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.