Study Suggests Progress in Reporting, Management of IRB Conflicts of Interest
14 Jul 2015
While the percentage of institutional review board (IRB) members with an industry relationship has not changed significantly since 2005, the percentage of members who felt other members had not properly disclosed a financial relationship has decreased as did the percentage of IRB members who felt pressure from their institution or department to approve a protocol, according to an article published online by JAMA Internal Medicine.1
Academic-industry relationships are defined as academics who provide life science companies (for example biotechnology, drug and device companies) with their knowledge, skills, services or intellectual property in exchange for payment to the scientist or their institution.
Eric G. Campbell, Ph.D., of Massachusetts General Hospital, Boston, and colleagues replicated a 2005 study that members of their group conducted to understand changes in the nature, extent and consequences of industry relationships among IRB members in academic health centers. A survey was mailed to IRB members from the 115 most research-intensive medical schools and teaching hospitals in the United States. The final analytic data set included survey responses from 439 members in 2005 and 493 members in 2014.
The authors found that:
The percentage of IRB members with an industry relationship of any type did not change significantly from 2005 to 2014 (37.2 percent vs. 32.1 percent).
The percentage of IRB members who served on speakers bureaus decreased from 13.8 percent in 2005 to 4.2 percent in 2014.
IRB members were more likely in 2014 to report that their IRB had a formal written definition of what constituted a conflict of interest (63.1 percent in 2014 compared with 45.6 percent in 2005).
The percentage of IRB members who felt another member did not properly disclose their financial relationships in the past year decreased from 10.8 percent in 2005 to 6.7 percent in 2014.
The percentage of IRB members who felt pressure for their institution or department to approve a protocol they felt was not ready decreased from 18.6 percent in 2005 to 10 percent in 2014.
The percentage of members who felt another IRB member had presented a protocol in a biased manner because of their industry relationship decreased from 13.5 percent in 2005 to 8.4 percent in 2014.
A greater percentage of IRB members with conflicts of interest reported always disclosing their industry relationships (80 percent in 2014 vs. 54.9 percent in 2005).
The percentage of members who voted on a protocol with which they had a conflict of interest did not decrease significantly (35.2 percent in 2005 vs. 24.9 percent in 2014).
“The good news is that during the past decade, significant progress has been made in disclosing and managing COIs [conflicts of interest] among IRB members. Nevertheless, there is still work to be done, including educating members about what constitutes a COI, stopping IRB members with COIs from voting on protocols with which they have a conflict, and researching bias in the presentation of industry-sponsored protocols,” the study concludes.
In a related commentary 2, Laura Weiss Roberts, M.D., M.A., of Stanford University School of Medicine, California, writes: “The findings by Campbell et al suggest that actions and safeguards related to IRB oversight have improved in recent years, but there is progress to be made in attaining the conditions needed for the ethical conduct of human studies.”
1. JAMA Intern Med. Published online July 13, 2015. doi:10.1001/jamainternmed.2015.3167.
2. JAMA Intern Med. Published online July 13, 2015. doi:10.1001/jamainternmed.2015.3172.