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This document defines American Psychological Association’s (APA) policy and procedures regarding financial conflicts of interest with respect to projects funded under Public Health Service (PHS) grants or cooperative agreements. The purpose of the policy is to protect the credibility and integrity of the APA, and to ensure that the design, conduct, and reporting of research funded under PHS funds are free from bias resulting from financial conflicts of interest.

In accordance with Federal regulations, the APA has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of an investigator. Thus, the APA requires that its investigators disclose any significant financial interest that may reasonably appear to be related to the investigator’s institutional responsibilities.  This Financial Conflict of Interest Policy is designed to comply with the federal regulations and hereby incorporates by reference 42 C.F.R. 50 subpart F.

This policy is adopted in addition to and as a supplement to the following APA policies:

  • Section B1.30 of “Personnel Policies and Procedures”
  • Section IV.H and Section VII.C. of “Government Grants and Contracts Compliance Manual and Code of Business Ethics.”

This policy applies to all APA Investigators (as defined herein) who are involved with PHS-funded research. The Institutional Official (as defined herein) is responsible for ensuring implementation of this policy and may suspend all relevant activities until a potential conflict of interest is resolved or other action deemed appropriate by the Institutional Official is implemented. Violation of any part of these policies may constitute cause for disciplinary or other administrative action pursuant to APA policy.

I. Definitions

The following definitions apply to this policy.

A potential conflict of interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the APA 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.

Equity interest is a financial interest that includes, but is not limited to, stock, stock option, and other ownership interest.

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

A Financial Conflict of Interest (FCOI) exists, for the purposes of this policy, when the APA, through procedures described herein, reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

FCOI Report means the APA’s report of a financial conflict of interest to a PHS Awarding Component.

Investigator means the project director or principal investigator (“PD/PI”), any other person identified as senior/key personnel by the APA in the grant application, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

Institutional Official means the individual within the APA who is responsible for the solicitation and review of disclosures of significant financial interests (including those of the Investigator’s family) related to the Investigator’s institutional responsibilities. For the purposes of this policy the Institutional Official is the Director of Grants & Contracts.

Institutional Responsibilities means the Investigator’s responsibilities on behalf of the APA, which are defined by the APA as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as institutional review boards.

Payment for services is a financial interest that includes, but is not limited to salary, consulting fees, honoraria, and paid authorship.

PHS  means the Public Health Service 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.

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

Significant Financial Interest means a financial interest consisting of one or more of the following of the Investigator or an Investigator’s spouse or dependent children that reasonably appears to be related to the Investigator's institutional responsibilities:

  • Any intellectual property rights and interest (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.
  • For any publicly traded entity, if the value of the following when aggregated, exceeds $5,000:
    • Any payment for services received from the entity in the twelve 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.
  • For any non-publicly traded entity, if either of the following conditions exist:
    • The value of any payment for services received from the entity in the twelve months preceding the disclosure exceeds $5,000, or
    • The Investigator’s spouse or dependent children hold any amount of equity in the entity as of the date of disclosure.

The term Significant Financial Interest does not include:

  • Salary, royalties, or other remuneration from the APA to the Investigator if the Investigator is currently employed by the APA;
  • Income from investment vehicle, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
  • Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse or domestic partner and dependent children over the next twelve months, are not expected to exceed $5,000;
  • Income from seminars, lectures, or teaching engagements 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 that is affiliated with an institution of higher education; or
  • Income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Provided, however, that the exclusions above shall not apply if the compensation or transfer of an equity interest is conditioned upon a particular outcome in a sponsored research project.

II. Disclosure of Significant Financial Interests

All Investigators are required to disclose their outside financial interests to the APA on an annual and ad hoc basis, as described below, using the Significant Financial Interest Disclosure Form (“Disclosure Form”), attached hereto as Attachment A and available from the Institutional Officer.

A. Required Disclosures

Each Investigator is required to disclose the following Significant Financial Interests:

  • Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or
  • Any Significant Financial Interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor.

Regardless of the above minimum requirements, any APA staff, in his or her own best interest, may choose to disclose any other financial interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.

The project director or principal investigator (“PD/PI”) on a proposed PHS application is responsible for obtaining a Disclosure Form from all participating Investigators. Each Investigator shall complete a Disclosure Form and attach all required supporting documentation. The completed Disclosure Form must be submitted to the Institutional Official’s office. Supporting documentation that identifies the affiliation or entity involved and the nature and amount of the interest and/or income should be submitted in a sealed envelope marked confidential and accompany the Disclosure Form.

Investigators must also disclose reimbursed or sponsored travel related to his or her institutional responsibilities, as defined above. Such disclosures must, at a minimum, include the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value.  Excluded from this requirement is reimbursed travel or sponsored travel by federal, state, or local government agencies, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. The Institution Official will determine if any travel requires further investigation, including determination or disclosure of the monetary value.

B. Timing

All Significant Financial Interests must be disclosed prior to the time a proposal for PHS-funded research is submitted. All Disclosure Forms must be updated by Investigators during the period of the award on an annual basis and within 30 days of discovering or acquiring (through, e.g., purchase, marriage, or inheritance) a new Significant Financial Interest. Individuals who intend to contribute as an Investigator to an ongoing PHS-funded project must submit a Disclosure Form prior to contributing to the PHS-funded project.

III. Review of Disclosure Forms

The Institutional Official shall review all Disclosure Forms to determine (i) whether each Significant Financial Interest relates to PHS-funded research, and (ii) whether a Financial Conflict of Interest exists. This review will occur prior to the APA’s expenditure of any funds under a PHS-funded research project, and in the course of a PHS-funded research project, within 60 days of an Investigator’s disclosure of a new Significant Financial Interest or discovery of a Significant Financial Interest that was not timely disclosed by an Investigator.

A Significant Financial Interest is related to PHS-funded research when the Intuitional Official reasonably determines that the Significant Financial Interest could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research. A Financial Conflict of Interest exists when the Institutional Official reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project.

IV. Management of FCOI

If the Institutional Official determines that an APA or subrecipient Investigator has a potential Financial Conflict of Interest, then the Institutional Official will determine what conditions or restrictions, if any, should be imposed by the institution to eliminate, reduce, or manage actual or potential conflicts of interest.

Prior to submitting a proposal that involves disclosure of Significant Financial Interests or after a new Significant Financial Interest has been discovered or acquired, the Investigator should discuss with appropriate APA officials (including Directorate Chiefs) proposed measures that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a Significant Financial Interest. Such measures could include:

  1. Public disclosure of significant financial interests;
  2. Review of research protocol by independent reviewers;
  3. Monitoring of research by independent reviewers; and/or
  4. Modification of research plan.

Following review of the Disclosure Forms for each Investigator on a particular proposal, the Institutional Officer may impose additional conditions or restrictions, including the following:

  1. Modification of the research plan;
  2. Disqualification from participation in all or a portion of the research funded;
  3. Divestiture of significant financial interests; and/or
  4. Severance of relationships that create actual or potential conflict of interest.

The Institutional Official will require that a plan for reducing or eliminating conflicts of interest be incorporated into a Memorandum of Understanding between the APA and the Investigator, providing a management plan on an on-going basis until completion of the PHS-funded research project.

To address complex situations, oversight committees may be established by the Institutional Official to periodically review the ongoing activity, to monitor the conduct of the activity (including use of students and postdoctoral appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.

V. Reporting to PHS

Prior to the APA’s expenditure of funds under a PHS-funded research project, the Institutional Official shall provide to the PHS Awarding Component an FCOI Report regarding any Financial Conflicts of Interest that have not been eliminated prior to the expenditure of PHS-awarded funds, if any remain. A FCOI Report must also be submitted within 60 days of the APA’s identification of a new Financial Conflict of Interest during an ongoing PHS-funded project.

The FCOI Report must include the following information, plus any additional information that will enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the APA’s management plan:

  • Grant number
  • Project number
  • PD/PI
  • Name of Investigator with FCOI
  • Name of entity with which the investigator has a FCOI
  • Nature of FCOI (e.g., consulting fees, travel, equity)
  • Value of financial interest
  • A description of how the financial interest relates to PHS-funded research and the basis for the APA’s determination that the financial interest conflicts with such research
  • Key elements of the Institution’s management plan, including role and principal duties of the conflicted Investigator in the research project; conditions of the management plan; how the management plan is designed to safeguard objectivity in the research project; confirmation of the Investigator's agreement to the management plan; and how the management plan will be monitored to ensure Investigator compliance.

Annual FCOI Reports to PHS must include the above, as well as the status of the FCOI and any changes to the management plan.

VI. Violations of Conflict of Interest Policy

Whenever an Investigator has violated this policy or the terms of any resolution plan (including failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms) the Institutional Official shall notify the Office of General Counsel who will impose sanctions or institute disciplinary proceedings against the violating individual, including suspension of all relevant activities and FCOI training (see Section X) until the matter is resolved.

In addition, the APA shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the Investigator until the matter is resolved.

VII. Retrospective Review

If the Institutional Official 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, a committee appointed by the Institutional Official 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, PD/PI(s), 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. This review shall take place within 120 days of the Institutional Official’s determination of noncompliance.

The Institutional Official or designee will update any previously submitted report to the 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 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.

VIII. Record Maintenance

Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest, shall be retained by office of the Institutional Official’s until three years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

IX. Subawards

Subrecipients that carry out PHS-funded research on behalf of APA must either comply with this policy or provide a certification that they have a financial conflicts of interest policy that complies with the requirements of 42 C.F.R. 50, subpart F. Subawards with such subrecipients will incorporate the form attached as Attachment B.

The form attached as Attachment B requires that subrecipients report all identified Financial Conflicts of Interest to APA prior to expenditure of PHS-funds or, at the latest, within 30 days of (i) execution of the subaward and (ii) an Investigator’s discovery or acquisition (through, e.g., purchase, marriage, or inheritance) of a new Significant Financial Interest during a PHS-funded project.

APA shall provide FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.

X. Training

Each Investigator must complete training on this policy prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that the FCOI 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.

XI. Public Accessibility

Prior to the expenditure of funds, APA will ensure public accessibility of information about any FCOI, via response to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:

  • The Significant Financial Interest was disclosed and is still held by an Investigator;
  • APA determined that the Significant Financial Interest is related to the PHS-funded research; and
  • APA determined that the Significant Financial Interest is a Financial Conflict of Interest.

The information to be made available shall include at a minimum: the Investigator's name; the Investigator's title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest, 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.

Date created: March 2021