Conflicts of interest (COI) issues in research institutions and IRBs have drawn more attention in recent years, resulting in better institutional policies and changes. A new study examined the nature and consequences of relationships between industry and IRB members in the years between 2005 and 2014, finding both good news and not-so-great news.
“Some things have improved, but there are a few things left to work on,” says Eric G. Campbell, PhD, director of research at Mongan Institute for Health Policy, and professor of medicine at Harvard Medical School in Boston. Campbell was the lead author of the study about IRBs and COI.
On the positive side: “IRBs are doing a much better job of having their members disclose their relationships and making sure their members know they have to disclose those,” Campbell says.
IRBs also are doing a better job of making sure members with COIs on specific protocols leave the room during discussions, and they’ve eliminated the problematic relationship of having members speak on the Speaker’s Bureau, he adds.
One continuing problem discovered by the study was that there has been no significant improvement in members with COIs abstaining from voting at IRB meetings, Campbell says.
About one in four IRB members surveyed reported voting recently on a protocol in a way that violated federal guidelines, he adds.
The study advises that additional attention should be focused on deterring IRB members from inappropriately voting on or presenting protocols in a biased manner.1
When preparing to do the survey of IRB members, researchers made certain that the IRB that reviewed the COI study was not included in the study to avoid that conflict of interest, Campbell notes.
“We felt it would be unethical for them to oversee the study and also be subjects,” he adds.
Another troubling finding from the research was that nearly one-third of IRB members surveyed said they didn’t know if their IRB had a conflict of interest policy, Campbell says.
“All members should know if there is a policy, and all IRBs should have a policy,” he says.
“The context of this is there is a debate in academia right now as to whether institutions have gone overboard in regulating conflicts of interest in a way that harms medical innovation and research,” Campbell says. “This is being played out in the New England Journal of Medicine and British Medical Journal.”
IRBs are a special case when it comes to COI because they’re the primary and sole mechanism by which organizations and the government oversee the integrity of the research process, Campbell says.
“We have to make sure those industry relationships are disclosed to the IRB,” he adds. “This appears to be happening more frequently, and it also appears that people with conflicts are taking appropriate actions.”
Problems with voting when it’s not appropriate need more attention, however, he says.
“It’s not a ‘one person, one time’ kind of problem,” Campbell says. “It also shows that it might be due to things as simple as people not knowing what the rules were or people with a conflict not voting even when the board needs a quorum.”
Another educational issue relates to the definition of conflict of interest. Universities and research organizations generally believe that any financial relationship with a parent company constitutes a conflict of interest, he explains.
“Say, for example, somebody had a financial relationship with the cardiac division of Company X, and a protocol came from OB-GYN division of Company X, the question is whether that should be a conflict of interest they recuse themselves for,” Campbell says. “Generally, when universities think about [the financial relationship being with the one company], they believe that regardless of whether it’s with the cardiac division or the OB-GYN division, you still have to disclose this as a conflict of interest.”
Going forward, the big question is whether IRBs are willing to further improve their handling of COIs, or whether it’s time for the government or a third party to step in and assist them with overseeing studies and subjects, Campbell says.
REFERENCE
- Campbell EG, Vogeli C, Rao SR, et al. Industry relationships among academic institutional review board members: changes from 2005 through 2014. JAMA Intern Med. 2015; Epub ahead of print.
A new study examined the nature and consequences of relationships between industry and IRB members in the years between 2005 and 2014, finding both good news and not-so-great news.
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