Institutional Review Board Approval of Practice-based Research Network Patient Safety Studies

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.