The National Institutes of Health (NIH) is receiving a lot of advice on how to tighten its conflict-of-interest standards, and much of it favors increasing transparency and expanding disclosure. Sixty-two organizations responded this week to a call for public comments about how investigators and institutions should disclose financial interests related to publicly-funded research. Among the specific questions NIH asked:
- Would expanded disclosure by investigators allow institutions to better identify conflicts?
- Should exemptions, including a $10,000 annual payment disclosure floor, be altered?
- Should institutions report additional information to NIH along with identified Financial Conflicts of Interest (FCOIs)?
- Should certain financial interests always be considered a conflict / be prohibited for certain types of research?
- Should there independent confirmation of institutional compliance be required?
- Investigators should disclose all financial relationships to their university or affiliated institution, regardless of value;
- NIH should lower its current threshold for institutions to report conflicts (currently set at $10,000 or 5 percent equity);
- Reports of Financial Conflicts of Interest (FCOI) to NIH should include more information, specifically the criteria and categories identified in the Physician Payments Sunshine Act, S.301;
- The proposed increased disclosure will enable NIH to better enforce its regulations around objectivity in research; and
- S. 301 will be an important tool for NIH and institutions to audit disclosures, underscoring the need to align the information reported to NIH with the proposed Sunshine criteria.
- The definition of a Significant Financial Interest, and therefore what is reported, be changed from its current level – payments above $10,000 – to $5000, which would mean universities would have to report all such payments to the NIH. They also recommended lowering the reporting floor on equity from 5 percent to .1 percent.
- Institutions provide more details about the management plans they develop for researcher conflicts of interest,
- That there be no automatic dollar-amount “trigger” from participating in research, leaving those decisions to individual institutions
U.S. Senators Charles Grassley (R-IA) and Herb Kohl (D-WI), both dogged investigators of academic-industry conflicts in the last two years, and co-sponsors of S.301, suggested that:
- researchers be required to report all of their outside income to the nearest $1000;
- a required university management plan be developed for all potential conflicts of interest
- both disclosures and management plans be publicly available on the NIH website.
But not everyone supported greater disclosure. At least one group called for looser standards. The Biotechnology Industry Organization (BIO), a trade group, recommended that the reporting floor be raised, in order to align with the FDA’s regulations on payments that must be reported with a marketing application for a new drug: $25,000 in industry payments or $50,000 in equity interests. BIO also suggested the NIH monitor institutional conflicts of deans, department chairs, and institutional trustees, who are often charged with managing the conflicts of faculty researchers.
Other industry groups, though, favored more transparency. Bayer called for the exemptions to be struck from “significant financial interests,” recommending that researchers report payments of all sizes to their university or research institution, though Bayer said that any additional information about conflicts sent to the NIH would be burdensome. And Merck, citing S. 301 and the Institute of Medicine’s call for a national disclosure law, suggested that the new NIH rules match any federal transparency law that is enacted.
To see the full docket, go here.