Article type
Year
Abstract
Background:
University institutional review boards (IRBs) are the main gatekeepers for approval of clinical research studies in the US. However, little is known about their basic knowledge of clinical research study designs.
Objective:
To assess the knowledge of IRB members regarding clinical research designs.
Methods:
A nationwide sample of IRB members from major US research universities completed a simple web-based 11-question quiz. The quiz was designed to be fairly easy, covering basic knowledge about clinical research study designs. It included questions about randomized controlled trials (RCTs) and other clinical research study designs. Potential predictors of incorrect answers (age, gender, educational attainment, type of IRB, current IRB membership, years of IRB service, clinical research experience, and self-identification as a scientist) were evaluated in multivariate logistic regression models.
Results:
Most of the 148 individuals from 36 universities who participated held a medical or doctoral degree 68.9% (102/148). 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 versus not perfect), revealed no significant predictors - indicating that knowledge deficits were not limited to specific subgroups of IRB members (table 1). For the RCT knowledge score there was one significant predictor: compared with MDs, IRB members without a doctorate were three times as likely to answer at least one RCT question incorrectly (odds ratio = 3.00, 95% confidence interval 1.10 to 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 ethical training requirements, IRB members should undergo systematic training on clinical research designs.
University institutional review boards (IRBs) are the main gatekeepers for approval of clinical research studies in the US. However, little is known about their basic knowledge of clinical research study designs.
Objective:
To assess the knowledge of IRB members regarding clinical research designs.
Methods:
A nationwide sample of IRB members from major US research universities completed a simple web-based 11-question quiz. The quiz was designed to be fairly easy, covering basic knowledge about clinical research study designs. It included questions about randomized controlled trials (RCTs) and other clinical research study designs. Potential predictors of incorrect answers (age, gender, educational attainment, type of IRB, current IRB membership, years of IRB service, clinical research experience, and self-identification as a scientist) were evaluated in multivariate logistic regression models.
Results:
Most of the 148 individuals from 36 universities who participated held a medical or doctoral degree 68.9% (102/148). 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 versus not perfect), revealed no significant predictors - indicating that knowledge deficits were not limited to specific subgroups of IRB members (table 1). For the RCT knowledge score there was one significant predictor: compared with MDs, IRB members without a doctorate were three times as likely to answer at least one RCT question incorrectly (odds ratio = 3.00, 95% confidence interval 1.10 to 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 ethical training requirements, IRB members should undergo systematic training on clinical research designs.