Conflicts of Interest in Research

Wesleyan University is committed to overseeing the conduct of research to ensure that research results are not biased by external commitments or financial interests of persons who are responsible for the design, conduct, reporting, or direct administration of University research. 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 will be biased by any conflicting financial interest of an Investigator” (defined below). 45 CFR § 50.601.

General Conflict of Interest Guidelines

1.Goals of Research at Wesleyan

Research activity at Wesleyan is dedicated to the advancement, preservation, and dissemination of knowledge and to the instruction of undergraduate and graduate students. While such research may incidentally generate financial benefits to individual investigators and to the University—for example, through patents or licensing—decisions regarding the nature and orientation of research must be based on University values rather than the prospect of financial gain. Sponsored projects should reflect a coincidence of research interests on the part of sponsors and University.

2.Outside Activities of Faculty and Staff

Outside professional, financial, and entrepreneurial activities of individual faculty and staff can contribute to University goals and provide valuable public and personal benefits as well, but one’s primary commitment must be devoted to the University. External interests and activities must be ordered so as to minimize any risk of conflict with University objectives and values.

3.Duty to Disclose Possible Conflicts

Faculty and staff are counted on to monitor their own activities. Whenever they perceive that a conflict might arise, or the serious appearance of a conflict, faculty are expected to disclose the relevant facts to the VPAA and their divisional dean, and staff are expected to disclose the relevant facts to their supervisor, for guidance, possible adjustments, and resolution. What is called for in such cases is full and current disclosure of all interests that bear on the particular instance of conflict. Wider disclosure of personal interests beyond that is not sought.

4.Student Participation in Research Activities

Student participation in research is a central educational goal of the University. The selection and involvement of students must be governed primarily by consideration of the students' own educational goals as well as the legitimate needs and objectives of the research project. Faculty and staff must avoid providing research guidance and facilities to students with the aim of serving their own outside professional, financial, or entrepreneurial activities or objectives.

5. Rights to Publication of Research Findings

Open communication of research findings is an important University value. Outside sponsorship or other associations should not be a basis for inhibiting the publication or sharing of information. In the case of sponsored research, University researchers must retain full rights concerning the timing and content of publications, apart from those safeguards established by the University to protect privacy, proprietary information, and patentable inventions.

Research data and materials owned by or in the custody of the University, if they are to be made available externally, must be made generally available. In no case can the transfer of data or materials be made for reasons of personal gain, except in accordance with the University’s Patent and Invention Policy (http://www.wesleyan.edu/cfgg/policies/patents_inventions.html).

6. Predetermination of Research Results

The University does not accept research sponsorship predicated on the finding of predetermined research results.

7. Personal Business or Consulting Activities

Except in the most incidental of ways, members of the Wesleyan community should not use University research or administrative facilities to pursue personal business or commercial consulting activities.

8. University Approval for Research that Benefits Outside Interests

Research at Wesleyan may not be undertaken or oriented with the purpose of serving the interests of outside persons or organizations unless there is approval from the VPAA and, typically, appropriate financial support from the same persons or organizations.

9.Potential Conflicts with Patent or other University Policy

Wesleyan faculty and staff who enter into external consulting or other agreements must take care that these are not in conflict with the provisions of Wesleyan's Patent and Invention Policy (http://www.wesleyan.edu/cfgg/policies/patents_inventions.html), Wesleyan’s obligations under any sponsored grant or contract, or any other policies of the University.

10. Outside Financial Interests Related to Wesleyan Research

The risk of conflict of interest, or serious appearance of conflict, can arise when a Wesleyan researcher (or immediate relative or household member) has significant financial interests in an external enterprise engaged in activities closely related to their line of Wesleyan research. Activities that would be counted as "significant" include: paid consultantships, paid service on an advisory board, substantial equity holdings in or royalty income from the enterprise, etc. By no means does the existence of such interests necessarily imply conflict. Nevertheless, where there are such interests, the investigator is obligated to provide full and current disclosure to the VPAA or supervisor. The VPAA or supervisor will err on the side of disclosure rather than nondisclosure in cases where it is unclear whether or not the outside financial interests rise to the level of "significant."

11. Sponsors’ Right to Request Information

Federal agencies and other sponsors have a legitimate interest in knowing of any significant financial interests that investigators may have in areas closely related to that of the research being sponsored; as well as a legitimate interest in the identity of other organizations, if any, that may be involved in sponsorship of the research. The University requires compliance with reasonable requests for such information.

12. VPAA’s or Supervisor’s Role at Time of Disclosure

The VPAA, or supervisor in the case of staff, will analyze any disclosure material and will propose to the investigator suitable adjustments in project arrangements when these are deemed necessary to remove, minimize, or manage conflict of interest.

Guidelines Specific to NIH and NSF Funded Activities

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 NSF, 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 with NIH grants 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, royalties, 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 royalties 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 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; 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.

INVESTIGATOR RESPONSIBILITIES

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 available from the Office of Corporate, Foundation & Government Grants at the time of proposal submission;

(2) Update their Disclosure Forms annually or within 30 days of obtaining a new reportable Significant Conflict of Financial Interest; and

(3) Submit appropriate information regarding reimbursed or sponsored travel (see above).

Significant Financial Conflict of Interest forms will be reviewed by Valerie Nye, Director of Financial Services and Authorized Organization Representative, and as necessary, by the VPAA if there appears to be a potential conflict. Together, they 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 Valerie Nye.

INSTITUTION RESPONSIBILITIES

Training for NIH funded projects

Wesleyan requires that each Investigator complete Financial Conflict of Interest training prior to engaging in research related to any NIH funded project, and 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 here and need to confirm with Valerie Nye, Director of Financial Services, 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 the University annually.

Training for NSF and other federal agencies/departments:

We encourage those Investigators with funding from the NSF or other federal agencies to complete the Conflict of Interest module offered by the Collaborative Institutional Training Initiative (CITI) by clicking here and creating an account. For more information please contact the Office of Corporate, Foundation and Government Grants.

Establishing/Maintaining Policy

Institutions 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; and
require severance of relationships that create conflicts of interest.

Subawardees/Subcontracts/Subrecipients

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 terms 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 Interest disclosure, if applicable, and Financial Conflict of Interest reporting requirements.

(2) Subawardee/Subcontract/Subrecipients institutions 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 or NSF Awarding Component to meet Financial Conflict of Interest reporting obligations.

Reporting

Wesleyan University must provide reports on Financial Conflict of Interest:

1. - Prior to the expenditure of funds;
  - Within 60 days of identifying a new Financial Conflict of Interest;
  - Annually to include a report on the status of Financial Conflict of Interest and any changes in the management plan (due at the same time as when grantee submits the annual progress report, including a multi-year progress report, or at the 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:

Noncompliance

In the event of noncompliance Wesleyan shall, within 120 days of the University's determination of noncompliance, 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 is 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 on misconduct in scientific research. 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.

Record Retention

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. All records are maintained according to the University document retention schedule.

Public Accessibility

Wesleyan will respond within five business days to any request for information on financial conflicts on interests held by any of its Investigators. At a minimum this information will include: the Investigator’s name, the Investigator’s 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 (http://www.wesleyan.edu/cfgg/FCOI1/FCOI2.html).

Contact Information:

Valerie Nye Director of Financial Services 237 High Street Middletown, CT 06459 phone: 860-685-3192 vnye@wesleyan.edu