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 as:

1) The process determining and managing FCOI is managed locally

2) Reporting needs to be carried out on a project by project basis.

The Faculty Research and Innovation Office will also be responsible for notifying the Designated Official as soon as it becomes aware of a Significant Financial Interest declaration or when as 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 Documentum.

  • 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 in the event that the Designated Official cannot/does not review a disclosed SFDI within the defined timeframe).
  • 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 final payment.

The FRIO shall also 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, but the following is a summary: