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    American Psychiatric Association and American Psychiatric Association Foundation

    Project Specific Conflict of Interest Policy

    Per 42 CFR Part 50 Subpart F

    1. Policy Purpose and Summary
      This policy is established to ensure the highest level of ethical standards in activities entered on behalf of the American Psychiatric Association (APA) and American Psychiatric Association Foundation (APAF) as it relates to promoting objectivity in research. The expectation is that the design, conduct, and reporting of grants, contracts and cooperative agreements are free from bias due to any potential or perceived conflict of financial interest as well as to ensure the APA/APAF compliance with federal, state, local and institutional policies.
    2. Definitions
      • 2.1. Financial Conflict of Interest (FCoI): a significant financial interest that may affect or give a perception of affecting the design, conduct, or reporting.
      • 2.2. FCoI report: Institutional report of a financial conflict of interest to a Public Health Service (PHS) Awarding Component
      • 2.3. Financial Interest: anything of monetary value, whether or not the value is readily ascertainable.
      • 2.4. Institutional responsibilities: Investigator's professional responsibilities on behalf of the APA/APAF, and as defined by the APA/APAF in its policy on financial conflicts of interest, 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 (IRB’s).
      • 2.5. Investigator: any person who is responsible for the design, conduct or reporting of research funded by PHS, or proposed funding, which may include, for example, collaborators or consultants.
      • 2.6. 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.
      • 2.7. PHS: 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 (NIH)
      • 2.8. PHS Awarding Component: means the organizational unit of the PHS that funds the research that is subject to this subpart.
      • 2.9. Significant Financial Interest: A 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.
    3. Training Requirements
      Each Investigator is required to complete training regarding the disclosure of Significant Financial Interests, and of the applicable regulations related to any PHS-funded grant at least every 4 years, and immediately when any of the following circumstances apply:
      • 3.1. APA/APAF revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
      • 3.2. An Investigator is new to APA/APAF; or
      • 3.3. APA/APAF finds that an Investigator is not in compliance with the Institution's financial conflict of interest policy or management plan.
      The NIH has provided a Financial Conflict of Interest tutorial; which can be found at: NIH FCOI-Tutorial Upon completion of this tutorial, Investigator will be provided a certification. This certification should accompany the Investigator’s disclosure form.
    4. Disclosure, Review, and Monitoring Requirements
      • 4.1. What is considered a Significant Financial Interest?
        • 4.1.1. With regard to any publicly traded entity: The value of any renumeration received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, which, when aggregated, exceeds $5,000. Renumeration 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;
        • 4.1.2. With regard to any non-publicly traded entity, the value of any renumeration received from the entity in the 12 months preceding the disclosure, which, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
        • 4.1.3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
        • 4.1.4. The term Significant Financial Interest does not include the following types of Financial Interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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; 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, 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 as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
      • 4.2. Who must comply with the project specific conflict of interest policy?
        All Investigators subject to APA/APAF Project Specific Conflict of Interest policy who are participating in or plan to participate in the PHS-funded research.
      • 4.3. When to disclose – Financial disclosure statements are to be received and reviewed from each Investigator at the following times:
        • 4.3.1. With initial proposal submission
        • 4.3.2. annually during the period of the award
        • 4.3.3. within thirty (30) days of discovering or acquiring a new Significant Financial Interest
      • 4.4. What must be disclosed?
        4.4.1. Investigators also must disclose the occurrence of 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 their institutional responsibilities; provided, however, that this disclosure requirement does not apply to 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), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, APA/APAF will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
      • 4.5. Disclosure review process
        4.5.1. What happens if a conflict of interest is reported?
        • 4.5.1.1. APA/APAF Grant Manager is the designated official who will receive and review financial disclosure statements from each Investigators in accordance with timeline stated above and keep a record of all actions taken by the Institution with respect to each interest for at least three (3) years.
        • 4.5.1.2. Other Institutional officials and the relevant project manager will be informed of disclosures.
        • 4.5.1.3. Investigators shall provide FCOI disclosure for review. Upon review, if any financial conflict of interest if found, Institution’s Grant Manager will work with the Investigator and other relevant officials at Institution to develop and implement a management plan to manage, reduce or eliminate the conflict.
        • 4.5.1.4. The management plan may include, but is not limited to the following actions: (a) public disclosure of Significant Financial Interests; (b) monitoring of research by independent reviewers; (c) modification of the research plan; (d) disqualification from participation in all or a portion of the funded research; (e) divestiture of Significant Financial Interests; or (f) severance of relationships that create actual or potential conflicts.
        • 4.5.1.5. Institution shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the project
      • 4.6. Reporting to PHS Awarding Agency about financial conflicts of interest:
        • 4.6.1. Prior to APA/APAF/s expenditure of any funds under the PHS -funded research project. APA/APAF shall provide to the PHS Awarding Component an FCOI report regarding any Investigator's Significant Financial Interest found by the Institution to be conflicting and ensure that APA/APAF has implemented a management plan in accordance with this subpart. **In cases in which APA/APAF identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, APA/APAF shall not submit an FCOI report to the PHS Awarding Component.
        • 4.6.2. What information needs to be provided to the PHS Awarding Component regarding financial conflict of interest?
          • 4.6.2.1. Any report shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict and assess the appropriateness of APA/APAF’s management plan. Data elements to be included in this report are:
            • Project number;
            • PD/PI or Contact PD/PI if a multiple PD/PI model is used;
            • Name of the Investigator with the financial conflict of interest;
            • Name of the entity with which the Investigator has a financial conflict of interest;
            • Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
            • Value of the financial interest (dollar ranges are permissible: $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;
            • A description of how the financial interest relates to the PHS-funded research and the basis for the APA/APAF's determination that the financial interest conflicts with such research; and
            • A description of the key elements of the APA/APAF’s management plan, including:
              1. Role and principal duties of the conflicted Investigator in the research project;
              2. Conditions of the management plan;
              3. How the management plan is designed to safeguard objectivity in the research project;
              4. Confirmation of the Investigator's agreement to the management plan;
              5. How the management plan will be monitored to ensure Investigator compliance; and
              6. Other information as needed.
          • 4.6.2.2. For any significant financial interest that APA/APAF’s identifies as conflicting subsequent to the Institution's initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), APA/APAF shall provide to the PHS Awarding Component, within 60 days, an FCOI report regarding the financial conflict of interest and ensure that APA/APAF has implemented a management plan in accordance with this subpart. Pursuant to paragraph (a)(3)(ii) of this section, where such FCOI report involves a Significant Financial Interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by APA/APAF (e.g., was not timely reviewed or reported by a subrecipient), APA/APAF shall complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. Additionally, pursuant to paragraph (a)(3)(iii) of this section, if bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.
          • 4.6.2.3. APA/APAF shall document the retrospective review and provide the following key elements:
            • Project number
            • Project Title
            • PD/PI
            • Name of the Investigator with the FCOI
            • Name of the entity with which the investigator has a FCOI
            • Reason for the retrospective review
            • Detailed methodology used for the retrospective review
            • Findings of the review
            • Conclusion of the review
              • If appropriate, APA/APAF shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward
              • If bias is found, APA/APAF is required to notify the PHS Awarding Component and submit a mitigation report
                • Key elements as listed above in this section
                • Description of the impact of the bias on the research project
                • APA/APAF’s plan of action or actions taken to eliminate or mitigate the effect of the bias
      • 4.7. Maintenance of Records
        Records relating to conflict of interest matters covered under this Investigator Conflict of Interest Policy for PHS-funded research shall be maintained by APA/APAF for a minimum period of three (3) years after any applicable research project’s final financial report is submitted to the funding agency, or until three (3) years after the final action has been taken on any audit, litigation or claim, whichever is longer.
      • 4.8. Subrecipient Requirements

        A subrecipient relationship is established when federal funds flow down from or through the APA/APAF to another entity and the subrecipient will be conducting a substantive portion of a PHS-funded research project and is accountable to the APA/APAF for programmatic outcomes and compliance matters. Pass through entities include but are not limited to collaborators, consortium members, consultants, contractors, subcontractors and subawardees, are subject to the APA/APAF’s terms and conditions, and as such, the APA/APAF will take reasonable steps to ensure that any subrecipient Investigator is in compliance with the federal FCOI regulation. The APA/APAF will incorporate as part of a written agreement with the subrecipient, terms that establish whether the APA/APAF’s Investigator Conflict of Interest Policy or that of the subrecipient’s institution will apply to the subrecipient Investigator.

        If the subrecipient’s conflict of interest policy applies to the subrecipient Investigator, the subrecipient institution will certify as part of the agreement with the APA/APAF that it is in compliance with the federal FCOI regulation, and that the institution’s portion of the project is in compliance with the federal conflict of interest policy. If the subrecipient cannot provide the certification, the agreement shall state that the subrecipient Investigator is subject to the APA/APAF’s Investigator Conflict of Interest Policy for disclosing Significant Financial Interests that are directly related to the subrecipient’s work for the APA/APAF. The APA/APAF will, if applicable, submit a FCOI report through the eRA Commons FCOI Module for any FCOIs identified for a subrecipient Investigator.

        If the subrecipient’s conflict of interest policy applies to the subrecipient Investigator, the agreement shall specify the time period for the subrecipient to report all identified FCOIs to the APA/APAF. Such time period must be sufficient to enable the APA/APAF to provide timely FCOI reports as necessary, through the eRA Commons FCOI Module.

        Other funding agencies outside the PHS may have a different process as it pertains to subrecipients, and the APA/APAF will meet their requirements as instructed.

      • 4.9. Public Accessibility Requirements
        Prior to APA/APAFs’ expenditure of any funds under a PHS-funded project, APA/APAF shall make publicly accessible, via a website or written response to any requestor within 5 business day of a request, information concerning any Significant Financial Interest disclosed to APA/APAF that meets the following criteria:
        • 4.9.1. the Significant Financial Interest was disclosed and is still held by the Investigator who is senior/key personnel.
        • 4.9.2. APA/APAF determines that the Significant Financial Interest is related to the PHS-funded research; and
        • 4.9.3. APA/APAF determines that the Significant Financial Interest is a financial conflict of interest.
          4.9.3.1. The information that APA/APAF makes available via the publicly accessible website or written response shall include, at a minimum the following:
          • Investigator’s name
          • Investigator’s title and role on the project
          • Name of the entity in which the Significant Financial Interest is held
          • Nature of the Significant Financial Interest
          • Approximate dollar value of the Significant Financial Interest (dollar ranges are acceptable: $0-$4,999; $5,000-$9,999) 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.
          • Information concerning the Significant Financial Interests of the individuals; to be posted for 3 years from the date that the information was most recently updated.
        **If APA/APAF uses a publicly accessible website to make this information available, the information that APA/APAF posts shall be updated annually. APA/APAF shall update the website within 60 days of receipt or identification of information concerning any additional Significant Financial Interest of the senior/key personnel for the PHS-funded research project that was not previously disclosed, or upon the disclosure of the Significant Financial Interest of the senior/key personnel new to the APA/APAF.
      • 4.10. Other HHS regulations that apply
        Several other regulations and policies apply to this subpart. They include, but are not necessarily limited to:

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