Background: Institutional Review Board (IRB) members have a duty to protect the integrity of the research process, but little is known about their basic knowledge of clinical research study designs. Methods: A nationwide sample of IRB members from major US research universities completed a web-based questionnaire consisting of 11 questions focusing on basic knowledge about clinical research study designs. It included questions about randomized controlled trials (RCTs) and other observational research study designs. Potential predictors (age, gender, educational attainment, type of IRB, current IRB membership, years of IRB service, clinical research experience, and self-identification as a scientist) of incorrect answers were evaluated using multivariate logistic regression models. Results: 148 individuals from 36 universities participated. The majority of participants, 68.9% (102/148), were holding a medical or doctoral degree. Overall, only 26.5% (39/148) of participants achieved a perfect score of 11. On the six-question subset addressing RCTs, 46.6% (69/148) had a perfect score. Most individual questions, and the summary model of overall quiz score (perfect vs. not perfect), revealed no significant predictors – indicating that knowledge deficits were not limited to specific subgroups of IRB members. For the RCT knowledge score there was one significant predictor: compared with MDs, IRB members without a doctoral degree were three times as likely to answer at least one RCT question incorrectly (Odds Ratio: 3.00, 95% CI 1.10-8.20). However, even among MD IRB members, 34.1% (14/41) did not achieve a perfect score on the six RCT questions. Conclusions: This first nationwide study of IRB member knowledge about clinical research study designs found significant knowledge deficits. Knowledge deficits were not limited to laypersons or community advocate members of IRBs, as previously suggested. Akin to widespread ethical training requirements for clinical researchers, IRB members should undergo systematic training on clinical research designs.
institutional review board, clinical trials, approval, study design, knowledge, randomized controlled trials, observational studies.