New NIH financial conflict-of-interest rules now in effect

As of Aug. 24, new regulations on financial conflicts of interest require researchers who receive grants from the National Institutes of Health and other federal agencies to disclose payments and equity received from companies, foundations and medical societies related to their "institutional responsibilities," now expanded to include teaching, clinical care and administration, as well as research. The goal of these new regulations is to further promote objectivity in all of these institutional activities, which in rare instances could be adversely influenced by personal financial interests.

Academic medical centers will now be expected to take a more active role in reviewing and managing researchers' potential financial conflicts of interest. University officials are required to review outside financial interests in a timely fashion and determine if they could have a direct and significant effect on the research or other duties. If a conflict is found, Stanford administrators, just like their counterparts at other institutions, must inform the NIH about it, and describe how the conflict will be managed

Because the NIH reporting threshold for "significant financial interests" has been lowered and the definition widened, more researchers are likely to be subject to institutional review. The dollar threshold for reporting "significant financial interests" was lowered from $10,000 to $5,000, and institutions now need to examine all financial relationships that relate to a faculty member's "institutional responsibilities," including teaching, clinical care and administration, as well as research. Payments related to clinical and teaching duties, such as authorship fees from medical societies, also have to be reported.

In addition, relationships identified as "financial conflicts of interests" that could have a direct and significant effect on federally funded research will now have to be publicly disclosed upon written request. (Stanford investigators already publicly disclose industry relationships greater than $5,000, including equity in privately held companies, on their Community Academic Profile.)

The new rules are the latest revisions to the NIH "Objectivity in Research" rules that date back to 1995. While the medical school has had its own extensive conflict of interest policies in place for some time, these new rules are significantly different, and Stanford researchers are encouraged to familiarize themselves with these changes. To help faculty and investigators comply, Stanford has launched a new conflict of interest website at http://www.stanford.edu/group/coi/. A link to Stanford's new self-paced training course, which is mandatory for all newly hired faculty and investigators undertaking new NIH-funded research, can also be found on this website.