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:
*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.
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:
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
In addition, you are required to repeat the training when:
2) Disclosing Significant Financial Interests (SFI) within timeframes specified by the NIH
The timeframe for SFI disclosure is:
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.
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
The responsibilities of the Designated Official are:
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 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:
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.