obtaining IRB approval. There was great variation in submission requirements, level of review, length of time to obtain approval, and required revisions. PBRN research often includes atypical, multisite research activity, with practices simultaneously serving as research subjects and investigators. The high-risk nature of patient safety work further complicates this situation. Investigative work with the Office for Human Research Protections and the Agency for Healthcare Research and Quality to create a central IRB process could greatly facilitate work of this nature.
机构审查委员会（IRB）对涉及收集医疗差错报告的研究进行批准是一项重大挑战。该过程涉及保密、隐私、可发现性、知情同意以及网站安全等问题。对于多中心研究而言，这些挑战更为复杂。本文描述了美国家庭医师学会（AAFP）和科罗拉多大学（CU）为应对IRB批准程序给多中心患者安全研究带来的挑战和障碍所采取的方法。在2001年至2004年期间，AAFP和CU开展了多项患者安全研究，涉及三个基于实践的研究网络（PBRN）中的基层医疗实践。AAFP在18家基层医疗诊所进行了两项试点研究，由医生、工作人员和患者提交差错报告。AAFP就这些研究向15个不同的IRB寻求批准。CU开展了一个为期3年的项目，从隶属于7个不同IRB的38家基层医疗实践中收集医疗差错。AAFP成功获得了所有15个IRB的批准。有几个机构还需要风险管理和法律部门的批准。CU的主要研究获得了7个IRB和两个医院研究委员会的批准。二次研究需要额外的批准。总体而言，这两个项目在获得IRB批准方面取得了很高的成功率。在提交要求、审查级别、获得批准的时间长度以及所需修订方面存在很大差异。PBRN研究通常包括非典型的多中心研究活动，各实践同时充当研究对象和研究者。患者安全工作的高风险性质使这种情况更加复杂。与人类研究保护办公室和医疗保健研究与质量局合作开展调查工作，以建立一个中央IRB程序，可能会极大地促进这类性质的工作。
