NIH Financial Conflict of Interest Policy

“Investigator” means the Principal Investigator (PI) and any other person (e.g. collaborators or consultants), regardless of title or position, who is responsible for the design, conduct or reporting of research funded by the U.S. Public Health Service (PHS), including the NIH.

The Principal Investigator has three main responsibilities:

1.  Timely Disclosure of Significant Financial Interests (SFIs)

An Investigator is responsible for disclosing SFIs (and those of the Investigator’s spouse and dependent children) within the timeframes specified by the NIH as follows:

a)    No later than at the time of application for NIH-funded research;

b)    Within thirty (30) days of discovering or acquiring a new SFI (e.g. through purchase, marriage, or inheritance); and

c)     At least annually during the period of award.

Disclosure of a SFI should be made promptly to the Head of Department (i.e. “Designated Departmental Official”) by completing the NIH Disclosure of Significant Financial Interest form - Investigators [Word].

A copy of the Disclosure of SFI Form must also be sent to the Research Office at ro.audit@imperial.ac.uk

“Significant Financial Interest” means:

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:

a)    With regard to any publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. 

For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

b)    With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g. stock, stock option or other ownership interest).

c)     Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.

2.  Mandatory completion of the NIH online tutorial by Principal Investigator and all associated staff

The Investigator must complete the online NIH FCOI tutorial which is available at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html prior to engaging in research related to any NIH grant and every four years thereafter.

It is the Principal Investigator’s responsibility to ensure that all staff (both existing and new employees) who are involved in the NIH-funded project during the life of the project are informed of their responsibilities in relation to the NIH FCOI Policy. All associated staff are also required to complete the NIH web tutorial.

Upon completion of the tutorial, copies of the Certificate of Completion for the Investigator and all associated staff should be forwarded to the Research Office at ro.audit@imperial.ac.uk

Further guidance and FAQs relating to the online tutorial can be found here

3.  Adherence to an agreed Management Plan to manage an identified Financial Conflict of Interest (FCOI).

If the Head of Department (i.e. “Designated Departmental Official”) reasonably determines that a disclosed SFI constitutes a Financial Conflict of Interest (FCOI) because it could directly and significantly affect the design, conduct or reporting of the NIH-funded research, then the Investigator will be required to implement a management plan (developed with and agreed by the Head of Department) to manage the FCOI(s). The Investigator is required to comply with the Management Plan until completion of the project.

The Head of Department is the “Designated Departmental Official” and is defined as follows:

a)     the Investigator's Head of Department (where the Investigator is a member of staff or an affiliate) OR

b)     the Investigator's line manager (in cases where the Investigator is a Head of Department, Faculty Dean or College Officer)

The Designated Departmental Official has four main responsibilities:

1.          Review a disclosed Significant Financial Interest (SFI)

The Designated Departmental Official is responsible for reviewing any disclosed Significant Financial Interest (SFI) and determining if the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research, and if so related, determine whether it constitutes a Financial Conflict of Interest (FCOI). Decisions should fully consider the scope, definitions, procedures and requirements set out in Imperial College’s own Conflict of Interest Policy in addition to the requirements of the NIH FCOI policy (42 CFR 50 Subpart F).

Within sixty (60) days, the Designated Departmental Official should review the Significant Financial Interest (SFI);  determine whether it is related to the NIH-funded research; determine whether a Financial Conflict of Interest (FCOI) exists; and if so, implement, on at least an interim basis, a Management Plan that specifies the actions that have been, or will be, taken to manage such FCOI going forward.

Questions about the requirements of the NIH FCOI policy should be directed to the Research Office at ro.audit@imperial.ac.uk

2.          Develop a Management Plan to manage an identified Financial Conflict of Interest (FCOI) and monitor Investigator compliance

Where a Financial Conflict of Interest (FCOI) is determined to exist, the Designated Departmental Official is required to develop and agree a Management Plan to manage the FCOI(s) which the Investigator will be required to implement.

Examples of conditions or restrictions that might be imposed to manage an Investigator’s FCOI include, but are not limited to:

a)      Public disclosure of FCOIs (e.g. when presenting or publishing the research; to staff members working on the project; to Research Ethics Committee(s); to Imperial College’s Animal Welfare and Ethical Review Body (AWERB) Committee etc)

b)     For research projects involving human subjects research, disclosure of FCOIs directly to participants

c)      Appointment of an independent monitor capable of taking measures to protect the design, conduct and reporting of the research against bias resulting from the FCOI

d)     Modification of the research plan

e)      Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research

f)       Reduction or elimination of the financial interest (e.g. sale of an equity interest)

g)      Severance of relationships that create financial conflicts

The NIH Management Plan - Financial Conflict of Interest [Word] form should be completed and signed by both the Investigator and Designated Departmental Official to confirm agreement of the Plan.

The Designated Departmental Official is also responsible for monitoring the Investigator’s compliance with the Management Plan until completion of the project.

The Research Office must be notified promptly at ro.audit@imperial.ac.uk as soon as a FCOI is determined to exist. A copy of the agreed Management Plan should also be sent to the Research Office so a FCOI report can be submitted to the NIH in line with the requirements of the NIH FCOI policy.

3.          Conduct a Retrospective Review of a Financial Conflict of Interest (FCOI)

The Designated Departmental Official will be required to conduct a Retrospective Review whenever a Financial Conflict of Interest (FCOI) is not identified or managed in a timely manner, including in the following circumstances:

a)      If the Investigator does not disclose a Significant Financial Interest (SFI) that is determined by the College to constitute a FCOI

b)     If a previously disclosed Significant Financial Interest (SFI) has not been reviewed or managed

c)      If the Investigator does not comply with a FCOI management plan

Within sixty (60) days, the Designated Departmental Official should review the Significant Financial Interest (SFI);  determine whether it is related to the NIH-funded research; determine whether a Financial Conflict of Interest (FCOI) exists; and if so, implement, on at least an interim basis, a Management Plan that specifies the actions that have been, or will be, taken to manage such FCOI going forward.

The NIH Retrospective Review Form - Financial Conflict of Interest [Word] form should be completed.

A copy of the Retrospective Review must be sent to the Research Office promptly at ro.audit@imperial.ac.uk so a FCOI report can be submitted to the NIH in line with the requirements of the NIH FCOI policy.

4.          Reporting a Financial Conflict of Interest (FCOI)

Copies of the agreed Management Plan and Retrospective Review must be sent to the Research Office promptly at ro.audit@imperial.ac.uk to ensure the College can comply with the reporting requirements of the NIH FCOI policy (see Research Office section below).

Faculty Research Services/Joint Research Office (RS/JRO) have four main responsibilities:

1.     Proposal Submission

During the proposal submission stage, RS/JRO are required to notify the Investigator (PI and Co-Is) about their responsibilities in relation to the NIH FCOI Policy by drawing their attention to the information detailed on this webpage.

2.     Award Acceptance

At award acceptance stage, RS/JRO are required to notify the Investigator (PI and Co-Is) about their responsibilities in relation to the NIH FCOI Policy by drawing their attention to the information detailed this webpage. This applies to new awards, annual renewals and revised awards.

Additionally, RS/JRO should inform the Principal Investigator that it is the PI’s responsibility to ensure that all staff (existing and new employees) who are involved in the NIH-funded project during the life of the project are informed of their responsibilities in relation to the NIH FCOI Policy, particularly in relation to mandatory completion of the NIH web tutorial available at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html (see Investigator section above).

3.     Imperial College is a Lead Institution (i.e. Awardee Institution)

If the College is the lead awardee institution on an NIH award, RS/JRO are required to obtain a certification from the subrecipient institution that its FCOI policy complies with the NIH FCOI policy. If this is not provided, then the subagreement will require the subrecipient to comply with the College’s own Conflict of Interest policy and internal NIH FCOI policy related procedures. The College subagreement should require each subrecipient to report any identified FCOIs to the College within specified time periods so it can fulfil its reporting obligations to NIH as the lead awardee institution. The College is required by the NIH FCOI policy to manage and report identified FCOIs to the NIH on behalf of itself and each subrecipient.

4.     Imperial College is a Subrecipient Institution

If the College is a subrecipient on an NIH award (i.e. funding comes directly from the lead awardee institution instead of NIH), RS/JRO are required to ensure that the subagreement entered into with the lead institution states that Imperial College will follow its own institutional Conflict of Interest Policy and internal NIH FCOI policy related procedures which specify that College staff (and anyone affiliated to the College by way of an honorary contract) must comply with all relevant external research funding bodies’ policies pertaining to conflicts of interests and external interests, including the NIH FCOI policy.

The central Research Office has three main responsibilities:

1.     Public Accessibility of Institutional Conflict of Interest policy and Internal NIH FCOI Procedures

The Research Office is responsible for ensuring that this webpage is publicly accessible, reflects the requirements of the current NIH FCOI policy and is updated in line with any subsequent changes.  An up to date version of the webpage content and Imperial College’s Conflict of Interest Policy will also be maintained on the eRA Commons Institution Profile (IPF) Module.

2.     Monitoring Compliance

The Research Office will monitor compliance with the main responsibilities outlined above. In the event of non-compliance, the Research Office will liaise with the relevant Investigator, Designated Departmental Official and other relevant College stakeholders to implement appropriate corrective actions, e.g. updating a management plan; requiring an Investigator to revisit the online NIH FCOI tutorial. 

3.     Reporting Requirements and Maintenance of Records

The Research Office is responsible for maintaining appropriate records of FCOI disclosures,  Management Plans and Retrospective Reviews,  and for submitting FCOI reports to NIH via the eRA Commons FCOI module (or reporting directly to the lead institution for joint awards) within the timelines set by NIH. This includes, but is not limited to, the following:

• Report any FCOIs prior to expenditure of funds
• Report any FCOIs within thirty (30) days of an Investigator discovering or acquiring a new SFI
• Report any FCOIs within sixty (60) days of identification for an Investigator who is newly participating in a project
• Report any FCOIs within sixty (60) days for existing Investigators who disclose a new SFI
• Report any FCOIs following a Retrospective Review to update a previous report, if appropriate
• Report any FCOIs following a Retrospective Review within 120 days of the College determining non-compliance whenever a SFI is not disclosed, reviewed or managed in a timely manner
• Report annually on the status of FCOIs and any changes to Management Plans