IRBs: Study Suggests More COI Reporting, Management

Marcia Frellick

July 15, 2015

Although the percentages of institutional review board (IRB) members who report having industry relationships has not changed much since 2005 (37.2% then vs 32.1% in 2014), there is good news in the transparency and management of those relationships, according to a new study.

Eric Campbell, PhD, a sociologist at Massachusetts General Hospital in Boston, and colleagues replicated their 2005 study to understand changes in industry relationships and their consequences among IRB members in the 115 most research-intensive medical schools and teaching hospitals in the United States. They mailed surveys and got responses from 493 members in 2014 compared with 439 in 2005. Results were published online July 13 in JAMA Internal Medicine.

"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 authors conclude.

They found the percentage of IRB members who felt pressure for their institution or department to approve a protocol they felt was not ready dropped from 18.6% (95% confidence interval [CI], 15.0% - 22.9%) in 2005 to 10.0% (95% CI, 7.6% - 13.0%; P < .001) in 2014.

The percentage of members who felt another member did not properly disclose a financial relationship also dropped from 10.8% (95% CI, 8.0% - 14.4%) to 6.7% (95% CI, 4.7% - 9.4%; P = .04).

There also was a large jump in the percentage who said they always disclose relationships: 54.9% said they did in 2005 (95% CI, 42.2% - 66.9%) compared with 80.0% in 2014 (95% CI, 65.3% - 89.4%; P = .01).

Academic–industry research relationships are defined as academics who give life science companies (ie, biotechnology, drug, and device companies) access to their knowledge, skills, services, or intellectual property in exchange for payment to the scientist or his or her institution.

More Have Formal Policy

The researchers also found that in 2014, more institutions had a formal policy on what constituted a conflict. The percentage of members who said that no policy existed decreased significantly, going from 13.8% in 2005 to 5.1% in 2014.

However, the percentage of members who voted on a protocol with which they had a conflict of interest did not decrease significantly (35.2% in 2005 vs 24.9% in 2014; P = .24).

In a related commentary, Laura Weiss Roberts, MD, from Stanford University School of Medicine in California, points out several concerning findings from the study and says such findings may be underreported.

"One of 3 IRB members was still unaware of federal and institutional policies pertaining to one's industry relationships in 2014. The fact that any IRB member felt pressure to advance protocols that had not been sufficiently evaluated is yet another concern. These worrisome data, moreover, are likely to be underestimated because of the effect of social desirability in self-report surveys and the authors' sole focus on academic IRBs," she writes.

She says other emerging studies suggest more work is needed. She cited a study by Wolf and Zandecki (IRB. 2007;29:6-12) that found that 74% of US medical schools had formal policies addressing IRB members' COIs, but 21% of those had no formal definition for COI.

"In the future, it will be important to see if the array of safeguards, including informed consent, confidentiality protections, and data safety monitoring, as well as institutional review and management of COI disclosures, serve to adequately protect human research participants," she writes.

The study was funded by the National Institute of General Medical Sciences, National Institutes of Health. The other authors have disclosed no relevant financial relationships. Dr Roberts reports that she is the owner of and investigator for Terra Nova Learning Systems, LLC.

JAMA Intern Med. Published online July 13, 2015. Article abstract, Commentary extract

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