Key Definitions

"Investigator" refers to all personnel, regardless of title or position, responsible for the design, conduct, or reporting of research under the terms of a federal grant or contract, or the subaward to a federal grant or contract. All Investigators are required to disclose to the Associate Dean of the Faculty for Research any of their own "Significant Financial Interests" or those of their spouses, partners, or dependent children. Contact the Office of Sponsored Research for a copy of the "Significant Financial Disclosure Form."

"Significant Financial Interest" (SFI) is anything of monetary value, including but not limited to: Remuneration for services exceeding $5,000 in the twelve months prior to the disclosure (e.g., speaking or consulting fees, paid authorship); Equity interest exceeding $5,000 in the twelve months prior to disclosure (e.g., stock, stock options, other ownership instruments); Gains from intellectual property rights (e.g., patents, copyrights, royalties); Travel reimbursed by other than a government agency, college or university, or academic medical institution.

Significant Financial Interest does not include: remuneration from Franklin & Marshall College; Income from investment instruments (e.g., retirement account, mutual funds) in which the Investigator does not control investment decisions; Income from speaking or teaching engagements sponsored by any government agency, college or university, or academic medical institution; income from service on a review panel or advisory committee affiliated with any government agency, college or university, or academic medical institution.

Having Significant Financial Interests does not necessarily entail a Financial Conflict of Interest. A potential financial conflict of interest (FCOI) exists when the Associate Dean of the Faculty reasonably determines that an SFI could directly or indirectly affect the design, conduct, and reporting of federally-funded research, teaching, or mentoring.

A Subrecipient is an entity that receives a subaward from the prime recipient under an award and is accountable to the prime recipient for the use of the Federal funds provided by the subaward.

Timing of Disclosures

Investigators must provide the required Significant Financial Interest disclosures by filling out the form immediately prior to the submission of a proposal. The form may be obtained from the Office of Sponsored Research. Investigators must update financial disclosures within thirty days of acquiring or discovering any new Significant Financial Interest. Investigators must update their financial disclosure forms annually within the period of the grant, beginning with the anniversary date of the original disclosure. Individuals who are grant recipients as of the effective date of this policy should complete this form within thirty days and then annually in subsequent years. Completed and signed Significant Financial Disclosure Forms should be returned to the Associate Dean of the Faculty. If you have questions please contact the Office of Sponsored Research.

Process of Financial Disclosure—Investigator Obligations

Investigators about to submit a federal grant must fill out the College's Significant Financial Disclosure Form. Investigators about to submit a grant to NIH are also required to complete Modules 1 and 2 of the Conflict of Interest Mini-Course developed by the Collaborative Institutional Training Initiative (CITI). Investigators applying for funding from NSF or any other federal agency are strongly encouraged to take the CITI mini-course.

The Associate Dean of the Faculty for Research will review every Financial Disclosure Form. They will determine whether any Significant Financial Interests disclosed by the Investigator apply to the federally-funded research and, if so, whether a financial conflict of interest potentially exists. If there are no Significant Financial Interests or the Associate Dean determines that none of the disclosed Significant Financial Interests are relevant to the federally-funded research or present any potential conflict of interest for the research, the Associate Dean will present the Form to the Provost for review and signature. If the Associate Dean determines that a conflict of interest may exist, they will bring this to the attention of the Provost. The Provost and Associate Dean will then decide what conditions or restrictions should be imposed to manage, eliminate, or reduce the conflict. This will ordinarily entail the convening of an ad hoc Financial Conflict Of Interest committee of faculty, senior staff, and one community member to provide oversight to ensure the integrity of the research.

A potential conflict of interest exists when the Associate Dean reasonably determines that a Significant Financial Interest could directly or indirectly affect the design, conduct, or reporting of federally-funded research, teaching, or mentoring.

If an ad hoc FCOI committee is convened at the behest of the Associate Dean and Provost, the committee will be charged to develop a plan to allow the research to proceed free of the conflict. Some of the elements of such a plan may include (but are not limited to): Review and/or monitoring of the design, conduct, and reporting of the research by independent reviewers; Modification of the research protocol; Disqualification of the Investigator from that part of the research to which the Significant Financial Interest is relevant; Divestiture of the Significant Financial Interest; Severance of the relationships that create the conflict; and, Public disclosure of the Significant Financial Interests. The plan will be created in consultation with the Investigator. Investigators must participate in and comply with any FCOI management plan, including any retrospective review and/or mitigation plan. For the research project to proceed, the Provost must approve the plan developed by the Associate Dean. If the FCOI committee and the Investigator are unable to agree on a plan, the relevant regulatory bodies and funding agencies will be notified.

In some cases the Provost and Associate Dean may determine retrospectively that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator's failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or an Investigator's failure to materially comply with a management plan for a Financial Conflict of Interest. In such cases, a committee appointed by the Provost will complete a retrospective review of the Investigator's activities and the research project to determine whether the research conducted during the period of non-compliance was biased in its design, conduct, or reporting.

The Associate Dean will update any previously submitted report to the funding agency, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias by the investigator is found, the report will include a mitigation report in accordance with the applicable regulations, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.

Federal regulations require the College to impose sanctions or take other administrative actions where appropriate. Franklin & Marshall maintains the right to impose sanctions on Investigators for failure to disclose Significant Financial Interests and for failure to abide by this Policy. Sanctions may include restrictions on future submission of research proposals and other disciplinary actions up to and including dismissal in accordance with judicial procedures outlined in the Faculty Handbook.

Except to the extent required by law and federal regulations, the information disclosed throughout these processes will be kept confidential. The College, however, is required to report the existence of real or potential conflicts of interest to certain federal agencies. Specifically, the NIH requires institutions to report the existence of any conflicting interests and to assure that the interest has been managed, reduced, or eliminated. NSF requires that only conflicts that have not been managed, reduced, or eliminated prior to the expenditure of funds under an award be reported to NSF.

Reporting Financial Conflicts of Interest

Significant Financial Interests determined to be Financial Conflicts of Interest by the Associate Dean will be reported to the sponsoring agency within 60 days of their disclosure.

As required by federal regulations, the Associate Dean will make information about Financial Conflicts of Interest concerning federally-funded research available to members of the public in response to inquiries specifying the Investigator name and research project within five business days of requests for such information.

The College shall maintain a record of all financial disclosures and all actions taken to resolve Conflicts of Interest for at least three years beyond the termination or completion of the grant to which they relate.

Training

Each Investigator on a currently funded NIH grant must complete Modules 1 and 2 of the Conflict of Interest Mini-Course developed by CITI. Each Investigator of a new or previously unfunded NIH grant must take the CITI mini-course prior to the submission or resubmission of his/her proposal. Those currently funded by, or about to submit a proposal to, other federal agencies (including NSF) are strongly encouraged to complete the CITI mini-course. Those funded by a private, for-profit entity are also encouraged to take the mini-course. If you need assistance accessing the CITI mini-course, contact the Office of Sponsored Research.

Subrecipients

Franklin & Marshall College is responsible for ensuring that all subrecipients are compliant with federal regulations regarding Financial Conflict of Interest. The College shall enter a written agreement with all subrecipients that shall specify that they have fulfilled these regulations through their home institutions.

F&M affiliated Investigators who are currently subrecipients via another institution with NIH (or other federal) funding, and those who plan to submit such a subaward via another institution for NIH (or other federal) funding, must complete F&M's Financial Disclosure Form and should (must, if NIH) also take the CITI Conflict of Interest mini-course.

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Policy Maintained by: Office of the Provost, Associate Dean of the Faculty
Original Effective Date: October 16, 2012
Last Reviewed: May 9, 2024