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) – will help provide data to help institutions develop conflict of interest policies. COINS is headed by Jeremy Sugarman, M.D., a bioethicist at Johns Hopkins University.
"The field is moving quite rapidly, with recommendations like those from the AAMC being relatively new," Sugarman explained. "We would expect official policies put into place by institutions to lag behind guidance, but we are encouraged that institutions are taking the issue of conflict of interest seriously.
"I am not surprised, given the lack of data on the best way of disclosing conflicts, that all institutions have not adopted wholesale new and untested recommendations based on guidance from outside bodies who are similarly concerned about this important issue," Sugarman said.
When looking at an academic medical center's disclosure of conflict of interest to their trial participants, the researchers said there are three possible goals of disclosing to participants.
"The first is to ensure that patients have all the information they need in order to make an informed consent about participating in a trial," Weinfurt explained. "The information should be presented in such a way that patients understand the nature and likely consequences of any financial conflicts of interest."
The second possible goal of disclosure is to make sure that the research in question adheres to legal or regulatory requirements, said Weinfurt. The final goal of including conflict of interest information in the consent process is that it might serve as a deterrent to investigators or institutions from engaging in significant conflicts of interest, since they would have to disclose them to patients.
The researchers found a wide variety of ways different institutions communicate this information to their patients -- ranging from detailed information in the consent forms to required discussion between investigators and participants. Some consent forms mentioned only the sponsor by name, while others went into detail about where and how the sponsor's support was being spent.
"From our study, it appears that most of the policies in place at academic medical centers were the most consistent with the goal of avoiding legal liability," Weinfurt said. "While it is difficult to determine the motivation, it appears that the language usage in consent forms better served the legal goal than the informed choice or deterrent goal.
Both Weinfurt and Sugarman agreed that many institutions are unsure about how to move forward with conflict of interest disclosures, and they are looking for guidance. They believe that this and subsequent COINS studies can lead to different models that could then be tested.
"For example, would a simple disclosure that an individual investigator could benefit from the results of study be better understood by a participant than a long description of the nature and possible implications of the financial relationship?" Weinfurt said. "We are currently focusing on these sorts of issues."
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