On May 8, 2009, the National Institutes of Health (NIH) published an Advance Notice of Proposed Rulemaking seeking public comment on possible amendment of the regulations on financial conflicts of interest (FCOIs) in research funded by the Public Health Service (PHS).1 Many of the regulatory changes NIH is apparently contemplating would require universities and other research institutions to review and perhaps amend their conflict of interest policies and disclosure forms pertinent to researchers. The contemplated changes would require more disclosure by investigators to institutions and more reporting by institutions to NIH. It remains unclear whether the changes would provide significantly more or better guidance to institutions on the situations that
NIH considers to be a conflict of interest and what steps NIH would consider sufficient to manage them. NIH’s oversight of extramural conflicts of interest has been subject to criticism by Senator Charles Grassley and the Department of Health and Human Services Office of Inspector General, and news media have scrutinized financial relationships between academic physicians and the pharmaceutical industry. An NIH review found compliance or only minor non-compliance with the regulations in 19 of 20 high-profile cases. The advance notice indicates that NIH is considering adopting as regulation some of the recommendations the Association of American Medical Colleges and the Association of American Universities made in a February 2008 report. A recent Institute of Medicine report echoed some of those same recommendations.
The advance notice invites input on all aspects of the FCOI regulations,2 and particularly on certain questions, such as these:
- Scope of research covered: Should the regulations be expanded to cover Small Business Innovation Research and Small Business Technology Transfer Research Phase I applications/proposals, which are currently excluded?
- Scope of investigators’ disclosures: Should investigators be required to disclose all significant financial interests related to their institutional responsibilities, without regard to whether the investigator believes his/her research could reasonably appear to affect the interests?
- Definition of “significant financial interest”: Should the current exemptions from the definition of a “significant financial interest” be reevaluated (e.g., income from the institution, or from public and nonprofit entities, or amounts less than or equal to $10,000 and less than or equal to 5 percent ownership)? Should the regulations automatically deem as FCOIs certain categories of significant financial interests (e.g., interests from specific sources or interests related to particular types of research)?
- FCOI identification/management: Should the regulations require each large institution (more than 50 employees) to create an “independent committee” that would review disclosures and report to a non-conflicted “organizational level” at the institution? Should the regulations mandate that institutions adopt conflict management plans for FCOIs in certain categories of research, mandate standards for such plans, and/or require particular management approaches for certain types of FCOI? Should the regulations include specific requirements for addressing sub-recipient FCOIs? Should they generally prohibit investigators with key roles in human subjects research from holding a significant financial interest in companies whose interests could be affected? Which, if any, special circumstances would warrant waiver of such a prohibition? Should investigator interests in particular types of organizations be capped?
- Institutional compliance: Should the regulations enhance existing government enforcement options that may be utilized in response to institutions’ noncompliance, require “independent confirmation” of an institution’s compliance (e.g., through accreditation or an independent audit), and/or mandate that investigators complete routine FCOI training?
- Reports to funding component: Should institutions’ reports to the PHS funding component describe the nature of and other details regarding an FCOI? If so, what additional information should be mandated? Should it be required for all or only certain categories of research?
- Institutional conflicts: The current FCOI regulations do not address institutional conflicts of interest, which the advance notice describes as “an area of increasing concern.” If amended to include provisions regarding institutional conflicts, how should the regulations define an institutional conflict of interest and what should they require institutional conflict of interest policies to address?
Comments to NIH on the advance notice are due by July 7, 2009. NIH is expected to issue for further comment a Notice of Proposed Rulemaking before it promulgates final regulations.