Office of Sponsored Programs and Research

Red Square Clark University Worcester MA

Clark University Policy on Financial Conflict of Interest (FCOI)
in Sponsored Programs and Research

Policy Statement

All faculty members and other individuals (staff, researchers, students, postdoctoral fellows and visiting researchers) who are responsible for the design, conduct or reporting of research or other educational programs/activities which are funded or proposed for funding by external funding agencies/institutions, are required to disclose whether they, their spouse/domestic partner, or any of their dependent children have any Significant Financial Interests related to their institutional responsibilities. These disclosures are reviewed in accordance with Clark University’s (University) policies regarding Financial Conflicts of Interest and if necessary a management plan will be developed to limit the potential for or perception of bias in the design, conduct or reporting of their research or other programs and activities.

Definitions

Significant Financial Interest (SFI) — anything of monetary value including, but not limited to salary or other payments for services (e.g. consulting fees, honoraria, paid authorship), equity interests (e.g., stock, stock options or other ownership interests), investment income (e.g., dividends or interest), and intellectual property rights (e.g., patents, copyrights) which reasonably appear to be related to the Investigator’s institutional responsibilities. This also includes reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator) reasonably related to their institutional responsibilities except with travel reimbursed or sponsored by a federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

This definition of SFI does NOT include:

  • SFIs less than $50001.
  • Income from seminars, lectures or teaching engagements sponsored by government entities, institutions of higher education, or research institutes affiliated with higher education institutions.
  • Income from investment vehicles (e.g., mutual funds, retirement accounts) assuming Investigator does not directly control the investment decisions made in those vehicles.

Investigator — principal investigator (PI), co—principal investigator (co—PI), and any other person (e.g., staff, researcher, student, postdoctoral fellow, visiting researcher, etc.) who is responsible for the design, conduct or reporting of sponsored research or other sponsored activities.

Senior/Key Personnel — project director/principal investigator (PD/PI) and any other person identified as Senior/Key Personnel by the institution in the grant application, progress report, or any other report submitted to the funding agency.

Responsibilities of the Investigator

All Investigators must:

  • Comply with the University’s FCOI policies and procedures
  • Complete a FCOI disclosure form at least annually
  • Complete FCOI training prior to engaging in any PHS funded grant or contract and at least every four years. Training must occur immediately if:
    • University FCOI policy as it applies to Investigator requirements changes
    • Investigator is new to the institution
    • University finds the Investigator is noncompliant with the FCOI policy or an established FCOI management plan
  • Submit to the Office of Sponsored Programs and Research (OSPR) the Financial Conflict of Interest In Sponsored Programs and Research Disclosure Form at the time of an application for external funding.
  • During an award period, update all financial disclosures either on an annual basis or within 30 days of the acquisition or discovery of a new SFI.

Responsibilties of the University

SFI /FCOI Review

The Director of Sponsored Programs and Research is designated to review SFI disclosures. This person will determine if there is a FCOI because of an SFI that could directly and significantly affect the design, conduct, or reporting of externally funded research or other sponsored activities.

FCOI Management

When a FCOI is identified, the University will develop a management plan specifying the actions that will be taken to manage such FCOI.

Retrospective Review

The University will undertake retrospective review of an Investigator’s activities whenever a FCOI is found not to have been identified, disclosed or managed in a timely manner and/or an Investigator is found not to have complied with a FCOI management plan. Such review will be documented and if bias is found a mitigation report will be developed and submitted to the funder as required.

Publicly Accessible FCOI Information

If a FCOI is identified with any Senior/Key Personnel, certain information may be required by the funder to be made publicly accessible via a publicly available website or by written response within 5 days of a request. PHS funding agencies require that this information be publicly accessible for three years from the date the information is most recently updated. This information may include:

  • Investigator’s name,
  • Investigator’s title and role in the research project,
  • Entity where the SFI is held,
  • Nature of the SFI (e.g. equity, consulting fees, travel reimbursement, honoraria, etc.), and
  • Approximate dollar value of the SFI (dollar ranges permissible (0—4999; 5K—9999;10K—19999; between 20K—100K in 20K increments; over 100K by 50K increments) or a statement that the value cannot be determined by public prices or other reasonable measures of fair market value.

Agency Reporting

If a FCOI is identified, the University may have to report to the funding agency any or all of the following information pursuant to the funder’s guidelines:

  • Project Number
  • PD/PI or Contact PD/PI if a multiple PD/PI model used
  • Name of the Investigator with the FCOI
  • Name of the entity with which the Investigator has a FCOI
  • Nature of financial interest (e.g. equity, consulting fee, travel reimbursement, honorarium)
  • Approximate dollar value of the SFI (dollar ranges permissible (0—4999; 5K—9999;10K—19999; between 20K—100K in 20K increments; over 100K by 50K increments) or a statement that the value cannot be determined by public prices or other reasonable measures of fair market value
  • Description of how the financial interest relates to funded research and the basis for the Institution’s determination that the financial interest conflicts with the research.
  • Description of key elements of the management plan including:
    • Role and principal duties of conflicted investigator in the project,
    • Conditions of the management plan,
    • How the management plan is designed to safeguard objectivity in the project,
    • Confirmation of Investigator’s agreement to the management plan,
    • How the management plan will be monitored to ensure compliance, and
    • Other information as needed.

Sub-Recipient Monitoring

The University must take reasonable steps to ensure that sub—recipient Investigators comply with the funders’ FCOI requirements. Sub—recipients must make a written assurance that their FCOI policy complies with funders’ regulations. In the case of PHS funded projects, if the sub—recipient cannot certify they have an FCOI policy that is consistent with PHS regulations, they will be subject to the University’s FCOI policy. Written agreements with sub—recipients must establish whether the FCOI policy of the awardee institution or the sub—recipient will apply. In the case of NIH funded projects the awardee institution is responsible for reporting all identified FCOIs for sub-recipient investigators to NIH through eRA Commons.

Sanctions

Failure to disclose a FCOI or to comply with management plans or other corrective actions can result in disciplinary actions or sanctions by the University and/or the funding agency. Disciplinary actions and sanctions may include suspension or dismissal, non-renewal of appointment, denial of eligibility to engage in funded research through the University, restitution, criminal prosecution, or other penalties. Sanctions may also require giving notice to the funding agency/sponsoring agency, professional associations, journals, and/or the public.

Records

Records of all Investigator disclosures of financial interests and the University’s review of or response to such disclosures whether or not determined to be a FCOI will be maintained for at least three years from the expiration and final close—out of award.

Confidentiality

Information submitted by Investigators will be treated as confidential and will not be disclosed except as required by law or the funding agency, or as may be deemed necessary by the University and any related sponsoring agency.

Related Links:

Financial Conflict of Interest in Sponsored Programs and Research Disclosure Form
NIH Financial Conflict of Interest
Department of Health and Human Services 42 CFR Part 50 [PDF]
NSF Conflict of Interest Policy
CITI Training Module

1If the value of the financial interest cannot be determined then it should be assumed to be a SFI.