Financial Conflict of Interest in Research
Wesleyan University is committed to overseeing the conduct of Public Health Service/National Institutes of Health research to ensure that research results are not biased by the external commitments and financial interests of persons who are responsible for the design, conduct, reporting, or direct administration of University research. Since the promulgation of NIH regulations in 1995, biomedical and behavioral research and the resulting interactions among government, research institutions, and the private sector have become increasingly complex. The objective of this Policy and the federal regulations on which it is based is to promote “objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under [federal grants] will be biased by any conflicting financial interest of an Investigator” (defined below). 45 CFR § 50.601.
Investigator - Investigator means the 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.
Significant Financial Interest -
(1) 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:
(i) With regard to any publicly traded entity, a significant financial interest 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;
(ii) With regard to any non-publicly traded entity, a significant financial interest 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); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities, provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by:
- a federal, state, or local government agency,
- an Institution of higher education as defined at 20 U.S.C. 1001(a),
- an academic teaching hospital,
- a medical center, or
- a research institute that is affiliated with an Institution of higher education.
This disclosure will include, at a minimum, the following:
- purpose of the trip,
- the identity of the sponsor/organizer
- the destination, and
- the duration.
(3) The term significant financial interest does not apply to:
- Salary, royalities, or other remuneration paid by the University to the investigator if the investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalities related to such rights;
- any ownership interest in the institution held by the investigator, if the institution is a commercial, for profit organization;
- income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investments made in these vehicles;
- income from seminars, lectures or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as definded by 20 U.S.C. 1001 (a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or
- income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education as defined by 20 U.S.C. 1001 (a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
To comply with federal regulations and the University's policy on Financial Conflict of Interest, investigators will need to complete the following steps when submitting research proposals to the NIH:
(1) Complete and submit the Financial Conflict of Interest Form to the Office of Corporate, Foundation & Government Grants at the time of proposal submission.
(2) Update their Disclosure Forms annually annually or within 30 days of obtaining a new reportable Significant Conflict of Financial Interest.
(3) Submit appropriate information regarding reimbursed or sponsored travel (see above).
Significant Financial Conflict of Interest forms will be reviewed by Nathan Peters, Associate Vice President for Finance, and Authorized Organization Representative, and as necessary, the Office of Academic Affairs if there appears to be a potential conflict. Together, these offices will review the conflict and initiate steps to manage or eliminate the conflict as appropriate. Reimbursed or sponsored travel information should be submitted via email to Nathan Peters.
Wesleyan requires that each investigator complete Financial Conflict of Interest training:
Prior to engaging in research related to any NIH funded project; at least every four years, and immediately when any of the following circumstances apply:
(i) Institution revises its policy in a manner that affects the investigator;
(ii) When an investigator is new to the institution; or
(iii) When the institution finds an Investigator is not in compliance with the Institution’s policy or management plan.
Investigators are required to complete the NIH training module on Financial Conflict of Interest found at www.nih.gov and need to confirm with Nathan Peters, Associated Vice President of Finance, via email that the training has been completed prior to a smartkey being issued for the grant.
Investigators must also sign off as having read the Wesleyan Conflict of Interest policy through the Portfolio as required by University annually.
Establishing/Maintaining PolicyInstitutions are required to develop a Financial Conflict of Interest Policy or revise an existing policy that will be maintained and enforced, and that meets or exceeds the regulatory requirements. The policy must apply to each investigator, as defined by the regulation, who is planning to participate in or is participating in Public Health Service (PHS) funded research. Institutions must be able to certify, in each application for funding, that the Institution:
- Has in effect an up-to-date, written and enforced administrative process to identify and manage Financial Conflict of Interest.
- Shall promote and enforce investigator compliance with the regulation.
- Shall manage Financial Conflict of Interest and provide initial and ongoing Financial Conflict of Interest reports.
- Agrees to make Financial Conflict of Interest and Significant Financial Interest information (including related institutional reviews and determinations) available to the U.S. Department of Health and Human Services, promptly, upon request.
- Shall fully comply with the regulation’s requirements.
In order to manage, reduce or eliminate potential conflicts, the University may take any of the following steps:
- public disclosure of Significant Financial Interests
- monitoring of research by independent reviewers
- modification of the research plan to avoid conflicts of interest
- disqualification of Investigators from the portion of the funded research that could create conflicts of interest
- require divestiture of Significant Financial Interests
- require severance of relationships that create conflicts of interest.
Financial Conflict of Interest policies and regulations extend to subawardees/subcontracts/subrecipients. The following two conditions apply:
(1) Wesleyan will incorporate as part of a written agreement terems that establish whether Wesleyan's Financial Conflict of Interest policy or that of the subawardee/subcontract/subrecipient investigator's institution will apply to the subawardee/subcontract/subrecipient investigator and include time periods to meet the Significant Financial Intersest disclosure, if applicable, an Financial Conflict of Interest reporting requirements.
(2) Subawardee/Subcontract/Subrecipients instititutions who rely on their Financial Conflict of Interest policy must report identified Financial Conflict of Interests to the Wesleyan in sufficient time to allow Wesleyan to report the Financial Conflict of Interest to the Public Health Service/National Institutes of Health Awarding Component to meet Financial Conflict of Interest reporting obligations.
Wesleyan University must provide reports on Financial Conflict of Interest:
- Prior to the expenditure of funds;
- Within 60 days of identifying a new Financial Conflict of Interest;
- Annually to include report on the status of Financial Conflict of Interest and any changes in management plan (Due at same time as when grantee submits annual progress report, including multi-year progress report, or at time of extension).
- Role and principal duties of the conflicted Investigator in the research project;
- Conditions of the management plan;
- How the management plan is designed to safeguard objectivity in the research project;
- Confirmation of the Investigator’s agreement to the management plan;
- How the management plan will be monitored to ensure Investigator compliance; and
- Other information as needed.
If a Financial Conflict of Interest is identified, the University must create a management plan for that conflict Key elements of that plan include:
In the event of noncompliance Wesleyan shall, within 120 days of the University's determination of non compliance, complete a retrospective review of the investigator’s activities and the NIH-funded research project to determine if there was bias in the design, conduct, or reporting of such research. The University is required to document the retrospective review. A Mitigation Report required if bias is found.
The regulations also require institutions to establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure investigator compliance as appropriate. Please consult the Faculty Handbook for Wesleyan's policies. In addition, NIH is permitted to take appropriate action or direct the Institution to take action to maintain appropriate objectivity in Public Health Service-funded research.
Wesleyan will maintain records of all investigator disclosures of financial interests and the University's review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution’s determination of Financial Conflict of Interest) and all actions under the Institution’s policy or retrospective review, if applicable for at least three years from the date of submission of the final expenditures report or longer depending on specific circumstances such as litigation, claims, financial management review, or audit.
Wesleyan will respond within five business days to any request for infomration on financial conflicts on interests dscipled by and still held by any of its investigators. At a minimum this information will include: the investigators name, the invesigators title and role with respect to the project, the name of the entity in which the significant financial interest is held, and the nature and approximate dollar value of the interest. That information can be found by clicking here.
Contact InformationNathan D. PetersAssociate Vice President for Finance237 High StreetMiddletown, CT 06459phone: email@example.com
Federal Regulations and Information:
For more information on the PHS/NIH Financial Conflict of Interest policies please visit: