NIH director seeks greater transparency for biomedical research financial conflicts of interest

Under proposed new rules to enhance disclosure of financial conflict of interest by federally funded biomedical researchers and their institutions, the chief responsibility for disclosing significant and potentially conflicting financial interests would shift from individual investigators to their institutions, according to a Journal of the American Medical Association commentary written by Francis S. Collins, MD, PhD, director of the National Institutes of Health, and colleague Sally J. Rockey, PhD.

To raise awareness about the proposed new regulations, JAMA posted Collins and Rockey’s commentary online on May 24. According to a JAMA press release announcing the publication of the commentary, new rules are needed to uphold scientific integrity.

“Plain and simple, Americans do not want financial conflicts of interest (FCOI) to influence federally funded research they hope will yield better ways to fight disease and improve health,” Collins and Rockey wrote. “Managing FCOI in biomedical and behavioral research, however, can prove to be a major challenge because of the complex relationships among government, academia, and industry. Partnerships between NIH-funded researchers and industry are often essential to the process of moving discoveries from the bench to the bedside.”

Updated rules

Since regulations regarding disclosing FCOI with the NIH-funded research date back to 1995, better guidelines are needed to manage the current, and often times complex, financial relationships among those involved in biomedical research. Therefore, in 2009 the NIH posted an Advanced Notice for Proposed Rulemaking, inviting input from the public, Congress, professional societies, universities and others. According to the commentary, the public was asked on May 21 to provide comments on its new proposed rule, which differs substantially from current regulations.

Final rules are expected to be issued before the end of the year.

Another change being proposed by NIH would “require institutions to develop a management plan for every identified FCOI, which may include reduction or elimination of the FCOI,” they wrote.

Furthermore, the new regulations propose that all NIH-funded institutions post on a website key conflicts of interest that the institution has determined are related to NIH-funded research and represent a real conflict of interest.

Collins and Rockey concluded that, “Consequently, for the good of the research enterprise and for our nation as a whole, it is imperative to take collective steps now to usher in a new era of clarity and transparency in the management of FCOI.”

Rockey SJ. JAMA. 2010;303: doi:10.1001/jama.2010.774.