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Introduction

This financial conflict of interest (“FCOI”) policy applies to all ������Ƶ (“University”) investigators and to funded research as stated below, including research funded by government agencies that require the University to adopt a financial conflict of interest policy. Nothing in this policy limits the requirement of employees to also comply with the University’s general Conflict of Interest and Disclosure Policy for Employees. (See Conflict of Interest and Disclosure Policy for Employees.) 

Reason for Policy: 

When a University investigator involved in scientific research has financial interests in a company, organization, or institution external to the University, or receives compensation, funding, or other assistance from entities that can be affected by the investigator’s research, there is the potential for a conflict of interest or the appearance of a conflict. Conflicts of interest can arise in grant research projects, for example, when personal financial interests are held by investigators in a company either sponsoring the research or potentially benefiting from the results of the research. Again, for example, they may occur should the University subcontract with a company owned by the investigator or a member of his or her family. Thus, it would violate the University’s FCOI policy for an investigator to influence the University's business decisions in ways that could lead to personal gain or give improper advantage to members of his or her family or to associates.

������Ƶ is committed to conducting research that reflects its Christian identity and mission. Therefore, it is committed to research that is free of outside conflicts of interest that might compromise—or even give the appearance of compromising—the sound professional judgment of its investigators. Government regulations also require that institutions applying for research grants from certain federal agencies maintain a policy on financial conflicts of interest and require that investigators disclose any potential financial conflicts of interest when applying for support for their research.

Policy Oversight and Enforcement: 

The University conflict of interest committee is responsible for ensuring implementation of this policy and may recommend that all relevant activities be suspended until the financial conflict of interest is resolved or other action deemed appropriate by the committee is implemented. Violation of any part of these policies may also constitute cause for disciplinary or other administrative action pursuant to the University’s policy.

Definitions

Disclosure of significant financial interests: an investigator's disclosure of significant financial interests to the University.

Family: any member of the investigator’s immediate family, specifically, any dependent children and spouse.

Financial conflict of interest (FCOI): a significant financial interest that the committee reasonably determines could directly and significantly affect the design, conduct or reporting of PHS-funded research.

FCOI report: the University's report of a financial conflict of interest to a government awarding component.

Financial interest: anything of monetary value, whether or not the value is readily ascertainable. ������Ƶ – Financial Conflict of Interest Policy Revised June 2026

Significant financial interest: a domestic and foreign (non-United States) 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, and:

 i. if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the discl sure, and the value of any equity interest during the 12-month period preceding or as of the date of disclosure, exceeds $5,000; or

 ii. if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure exceeds $5,000; or

 iii. if with a non-publicly-traded company, is an equity interest of any value during the 12-month period preceding or as of the date of disclosure; or

 iv. is income related to intellectual property rights and interests not reimbursed through the Institution that, in the aggregate, exceeds $5,000 over the preceding 12-month period; or

 v. is reimbursed or sponsored travel, as described in the definition of financial interest above, with a value that, in the aggregate, exceeds $5,000 during the 12-month period preceding the disclosure. Investigators also must disclose the occurrence of reimbursed or sponsored travel undertaken by the investigator and related to his or 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.

Significant financial interest does NOT include the following types of financial interests:

 i. salary, royalties, or other remuneration paid by the University to the investigator, provided the investigator is currently employed or otherwise appointed by the University — including intellectual property rights assigned to the University and any agreement to share in royalties related to such rights;

 ii. any ownership interest in the University held by the investigator, if the University is a commercial or for-profit organization;

 iii. income from seminars, lectures, or teaching engagements sponsored by, or income from service on advisory committees or review panels for, a U.S. Federal, state, or local governmental agency; a U.S. institution of higher education; or a research institute affiliated with a U.S. institution of higher education, academic teaching hospital, or medical center; or

 iv. income from investment vehicles, such as mutual funds and retirement accounts, so long as the investigator does not directly control the investment decisions made in these vehicles.

Foreign financial interests: The exclusions described above for income, compensation, or reimbursed or sponsored travel from U.S. Federal, state, or local governmental agencies, U.S. institutions of higher education, U.S. research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers do NOT extend to the foreign equivalents of such entities, including foreign governments, foreign institutions of higher education, foreign research institutes, or other foreign organizations. Investigators must disclose all foreign financial interests related to their Institutional Responsibilities, including but not limited to: income from foreign seminars, lectures, teaching engagements, or service on foreign advisory committees or review panels; and reimbursed or sponsored travel from a foreign entity, foreign government, or foreign institution of higher education.

Institutional responsibilities or University responsibilities: an investigator's professional responsibilities on behalf of the University, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Investigator: 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 government or other funding entity, or proposed for such funding, which may include, for example, collaborators or
consultants. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postgraduate associates, senior scientists, or graduate students. The definition may also include collaborators or consultants as appropriate.

Manage: taking 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 will be free from bias.

PD/PI: a project director or principal investigator of a government-funded research project; the PD/PI is included in the definitions of senior/key personnel and investigator under this Rule.

Government: Any state or federal government agency that requires this financial conflict of interest Policy, including but not limited to the Public Health Service (PHS) of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

Government awarding component: the organizational unit of the government that funds the research or project that is subject to this policy.

Public Health Service Act or PHS Act: the statute codified at 42 U.S.C. 201 et seq.

Research: a systematic investigation, study or experiment designed to develop or contribute to generalized knowledge. 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). As used in this subpart, the term includes any such activity for which research funding is available from a government awarding component (that requires compliance with this policy) through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

Senior/key personnel: the PD/PI and any other person identified as senior/key personnel by the University in the grant application, progress report, or any other report submitted to the government by the Institution under this policy.

Conflict of interest committee (“committee”): Team from the University named by the President and charged with reviewing and managing the requirements of this policy, initially consisting of the University’s Vice President for Finance & CFO or designee, the General Legal Counsel or outside counsel engaged by the University for this purpose, and the Director of Grants & Sponsored Research or designee.

Procedure and Guidelines

1. Disclosure of Financial Interests

All investigators are required to disclose their outside significant financial interests to the University annually and upon certain events as described below. (See Disclosure Form attached as Exhibit 1.) All Disclosure Forms and related correspondence required under this Policy shall be submitted to the Director of Grants & Sponsored Research at grants@calvin.edu, who is responsible, on behalf of the committee, for the distribution, receipt, processing, review, and retention of the Disclosure Forms.

1.1 Annual Disclosures: All investigators must disclose their significant financial interests to the University, through the Director of Grants & Sponsored Research, on an annual basis. All forms should be submitted by March 1 for the previous calendar year or as determined by the committee. The Director will distribute the Disclosure Form to each investigator each January, together with the training materials described in Section 6 of this Policy.
1.2 Other Disclosures: In addition to the annual disclosure, certain situations require other disclosures.

 i. All investigators must disclose their significant financial interests to the Director of Grants & Sponsored Research within 30 days of their initial appointment or employment.

 ii. Prior to entering into sponsored projects or applications for sponsored projects, where the investigator has a significant financial interest, the investigator must submit to the Director of Grants & Sponsored Research an updated disclosure of his or her significant financial interests with the outside entity. The University will not submit a research proposal unless the investigator(s) have submitted such disclosures.

 iii. In addition, all investigators must submit to the Director of Grants & Sponsored Research a disclosure of any significant financial interest they acquire during the year within thirty (30) days of discovering or acquiring the significant financial interest.

1.3 Travel: Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of financial interest, including foreign-sponsored or foreign-reimbursed travel. Investigators must disclose each occurrence of such travel within 30 days of
the travel, in addition to including such travel in their annual and event-driven disclosures under this Section. Such disclosures 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. An investigator is not required to determine the monetary value of the travel before disclosing its occurrence. The committee or its designee will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a significant financial interest under this Policy and, if so, whether the travel constitutes a financial conflict of interest with the investigator’s research.

2. Review and Decision of Committee

Before determining whether a significant financial interest constitutes a financial conflict of interest, the committee or its designee will first determine whether the significant financial interest is related to the investigator’s PHS-funded or other government-funded research. A significant financial interest is related to the research when the committee or its designee, applying a reasonable person standard, determines that the significant financial interest: (i) could be affected by the research; or (ii) is held in an entity whose financial interest could be affected by the research. Only a significant financial interest determined to be related to the research will be evaluated further to determine whether it constitutes a financial conflict of interest. 

If the Disclosure Form reveals a significant financial interest, it will be reviewed promptly by the committee or its designee in a closed session for a determination of whether it constitutes a Financial Conflict of Interest. If a financial conflict of interest exists, the committee or its designee will take action to eliminate, reduce, or manage the conflict, as appropriate. If the committee or its designee determines that there is a financial conflict of interest that can be managed, it must require and approve a written management plan before any related research goes forward. The affected investigator and the committee are responsible for developing and submitting a proposed management plan. Any management action shall be taken after consideration of such factors as the nature of the research, the nature and size of the interest, the degree to which the conflict is related to the research, the extent to which the interest could be affected by the research, and any management strategies that would mitigate or eliminate the conflict. Management strategies may include, but are not limited to:

• public disclosure of the FCOI in publications, presentations, to research personnel working on the study, to the Institutional Review Board, Institutional Animal Care and Use Committee, the Data and Safety Monitoring Board, etc.
• for projects involving human subjects, disclosure of the FCOI directly to participants
• 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 financial conflicts.

The committee or its designee will also notify the Provost or his or her designee of the existence of the financial conflict of interest in the event he or she does not support, or no longer supports, the research.

No member of the committee who holds a significant financial interest in a project considered under this section may participate in the review or development of a management plan for the project.

A financial conflict of interest will exist when the committee or its designee determines that a significant financial interest is related to the research and could directly and significantly affect the design, conduct, or reporting of government-supported research.

To address complex situations, an additional oversight committee may be established by the committee or its designee to periodically review the ongoing activity, to monitor the conduct of the activity (including use of students and post-graduate appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.

3. Reporting to Government

The Director of Grants & Sponsored Research, on behalf of the committee, is responsible for submitting all FCOI reports to the applicable government awarding component, using the reporting mechanism required by that government awarding component (e.g., the NIH eRA Commons FCOI Module).

3.1 Initial Report. Where the committee or its designee determines that a financial conflict of interest exists, the University will submit an FCOI report to the government awarding component prior to the expenditure of any funds under the applicable award. The Initial Report will include, at a minimum: the project number and title; the name of the PD/PI; the name of the investigator with the financial conflict of interest; the name of the entity with which the investigator has the financial conflict of interest; the nature of the financial interest (e.g., equity, consulting fees, honoraria, paid authorship, intellectual property rights, or reimbursed or sponsored travel); the value of the financial interest, or a statement that the value cannot be readily determined; a description of how the financial interest relates to the research and the basis for the University’s determination that the financial interest conflicts with the research; and a
description of the key elements of the management plan, including the role and principal duties of the investigator in the research, the conditions of the plan, how the plan is designed to safeguard objectivity, confirmation that the investigator has agreed to the plan, and how the plan will be monitored.

3.2 Annual Report. For as long as a financial conflict of interest persists, the University will submit an Annual Report to the government awarding component addressing the status of the financial conflict of interest and any changes to the management plan, until the end of the period of the award or until the committee determines that the financial conflict of interest no longer exists, whichever occurs first.

3.3 Revision (or Mitigation) FCOI Report. After completing a retrospective review, the Institution will submit a Revision Report to NIH if new information about the FCOI is discovered or a Mitigation Report if the review finds that bias has occurred.

3.4 Subrecipients and Prime Awardees. Should any reported conflict or non-compliance require reporting to government agencies such as PHS, the committee or its designee will report in accordance with PHS or other applicable government regulations. If the funding for the research is made available from a prime PHS-awardee, such reporting shall be made available to the prime awardee such that they may fulfill their reporting obligations to the PHS.

4. Subrecipients

4.1 Where the University carries out PHS-funded or other government-funded research through a subrecipient (sometimes also referred to as a “subgrantee”) (e.g., a subcontractor or consortium member), the University will take reasonable steps to ensure that the subrecipient’s investigators comply with this Policy. The University’s written agreement with the subrecipient will establish whether the University’s financial conflict of interest Policy or the subrecipient’s own financial conflict of interest policy applies to the subrecipient’s investigators:

 i. If the subrecipient’s own policy is to apply, the subrecipient must certify, as part of the agreement, that its policy complies with 42 CFR Part 50, Subpart F. If the subrecipient cannot provide that certification, the agreement will instead state that the subrecipient’s investigators are subject to the University’s Policy for purposes of disclosing significant financial interests that are directly related to the subrecipient’s work for the University.

 ii. If the subrecipient’s own policy applies, the agreement will specify time period(s), sufficient to allow the University to meet its own FCOI reporting deadlines to the government, for the subrecipient to report any identified financial conflicts of interest to the University.

 iii. If the University’s Policy applies instead, the agreement will specify time period(s), sufficient to allow the University to timely review, manage, and report financial conflicts of interest, for the subrecipient to submit its investigators’ disclosures of significant financial interests to the University.

4.2 The University will use the Subrecipient Assurance Form (See Exhibit 2) to document the certification described in subsection (a)(i) above.
4.3 The University will provide FCOI reports to the government awarding component regarding all financial conflicts of interest of subrecipient investigators consistent with this Policy, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.

5. Noncompliance

5.1 Disciplinary Action: In the event of an investigator’s failure to comply with this Policy, the committee or its designee shall report the matter to the Provost, who may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the committee or its
designee is implemented.

The Provost’s decision to impose sanctions on an investigator because of failure to comply with this Policy, or failure to comply with the decision of the committee or its designee, will be described in a written explanation of the decision to the investigator, committee and, where applicable, other University officials, and will notify the individual of the right to appeal the decision.

5.2 Retrospective Review: In addition, if the committee or its designee determines 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
failure by an investigator to materially comply with a management plan for a financial conflict of interest, or the University’s failure to review or manage a financial conflict of interest within the timeframes required by this Policy or applicable government regulations, the committee or its designee 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 the design, conduct or reporting of the research.

Documentation of the retrospective review shall include the project number, project title, PI, name of investigator with the financial conflict of interest, name of the entity with which the investigator has the financial conflict of interest, reason(s) for the retrospective review, detailed methodology used for the
retrospective review, and findings and conclusions of the review. The committee or its designee will update any previously submitted report to the government or PHS or the prime PHS-awardee relating to the research, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the report will include a mitigation report in accordance with the relevant government regulations (such as PHS 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.

5.3 Clinical Research: In any case in which HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an investigator with a financial conflict of interest that was not managed or reported by the University as required by this Policy, the University will require the investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

6. Training

Each investigator must complete training on this policy prior to engaging in research funded by PHS, and at least every four years thereafter. Investigators must also complete training within a reasonable period of time as determined by the committee or its designee in the event that this policy is substantively amended in a manner that affects the requirements of investigators, or if it is determined that the investigator has not complied with this policy or with a management plan related to their activities.

Training must address, at a minimum: (i) the FCOI regulation set forth at 42 CFR Part 50, Subpart F and 45 CFR Part 94; (ii) this Policy; and (iii) the investigator’s responsibility to fully disclose all domestic and foreign significant financial interests, including those of the investigator’s spouse and dependent children, that are related to the investigator’s institutional responsibilities.

The Director of Grants & Sponsored Research will satisfy (i) above through a designated external training program addressing the FCOI regulation (e.g., the CITI Program’s FCOI training module). The Director will satisfy the requirements described in (ii) and (iii) above by providing each investigator, directly, with

Calvin-specific training materials on the same schedule described above. The Director will also distribute these materials annually each January, alongside the Disclosure Form described in Section 1, due back by the March 1 deadline described in Section 1(a) to keep investigators current between required training cycles. The investigator’s certification on the Disclosure Form will serve as documentation that the investigator has received and reviewed this institution-specific training content.

Failure to complete required training in a timely manner will be addressed in accordance with Section 5 (Noncompliance) of this Policy.

Subrecipient investigators must complete training consistent with Section 4 (Subrecipients) of this Policy.

7. Records

The Director of Grants & Sponsored Research will retain all disclosure forms, conflict management plans, records of retrospective reviews, and related documents — including records relating to all investigator disclosures of financial interests and the University’s review of, and response to, such disclosures, regardless of whether the disclosure resulted in a determination that a financial conflict of interest exists, and all actions taken under this Policy for a period of three years from the date the final expenditure report is submitted to the PHS or to the prime PHS awardee, or, where applicable, from such other date specified in 2 CFR 200.334, and in accord with applicable government regulations.

8. Confidentiality

To the extent permitted by law, all Disclosure Forms, conflict management plans, and related information will be confidential. However, the University may make such information available to an agency funding research of the faculty member, to a requestor of information concerning a financial conflict of interest related to PHS funding or to the primary entity who made the funding available to the Institution, if requested and required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the investigator will be informed of this disclosure.

9. Public Accessibility

Prior to the expenditure of funds, the University will respond to any requestor within five business days of the request by making available information concerning any significant financial interest of senior/key personnel that meets the following criteria:

9.1 The significant financial interest was disclosed and is still held by the senior/key personnel member;

9.2 A determination has been made that the significant financial interest is related to the PHS-funded research; and

9.3 A determination has been made that the significant financial interest is a financial conflict of interest. The information to be made available shall be consistent with the requirements of the PHS regulations specified in 42 CFR 50.605(a)(5)(ii) and include the following

   1. The investigator's name;
   2. The investigator's title and role with respect to the research project;
   3. The name of the entity in which the SFI is held;
   4. The nature of the SFI; and

Approximate dollar value of the SFI in the following ranges: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

10. Appeal

Any investigator may appeal the decision of the committee regarding management of a financial conflict of interest in writing to the Provost who will consult with the investigator and committee as the Provost deems necessary and appropriate to the particular circumstance. The decision of the Provost will be final.

11. Regulatory Authority

This policy implements the requirements of 42 CFR Part 50, Subpart F; where there are substantive differences between this policy and the requirements, the requirements shall take precedence. 

Cabinet – Approved, August 22, 2012. Revised June 2026 to update institutional name and titles, conflict of interest committee composition, foreign financial interest disclosure requirements, FCOI reporting procedures, and subrecipient compliance requirements, consistent with NIH Guide Notices NOT-OD-18-
160 and NOT-OD-22-210.