Financial Conflict of Interest (Externally Funded Research)

Earlham monitors and documents significant financial interest that may conflict or, be perceived to conflict, with research funded by external sources, in compliance with federal requirements. All Investigators are required to report to the Office of Grants and Sponsored Research (OGSR) any significant financial interest that may pose such a conflict.

The purpose of this policy is to promote objectivity in the conduct of sponsored projects by ensuring the disclosure of significant financial interests and the appropriate management of Conflicts of Interest (COIs) on externally sponsored projects in accordance with federal, state, and institutional regulations and policies. The procedures herein are established to satisfy the requirements for reporting and managing COIs related to federally-funded activities as well as any COI requirements for externally funded projects that require COI disclosure per federal regulations (Code of Federal Regulations (42 CFR Part 50.604(a)). This policy explains possible areas of financial interests and conflicts of such interests for sponsored research, responsibilities of all researchers funded by the Public Health Service (PHS) or similar entities with regards to financial conflicts of interest, describes the disclosure document that all researchers must complete, and details procedures to follow if a conflict arises.

This policy pertains to all Earlham Investigators who apply to or receive external research support from agencies that require Financial Conflict of Interest (FCOI) declarations.

A potential Conflict of Interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to Earlham such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise.

Financial Conflict of Interest (FCOI): A Significant Financial Interest that Earlham reasonably determines could directly and/or significantly affect the design, conduct or reporting of the externally sponsored research.

Institutional Official (IO): The individual at Earlham who is responsible for the review of disclosures of significant financial interest. The IO has authority to suspend all relevant activities until the financial conflict of interest is resolved or mitigated. For the purposes of this policy, the IO is the College’s Chief Academic Officer.

Institutional Responsibilities: The Investigator’s professional responsibilities associated with their Earlham appointment or position, including but not limited to research, teaching, clinical activities, administration, and institutional, internal and external professional committee service.

Investigator: Defined as the Principal Investigator (PI)/Project Director (PD) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of the sponsored or proposed research, which may include, collaborators or consultants. For the purposes of the requirements of this policy relating to financial interests, “Investigator” also includes the Investigator’s spouse, domestic partner, and dependent relatives.

Manage means to take action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest to ensure, to the extent possible, that the design, conduct, and reporting of research or educational activities will be free from bias.

Research for the purposes of this policy is defined as a systematic investigation, study, or experiment designed to contribute to generalizable knowledge, including behavioral and social-sciences research.  The term encompasses basic and applied research (e.g. a published article, book or book chapter) and product development (e.g. a diagnostic test or drug).

Significant Financial Interest (SFI) is anything of monetary value (whether or not the value is readily ascertainable) that reasonably appears to be related to the Investigator’s Institutional Responsibilities. An SFI exists:

1. With regard to any publicly traded entity, if the value of any remuneration received during the 12-month period preceding the disclosure, and the value of any equity interest during the 12-month period preceding or as of the date of disclosure, when aggregated, exceeds $5,000.
2. With regard to any non-publicly traded entity, if the value of any remuneration received during the 12-month period preceding the disclosure, when aggregated, exceeds $5,000 OR when the Investigator holds any equity interest in the entity.
3. When receiving income related to intellectual property rights and interests (not reimbursed through Earlham).
4. When any reimbursed or sponsored travel is undertaken by the Investigator and related to his/her institutional responsibilities. This includes travel that is paid on behalf of the Investigator rather than reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers.
5. Note, disclosure of foreign financial interests differs from disclosure of domestic financial interests. Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign institutions of higher education or foreign governments (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).

The term Significant Financial Interest DOES NOT INCLUDE:

1. salary, royalties, or other remuneration from Earlham;
2. Income from seminars, lectures or teaching engagements sponsored by a federal, state or local government agency within the U.S.; a U.S. institution of higher education as defined at 20 U.S.C. 1001(a); or an academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education in the U.S.
3. Income from service on advisory committees or review panels for a federal, state or local government agency within the U.S.; a U.S. institution of higher education as defined at 20 U.S.C. 1001(a); or an academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education within the U.S.
4. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

Investigator Disclosures

Investigators and designated personnel are required to complete FCOI disclosures as follows:

1. Prior to submission of a proposal to an external funding agency that requires a financial conflict of interest disclosure.
2. Annually for funded grants: In September of each year, Investigators will complete an updated FCOI Disclosure Form.
3. Within 30 days of acquiring or discovering any new reportable Significant Financial Interests.
4. Investigators joining the College who are conducting research sponsored by the agencies to which this policy applies will provide all necessary disclosures within 30 days.

Using the College’s FCOI Disclosure Form, each Investigator will disclose all Significant Financial Interests:

• that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by the grant source; or
• in entities whose financial interests would reasonably appear to be affected by such activities.

The disclosure form can be completed here: Financial Conflict of Interest Form.

Disclosures of travel must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value. The IO will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes an FCOI with the Investigator’s research.

Review of Disclosures

OGSR will perform an initial review of all financial disclosure forms submitted by Investigators to determine whether any potential conflicts of interest were disclosed. If OGSR determines that a potential COI may exist, OGSR will inform the Institutional Official, who will review the form prior to the expenditure of any funds and determine whether an FCOI exists. An FCOI exists if the IO or designee reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of federally-supported research.

Management Plans

If the IO or designee determines that there are any FCOI(s), the IO or designee must approve a written management plan to manage, reduce or eliminate the conflict before any related research goes forward. Such plans will be designed to meet applicable legal requirements, facilitate the local resolution or management of any conflict, and protect the sensitivity of disclosed information. The affected Investigator is responsible for developing and submitting a proposed management plan to, and in consultation with, the OGSR. Management Plans may include one or more elements, such as the following:

• Public disclosure of conflicts when presenting or publishing research;
• Monitoring of the sponsored program by independent reviewers;
• Modifications to the research or program plan;
• Appointment of an oversight panel or person to review research/scholarship;
• Limitations on the Investigator’s involvement in all or a portion of the funded research or program;
• Divestiture of Significant Financial Interests;
• Severance of relationships that create actual or potential conflicts of interest; and/or
• Other arrangements that manage, reduce, or eliminate a potential Financial Conflict of Interest.

The management strategies will be incorporated into a Memorandum of Understanding (MOU) between Earlham and the Investigator which will detail the conditions or restrictions imposed upon the Investigator in the conduct of the project or in the relationship with the Business Enterprise or Entity. The Management Plan MOU will be signed by the Investigator, the Department Convener or Program Director, and the IO and filed with the OGSR. OGSR will certify that actual or potential conflicts of interests will be satisfactorily managed, reduced, or eliminated in accordance with these guidelines prior to forwarding to the Controller approval for expending any funds from the applicable federal award, or they will be disclosed to the sponsoring agency in writing for action.

External Reporting to a Federal Sponsor

The review of disclosures and development of any necessary management strategies shall be conducted prior to the institution’s expenditure of funds; and within the required compliance timelines of the sponsoring federal agency for investigators newly assigned to an existing project or for newly identified FCOIs for existing investigators.

If any identified conflict or non-compliance requires reporting to the sponsoring federal agency, OGSR will produce such a report in accordance with applicable regulations.

Review, determination of whether a conflict exists, creation and implementation of management plan, and any required reports to the Federal sponsor will occur within sixty (60) days of submission of the FCOI disclosure form.

1. Disciplinary Action

If an Investigator fails to comply with this Policy the OGSR shall report the noncompliance to the agency that requires the financial conflict of interest declaration. As a result of the failure, the Institutional Official (IO) may suspend all relevant activities until the matter is resolved. Further, the IO may recommend disciplinary action for failure to comply with this policy, ranging from a public letter of reprimand to dismissal and termination of employment. The decision to impose sanctions on an Investigator will 1) be described in writing to the Investigator and 2) notify the individual of their right to appeal the decision. If the violation results in a collateral proceeding under Earlham policies regarding Research Misconduct then the IO will defer a decision on sanctions until the misconduct review proceedings are completed and decide upon sanctions under guidance of Earlham FCOI and Research Misconduct policies.

2. Retrospective Review

In some cases, the IO or designee may determine that an FCOI 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 an FCOI, failure by the institution to review or manage such a financial conflict of interest, or an Investigator’s failure to materially comply with their approved FCOI Management Plan. In such cases, a committee appointed by the IO will complete a retrospective review of the Investigator’s activities and the research project within 120 days of determination of non-compliance to determine whether the research conducted during the period of non-compliance was biased in the design, conduct, or reporting of the research.

Documentation of the retrospective review will include the project number, project title, PI, name of Investigator with the FCOI, name of the entity with which the Investigator has the FCOI, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.

The IO or designee will update any previously submitted report to the funding agency, specifying the actions that will be taken to manage the FCOI 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.

Each Investigator federally required to participate in FCOI disclosure is required to complete FCOI training prior to starting the federally funded project and to renew this training at least every four (4) years thereafter. Additionally, training within a reasonable period of time (as determined by the IO) will be required in the event of the following:

1. This FCOI policy is materially revised in any manner that affects the requirements of Investigators;
2. An Investigator is newly appointed to Earlham; or
3. Earlham finds that an Investigator is not in compliance with this policy or their FCOI management plan.

Investigators will be required to submit certification of completion of training to the OSP.

All disclosure forms, conflict management plans, and related documents will be retained by OGSR for a period of three (3) years after of the termination or completion of the award and submission of the final expenditure report to which they relate, or the resolution of any government action involving those records, whichever comes later.

To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be kept confidential.  However, Earlham may make such information available to the agency funding the research or to a requestor of information concerning financial conflict of interest related to relevant federal funding, if requested or required. If Earlham is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.

The information to be made available will be consistent with the requirements of the applicable federal regulation or official funding agency policy. Earlham will respond to any requestor within five (5) business days of the request, with information concerning any Significant Financial Interest that meets the following criteria:

• The Significant Financial Interest was disclosed and is still held by the Investigator;
• A determination has been made that the Significant Financial Interest is related to the federally funded research; and
• A determination has been made that the Significant Financial Interest is an FCOI.

When Earlham works with subrecipients or subawardees of grant funds from the federal agencies to which this Policy applies, it will enter into written agreements specifying whether the subrecipient institution will follow Earlham’s FCOI Policy or its own. Subrecipients and subawardees will be required to comply with any applicable federal regulations.

This policy is to be reviewed at least every three years. Review will be initiated by the OGSR.