NIH Financial Conflict of Interest Guidance Note and Procedures for Compliance

 

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 new 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. The same requirements also apply to PHS funders. Where NIH is stated below, PHS equally applies.

The new regulations:

 

  1. Reduced the Significant Financial Interest (SFI) threshold from $10,000 to $5,000, and are expanded to include SFIs related to Investigator’s University responsibilities.
  2. Require Investigators to complete an online NIH FCOI Training tutorial and to sign the last page before applying for NIH funding or becoming involved in an NIH funded project.
  3. Have imposed strict deadlines and requirements on Disclosure and Reporting.
  4. Require institutions to make certain information accessible to the public concerning identified financial conflicts of interest held by senior/key personnel.
  5. Requires all significant financial interests to be reviewed prior to Application and Award Acceptance, and if required a plan put in place to manage and conflicts.

 

Frequently Asked Questions (FAQs) about the new regulations

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 Faculty:

 

  1. Investigators
  2. Designated Officials
  3. Faculty Research and Innovation Offices.