A study published in JAMA this month looked into the frequency of industry relationships among members of Institutional Review Boards (IRBs) and the “perceived effect of those relationships on IRB-related activities,” as compared to a virtually identical study conducted in 2005. “Because IRBs are responsible for overseeing and protecting the safety and well-being of research participants, they should be free of undue influence by financial interests or by the appearance of such interests,” the researchers wrote in 2005. Their new study concluded that “significant positive progress in the reporting and management of conflicts of interest among IRB members in academic health centers since 2005,” but that “[a]dditional attention should be focused on deterring IRB members from inappropriately voting on or presenting protocols in a biased manner.”
IRBs are committees that evaluate and oversee human research trials. Among other responsibilities, IRBs ensure that the risks to research participants are minimized and reasonable in relation to any anticipated benefit from the study and that the selection of subjects is equitable. Over the last decade, more time and effort has been placed on identifying whether IRB members have any direct or indirect relationship with the life sciences industry. Often institutions will hold that certain conflicts of interest require IRB member recusal–such as where members are an investigator or sponsor on the project under review, or have direct financial interests in the product being researched.
In 2005, a group of academics lead by Eric G, Campbell, PhD, of Massachusetts General Hospital published an article entitled “Financial Relationships between Institutional Review Board Members and Industry.” The study attempted to take a then-current snapshot of how many members of IRB boards maintain relationships with companies in the year prior. Such relationships included research funding, payment for consulting or input on an advisory board, royalties, etc. The researchers then sought to figure out the effect of these relationships—“both positive and negative.”
The study found that IRB members’ “perceived beneficial effects of relationships with industry” included the conveyance of the scientific superiority of an investigational drug or medical device or product in comparison with others currently on the market, and improved understanding of industry standards for data management. However, the researchers were concerned about certain aspects of the survey results, including that many IRB member reported no formal process for disclosure of industry relationships. Furthermore, a small number of respondents reported participating in discussions and voting on protocols for which they had a conflict.
The new study conducted in 2014 analyzes the changes over the last ten years. The authors found that there was no significant difference in the percentage of IRB members with an industry relationship: about one-third of IRB members had some industry relationship in both 2005 and 2014. However, the number of respondents who stated that they always disclose industry relationships increased significantly from 54.9% in 2005 to 80.0% in 2014. IRB members also reported a decrease in instances where they felt another IRB member did not properly disclose a financial relationship, down from 10.8% to 6.7%. The percentage of respondents who felt another IRB member had presented a protocol in a biased manner because of their industry relationship also decreased, as did the percentage who felt pressure to approve a research protocol.
However, the results found an insignificant change among the number of IRB members who voted on protocols in which they had a conflict of interests (though both 2005 and 2014 were very low percentages). The study authors concluded that additional work was needed to ensure that IRB members are educated on what constitutes a conflict of interest, and to deter IRB members from inappropriately voting on protocols in which they have a conflict.
The push towards disclosure and proper “management” of conflicts of interest is certainly an important goal—and it looks from the results of the study that institutions have much more formalized disclosure policies for IRB members. It is also essential not to stigmatize the valuable services that physician can bring to medical progress. In many cases conflicts arise simply because a doctor is sharing their experience with others, rather than being an expert for the sake of being an expert.
Also, it is important to remember that not all interests are conflicts, and that almost all IRB members understand their fiduciary responsibility to patients. Oversight of clinical trials is not a game for the uninitiated, so it is important that the overseer or IRB member has experience in conducting clinical trials themselves. Often this experience comes from working on company sponsored trials. Experienced practitioners may offer their insights to companies on fixable treatment gaps that could help that doctor’s patients; inventors receive royalties for innovations that have positively impacted patients’ lives; physician speakers bring new treatment methods to a wider audience of healthcare professionals. It’s easy to read the word “conflict” and forget the benefits that come along with collaboration.