Research subjects want to know investigators' financial ties
■ But disclosure is not enough, study authors say. Medical centers should take an active role in managing conflicts to protect patients.
By Kevin B. O’Reilly — Posted Sept. 9, 2009
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Research participants want to be told about clinical investigators' financial conflicts, and sharing that information usually enhances trust, a new study says.
But researchers behind the five-year, $3 million Conflict of Interest Notification Study, or COINS, warn that disclosure should not be the only strategy used to protect human subjects from the potential harms posed by investigators' financial relationships with research sponsors.
"Potential research participants value discussion of information regarding investigators' financial interests and research," said Jeremy Sugarman, MD, MPH, senior author of an Aug. 27 New England Journal of Medicine article summarizing the COINS findings. "At the same time, most financial interests are unlikely to affect their decision whether to participate in research."
The disclosures sometimes scare patients away from participation. A study of 470 cardiac patients conducted as part of COINS found that 5% decided to withdraw because of a hypothetical investigator's equity interest.
Patients were less bothered by the idea of physician investigators receiving per capita payments for their work with the study. Paradoxically, some patients took comfort from the idea that investigators had money at stake, believing that could mean the doctors had greater confidence in the study intervention's efficacy. The study was funded by the National Institutes of Health's National Heart, Lung, and Blood Institute.
In 2001, the Assn. of American Medical Colleges recommended that academic medical centers bar individuals with a financial stake in a study's outcome from taking part as investigators unless there is a compelling reason why their participation is vital. An Institute of Medicine panel report released in April said research institutions must establish "an effective mechanism for managing the conflict and protecting the integrity of research" to oversee investigators with financial stakes in study outcomes.
Dr. Sugarman said that because patients may not understand all the intricacies of the financial relationships at play, conflict-of-interest committees should play a key role in helping protect research subjects.
"Groups that can have full access to information about the study design, the financial relationships involved, the potential risks of any financial interests to the safety and welfare of subjects, as well as the integrity of the data -- they are best positioned to make decisions about a potential management strategy," said Dr. Sugarman, professor of bioethics and medicine at the Johns Hopkins Berman Institute of Bioethics. "Sometimes that strategy may be disclosure, and sometimes it may be more elaborate, based on the conditions at hand."