Institutional Review Boards (IRBs) at academic health centers have gotten better at managing members’ industry relationships in the last several years, but issues persist, according to a new study.
The research is a follow-up to a study published in 2006.
The new study showed improvements in the management of industry relationships, with increased levels of disclosure and fewer “problematic relationships” than were reported in the previous study.
However, nearly a third of IRB members in the new study said they were unaware of their board’s conflict of interest policies. And a quarter of IRB members reported voting on protocols with which they have conflicts of interest, which is a violation of federal regulations.
“IRBs are the primary mechanisms by which institutions oversee research that involves human participants, and industry relationships of IRB members have the potential to impact their IRB-related activities in both positive and negative ways,” said Eric G. Campbell, PhD, of the Mongan Institute for Health Policy at Massachusetts General Hospital in Boston.
“While our principal findings are that, compared to a decade ago, IRBs appear to be doing a much better job at managing their members’ industry relationships, there still are findings that are concerning.”
Dr Campbell and his colleagues described these findings in JAMA Internal Medicine.
Every US institution that conducts research involving human participants must have an IRB, which reviews proposed studies to ensure their design is scientifically valid and does not violate ethical and regulatory guidelines. IRBs also monitor ongoing studies to make sure they maintain appropriate practices.
The first study to examine industry relationships of IRB members, conducted by Dr Campbell and his colleagues, was based on a survey of IRB members at 100 institutions that was published in NEJM in November 2006.
That study showed that more than a third of IRB members had some sort of financial relationship with commercial firms. And while most respondents did not believe that such relationships had an inappropriate impact on IRB decision making, significant percentages were not aware of institutional guidelines for disclosing industry relationships or defining conflicts of interest.
The current study involved an identical survey administered in 2014 to nearly 500 IRB members at 115 medical schools and teaching hospitals around the country.
As in the 2006 study, respondents were asked about specific types of relationships with commercial companies, whether they received any industry funding and for what purposes, and how many protocols had come before their IRB that involved companies with which they had a relationship.
For protocols with which IRB members had a conflict—relating either to companies they had relationships with or to competitors—they were asked whether they had disclosed their relationships to the IRB, whether they participated in discussion of those protocols, and whether they voted on the protocols.
Results
There was no significant difference between the current study and the previous study in the percentage of IRB members who reported having industry relationships overall—37% and 32%, respectively.
However, the percentage of respondents who reported receiving payments for attending meetings and conferences or for serving on speakers’ bureaus—relationships that are considered problematic—dropped significantly. The percentages fell from 16% to 9% for meeting/conference participation and from 14% to 4% for speakers’ bureaus.
“We were encouraged to see that the prevalence of potentially beneficial relationships—such as industry funding to support research studies—was essentially unchanged, indicating IRBs have not tried to eliminate members’ industry relationships across the board,” said Christine Vogeli, PhD, also of the Mongan Institute.
Survey respondents were more likely in the current study than in the previous one to say that their IRB had a written definition of conflicts of interest—63% compared with 46%. In addition, the percentage of respondents who reported their IRB had no policy related to conflicts dropped from 14% to 5%.
However, the researchers were concerned by the fact that 32% of respondents still did not know whether or not their IRB had a policy on conflicts, even though that number had dropped from 41% in the previous study.
The percentage of respondents who handled their conflicts of interest in an appropriate manner increased. Eighty percent of respondents with conflicts reported them to the IRB, up from 55% in the previous study.
And 68% of respondents said they always left the room when a protocol with which they had a conflict was being discussed, up from 38% in the previous study.
However, a quarter of respondents with conflicts indicated they had voted on protocols with which they had a conflict. While that was a drop from what was reported in the previous study, it was not statistically significant.
The percentage of respondents who felt that at least one protocol had been presented to their IRB in a biased fashion because of another member’s industry relationships dropped from 14% in the previous study to 8% in this study.
And when asked about the types of bias they perceived in the presentation—questions not included in the previous survey—8% of respondents reported a pro-industry bias, and 14% reported an anti-industry bias.
“The fact that we found any bias—either pro- or anti-industry—is an issue, since bias is antithetical to research and should be eliminated,” Dr Campbell said. “IRBs should address that issue, along with increasing efforts to educate their members about what constitutes a conflict of interest and the inappropriateness of voting on protocols with which they have a conflict.”
