The University of Sheffield Financial Conflict of Interest (FCOI) policy for US Public Health Service funded research
- When applying to, and receiving funding from, US Public Health Service (PHS) funding bodies such as the NIH, there are additional requirements for the investigator and research team to adhere to.
- The information below outlines the responsibilities of each role.
- We are unable to submit grant applications to PHS bodies if you are unable to demonstrate that you have undertaken the required training and disclosures.
- Failure to comply with the policy once a grant is awarded may have more severe consequences externally, as identified by the NIH.
- FCOI exists to ensure that research is free from bias resulting from investigator commercial conflicts of interest. This University FCOI policy applies to all staff applying to or working on projects funded by PHS, which includes a variety of agencies.
- This FCOI policy aims to ensure research integrity by establishing standards to promote objectivity and provide a reasonable expectation that the design, conduct, and reporting of research funded by PHS (or its agencies) is not jeopardised by a FCOI. It also ensures US Federal regulations are adhered to.
- The FCOI policy applies to everyone who applies for, designs a study for or who works on projects funded by the National Institutes of Health (NIH) (an agency governed by the PHS) but may be adapted to include work funded by other PHS agencies.
- The term 'investigator' is used to describe everyone including researchers, administrators, technicians, honorary staff, students, consultants, subcontractors, collaborators.
- There are Federal statutes, regulations and policies which make up the full NIH FCOI policy. The University's institutional policy ensures investigators meet the PHS requirements.
A. Principal Investigator
The Principal Investigator on NIH funded projects has four main responsibilities under the FCOI:
- To disclose any Significant Financial Interest (SFI) within the timeframes specified by the sponsor by completing the internal SFI declaration form. For example, failure to disclose as per the timelines will result in additional reporting to the NIH.
- To complete the compulsory FCOI training: the PI must complete online FCOI training required by a sponsor. The NIH has a FCOI online tutorial which must be completed prior to undertaking any NIH research and must refresh the online FCOI training every four years. The University also has FCOI training and a conflict of interest policy which must be read and understood.
- To adhere to the agreed Management Plan in case of any identified FCOI. Non-compliance must be reported to the sponsor.
- To ensure all staff working on the project adhere to the FCOI policy. The PI is responsible for the conduct of all 'investigators' working on a project and must ensure they also complete the compulsory NIH online FCOI training and University training. The PI must also inform new researchers of the requirements when working on projects funded by the sponsor.
'Investigators' have the following responsibilities to comply with the FCOI policy:
- Complete the NIH online FCOI training tutorial at least once every four years.
- Review all of their financial interests (and those of their spouse and dependent children) and disclose and Significant Financial Interests (SFI) to their HoD via the internal SFI declaration form.
- Disclose any bias found in the design, conduct or reporting of the project.
- Throughout the project (at least annually throughout the project) and on completion of the project, review any financial interests.
- Submit a new internal SFI declaration form to notify of any SFI within ten days of discovering or acquiring (eg through purchase, marriage, or inheritance) a new significant financial interest.
- Maintain objectivity in research.
C. Head of Department
The HoD has the following responsibilities to comply with the FCOI policy:
- Review submitted internal SFI declaration forms highlighting any undeclared financial interests and assessing declared conflicts (HoD should contact Research Services for further support if needed); or
- Return completed forms to email@example.com and marking the email as NIH SFI. Advice via telephone is available on ext 27444.
D. The Faculty Director of Research & Innovation (FRDI)
Research Services will notify the FDRI of any declaration forms. They have the following responsibilities to comply with the FCOI policy:
- Act as the institutional official(s) to solicit and review disclosures of SFI.
- Report any identified FCOI via the NIH's electronic systems (eRA Commons FCOI module) within the 60-day deadline or report any FCOI to the lead applicant within the deadline set by them and is specifically responsible for reviewing the SFI and determining if the SFI constitutes a FCOI due to (a) the impact on the NIH-funded project or (b) the outcome the NIH-funded project may have on the SFI.
- Where relevant, work with the HoD and Investigators to put a management plan in place to manage any potential conflict of interest on the project.
- Ensure new internal SFI declaration forms are completed by investigators within ten days of discovering or acquiring (e.g. through purchase, marriage, or inheritance) a new significant financial interest.
E. The University
The University (via Research Services, Finance and HR) has the following responsibilities to comply with the FCOI policy:
- Maintain and enforce an up to date FCOI policy and ensure the policy is available on a publicly accessible web site (ensuring any updates are communicated to staff working on NIH funded projects).
- Manage and enforce the administrative process to identify and manage FCOI.
- Manage, reduce or eliminate identified conflicts to the PHS.
- Ensure all investigators involved in US PHS funded research applications and awards are aware of this University FCOI policy and ensure investigator compliance.
- Ensure all investigators have completed the NIH online tutorial at Sheffield within the last four years.
- Ensure subcontractors, consultants and collaborators comply with the NIH FCOI policy either through their own FCOI policy or by adoption of the University policy (with revised time periods to ensure time to report to the PHS).
- Submit to the NIH; initial, ongoing and annual FCOI reports throughout the duration of the funded project via the NIH system.
- Maintain records relating to all investigator disclosures and all actions under the institution’s policy for at least three years from the date of final payment.
- Retain any relevant documentation for at least three years from the date the final expenditure report is submitted as specified in 45 CFR 74.53b and 92.42(b).
- Undertake audits of projects to ensure continued compliance with the FCOI policy.
- Establish adequate enforcement mechanisms and employee sanctions.