Institutions that receive funding from the National Institutes of Health soon will have to publicly post information about any significant financial interests related to their government-funded research under proposed federal regulations published May 21.
The proposed regulation, which has been in the works for about a year, follows several high-profile cases in which NIH-funded researchers failed to disclose large amounts of industry funding. Federal regulations on this subject have not been updated since 1995
In a commentary published online by JAMA on May 24, Dr. Francis S. Collins, NIH director, and Sally J. Rockey, Ph.D., acting director of the NIH Office of Extramural Research, wrote that the 1995 regulations needed to be "clarified and strengthened" in order to maintain the public's trust in federally funded research (doi: 10.1001/jama.2010.774).
"The public may not always understand the intricacies of rigorous science, but most individuals quickly grasp the concept of bias," Dr. Collins and Dr. Rockey wrote in JAMA. "Plain and simple, Americans do not want financial conflicts of interest to influence the federally funded research they hope will yield better ways to fight disease and improve health."
Under the proposed regulation, researchers would be required to make broader disclosures and institutions are given greater responsibility for determining whether a disclosed financial interest would impact research.
Currently, individual researchers are only required to report significant financial interests that could affect their NIH-funded research or any significant financial interest they have in a company whose own monetary interests could affect the research.
The proposed rule would require researchers to report all significant financial interests. It would then be the institution's responsibility to determine whether those could reasonably appear to affect their NIH-funded research. Additionally, the proposal would lower the threshold for reporting financial interests from $10,000 to $5,000 for all equity interests and payment for services.
Along with evaluating potential financial conflicts, institutions also would be required to create a management plan for every identified financial conflict of interest. The management plan would be aimed at either reducing or eliminating the conflict, and institutions would have to report those plans to the NIH.
The proposed rule also aims to improve transparency regarding financial conflicts of interest. Under the rule, NIH would require every institution that receives NIH funding to post information on potential conflicts of interest on a publicly accessible Web site. Institutions would be required to post the researcher's name, role in the study, nature of the financial interest, and the approximate dollar value.
The public may comment on the proposed federal regulation until July 20; it is expected to be made final before the end of the year.