As mentioned in recent issues of the Nexus, the NIH is engaged in a system-wide review of policies, procedures and guidance on financial conflicts of interests (FCOI). The results of the review are still being analyzed but we noted a number of issues related to compliance with the regulation governing Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50 Subpart F). We are concerned that these issues were also identified during previous compliance efforts conducted by the Office of Extramural Research (including Targeted Site Reviews in 2006 and the Review of Institutional Conflict of Interest Policies in 2002) and continue to be compliance issues.
The three major recurring concerns are:
- Definition of Investigator
Typically, Institutions define “Investigator” too narrowly by qualifying the individuals covered by the term (e.g., senior faculty, key personnel, co-investigators), which is inconsistent with the regulation. The FCOI regulation defines “Investigator” as the “principal investigator and any other person who is responsible for the design, conduct, or reporting of” funded research, and the definition includes the Investigator’s spouse and dependent children. The regulation is thus very broad in its definition. An Institution that limits the definition of “Investigator” by titles or other designations increases the risk that an unidentified FCOI may compromise the research enterprise.
Institutions are required to report identified FCOIs to NIH prior to the expenditure of any funds under the grant award, and assure that the conflict has been managed, reduced or eliminated. Further, Institutions must report any FCOI identified subsequent to the initial report under the award within 60 days of that identification. We observed that Institutions seldom include a provision in their policies that require a report be sent to NIH when a new FCOI has been identified.
The regulation provides that if the Institution carries out NIH-funded research through subrecipients (i.e., subawardees, contractors, or collaborators); the Institution must take reasonable steps to ensure that Investigators working for such entities comply with the regulation. Subrecipient Investigators must be required to comply with the Institution’s policy or the entities must provide assurances to the Institution that will enable it to comply with the regulation. We found that Institutional FCOI policies do not generally address this requirement. In addition, the institution is responsible for reporting to the NIH any conflicting interests it has identified, including those of its subrecipients, and assuring that the interest has been managed, reduced, or eliminated in accordance with the regulation.
Given the importance of the promoting objectivity in research and maintaining the public’s trust in our endeavors, it is essential that extramural Institutions and Investigators alike are aware of and fully comply with the provisions of the regulation.