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Financial Conflict of Interest Policy

Financial Conflict of Interest Policy

Last Updated: May 1, 2025

1. BACKGROUND

The New York Academy of Sciences (“NYAS”) recognizes that many personnel (both internal and external) of NYAS may engage in relationships with outside entities, some of which may create the appearance of a conflict of interest. NYAS therefore, has promulgated the below policy (“Policy”) to ensure that all scholarly activities which rely on external funding are carried out under the highest standards of ethical conduct. This Policy shall protect the interests of the scholarly community of NYAS by ensuring the integrity and objectivity of the programmatic activities created and hosted by NYAS.

2. POLICY OVERVIEW

NYAS strives to ensure funded programmatic activities are free from bias resulting from financial conflicts of interest. Therefore, this Policy is applicable to everyone (internal and external) who participates in planning programmatic activities funded by NIH or PHS funds (or any other external agency) through NYAS (each an “Investigator” as further defined below). Each Investigator must:

  1. Disclose their significant financial interests (“SFI” as further defined below) in non-NYAS entities that would appear related to the Investigator’s professional responsibilities through NYAS;
  2. Comply with this Policy; and
  3. Undergo FCOI training, at least once every four (4) years.

Disclosure of SFI is essential for NYAS to determine if there are financial conflicts of interest and how such conflicts should be managed and reported in full compliance with all laws and regulations. Non-disclosure of SFI or non-compliance with this Policy will at a minimum require FCOI training and may lead to suspension or termination of employment or involvement with the applicable programmatic activities.

3. DEFINITIONS

  1. “Family Member” means, with respect to an Investigator, their immediate family members consisting of their spouse or domestic partner, ancestors, siblings and their spouses, and lineal descendants and their spouses.
  2. “Financial Conflict of Interest or FCOI” means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of funded programmatic activities.
  3. “Investigator” is any individual (whether or not an employee of NYAS) involved in an externally funded programmatic activity or proposal at NYAS who is responsible for the design, conduct, or reporting of such programmatic activity.
  4. “Key Person” means any person, whether or not an employee of the NYAS, who (i) has responsibilities, or exercises powers or influence over NYAS as a whole similar to the responsibilities, powers, or influence of Related Parties and officers; (ii) manages NYAS, or a segment of NYAS that represents a substantial portion of the activities, assets, income or expenses of NYAS; or (iii) alone or with others controls or determines a substantial portion of NYAS’s capital expenditures or operating budget.
  5. “Mitigation Report” means a report that follows a retrospective review if bias is found to have occurred. The Representative will draft a mitigation report to include, at a minimum, the key elements documented in the Retrospective Review and a description of the impact of the bias on the programmatic activity, and NYAS’s plan of action taken to eliminate or mitigate the effect of the bias (e.g., impact on the programmatic activity; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; and an analysis of whether the programmatic activity is salvageable). The Representative will promptly notify and submit a Mitigation Report to the external funding entity.
  6. “Related Entity” means, with respect to an Investigator, any entity in which they and/or their Family Members, have a thirty-five (35) percent or greater ownership interest or, in the case of a partnership or professional corporation, a direct or indirect ownership interest of more than five (5) percent.
  7. “Related Party” means a Key Person of NYAS or any affiliate of NYAS and their Family Members and Related Entities who the Investigator reports to or works with, and the Family Members and Related Entities of the Investigator.
  8. “Representative” is the individual or group tasked with reviewing potential FCOI cases, developing FCOI management plans, conducting retrospective reviews and writing mitigations reports when needed, overseeing FCOI training, and updating publicly available FCOI policies.
  9. “Responsibilities” means the professional responsibilities on behalf of NYAS related to funded programmatic activities, related publications, professional practice, committee memberships, and services on panels.
  10. “Retrospective Review” is an investigation undertaken by the Representative when an Investigator is found to have not disclosed in a timely manner an SFI that is determined to constitute an FCOI, or an SFI that is determined to constitute an FCOI and was not reviewed or managed in a timely manner, or the failure of the Investigator to comply with a management plan. The purpose of the retrospective review is to determine whether any funded programmatic activities, or a portion thereof, conducted during the time period of the noncompliance, was biased in its design, conduct, or reporting. Retrospective reviews document, at a minimum: the project number and title; principal Investigator’s names(s); name of Investigator with an FCOI; name of the entity with which the Investigator has an FCOI; the reason for the retrospective review; the detailed methodology used for the review; and findings and conclusions of the review. The Representatives completes and documents a retrospective review within 120 calendar days of the determination of noncompliance.
  11. “Significant Financial Interest or SFI” as defined in 42 CFR 50.603 means:
    1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s Related Parties) that reasonably appears to be related to the Investigator’s Responsibilities (as defined below):
      1. With regard to any publicly traded entity, an SFI exists if the value of any remuneration received from the 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. With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve (12) months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s Related Parties) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
      3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
    2. The occurrence of any reimbursed or sponsored travel related to their Responsibilities unless the sponsor is (a) a government agency (federal, state, or local), or (b) an institution of higher learning or its affiliated entities such as an academic teaching hospital, medical center, or research institute. This includes both travel that is reimbursed through payment directly to the traveler and travel that is paid in-kind (e.g., when a sponsor books and pays for a plane ticket or hotel room on the traveler’s behalf).
    3. An SFI does not include the following:
      1. Salary, royalties, or other remuneration paid by NYAS, including intellectual property rights and agreements to share in royalties related to such rights;
      2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the individual assets that comprise the investment vehicles;
      3. Income from seminars, lectures, or teaching engagements sponsored by a government agency or institution of higher education, to the extent such income is paid directly to NYAS; or
      4. Income from service on advisory committees or review panels for a government agency or institution of higher education, to the extent such income is paid directly to NYAS.

4. PROCEDURE

  1. Investigators who are planning to or participating in a programmatic activity that is externally funded must disclose to NYAS their SFIs in a timely fashion (when a project is submitted for funding, when they receive an award, annually during the term of the award, and within thirty (30) calendar days of discovering a new SFI), on the form provided by NYAS, to the Representative.
  2. The Representative will determine if whether the SFI constitutes an FCOI, based on guidance from NYAS in accordance with all laws and regulations. An SFI constitutes an FCOI, at a minimum, if the SFI could be affected by the funded programmatic activities, or is an entity whose financial interest could be affected by the programmatic activities. If the SFI is determined to be an FCOI, the Representative will take actions to discuss and approve the implementation of an FCOI management plan consistent with all laws and regulations and, furthermore, to promptly notify all external funding sources via a FCOI report. Investigators are responsible for complying with the terms of any FCOI management plan.
  3. The Representative will decide on one of the following actions in the instance of an FCOI, depending on the details of the FCOI:
    1. Requiring disclosure of the FCOI in all public presentations;
    2. Reassignment of the Investigator to another project;
    3. Reduction or elimination of the FCOI; or
    4. Severance of relationships that cause FCOI.
  4. Investigators who are planning to or participating in programmatic activities that are externally funded must complete the required FCOI training provided by the Representative prior to engaging in programmatic activities that are externally funded and at least every four (4) years thereafter. Investigators must also complete a new FCOI training whenever this Policy is revised in any manner that affects the requirements of the Investigators. Investigators new to NYAS (either as employees or external contractors) must complete an FCOI training within thirty (30) calendar days of their start date. Investigators found not complying with this Policy, or who must comply with a FCOI management plan, must also complete additional training.

5. ADMINISTRATION

  1. The Representative is responsible for administration of this Policy, including, but not limited to:
    1. Notifying the Governors of NYAS of any SFIs disclosed by Investigators when proposals are submitted for funding, and for providing backup materials to assist in evaluating the SFI for a FCOI;
    2. Identifying to the Governors any Investigators who should be required to file annual financial disclosure statements;
    3. Assisting NYAS in reviewing its 1085 form of annual disclosures to identify any potential conflicts of interest with ongoing grant/contract activities;
    4. Certifying in each application for funding to external sources that NYAS has this Policy in effect, and make any other required certifications;
    5. Track and notify appropriate parties of any incoming external funding source awards, and actual or potential FCOIs related to the awards, prior to the establishment of spending authority, within sixty (60) days for new or newly identified FCOIs, within sixty (60) days of identification of a new Investigator; at least annually, and after any retrospective reviews;
    6. Establish in any subaward from external funding sources whether the subrecipient will follow the FCOI policy of NYAS or of the subrecipient. This includes obtaining a certification from the subrecipient that its FCOI policy complies with all laws and regulations. If applicable, the subaward agreement will require the subrecipient to report identified FCOIs for its Investigators prior to the expenditure of funds, and within thirty (30) calendar days of identification, to allow NYAS to report identified FCOIs to the appropriate funding agency as required by law. If the subrecipient has no compliant FCOI policy, the subaward agreement will require the subrecipient to provide Investigator disclosures to NYAS in compliance with this Policy prior to the expenditure of funds.
    7. Lead FCOI reviews and develop, implement and monitor management plans that shall specify the actions that have been taken to manage the FCOI, should a conflict of interest be identified for an Investigator;
    8. Lead FCOI Retrospective Reviews and drafting of Mitigation Reports;
    9. Provide to the appropriate funding agency all FCOI reports required by law, including, but not limited to:
      1. the initial FCOI report;
      2. the ongoing annual FCOI report;
      3. a revised FCOI report if any SFIs are identified subsequent to the initial report within sixty (60) calendar days of the disclosure;
      4. a report of any Retrospective Reviews that reveal any programmatic activities bias, along with the Mitigation Report; and
      5. a report of any instances of Investigator noncompliance with this Policy or with a management plan.
    10. Maintaining all FCOI case records, for at least three (3) years from the date the final expenditure report was submitted to the funding agency or, when applicable, from other dates specified in 45 CFR 75.361.
  2. The Representative shall also be responsible for overseeing:
    1. Training for the members of the NYAS community including all required documentation and records of such training;
    2. Maintaining the publicly accessible website that shares this Policy and to report on the existence and management of any FCOI which shall be updated at least annually, or within sixty (60) calendar days of identification of information that was not previously disclosed. Information about FCOIs will remain available on the website for three (3) years from the date it was most recently updated.

6. ENFORCEMENT MECHANISMS

  1. NYAS does not at this time intend to participate in clinical, drug, or device evaluation research. However, in any case in which the Department of Health and Human Services (DHHS) 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 Institution as required by 42 CFR Part 50, NYAS shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
  2. NYAS Investigators will be subject to the disciplinary process, up to and including removal, if they fail to disclose FCOI situations fully and truthfully, or fail to comply with any stipulated plan for managing disclosed conduct.