In the interest of full disclosure

NIH proposes federal rule requiring researchers to publicly report payments from pharma companies

Kimberely Sirk
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BETHESDA, Md.—In part to tighten up existing federal regulations, and in part to quell some concerns over recent high-profile cases of suggested scientific quid pro quo, the National Institutes of Health (NIH) is accepting public comment on a series of rule changes and revisions introduced into the Federal Register on May 21.

Partnerships between NIH-funded researchers and industry are often essential to the process of moving discoveries from the bench to the bedside. However, managing financial conflicts of interest (FCOI) can be a major challenge because of the complex relationships among government, academia and industry.

A Notice of Proposed Rulemaking (NPRM), which is open for public comment until July 20, proposes significant revisions to the existing regulations that have been in place since 1995. A major substantive change in the proposal includes lowering the de minimis threshold on reporting of financial relationships from $10,000 to $5,000.

In a press briefing held May 20, NIH director Francis Collins explained that not only will the threshold for reporting be changed from a hard-dollar amount, but a change in the threshold for the level of public disclosure will also be instituted. Responsibility for reporting relationships for financial gain would fall more heavily on institutions, more so than on the individual researcher.

"The responsibility for deciding about whether a particular relationship is a potential financial conflict of interest will now rest upon the institution, as opposed to upon the investigator, so that the institution is therefore required to set up a process to review such potential conflicts of interest to identify those that may need an intervention, and to report to NIH its actions in that regard," Collins said in the briefing. "This will now include Small Business Innovation Research and Small Business Technology Transfer Phase 1 applications which were previously not included. It will exclude, however, income from seminars, lectures or teaching or service on advisory or review panels for government agencies or institutions of higher education.

"And there will be a disclosure component to this," Collins added. "So where institutions will now be required to develop a publicly accessible website, that will display significant financial interests of their faculty and other institutional members in order for the public to have a clear pathway towards identifying what kinds of arrangements have been made, so that there is transparency to the process."

Don Ralbovsky of the NIH's Office of Communications says the NIH is not granting interviews on the NPRM while the public comment period is in progress, to avoid agency comment influencing citizen input.

In published reports, Collins and Sally Rockey, deputy director of extramural research at the NIH, have indicated that the U.S. Public Health Service, of which NIH is a part, is the only federal agency to have regulations regarding FCOI in research. They opined that to keep the process transparent, while giving a nod to the accelerated pace of biomedical research, new disclosure requirement and benchmarks are required to maintain the public trust.

According to the Federal Register, the median amount of an NIH Phase I award increased from roughly $99,000 when the rules were instituted in 1995 to approximately $182,000 in 2009. The NIH has acknowledged that the importance of receiving this funding by noting that Phase I awards often lead to Phase II funding or significant outside financial support to researchers.

In addition, the government has acknowledged that biomedical and behavior research functions in the United States have grown significantly in the intervening time period, and that relationships between institutions and the private sector have become more complex, as many discoveries are now brought from the bench to the marketplace through multidisciplinary teams.

The rules are said to be in part a result of several high-profile cases where it was discovered that academic researchers had lucrative financial relationships with companies whose products were under scrutiny.

In response to this, the proposed regulations would require that NIH-funded investigators disclose to their institutions all significant financial interests related to their institutional responsibilities. This change would effectively shift the burden of determining the significance of and reporting that relationship from the investigator to his or her institution.

According to published comments made by Collins and Rockey, investigators will be required to determine and disclose to their institutions any significant financial interest that would reasonably appear to be affected by the NIH-supported research, as well as any significant financial interest involving entities whose financial interests would reasonably appear to be affected by the research. Institutions, in turn, are required to manage, reduce or eliminate the conflict; to report to NIH; and to assure NIH that this process has been followed for all identified FCOI that could have a significant and direct effect on NIH-funded research.

In addition, changes to numerous definitions pertaining to the research and funding process are on the table. These include revisions to the definitions of "contractor," "institution" and "investigator." New definitions would be promulgated for financial and significant financial interests, financial conflict of interest reporting, institutional responsibilities, what defines a project director/principal investigator and management of the entire funding process.

It is expected that any changes to the rules will be instituted by year's end.

Kimberely Sirk

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