Disclosure of financial conflicts of interests to potential participants in research is important, but may have a limited role in managing these conflicts, according to an article in the Aug. 27 issue of The New England Journal of Medicine.
The article contains recommendations that provide a framework for establishing sound policy and practices for how best to disclose financial conflicts of interests to potential participants in clinical research, according to senior author Jeremy Sugarman, MD, deputy director for medicine at the Johns Hopkins Berman Institute of Bioethics in Baltimore.
The authors drew on five years of research from the Conflict of Interest Notification Study, (COINS), a $3 million project led by Sugarman and funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Overall, COINS gathered information from thousands of patients, clinical trial investigators and those in charge of ethical oversight of research.
According to the authors, clinical investigators have long been urged to disclose their financial interests to potential study participants through the informed consent process.
Sugerman and colleagues questioned what goal this disclosure is hoping to achieve.
"[P]atients often don't understand such disclosures and generally don't use the information when deciding what they are going to do," said lead author Kevin Weinfurt, PhD, a medical psychologist at Duke University Medical Center in Durham, N.C. "The public is increasingly demanding transparency, but if our disclosure system isn't accomplishing what we hope it will, then we may need to change it."
Weinfurt, Sugarman and colleagues developed the following guidelines for institutions attempting to comply with the spirit and intent of disclosure:
- Study participants should not be allowed to be the sole arbiters of acceptable risk when evaluating researchers' financial relationships with organizations that support their work. Institutional Review Boards, conflict of interest oversight committees and other such authorities should play a much larger role.
- Disclosure statements during the consent process should be brief and simple, and should encourage patients' questions.
- Study coordinators need to be thoroughly familiar with researcher or institutional conflicts of interest so they can adequately answer patients' questions. COINS research showed that coordinators are often ill-prepared to do so, or are unaware of any financial conflicts of interest.
- Boards, committees or entities charged with designing disclosure regulations should be clear about the goals they want to achieve and should be able to determine if their directives help reach those goals.
“Disclosure alone is not enough," said Sugarman. "It is not the remedy that many seek, although the process may have a positive effect on patients' satisfaction with and trust in the research process."