Financial Conflict of Interest Policy

 

American Museum of Natural History Policy and Procedures on Financial Conflict of Interest Related to Federally Sponsored Projects

Policy

Whenever an investigator has a significant financial interest in an enterprise which might reasonably appear to be affected by discoveries in the investigator’s sponsored project, there is the potential for a real or perceived conflict of interest.  Although the American Museum of Natural History (AMNH) does not require investigators to disclose their personal financial interests as a matter of routine, AMNH is sometimes obligated to require disclosure under federal regulations.  Such disclosures are the most widely accepted method for identifying and managing actual or potential conflicts of interest related to federally sponsored projects.

It is the policy of AMNH that all investigators on federally sponsored projects are required to disclose significant personal financial interests related to that project, pursuant to circumstances specified by this policy.  When AMNH determines that such an interest might reasonably appear to be directly and significantly affected by the sponsored project, AMNH will take steps either to manage or to eliminate the conflict.

This policy implements federal requirements pertaining to U.S. Public Health Service (PHS), which includes National Institutes of Health (NIH), and which are published in 42 CFR Part 50 and 45 CFR Part 94. This policy also implements federal requirements contained in the National Science Foundation Award and Administration Guide’s “Conflict of Interest Policies.” Both agencies require AMNH maintains an appropriate written policy on conflict of interest disclosure as a condition for receiving their grants.  These  requirements, as implemented in this policy, are applicable to all proposals and awards for federally sponsored projects at AMNH.

Definitions

AMNH Reviewing Official

An official designated by AMNH to collect and review completed Financial Interest Disclosure Forms and to make the initial determination whether any reported financial interest would reasonably appear to  directly and significantly affect or be affected by the sponsored project.  The AMNH Reviewing Official is currently the Director, Government Grants.

Institutional Responsibilities

Institutional responsibilities are defined as an Investigator’s professional responsibilities on behalf of AMNH, and may include activities such as research, research consultation, teaching, and AMNH committee memberships.

Investigator

Any individual responsible for the design, conduct, or reporting of the results of work performed or to be performed under the sponsored project. This includes the Principal Investigator, Co-Investigators, and any other individual who has independent responsibility for designing, conducting or reporting the results of the sponsored project.  This term is not intended to include individuals who are purely advisory and thus are not in a position to influence design, conduct or reporting of the project.

Significant Financial Interest

A financial interest must be reported when required by the above-referenced federal regulations.  The requirement that an Investigator must report a significant financial interest under the terms of this policy does not in and of itself imply the existence of an actual or potential conflict of interest.  The existence of a conflict of interest is determined subsequently by the designated AMNH Reviewing Official, responsible Senior Vice President and, when necessary, review committee. If a conflict is identified,  additional steps to manage or eliminate the conflict may be required.

Consistent with current federal regulations, AMNH identifies two sets of definitions of Significant Financial Interest, one applicable to all federally-funded project proposals and awards except for those funded by PHS, and the other applicable only to PHS-funded project proposals and awards.  This policy defines Significant Financial Interest as anything of monetary value, including, but not limited to:

    All federal project funding except for PHS:

  1. Income from a single business entity, including salary, consulting payments, honoraria, royalty payments, dividends, loans from the entity, or any other payments or consideration with value, exceeding $10,000 during the prior twelve months when aggregated for an Investigator, Investigator’s spouse/domestic partner and dependent children;
  2. Income from a single public or nonprofit entity, including salary, consulting payments, honoraria, royalty payments, dividends, loans from the entity or any other payments or consideration with value, exceeding $10,000 during the prior twelve months when aggregated for an Investigator, Investigator’s spouse/domestic partner and dependent children, excluding income from seminars, lectures, teaching engagements, or service on advisory committees or review panels for public or non profit entities;
  3. An equity interest, in the form of stock, stock options, real estate, or any other investment or ownership interest, a 5% ownership interest, or a loan to the entity, exceeding $10,000 in value, for any one enterprise when aggregated for an Investigator and the Investigator’s spouse/domestic partner and dependent children;
  4. A management position such as board member, director, officer, partner, or trustee, held by the Investigator; or
  5. Intellectual property interest held by the Investigator or Investigator’s spouse/domestic partner or dependent children on a patent, patent application, or a copyright of software that would reasonably appear to be affected by the sponsored project at issue.

    PHS project funding:

    a.  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:

    (i)  With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration 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 purposes of this definition, 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;

    (ii)  With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve 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); or

    (iii)  Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. 

    b.  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. 

In all cases, the term Significant Financial Interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by AMNH to the Investigator if the Investigator is currently employed or otherwise appointed by AMNH, including intellectual property rights assigned to AMNH and agreements to share in royalties related to such rights; 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.

Investigator Responsibilities

All Investigators on proposed or funded federally supported projects are required to become familiar with the current AMNH policy and procedures for managing conflicts of interest (this document), and to distribute copies of the policy and procedures to all individuals who will participate as Investigators on the federally supported project. 

The federal regulations require that Investigators submit to the AMNH Reviewing Official financial disclosures related to a federally supported project in advance of submission of the application to the agency. Specifically, an Investigator must disclose all Significant Financial Interests that would reasonably appear to be affected by the activities funded by the agency, or that are in entities whose financial interests would reasonably appear to be affected by such activities.

To comply with federal regulations, AMNH will require the following actions from Investigators on federally funded projects:

  • An Investigator with no Significant Financial Interest to disclose must so certify by signing the Proposal Certification Form in advance of proposal submission, or re-certify by signing the annual Financial Interest Disclosure Form.
  • An Investigator with Significant Financial Interests which may reasonably appear to affect the design, conduct or reporting of a federally funded project must submit a Financial Interest Disclosure Form to the AMNH Reviewing Official prior to proposal submission.
  • Within 30 days of discovering or acquiring a new reportable Significant Financial Interest, submission of a Financial Interest Disclosure Form to the AMNH Reviewing Official is required from all Investigators with current awards or pending applications for federally funded projects. 
  • Completion of a Financial Interest Disclosure Form will be required at the beginning of the calendar year from all Investigators with current awards.

Additional Investigator Responsibilities under PHS-funded Projects

  • PHS-funded Investigators will complete training on Financial Conflicts of Interest in advance of proposal submission or prior to engaging in research related to a PHS-funded project and at least every four years thereafter. Investigators may use the NIH online course at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm, or, subject to approval from the AMNH Reviewing Official, another institution’s training course. Information on the training requirement will be provided by the AMNH Reviewing Official.
  • In addition to the above-required disclosures, PHS-funded Investigators must disclose reimbursed or sponsored travel related to their Institutional Responsibilities, as defined above.  The disclosure will include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  The AMNH Reviewing Official will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a Significant Financial Interest with the PHS-funded project.

AMNH Responsibilities

The Investigator will forward the Financial Interest Disclosure Form to the AMNH Reviewing Official, who will review it and confer with the responsible Senior Vice President as appropriate. Disclosures that in the opinion of the responsible Senior Vice President need the review of an ad hoc committee will be referred to a committee appointed by the Senior Vice President; composition of the committee will be determined by the Senior Vice President, and will typically include both scientists or educators and administrators. An Investigator who desires to have his/her own disclosure reviewed by the committee may so inform the AMNH Reviewing Official, for referral to the responsible Senior Vice President. Investigators may also elect to have the committee review other financial interests not related to federally sponsored project covered by this policy (in which case the portion of the policy regarding AMNH’s responsibility to report certain circumstances to the funding agency is not applicable). The committee will review disclosures referred to it and initiate steps to manage, reduce or eliminate potential conflicts in consultation with the responsible Senior Vice President.  The information disclosed will be kept confidential to the extent permitted by law.

Additional AMNH Responsibility for Retrospective Review of PHS-funded Projects

If AMNH 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, or failure by the Investigator to materially comply with a management plan for a financial conflict of interest, the responsible Senior Vice President and/or their review committee will, within 120 days of a finding, complete a retrospective review of the Investigator’s activities and the PHS-funded project to determine whether the project conducted during the period of non-compliance was biased in the design, conduct or reporting.  AMNH will document the review, develop a plan to manage any identified financial conflict of interest, and notify PHS as required.

Methods to Manage Conflicts of Interest

The responsible Senior Vice President and/or their review committee is responsible for determining what mechanisms are appropriate for managing, reducing or eliminating real or potential conflicts of interest.  Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include:

  • Public disclosure of Significant Financial Interests;
  • Monitoring of project activities by independent reviewers;
  • Modification of the project plan;
  • Disqualification from participation in the portion of funded project that could be affected by the Significant Financial Interests;
  • Divestiture of Significant Financial Interests; and/or
  • Severance of relationships that create actual or potential conflicts.

Enforcement Mechanisms

Certain federal regulations require that sanctions for non-compliance be imposed where necessary. Possible sanctions might include a letter of reprimand sent to the individual Investigator; a requirement for special certifications or assurances of compliance; restrictions on any grant awards involving the Investigator; barring the Investigator from submitting any new proposals through AMNH; suspension; dismissal, or other action as appropriate. These disciplinary sanctions are also referenced in the Museum’s Protocol for Responding to Allegations of Scientific Misconduct in Research.

Agency Notifications

All federal funding agencies except for PHS: If a conflict of interest cannot be resolved on a federally-funded project, the appropriate agency official must be so notified. The responsible Senior Vice President will provide appropriate written notice to the agency.

PHS: Prior to the expenditure of any funds under a PHS award or within 60 days of determination that a financial conflict of interest exists or annually during an award period to report on the status of an identified financial conflict of interest, the responsible Senior Vice President will report to PHS the finding of a conflicting interest and AMNH’s plan to manage the conflict. The report will contain all elements required under 42 CFR 50.605.

Record Retention

The AMNH Reviewing Official will maintain records of all financial disclosures and of all actions taken to resolve actual or potential conflicts of interest until at least 3 years after the later of the termination or completion date of the award to which they relate, or the resolution of any government action involving those records.

PHS Subawards, Subcontracts and Collaborators

For all PHS-funded projects carried out through subgrantees, contractors or collaborators (e.g., those persons or institutions conducting a substantive portion of the PHS-funded project, who will design, conduct or report the results of the project, and who are accountable to AMNH for programmatic outcomes and compliance matters), AMNH will ensure that Investigators working for such entities comply with the applicable PHS regulations, either by requiring those Investigators to comply with the AMNH policy or by requiring the entities provide assurances of compliance with applicable PHS regulations.

Public Accessibilty

AMNH will post its Policy and Procedures on Financial Conflict of Interest Related to Federally Sponsored Projects on its public website at www.amnh.org. Requests for information on PHS-funded financial conflicts of interest must be directed to the Reviewing Official; responses to requests will be issued per the PHS regulations at 42 CFR Part 50 within five business days of receipt of the request.

 

January 2003

Updated April 2010; August 2012