NIH wants tighter oversight of research money trail

May 28, 2010 – 10:37 am by Michael Christel

In our May cover story on patient recruitment, we talk a bit about the issue of transparency and how the federal government and industry are seemingly taking steps to better address public trust concerns in the research process.

The latest example is a new conflict of interest rule being proposed by the National Institutes of Health that would require NIH-funded researchers to disclose more information about their financial ties to industry. The hope for the rule, according to the official federal register filing (view here), would be to enhance regulatory compliance and effective institutional oversight and management of investigators’ financial conflicts of interests, as well as NIH’s compliance oversight.

“The public may not always understand the intricacies of rigorous science, but most individuals quickly grasp the concept of bias,� NIH Director Francis Collins, M.D., and Sally Rockey, Ph.D., wrote in an editorial on the topic published online in The Journal of the American Medical Association. “Plain and simple, Americans do not want financial conflicts of interest to influence federally funded research they hope will yield better ways to fight disease and improve health.�

Current regulations governing financial disclosures, which date back 15 years, put most of the onus on disclosing conflicts of interest on individual investigators, not their institutions. The NIH acknowledges a new approach is necessary, given the increasingly complex relationship between government, research institutions, and the private sector around biomedical and behavioral research.

The JAMA editorial notes that the U.S. Public Health Service, of which NIH is a part, is the only federal agency to have regulations regarding financial conflicts of interest in research.

“In recent years, it has become increasingly apparent that the existing federal regulations, which were promulgated in 1995, need to be clarified and strengthened to ensure greater transparency and accountability,� the authors write. “Without such changes, even more instances of real or perceived financial conflicts of interest will likely be encountered in the future.�

The NIH is proposing a general revision to the existing regulations. The proposal is open for public comment through July 20, feedback the agency says will be considered when drafting the final rules. A replay of a recent telebriefing with Dr. Collins can be viewed here.

Under the proposed rule, researchers would be required to report all financial interests related to their research, not just those that might directly conflict with NIH-funded R&D. This would transfer the responsibility for determining if an investigator’s significant financial interests are related to NIH-supported research from the individual to his or her institution.

The proposal would also lower the monetary threshold at which interests require disclosure from $10,000 to $5,000.

Two other key rule changes would be the requirement of institutions to develop a management plan for every identified financial conflict of interest and the requirement for every NIH-funded institution to post on a Website information about certain significant financial conflicts of interests.

Tags: NIH, transparency