NIH Financial Conflict of Interest Policy
The National Institutes of Health (NIH) have since the mid 1990s had a Financial Conflict of Interest (FCOI) policy. Due to some recent cases in other organisations, where the integrity of research was jeopardised because Investigators* with a financial interest in commercial organisations had directed the NIH-funded project towards a specific conclusion, the NIH have decided to strengthen the requirements in relation to the management of FCOI. This has resulted in the publication of the 2011 Revised Regulations.
Applications and/or research awards (new, annual renewals or revised) with a submission or issue date of the Notice of Award after 1 August 2012 are subject to the new requirements.
* Investigator in the context of the NIH means the 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.
The new NIH FCOI policy has an impact on three different groups within academic departments and on Faculty Research Services teams:
The Investigator has three main responsibilities under this policy:
1. Disclosure of Significant Financial Interest within the timeframes specified by the NIH.
Failure to disclose as per the timelines above will result in additional reporting to the NIH. For further advice and support, please contact firstname.lastname@example.org
2. Compulsory completion of the NIH online tutorial.
The Investigator must complete the online NIH FCOI tutorial prior to engaging in research related to any NIH grant and at least every four years. There are also additional training requirements depending on specific scenarios. Once complete, a copy of the certificate needs to be forwarded to email@example.com who will monitor compliance.
3. Adherence to the agreed Management Plan in case of any identified Financial Conflict of Interest (FCOI).
Non-compliance must be reported to the NIH.
Designated Departmental Officials
The Designated Departmental Official is defined in the College's Conflict of Interest policy as follows:
- (where the Investigator is a member of staff or an affiliate), the Investigator's Head of Department, via the Investigator's line manager
- (in all other cases where the Investigator is a Head of Department/Division, a Faculty Principal, or a College Official) the Investigator's line manager
The Designated Departmental Official is specifically responsible for reviewing the Significant Financial Interest (SFI) and determining if the SFI constitutes a Financial Conflict of Interest (FCOI) due to:
- the impact on the NIH-funded project
- the outcome the NIH-funded project may have on the SFI
NIH Financial Conflict of Interest Guidance for Dept Official and Champion [pdf] (please note that this document is ucrrently being reviewed and updated)
Where a Financial Conflict of Interest (FCOI) has been identified, this must be flagged with the Research Office to enable reporting via the NIH's electronic systems.
Faculty Research Services teams
Faculty Research Services/JRO teams are required to email the Investigator (PI, Co-I, any named researchers, technicians) the ‘National Institutes of Health – Financial Conflict of Interest – Guidance for Investigators’ document and draw their attention to the three listed responsibilities included within the document. This should be undertaken as part of the pre-award proposal checks (i.e. before Institutional Authorisation to submit) and subsequently reinforced at award set / notification stage.
Additionally at post-award stage, Faculty Research Services/JRO teams should inform the Principal Investigator that it is the PI’s responsibility to ensure that any Investigators new to the NIH-funded project during the life of the project are informed to follow the guidance and complete the NIH web tutorial.
Where the College is the lead institution, the Faculty Research Services/JRO teams will insert a specific paragraph with regard to Financial Conflict of Interest into the sub-agreement.
Where the College is a subrecipient, the Faculty Research Services/JRO teams will ensure that the sub-agreement received from the lead institution states that Imperial will follow its own Financial Conflict of Interest policy including the guidance issued on the NIH Financial Conflict of Interest requirements.
As part of its assurance function, the Research Office will bi-annually review whether the 3 main responsibilities of the PI have been complied with. In the event of non-compliance, the Research Office will implement a corrective action plan to ensure compliance and minimise risk of a recurrence.
The Research Office is responsible for reporting any identified Financial Conflict of Interest (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.