Public Health Service Issues Final Conflicts of Interest Rule

The U.S. government released new final rules today that will tighten up oversight of financial conflicts of interest in biomedical research. The rules are similar to draft regulations released in May of last year, but a requirement aimed at informing the public about conflicts has been watered down.

The 159-page rule (including preamble) tightens a 16-year-old Public Health Services regulation that requires researchers funded by the National Institutes of Health (NIH) or other PHS agencies to report their income from drug companies and other outside sources to their institutions. A previous income threshold of $10,000 per year has been lowered to $5000 and broadened to include any equity in a non-publicly traded company.

Another big change is that investigators will no longer decide whether their outside income poses a financial conflict. Instead, they must report all payments (or "interests") related to their grants or job to their institutions. Institutional officials will then determine if any payments constitute a conflict and report these financial conflicts to NIH along with how they are being managed.

"I think NIH's goal here is not to discourage relationships between academic investigators and the private sector. We depend critically on those for advances in biomedical research. But we do want to make sure those relationships are subject to appropriate scrutiny," said NIH Director Francis Collins in a teleconference today.

But some onlookers are disappointed with the final rule's provisions for public disclosure. A requirement in the draft version that institutions post their faculty's financial conflicts on a Web site drew complaints. Now, institutions can opt to provide written information in response to a request within five business days. Giving institutions "maximal flexibility" will be "least burdensome," explained NIH Deputy Director for Extramural Research Sally Rockey.

NIH also rejected a suggestion that it create a central public Web site listing the conflicts. The agency "felt the institutions were in the best position to be able to post information about their investigators in the context of the whole environment in which they work and also provide the most timely information," Rockey said.

The final rule doesn't specifically address another concern that Collins raised last summer: that an investigator who has been disciplined by their institution could escape punishment by moving to a new university. The fact that conflicts information will now be publicly accessible "will allow [the new] institutions to evaluate to see what kind of approach they want to take," Rockey explained.

Paul Thacker of the watchdog group Project on Government Oversight in Washington, D.C., says "it would have been so simple" for NIH to post the conflicts information it collects from institutions on its own Web site, including management plans. "Instead of increasing public trust they decided to [continue to] hide the information," he says. Thacker is a former staffer for Senator Charles Grassley (R-IA) whose investigation of undisclosed drug company payments in academia pushed NIH to overhaul the conflicts reg.

Some academic experts on conflicts of interest are also disappointed that the draft plan to require posting of faculty conflicts on the Web was dropped since that will make the information harder to obtain and analyze. The regulation will appear in this Thursday's Federal Register, and institutions will then have a year to begin complying.