Financial Conflict of Interest Policy

Policy Title	Financial Conflict of Interest Policy
Policy Category	Academic/Research Policies
Original Policy Approval Date	August 23, 2012
Policies Superseded	None
Responsible Office	Provost & Vice President for Academic Affairs
Related Policies	None
Frequency of Review	5 years
Date of Next Review	July 2030

I. Scope

This Financial Conflict of Interest Policy (“Policy”) applies to each Investigator at the University who is seeking or receiving support for externally funded Sponsored Research. Capitalized terms are defined as set forth in Section IV.

II. Policy Statement

The purpose of this Policy is to promote objectivity in research by establishing guidelines for disclosing significant financial interests and reporting and resolving financial conflicts of interest for Public Health Service (PHS) funded and other Sponsored Research, as applicable. This Policy is intended to comply with regulations regarding financial conflicts of interest (FCOI) for PHS funded research, 42 CFR Part 50, Subpart F, Promoting Objectivity in Research and other federal agencies with similar regulations.

This Policy was developed originally to ensure compliance with Public Health Service (PHS) regulations at 42 CFR Part 50, Subpart F. Its scope has been broadened to apply to all externally funded Sponsored Research at the University, whether funded by federal agencies (including the PHS), state and local governments, non-profit organizations, or industry sponsors.

Certain requirements such as training timelines, reporting procedures, and public accessibility are mandated only for PHS-funded research. However, the University elects, as a matter of institutional policy, to apply these standards to all Sponsored Research to maintain consistent research integrity practices and simplify compliance across diverse funding sources. Where a provision is specifically required by PHS or a comparable federal sponsor, this will be noted. Otherwise, the provision should be interpreted as applying to all Sponsored Research funded by external entities.

III. Policy

University faculty and staff from time to time may engage in a range of external activities related to their Institutional Responsibilities such as research, research consultation, teaching, professional practice, writing, and serving on review panels, among other activities.

To promote objectivity in research, it shall be the University’s Policy:

To inform each Investigator of this Policy and any changes that impact them and their training and disclosure responsibilities through written communications and the University Policy Library and Office of Sponsored Research & Programs websites.
To require Investigators, their spouses/domestic partners, and dependent children, to disclose annually and on an intermittent basis as needed foreign and domestic Significant Financial Interests (SFIs) for activities related to their Institutional Responsibilities that are received from and/or held in an entity outside the University;
To ensure that Subrecipients or collaborators on University proposals have policies compliant with Federal guidelines or are willing to comply with this Policy;
To review disclosed SFIs, determine if any so disclosed are reasonably considered FCOIs, and develop and oversee an appropriate management plan. In such cases, all FCOIs shall be reported to the Sponsor per their requirements, and;
Enforce this Policy and its associated procedures, which are designed to comply with applicable PHS regulations and procedures pertaining to FCOI training, reporting, management, monitoring, enforcement and records management.

A. Institutional Official for FCOI

The Provost is the Institutional Official responsible for ensuring that this Policy is followed and enforced. Authority is delegated by the Provost to the Director of the Office of Sponsored Research and Programs to be the designated Institutional Official (d-IO) to implement this Policy and solicit and review financial disclosure statements to determine whether an FCOI exists. Should the Director require additional expertise in assessing whether an SFI constitutes an FCOI or in developing an FCOI Management Plan, additional expertise may be sought from University personnel including the Investigator.

B. Institutional Training of Investigators

The University requires all Investigators, including Investigators new to an existing Sponsored Research award, to complete FCOI training prior to engaging in work on the project and at least every four years thereafter. In addition, Investigators shall complete training within 30 days of written notification of:

Any change to this Policy that affects Investigator requirements (e.g., substantive changes to the SFI disclosure form); or
Non-compliance with this Policy or any FCOI Management Plan.

Investigators must complete the following training activities:

Review of this Policy, associated procedures, and completion of the SFI form;
Review of 42 CFR 50 Subpart F;
Review the applicable Sponsor Conflict of Interest Policy, if available, prior to proposal submission; and
Successful completion of the Collaborative Institutional Training Initiative (CITI) FCOI training module.

Although CITI FCOI training is tailored to meet PHS requirements, the University requires all Investigators engaged in any externally funded Sponsored Research, regardless of funding source, to complete either (a) the standard CITI FCOI training module or (b) an equivalent institutional training module determined by the Office of Sponsored Research & Programs to be appropriate based on the sponsor’s specific requirements. The University may adapt or supplement training materials for non-PHS-funded Investigators to reflect relevant agency policies or internal risk management considerations. Investigators will be notified if alternate or additional training is required in accordance with a non-federal sponsor’s terms.

C. Disclosure, Review, and Monitoring

Investigator Disclosure Requirements

Investigators shall complete at least annually during an award period and on an ad hoc basis if required, a Disclosure of Significant Financial Interests Form. This disclosure mustprovide a complete listing of those domestic and all foreign interests (and those of their spouse / domestic partner and dependent children) that meet the definition of SFI and reasonably appear to be related to the Investigator’s Institutional Responsibilities.

Investigators shall certify on the Grant Proposal Routing and Approval Form prior to the submission of a proposal for a Sponsored Project or expenditure of funds that the SFI Disclosure form has been filed within the last twelve (12) months and is current and complete, or has been recently updated to reflect current financial interests.

Ad hoc disclosures shall be made immediately:

By an Investigator new to a Sponsored Project prior to initiating their research activities; or
When the Investigator is not in compliance with this Policy

In addition, ad hoc disclosures shall be made within 30 days of discovering or acquiring (e.g., through purchase, marriage or inheritance) a new SFI.

Subrecipient Requirements

Prior to submission of a proposal, the Authorized Organizational Representative will ensure that a suitable letter agreement is established between the University and all Subrecipients that indicates whether a Subrecipient will follow this Policy or certifies that its own FCOI policy complies with applicable federal regulations or policies.

As applicable, Sub-award agreements issued by the University to the Subrecipient for support of the collaboration will identify: (i) the specific entity’s FCOI policy to be followed; (ii) the dates when SFI disclosures shall be provided to the University and reviewed by it if the Subrecipient is following this Policy; and (iii) the timeline for when FCOI determinations shall be made by the University. Reporting timelines will be selected to enable the University and Subrecipient to identify, manage and report identified FCOIs, as appropriate, and for the University to adhere to the Sponsor’s reporting requirements and procedures, which ordinarily is prior to the expenditure of funds or within 60 days of any subsequently identified FCOI.

Institutional Review of Disclosures and Determination of FCOI

The d-IO shall review each SFI disclosed and within 60 days of receipt of the SFI or no later than the University’s expenditure of award funds, whichever is earlier, determine if it:

Is related to the Sponsored Research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research); and
Could directly and significantly affect the design, conduct, or reporting of Sponsored Research.

If both #1 and #2 are reasonably determined to be true, the SFI shall be determined to be an FCOI, and the d-IO will develop and implement on at least an interim basis a management plan that shall specify the actions that have been or will be taken to manage, mitigate, or eliminate the FCOI. The University will also submit an FCOI report to the Sponsor within this 60-day period per their procedures.

Management of FCOIs

Based on the specific facts and circumstances, the University may manage an Investigator’s FCOI through one or more suitable courses of action, including but not limited to:

Public disclosure of Financial Conflicts of Interests (e.g., when presenting or publishing the research; to staff members working on the project; to the University’s Institutional Review Board(s), University’s Institutional Animal Care and Use Committee(s), etc.);
For research projects involving human subjects research, disclosure of FCOIs directly to participants;
Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
Modification of the research plan;
Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research;
Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
Severance of relationships that create financial conflicts.
Monitoring

If the University identifies an SFI that was not disclosed by an Investigator from the University or a Subrecipient in a timely manner or that for whatever reason was not previously reviewed by the University during an ongoing Sponsored research award (e.g., was not timely reviewed or reported by a Subrecipient), the d-IO will review such disclosures as described in this section.

If the d-IO determines that an FCOI was not identified or managed in a timely manner, then the d-IO will make a determination of noncompliance for:

Failure by the Investigator to disclose an SFI that is determined by the University to constitute an FCOI; or
Failure by the University to review or manage such an FCOI; or
Failure by the Investigator to comply with an FCOI management plan.

D. Reporting an FCOI to the Sponsor

Three Types of Reports

The d-IO shall send the Sponsor FCOI reports for an award’s Investigator(s) from the University and its Subrecipients, as applicable, that include all reporting elements required by the Sponsor according to their procedures. Reports will ordinarily be considered of three types: initial reports, annual reports, and revised reports.

Initial FCOI reports shall be sent:

Prior to the expenditure of funds; or
Within 60 days of identification of an FCOI for an Investigator who is newly participating in an award; or
Within 60 days for new, or newly identified, FCOIs for existing Investigators.

Annual FCOI reports shall be sent in parallel to the PI’s submission of the annual progress report, multi-year progress report, if applicable, or at time of extension and address the status of the FCOI and any changes to previously reported management plan. Annual reports will be submitted for the duration of the Sponsored research project.

Revised FCOI reports shall be submitted after a Retrospective Review described below to update a previously submitted report if new information is discovered following completion of the review.

The d-IO shall notify the Sponsor (e.g., PHS Awarding Component) promptly if, during a Retrospective Review, bias is found with the design, conduct or reporting of funded research and include Mitigation Report.

Retrospective Review

Within 120 calendar days of the determination of noncompliance (section C, item 5), the d-IO shall conduct a Retrospective Review of the Investigator’s activities and the Sponsor-funded research to determine whether any Sponsor-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in its design, conduct, or reporting.

If bias is found, the University shall notify the Sponsor promptly and within 30 days submit a mitigation report following their procedures (i.e., submit a Revised FCOI Report). The mitigation report will include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).

The University shall implement remedies as directed by the Sponsor following their review of the Revised FCOI report, such as disclose the FCOI in each public presentation of the results of the research and request an addendum to previously published presentations. Thereafter, the University will submit FCOI reports annually as prescribed by the regulation.

E. Maintenance of Records

The d-IO shall maintain all records pertaining to all Investigators’ disclosures of SFI and the University’s review of and response to such disclosures, whether or not a disclosure resulted in a determination of FCOI for:

At least three (3) years from the date the award’s final expenditures report is submitted to the Sponsor; or
For other durations as may be required by the Sponsor under their applicable records retention authority (e.g., 45 CFR 75.361, 42 CFR 50.604 (i), or similar.

F. Enforcement Mechanisms, Remedies, and Noncompliance

The Provost shall adequately enforce and provide for sanctions or other administrative actions to ensure Investigator compliance with this Policy. These may include letters of reprimand, restrictions on the use of funds, and/or withdrawal of the privilege to apply for external grants among others.

In the event a PHS-funded clinical research project is supported to evaluate the safety or effectiveness of a drug, medical device or treatment and the Department of Health and Human Services determines that such PHS-funded research project was designed, conducted or reported by an Investigator with FCOI, that was not managed or reported by the Institution as required by the Regulation, the authorized Institutional Official shall require the Investigator involved to:

Disclose the FCOI in each public presentation of the results of the research; and
Request an addendum to previously published presentations.

The University may require similar disclosures for non-PHS-funded Sponsored Research. Additional institutional sanctions for noncompliance, whether related to PHS or non-PHS research, may include, but are not limited to, letters of reprimand, additional training, restrictions on the use of research funds, disqualification from future external grant submissions, and other administrative actions deemed appropriate by the Provost or designee.

G. Public Accessibility Requirements

For PHS-funded research only, the authorized Institutional Official shall make available information concerning identified FCOIs held by senior/key persons publicly accessible prior to the expenditure of funds. This information will:

Include the minimum elements as provided in 45 CFR 50.605 (a)(5)
Be posted on a publicly accessible website or, if not posted online, made available within five calendar days of written request
Be updated at least annually
Be updated within 60 days of a newly identified FCOI, and
Remain available for three years from the date the information was most recently updated.

The University may require similar disclosures for non-PHS-funded research.

IV. Definitions

Financial Conflict of Interest (FCOI) means a significant financial interest (SFI) that could directly and significantly affect the design, conduct or reporting of the research.

Fiduciary role means membership on the governing board of an entity, including service on its board of directors, or having a position of authority or responsibility to act in the best interest of the entity, including being an officer, manager, partner, or limited liability company member with management responsibility.

FCOI Report means the University’s report of an FCOI to a PHS Awarding Component.

Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.

University means Arcadia University, its colleges, schools, affiliates and subsidiaries.

Institutional Official (sometimes also referred to as authorized Institutional Official) for the purpose of this Policy means that person designated by the University as the person responsible for administration of financial conflicts of interest pursuant to this Policy.

Institutional Responsibilities mean an Investigator’s professional responsibilities on behalf of the University, such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data Monitoring committees.

Investigator means the Project Director (PD) or Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by PHS or other Sponsors, or proposed for such funding by an external Sponsor/s. Investigators include, but are not limited to the PI/PD, Senior/Key Personnel, individuals working under Subrecipient agreements, collaborators, and consultants who are responsible for the design, conduct, or reporting of research.

Manage or management of FCOI means taking action to address the FCOI, 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. A Management plan is usually prepared in cases when FCOI is identified.

New SFI means: (1) an SFI of the same type or nature (e.g., royalty payment) from a different source (e.g., company A versus company B) or (2) an SFI of a different type or nature (e.g., royalty payment versus consulting fees) than what had previously been disclosed from the same source that meets or exceeds the $5,000 threshold.

PD/PI means Project Director/Principal Investigator, or the individual designated by the University to have the appropriate level of authority and responsibility to direct a Sponsored Project.

PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this Policy.

Research means a systematic investigation, study, or experiment designed to contribute to generalizable knowledge consistent with 42 CFR § 50.603 and 45 CFR § 46.102. It includes behavioral and social-sciences research, as well as basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). For purposes of this Policy, research includes the above activities when funded by PHS or other Sponsors as specified in this Policy.

Senior/Key Personnel means 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 under this Policy.

SFI Disclosure Form means the disclosure form and accompanying documentation that an Investigator must submit to the University disclosing any SFI or confirming that there is no SFI.

Significant Financial Interest (SFI) means:

A financial Interest consisting of one or more of the following interests of the Investigator, and those of the Investigator’s spouse/domestic partner and dependent children, that reasonably appears to be related to the Investigator’s Institutional Responsibilities, including but not limited to:

1. Publicly traded entities: Any remuneration received from a publicly traded entity in the twelve (12) 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.
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.
2. Non-publicly traded entities: Any remuneration received from a non-publicly traded entity in the twelve (12) months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse/domestic partner or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest) regardless of value.
3. With regard to foreign financial interests, a significant financial interest exists when such income is received from any foreign entity, including a foreign Institution of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) for seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, reimbursed or Sponsored travel, or any other activity which is reasonably related to Institutional Responsibilities in the twelve (12) months preceding the disclosure.
4. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
5. Fiduciary role as defined in the definitions section above.

Reimbursed or Sponsored Travel

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 the Investigator’s Institutional Responsibilities.

SFI travel disclosure must include:

-the traveler’s name,
-the purpose of the trip,
-the identity of the Sponsor/organizer,
-the destination (city, state/province, country; hotel)
-the duration (dates); and
-a reasonable estimate of the trips’ value (e.g., honoraria, fees paid; airfare; lodging)

The Institutional Official will determine if further information is needed, including a determination or disclosure of monetary value, to determine whether the travel constitutes an FCOI with the PHS or non PHS funded research.

Exclusions from SFI Definition

Significant Financial Interest does not include:

1. Salary, royalties, or other remuneration paid by the University to the Investigator during the course of the Investigator’s employment with the University, including intellectual property rights assigned to the University and agreements to share royalties related to those rights;
2. 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;
3. Income from seminars, lectures or teaching engagements 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, medical center or research institute that is affiliated with an institution of higher education;
4. Income from service on advisory committees or review panels for a Public Agency, institution of higher education, academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education; or
5. 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), or an academic teaching hospital, medical center, or research institute that is affiliated with an institution of higher education.

Sponsor means the organization or funding agency that funds a Sponsored Project. The Sponsor may be a Federal, state, or local agency; a non-profit organization; a charitable or non-charitable foundation; a professional society; or a for-profit entity such as a corporation or a small business.

Sponsored Research means any Research (as defined in this Policy) that receives funding, in whole or in part, from sources external to Arcadia University, including but not limited to federal agencies such as the Public Health Service (PHS), state or local government agencies, non-profit organizations, industry partners, or other external entities. This includes research conducted under grants, cooperative agreements, contracts, subcontracts, material transfer agreements, and other funding arrangements that provide financial or other support for research activities related to Investigators’ Institutional Responsibilities.

Subaward means an award provided by a pass-through entity (PTE) to a Subrecipient to carry out part of a Sponsored Award received by the PTE.

Subrecipient means an entity that receives a Subaward from a pass-through entity to carry out part of a Federal award. A Subrecipient may also be a recipient of other Federal awards directly from a Federal awarding agency.

V. Effective Date

This Policy is effective on the date that it is signed by the President.

VI. Date of Approval

August 23, 2012, revised August 22, 2013, May 23, 2016, August 1, 2025