Medical Centers Vary In Disclosing Conflicts Of Interest
Only 48 percent of U.S. academic medical centers have a formal policy requiring that financial conflicts of interest are disclosed to potential participants in their clinical trials, a research team from Duke University Medical Center, Wake Forest University and Johns Hopkins University has found.
Among those institutions that do disclose this information to participants, there was considerable variation in the type of information and the way it is presented to potential research participants, found the researchers.
In their "snapshot" of how academic medical centers are managing the issue of conflicts of interest, the team sought to discover how much, if any, information about corporate sponsorship of clinical trials is reported to potential participants. They also said they hoped their study and others to come will help academic medical centers develop more effective conflict of interest disclosure policies.
Their findings were reported in a paper published in the February, 2006, edition of Academic Medicine.
The researchers said their findings indicate that institutions are grappling in their own ways with this important and complex issue. They added that more work is needed to develop national consensus on what exactly constitutes conflicts of interest and how information about them should be presented to potential research participants.
Financial interests that might create conflicts can range from corporate support for the costs of the trial and its personnel to a consulting contract to an investigator's ownership of stock in the sponsor.
A number of agencies, such as the Association of American Medical Colleges (AAMC), have recommended that one part of managing financial conflict of interest is to include information about it in the consent process that occurs between patients and researchers before enrollment in clinical trials.
"However, while the AAMC recommendations provide guidance when it comes to what and how to disclose potential conflicts, recommendations from other groups are not as clear," said Duke's Kevin Weinfurt, Ph.D., first author of the paper. "We wanted to see how institutions implemented the AAMC guidelines. We believe that our analysis shows that significant questions remain among academic medical centers about the exact goals of disclosure and how best to achieve and communicate them."
For their analysis, the team reviewed the conflict of interest policies from the 120 academic medical centers with institutional review boards (IRB), committees of specialists that evaluate clinical research protocols to ensure patient safety. Each institution's policies were obtained either from website searches or directly from the IRBs themselves. The researchers conducted the survey in February and March of 2004.
The new analysis is the first of many on the role of conflict of interest in medical research funded by a $3 million grant from the National Institutes of Health. The researchers said they hoped that results of the five-year effort -- "Conflict of Interest Notification Study" (COINS)