Many Clinical Trial Overseers Have Conflicts of Interest

BOSTON, Nov. 29 -- More than a third of clinical trials watchdogs have financial relationships with industry, calling into question the objectivity of institutional review boards, according to investigators here.

IRBs are charged with trial oversight and patient safety, and federal regulations stipulate that "no IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB."

But 36% of IRB members reported having some kind of financial relationship with industry that could represent a conflict of interest, according to a survey of members from 100 medical schools and 15 independent research hospitals by Eric G. Campbell, Ph.D., of Massachusetts General Hospital, and colleagues.

More than one in five IRB members reported receiving research funding from an industry source, the investigators reported in the Nov. 30 issue of the New England Journal of Medicine.

Other potential conflicts of interest included receiving compensation for attending meetings, paid consultancies, and serving on a companies' speakers bureaus.

"The IRB process must be independent and objective," said Dr. Campbell in a statement.

"Financial relationships with study sponsors create competing interests that could undermine the objectivity of the IRB process. Policies and practices regarding the disclosure and management of such relationships among IRB members need to withstand intense scrutiny, and our results suggest that we can do much better."

In a separate study, also reported in NEJM, ethicist Ezekiel J. Emanuel, M.D., Ph.D., of the National Institutes of Health and colleagues, reported on a survey of patients in cancer research trials, and found that while more than 90% of patients said they had little or no worries about investigators' financial ties, "a substantial minority wanted to be informed about the oversight system to protect against financial conflicts of interest and about researchers' financial interests."

They however pointed out an important limitation of the study. "Data from patients who were already enrolled in cancer trials might not be relevant for patients with other illnesses, patients considering participation in such trials, or patients who have refused to participate in research," they wrote.

The Boston investigators identified 100 medical schools and independent hospitals that received the largest amount of NIH research support, and asked them to supply lists of IRB members.

The Boston group randomly selected 893 IRB members from a pool of 3,946, and sent them a confidential, anonymous questionnaire focusing on financial relationships they had with industry, such as employment, memberships on corporate boards, consulting, royalty payments, and paid speaking. A total of 67.2% of those contacted responded.

They found that while 36% of IRB members reported having at least one relationship with industry in the past year, more than twice that number (85.5%) reported that they never thought that their fellow IRB members were affected by their industry ties, or that such ties had influenced their decisions inappropriately. Only 11.9% said that industry ties "rarely" affected IRB-related decisions, and only 0.2% thought that such conflicts occurred often.

Yet 78 IRB members (15.1% of respondents, 62 voting and 16 non-voting members) also said that "at least one protocol came before their IRB during the previous year that was sponsored either by a company with which they had a relationship or by a competitor of that company, both of which could be considered conflicts of interest," the authors wrote.

Of those 78 IRB members whose boards oversaw a protocol in which they had a potential conflict of interest, 57.7% said they always disclosed the potential conflict to an IRB official, but 7.7% said they did sometimes, 11.5% rarely reported it, and 23.1% admitted that they never reported a potentially conflicting relationship.

Additionally, while 64.5% of the 62 voting members reported that they never voted on protocols in which they had an interest, 4.8% said they rarely did, 11.3% said they sometimes did, and 19.4% said they always did.

The authors noted several limitations of the study. "Subjects may have been unwilling to admit to engaging in behaviors that might be viewed by others as undesirable, such as having relationships with industry or conflicts of interest," they wrote. "Thus, our data may underestimate the actual frequency of such behaviors." In addition, they suggested that "our results may not apply to IRBs at institutions that are not research intensive."

"While many IRB members have financial relationships with sponsors, those relationships are not presently seen by IRB members as having a major impact on their activities," said co-author Greg Koski, M.D., Ph.D., also of MGH, who formerly served as director of the Office for Human Research Protections at the federal Department of Health and Human Services. "The bad news is that our policies and procedures, as well as our efforts to educate IRB members about conflicts of interest, are clearly inadequate."

In an accompanying editorial, Elizabeth G. Nabel, M.D., director of the National Heart, Lung, and Blood Institute wrote that "it is unrealistic, impractical, and undesirable to make up an IRB of members who have no financial ties to entities that engage in biomedical research. Relationships must be managed, not prohibited."

She called for an open process in which IRB conflict-of-interest rules are clearly stated, members consistently disclose financial relationships, and recuse themselves from discussions and decision making when a potential conflict arises.