1. The percentage of institutional review board members with conflicts of interest who voted on protocols with which they have conflicts did not significantly change since 2005.
2. However, there was a significant decrease in the percentage of members who felt their colleagues did not properly disclose their financial industry relationships.
Evidence Rating Level: 2 (Good)
Study Rundown: In order to ensure the quality of medical research, it is important to understand the impact of academic and industry relationships. While most research has focused on individual researchers, it is equally important to quantify the influence that the industry has on academic organizational representatives in institutional review boards (IRB). In 2005, the first national survey of IRB members showed that more than one-third of IRB members had industry relationships. This study aimed to examine the nature, extent, and perceived consequences of industry relationships among IRB members in academic health centers, and to compare results with findings from 2005.
There was no significant change in the proportion of IRB members with industry affiliations from 2005 to 2014, or the percentage of members with conflicts of interest who voted on protocols with which they have conflicts. There were significant decreases in the percentages of members who felt another member failed to properly disclose their financial industry relationships, and the percentage that felt pressure to approve protocols from their institutions. Finally, there was a significant increase in the percentage of members who always disclose industry relationships. The strengths of this study include being a fairly comprehensive study, with surveys sent to the 115 most research-intensive schools and teaching hospitals. Limitations include the survey design, as well not being able to account for social desirability bias, and thus may underestimate the percentage of IRB members who report voting on proposals with which they have a conflict of interest.
In-Depth [cross-sectional study]: A sample was identified from medical schools and independent hospitals that are funded from the National Institutes of Health in 2012. From this sample, the IRBs were identified and surveys were sent to a random sample of 1016 members at 115 medical schools and teaching hospitals. The survey was validated and tested prior to being administered. Main outcomes of interest included the relationships with the life science industry and conflicts of interest. Data was pooled from 2005 to 2014 and statistical analysis includes multivariable analysis with fitted separate logistic regression models.
The response rate for the survey was 68.5%. There was no significant difference in the proportion of IRB members with an industry affiliation from 2005 to 2014. (2005: 37.2%, 95%CI 32.7% to 42.0%; 2014: 32.1%, 95%CI 28.0% to 36.4%; p = 0.09). There was a significant decrease in the percentage of members who felt another member did not properly disclose a financial conflict, from 10.8% to 6.7% (p = 0.04), as well as the proportion who felt pressure from their institution to approve a protocol from 18.6% to 10.0% (p < 0.001). Interestingly, the fraction of members with conflicts of interest who voted on protocols with which they have conflicts have not significantly changed, compared to the previous study in 2005.
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