Healthy Skepticism Library item: 15394

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Publication type: news

Gever J.
Little Policing to Guard Against Tainted Ivory Towers
MedPageToday 2009 Mar 27
http://www.medpagetoday.com/PublicHealthPolicy/Ethics/13454

Full text:

Clear and consistent policies governing conflicts of interest among members of research ethics panels are lacking at many institutions, likely allowing such conflicts to go unreported, researchers here said.

According to a survey of 107 chairs of institutional review boards (IRBs), one-third of medical schools and academic medical centers did not require board members to disclose relationships with industry, reported Christine Vogeli, Ph.D., of Massachusetts General Hospital, and colleagues in the April issue of Academic Medicine.

More than 30% of respondents said there was no clear policy defining what constituted a conflict of interest.

Moreover, 20% said they lacked confidence that their disclosure policies were adequate.

“Overall, our study shows significant variation among academic medicine IRBs in all aspects of the disclosure and management of IRB members’ relationships with industry and a concerning level of unawareness of industry relationships among IRB members,” Dr. Vogeli and colleagues wrote.

The researchers pointed out that the National Institutes of Health and other government agencies, as well as the Association of American Medical Colleges, have set forth guidelines calling on research institutions to establish clear policies on review board members’ ties with industry.

But adherence is largely voluntary. “Current federal regulations state only that IRB members may not participate in discussions or decisions on any protocol in which they may have a conflicting interest, except to provide information,” they wrote.

Dr. Vogeli and colleagues sent a questionnaire to 296 IRB chairs at 100 major academic research centers nationwide, with follow-up postcards and phone calls to encourage responses. They received 211 total responses, but nearly half were excluded because the respondents said they were not the current chairs of the panels, leaving 107 for analysis.

Key results included:

26% of respondents were unaware of a defined process at their institution for IRB members to disclose industry relationships
21% said it was up to individual IRB members to define and report conflicts of interest
26% reported no written policy on steps to take in response to reported conflicts of interest
42% of respondents said at least one conflict of interest was identified during the previous year
None of those reporting a conflict said the member with the conflict voted on the affected protocol; 64% said the member always left the room during discussion of the protocol
96% reporting at least one conflict were moderately or very confident that their IRBs correctly managed the conflicts
In an interview, Dr. Vogeli pointed out that some of the results contradicted those of a 2006 survey of individual IRB members. In that study, for example, one-third of members who said they had conflicts of interest also said they had voted on an affected protocol at least once.

Dr. Vogeli said the findings collectively indicate that IRB chairs are frequently unaware of their members’ conflicts.

She and her colleagues noted a lack of consensus among review board chairs on where oversight of conflicts of interest should lie.

In response to a survey question on that point, 25% said it should reside with the entire IRB, 52% recommended an outside person or office within the same institution, 5% said the IRB chair should have oversight, and 12% were content to leave it up to individual IRB members.

Similar variation was seen in responses to a question on who decides what to do about identified conflicts of interest, and to another on who defines conflicts of interest in the absence of a written policy.

But the researchers were most concerned about the one-third of institutions with no disclosure requirement.

“IRBs without a defined process for disclosure or requirements for disclosure will likely not only have incomplete disclosure but also will lack the ability to appropriately manage conflicts of interest within the IRB,” they warned.

The researchers said institutions should make greater efforts to follow the federal and Association of American Medical Colleges’ guidelines in developing consistent policies and procedures.

Action Points

Explain to interested patients that all studies involving human subjects have to be approved by an institutional review board (IRB).

Note that the purpose of the IRB is to protect the interests of the research participants, ensuring that they are treated ethically in a study.

Explain that pharmaceutical companies and other private entities often fund clinical research in these institutions, creating potential conflicts of interest if IRB members have relationships with those companies themselves.