The National Institutes of Health has proposed changes to its financial conflicts of interest policies that will place new disclosure responsibilities on institutions that receive funding from the agency in an effort to increase transparency and accountability while strengthening rules put into place in 1995.

“The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process,” NIH Director Francis Collins said during a press briefing announcing the proposed rules. “And therefore even though these proposed new rules may provide some burden to the investigator and to the institutions in terms of additional reporting requirements we believe that it is essential to tighten up this situation in order to be sure that we are obtaining and maintaining the public trust in the integrity of the scientific enterprise.”

Collins says the proposed rules represent a “substantial change” for investigators, universities, institutes, and small businesses that receive NIH funding.

Among the changes proposed is a lowering of the de minimis threshold for reporting to $5,000 from $10,000. In addition, the responsibility for deciding whether a particular relationship is a potential financial conflict of interest will be placed on the institution rather than the investigator as current rules require. This means that institutions will be required to set up a process to review potential conflicts of interest to identify those that may require action and to report to NIH about such situations.
Phase 1 Small Business Innovation Research grants and the Small Business Technology Transfer Program, currently excluded from conflict of interest rules, will be included under the proposed policy. The new rules, though, exclude income from seminars, lectures, teaching, or service on advisory or review panels for government agencies or institutions of higher education.

The new rules also impose disclosure requirements on the grant receiving bodies that call for publicly accessible websites that reveal significant financial interests of their faculty and other institutional members in order for the public to have an easy means of identifying the types of arrangements that have been made to provide transparency to the process.

The NIH, which published the proposed rules in the Federal Register on May 21, is seeking comments on the policy over the next 60 days.

“The public may not always understand the intricacies of rigorous science, but most individuals quickly grasp the concept of bias,” wrote Collins in a commentary 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.”