NIH Financial Conflict of Interest Guidance Notes and Procedures

Please note that the following only applies when applying for and accepting grants from the National Institutes of Health (NIH).

The US Department of Health and Human Services has revised the regulations on disclosing and reporting conflicts of interest for researchers funded via its Public Health Service (which includes the NIH). The regulations (which took effect on 24 August 2012) make some significant changes to the previous framework for disclosing, managing and reporting conflicts of interest, which we need to adhere to.

A Financial Conflict of Interest exists when the Institution (University of Leeds) reasonably determines that a Significant Financial Interest (SFI) could directly and significantly affect the design, conduct or reporting of NIH-funded research or funding awarded by other Public Health Service (PHS) funders. The same requirements also apply where the funding is awarded indirectly e.g. where the University of Leeds is (or receives funding from) a sub-awardee or sub-contractor.

Significant Financial Interest (SFI) is a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:

  • With regard to any publicly traded entity*, a significant financial interest exists if the value of any remuneration (including salary, and any payments for services not otherwise identified as salary e.g. consulting fees, honoraria, paid authorship) received from the entity in the twelve months preceding the disclosure and the value of any equity interest (includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value) in the entity as of the date of disclosure, when aggregated, exceeds $5,000.
  • With regard to any non-publicly traded entity*, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

*Entity means any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.

Frequently Asked Questions (FAQs)

NIH Definitions

Financial Conflict of Interest needs to be determined on a project by project basis, and the disclosure, management and reporting needs to be managed locally. The responsibility for ensuring compliance with NIH regulations therefore falls at three levels within the University:

Investigators

Investigator is a project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, which may include, for example, collaborators or consultants. The NIH (and PHS) regulation requires that Investigators take responsibility for the following:

1) Completing Compulsory Financial Conflict of Interest (FCOI) training

  • The online NIH FCOI Training tutorial must be completed before submitting an application or engaging in research relating to any NIH grant
  • A copy of the certificate needs to be forwarded to the Faculty Research and Innovation Office who will keep in on file for audit purposes. The training must be repeated at least every 4 years

In addition, you are required to repeat the training when:

  • The University’s FCOI policy changes in a manner that affects Investigator disclosure requirements.
  • You are new to the University.
  • When an academic department/school/faculty finds that you have been non-compliant with the University’s FCOI procedure on NIH funded projects

2) Disclosing Significant Financial Interests (SFI) within timeframes specified by the NIH

The timeframe for SFI disclosure is:

  • Before the time of application for the NIH funded research: this is done by completing the relevant FCOI declarations on the Risk Review dashboard that supports financial approvals.
  • At least annually during the period of the award
  • Within 30 days of discovering or acquiring a new SFI
  • Failure to disclose within the above timescales will result in additional reporting obligations to NIH
  • Where a Significant Financial Interest has been declared, immediately contact the Designated Official (contact details below) and your Faculty Research and Innovation Office for consideration of the SFI.

3) Adherence to an agreed Management plan (in the case that one is required following an identified Financial Conflict of Interest (FCOI)

Non-compliance must be reported to the NIH.

Designated Officials

The NIH (and PHS) regulation requires that an institution has Designated Official(s) that is/are responsible for reviewing and developing and implementing plans to manage Financial Conflict of Interest. The Designated Official for Leeds University is:

Frances Cameron (Senior Contracts Manager)

Telephone : +44 (0) 113 34 34057

Email: F.V.Cameron@leeds.ac.uk

The responsibilities of the Designated Official are:

  • Review of the SFI Disclosures to determine whether they constitute a Financial Conflict of Interest (FCOI), i.e. The SFI could be affected by the NIH (or PHS) funded research, or is an entity whose financial interest could be affected by the NIH funded research
  • If occurring during the course of an ongoing NIH funded project, that the Review is carried out within 60 days, or any deadline set by the lead applicant (where Leeds is in receipt of a sub agreement)
  • If required, development and implementation of Management Plans to control identified FCOIs. Examples of action that can be taken to manage FCOI can be found here in Section 50.605 (a) Management of Financial Conflicts of Interest
  • Undertaking retrospective reviews in the event that an Investigator fails to comply with NIH FCOI policy and development of a management plan if required.

Faculty Research and Innovation Office

Faculty Research and Innovation Office

The NIH (and PHS) regulation has a number or reporting and records maintenance requirements. This will be managed locally by the respective Faculty Research and Innovation Offices (FRIO) as:

  • The process determining and managing FCOI is managed locally
  • Reporting needs to be carried out on a project by project basis.

The Faculty Research and Innovation Office (FRIO) will also be responsible for notifying the Designated Official as soon as it becomes aware of a Significant Financial Interest declaration or when a Conflict of Interest is declared on the Risk Review Dashboard.  The FRIO will ensure that all documentation required to investigate a Conflict of Interest is stored in designated project file.

The responsibilities of the FRIO are:

  • Reporting identified FCOI within the 60 day deadline directly to NIH (where Leeds is the lead applicant) or where Leeds is a sub recipient, to the lead applicant within the deadline set by them, prior to the expenditure of funds.
  • Reporting any FCOI identified on behalf of a sub recipient to NIH
  • Maintain records of FCOI report due dates.
  • Maintain records of Significant Financial Interest, FCOI forms, FCOI training certificates etc.
  • Monitor sub-recipient compliance with the NIH FCOI policy requirements and any Management plans
  • Ensure a retrospective review occurs within 120 days of the determination of noncompliance:
    – if an Investigator fails to disclose a Significant Financial Interest;
    – if the Designated Official cannot/does not review a disclosed SFI within the defined timeframe
    – if an Investigator fails to comply with a Financial Conflict of Interest management plan
  • Maintain records relating to all Investigator disclosures, the review of such disclosures and all actions arising from the review for at least 3 years after the submission of the final expenditures report. if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken.

The FRIO shall also be responsible for reminding Investigators at application and award stages of their responsibilities with respect to the Leeds University procedures for ensuring compliance with NIH FCOI policy, and for negotiating reporting timelines in sub-agreements where the review period SFIs and reporting period of FCOIs are less than standard NIH timelines.

The detail of the reporting and records maintenance requirements can be found here.