Financial conflict of interest, responsibility of applicants for promoting objectivity in research, free from bias, FCOI, FCOIs, FCOI report, 42 CFR 50
NIH requires recipient institutions (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of 42 CFR Part 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought." (FCOI Regulation), as implemented in the 2011 Final Rule for grants and cooperative agreements. FCOI requirements are aligned with 42 CFR Part 50--Subpart F and the overarching goal for reporting is to promote and encourage transparency in order to avoid distorting NIH funding decisions; NIH staff consider reports in light of other disclosures, e.g. other support, biographical sketch data, and foreign components, etc., and provide a holistic approach to award and risk management principles.
The requirements under the 2011 revised regulation promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias by any conflicting financial interest of an Investigator, defined as the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding, which may include, for example, collaborators or consultants. These requirements do not apply to Federal employees or Federal agencies. Federal agencies have their own set of rules governing FCOI for employees. When submitting a grant application, the signature of the AOR certifies the applicant Institution's compliance with the requirements of the FCOI regulations, including that:
- There is in effect at the Institution an up-to-date, written and enforced administrative process to identify and manage FCOI with respect to all research projects for which NIH funding is sought or received;
- The Institution shall promote and enforce Investigator compliance with the regulation's requirements including those pertaining to disclosure of Significant Financial Interests (SFI);
- The Institution shall identify and manage FCOIs and provide initial and ongoing FCOI reports to NIH;
- When requested, the Institution will promptly make information available to the NIH/HHS relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of an FCOI;
- The Institution must fully comply with the requirements of the regulation.
When the Institution determines that an FCOI exists (see #3 above), the Institution must report to the NIH awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. through the submission of an initial and annual FCOI report using the eRA Commons FCOI Module. The initial FCOI report will include the following information:
- Grant number and PD/PI or Contact PD/PI if the grant is awarded under the multiple PI model;
- Name of Investigator (if different from the PD/PI) with the FCOI;
- Name of the entity with which the Investigator has an FCOI;
- Nature of the FCOI (e.g., consulting fees, honoraria, paid authorship, equity interest, intellectual property rights and interests, and reimbursed or sponsored travel);
- Value of the financial interest $0-4,999; $5,000-9,999; $10,000-19,999; amounts between $20,000-100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000 or a statement that a value cannot be readily determined;
- A description how the financial interest relates to NIH-funded research and the basis for the Institution's determination that the financial interest conflicts with such research; and
- Key elements of the Institution's management plan, including:
- Role and principal duties of the conflicted Investigator in the research project;
- Conditions of the management plan;
- How the management plan is designed to safeguard objectivity in the research project;
- Confirmation of the Investigator's agreement to the management plan;
- How the management plan will be monitored to ensure Investigator compliance; and
- Other information as needed.
The annual FCOI report must be submitted to NIH through the eRA Commons FCOI Module each year within a competitive segment or until the Institution reports that the FCOI no longer exists. The annual FCOI report will include the following information:
- Status of the FCOI
- Changes to the management plan, if applicable
The Institution will incorporate, as part of a written agreement with a subrecipient, terms that establish whether the FCOI policy of the recipient Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure and/or FCOI reporting requirements. Subrecipient Institutions who rely on their FCOI policy must report identified FCOIs to the recipient Institution in sufficient time to allow the recipient Institution to report the FCOI to NIH to meet its reporting obligations. (See Consortium Agreements, 15.2.1 Written Agreement.)
The Institution will make certain information available concerning identified FCOI held by senior/key personnel as defined in the regulation via a publicly accessible web site or by a written response to any requestor within five business days of a request and update such information as specified in the regulation.
Each Institution shall maintain an up-to-date, written, enforced policy on FCOI that complies with the regulation, and make the policy available via a publicly accessible web site. NIH funded recipients are required to submit their publicly accessible FCOI policy to NIH via the eRA Commons Institution Profile (IPF) Module (IPF Module). The information is provided on an institutional level as part of an institution's IPF, rather than on a grant-specific level, so it is not necessary to submit the FCOI policy with each grant application.
The Institution must require each Investigator to disclose their (and their spouse and dependent children) domestic and foreign SFIs that are related to their Institutional responsibilities to the Institution's designated official(s).
Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education and foreign governments (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000). Institutions are strongly encouraged to review their FCOI policy and make any necessary changes to ensure Investigators fully understand their disclosure responsibilities.
The Institution must require each Investigator (including subrecipient Investigators) to complete training prior to engaging in NIH-supported research and at least every four years, and immediately under the designated circumstances:
- Institutional FCOI policies change in a manner that affects Investigator requirements
- An Investigator is new to an Institution
- An Institution finds an Investigator noncompliant with the Institution's FCOI policy or management plan.
As described in the regulation, examples of how FCOIs might be managed include but are not limited to, the following:
- Public disclosure of FCOI (e.g., when presenting or publishing the research);
- Disclosure of FCOI directly to human subjects research participants;
- Monitoring of research by independent reviewer(s);
- Modification of the research plan;
- Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
- Reduction or elimination of SFIs (e.g., sale of an equity interest)
- Severance of relationships that create FCOIs.
The information above is only a sample of the regulatory requirements found in 42 CFR Part 50--Subpart F. Applicants and recipients must review the regulation in its entirety to ensure compliance with all of the requirements. Resources applicable to FCOI, including Frequently Asked Questions, etc. can be found on OER's Financial Conflict of Interest Web site. The NIH disclosure table can be found at https://grants.nih.gov/grants/forms/NIH-Disclosures-Table.pdf.