To the Editor,
Nurses or physicians, as clinical investigators, face the stark reality of either obtaining institutional review board (IRB) approval for a clinical investigation or else the investigation cannot be performed or published. When the study involves a particularly vulnerable population such as residents, fellows, or nursing students (Cappell, 2014), and the subject matter consists of complaints against them, a particularly sensitive subject, the standards for IRB approval are much stricter than ordinarily applied for retrospective investigations (Office for Human Research, United States Government, 1993). The following highlights a successful investigator strategy to overcome such strict IRB criteria by negotiation and compromise leading to reversal of an initial IRB rejection and eventual IRB approval of their IRB application.
I was invited to write an article on complaints against gastrointestinal (GI) fellows and strategies to prevent complaints against them in 2012. This project is particularly important to maintain high, professional standards of communication by GI fellows to gastroenterology nurses or other healthcare professionals in the endoscopy suite. In addition to my expertise on this subject as a GI fellowship program director for 11 years, I resolved to incorporate fellowship data to enhance my recommendations. Data analysis, however, necessitated the IRB approval.
The initial IRB application was limited to analysis of complaints against GI fellows during 6 years at one institution, and incorporated modest details on individual complaints. The IRB committee rejected investigation with intent to publish because of the limited number of fellows analyzed; the possibility of identifying individual fellows based on details of individual complaints even though these details were minimized; and the risks of adversely affecting job prospects after graduation from fellowship, if individual fellows were identifiable. The committee, however, approved the study as a quality assurance project without intent to publish, and graciously suggested adding data from the GI fellowship at one other institution to overcome all their objections.
Several months later, I resubmitted the IRB application incorporating the following revisions to preclude identification of individual fellows: (a) analysis of fellows at two institutions; (b) increasing the number of analyzed fellows to 28; and (c) reporting only general and aggregate data (e.g., complainant: doctor vs. nurse vs. administrator vs. other), instead of listing individual complaints.
This strategy paid off with the IRB approval 6 weeks after resubmission and publication 5 months thereafter (Cappell, 2014). The currently recommended strategy to successfully address IRB concerns is summarized in Table 1. This work, although novel, is limited by anecdotally and retrospectively reporting one case. The success of this strategy to overcome the most stringent IRB criteria suggests that it is all-the-more likely to prove successful for ordinary clinical studies facing less-stringent criteria. Ironically, the currently advocated strategy for IRB approval mimics that advocated in the published article for GI fellows to avoid complaints: "Avoid conflicts, be diplomatic, respect others, and obey straightforward rules" (Cappell, 2014).
The final tally: IRB was satisfied and medicine potentially benefits from publication of an article promoting professionalism of physicians-in-training!
Respectfully,
Mitchell S. Cappell, MD, PhD
Chief, Division of Gastroenterology & Hepatology
Department of Medicine
William Beaumont Hospital
Oakland University William Beaumont School of Medicine
Royal Oak, Michigan
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