Amniotic Membrane Wound Research Endeavors - Institutional Review Board (IRB)

Incorporating the intricacies of the Institutional Review Board (IRB) approval process into research endeavors, particularly those involving the collection of medical error reports, presents a significant challenge. This process is marked by considerations of confidentiality, privacy, discoverability, informed consent, and website security, with added complexities for multisite research. This paper elucidates the strategies employed by the American Academy of Family Physicians (AAFP) and the University of Colorado (CU) to navigate these challenges and barriers encountered during the IRB approval process for multisite patient safety research studies.

Between 2001 and 2004, AAFP and CU conducted several patient safety studies within primary care practices across three practice-based research networks (PBRNs). AAFP undertook two pilot studies in 18 primary care clinics, while CU embarked on a 3-year project involving 38 primary care practices affiliated with seven separate IRBs. Despite the complexity, both projects achieved a high level of success in obtaining IRB approval, albeit with considerable variation in submission requirements, review processes, approval timelines, and necessary revisions.

The increasing number of State, regional, and national primary care PBRNs engaged in multisite research underscores the need to address the challenges posed by local IRB requirements and reviews. While the observed variation in IRB processes may reflect local contextual nuances, it also underscores the absence of standardized guidelines. Multisite studies, especially those delving into sensitive areas like patient safety, often undergo secondary reviews, further prolonging the approval process and potentially compromising data integrity.

The experience of AAFP and CU underscores the formidable barrier posed by the IRB approval process in practice-based research networks. Addressing this barrier necessitates innovative solutions, such as the establishment of a central IRB model, akin to those employed in oncology clinical trials, to streamline ethical review processes and enhance efficiency. Alternatively, the adoption of generic application forms could alleviate the administrative burden associated with multiple IRB approvals, albeit to a lesser extent.

In conclusion, while the IRB approval process remains a formidable challenge for practice-based research networks, overcoming this barrier is essential to advancing high-quality primary care research. Finding solutions to streamline the approval process is imperative to enable PBRNs to expand their research endeavors and ultimately improve healthcare delivery.