Financial Conflict of Interest Policy for Federal Grants and Contracts

Purpose: External sponsorship of research can result in the development of complex relationships between researchers and the external sponsors who support specific programs. To assure that our research is conducted with the highest integrity and in response to regulations issued by the Public Health Service (PHS) and National Science Foundation (NSF) Rules on Objectivity in Research (Federal Register 42 CFR Part 50 subpart F July) and 45 C.F.R § 94.4 regarding institutional responsibility, Angion Biomedica Corporation (Angion) has developed this policy on Financial Conflict of Interest (FCOI). The intent of this policy is to promote objectivity in research, to identify and eliminate or manage any possible threat to the integrity of the research conducted by Angion  and to satisfy current Federal rules for disclosure.

Scope: This policy and associated procedures are immediately applicable to all sponsored program activity at Angion carried out by Angion  employees, consultants, students, trainees, or other agents of the Angion . These procedures will be followed whenever Angion  or its employees submit a request for funding from any external agency, whether it is the PHS, the NSF or another Federal agency.

Policy Statement: Prior to the submission of a research proposal to any federal agency, all Investigators who plan to participate in, or direct a sponsored research project must disclose to Angion  any significant financial interest which they or members of their immediate family have in any commercial enterprises that will, in any way, participate in the sponsored program or that potentially may be affected by the performance or completion of the sponsored program. Disclosure is accomplished through the completion of a “Financial Conflict of Interest Disclosure Form” (attachment A) which is subject to review by the FCOI Oversight Committee (FCOIC) of Angion .

Disclosure forms will be completed prior to the submission of a research proposal or at least annually, and within 30 days of discovering or acquiring a new significant financial interest (SFI). All FCOI disclosure forms will be reviewed by the FCOIC to determine the existence of potential for any financial conflicts of interest. In addition, all contracts for sub-recipient awards will include a requirement that the sub-recipient has a FCOI policy and that the sub-recipient will report any FCOI to Angion  in its proposal and within 30 days of any newly discovered FCOI.

Definitions - For purposes of this policy statement the following definitions are provided:

  1. Investigator - Includes the principal investigator and all staff members who will have responsibility for the design and conduct of the research as well as any individuals associated with the reporting of results.
  2. Immediate Family - refers to Investigators spouse and dependent children or other adults who qualify as dependents under the Internal Revenue Code definitions.
  3. FCOI Committee (FCOIC) - A committee, appointed by the CEOcomprised of the Chief Operating Officer, the Vice President and the Administrator, that reviews all Financial Conflict of Interest Disclosure Forms to identify conflicts of interest as defined below. The committee will meet on a quarterly basis and when new FCOI Disclosure Forms are completed by Angion  employees or received from any agent, consultant, or subcontractor.
  4. Financial Conflict of Interest (FCOI) – A financial conflict of interest exists when the Institution’s FCOIC reasonably determines that a Significant Financial Interest (defined below) could directly and significantly affect the design, conduct or reporting of NIH-funded research.
  5. 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.
  6. Person – any legal person, including an employee, agent, consultant, student, trainee, or subcontractor.
  7. Research - a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award
  8. Significant Financial Interest (SFI)
    1. Significant Financial Interest is defined by the regulations as 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 reasonable appears to be related to the Investigators institutional responsibilities:
      1. With regard to any publically 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 the 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 in stock, stock options or other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value
      2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remunerations from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interests (e.g. stock, stock options, 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. 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), or an academic teaching hospital, medical center, or research institute that is affiliated with an Institution of higher education. Details of this disclosure must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The Angion  FCOIC will, in accordance with this policy, determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI with the PHS-funded research.
    3. The term significant financial interest does not include the following types of financial interests: salaries, royalties, or other remuneration paid by Angion to the Investigator if the Investigator is currently employed or otherwise appointed by Angion , including intellectual property rights assigned to Angion  and agreements to share in royalties related to such rights; any ownership interest in Angion  held by the Investigator; income from investment vehicles, such as mutual funds and retirements 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, 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.

Roles and Responsibilities:

Angion  Responsibilities

  1. Angion ’s FCIOC is responsible for overall Angion  compliance with the regulation by developing, communicating, following, and enforcing a written FCOI policy, and for the following:
    • Collecting financial disclosures of participating investigators significant financial interests i) that would reasonable appear to be affected by the research for which the NIH funding is sought and ii) in entities whose financial interests would reasonably appear to be affected by the research;
    • Determining which disclosures are FCOI;
    • Managing, reducing or eliminating these FCOI;
    • Reporting to NIH, according to the requirements of 42 C.F.R § 50.605(b), any managed or reduced FCOI that exist prior to expenditure of funds;
    • Reporting any FCOI to NIH, according to the requirements of 42 C.F.R § 50.605(b), within sixty (60) days of any subsequently identified FCOI;
    • Conducting retrospective reviews of noncompliances:  Whenever a FCOI is not identified or managed in a timely manner (including any failure by the Investigator to disclose a SFI that is determined by the FCOIC to constitute a FCOI, or any failure by Angion  to review or manage such a financial conflict of interest, or failure by the Investigator to comply with a financial conflict of interest management plan), Angion  shall, within 120 days of Angion’s determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research; FCOI reports shall be made and updated as required by 50 C.F.R. § 50.605;
    • Ensuring investigator training; and
    • Ensuring accessibility of Angion’s Policy by making it available to the public on Angion’s Web site.
  2. Review and Management

Prior to Angion’s expenditure of any funds under a PHS-funded Research project, the FCOIC will:

Review all Investigators’ SFI Disclosure Forms;    

  • Determine whether any SFI relates to PHS-funded Research;
  • Develop and implement a Management Plan that specifies the actions that have been and will be taken to manage such a FCOI, should a FCOI be found.
  • Determine whether a FCOI exists; and,
  1. The FCOIC will, within fifty (50) days, perform the same above steps whenever in the course of an ongoing PHS-funded Research project an Investigator who is new to participating in the Research project discloses a SFI; an existing Investigator discloses a new SFI; or the FCOIC identifies a SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the FCOIC.
  2. Examples of conditions or restrictions that may be imposed to manage a FCOI include, but are not limited to:
    • Public disclosure of the FCOI;
    • Disclosure of the FCOI to participants;
    • Oversight of the FCOIC, or its duly appointed agent acting as FCOI Monitor, including taking measures to protect the design, conduct, and reporting of the Research against bias resulting from the FCOI;
    • Modification of the research plan;
    • Replacement of an Investigator with a FCOI, or revision of the Investigator’s responsibilities involved with the Research; disqualification of the Investigator from participation in all or a portion of the Research; or other removal of the FCOI;
    • Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
    • Severance of relationships that create financial conflicts.

Investigator Responsibilities: 

A participating Investigator is responsible for:

  • Reviewing and understanding this FCOI Policy;
  • Complying with all Angion  policies and procedures; and
  • Executing the attached Financial Conflict of Interest Disclosure Form for disclosing the required information to Angion upon hire, annually, for any grant application when it is discovered no current disclosure is in place (for whatever reason), and when an SFI arises or becomes known in-between other required disclosures.

Procedure:

  1. Whenever a request for funding (grant request) is submitted to the NIH the Angion FCOIC  will ensure that all associated Investigators have completed a Financial Conflict of Interest Disclosure Form (“disclosure forms”).
  2. Financial Conflict of Interest Disclosure Forms will be completed upon hire; within 30 days of discovery of a change in significant financial interest and at least annually.
  3. For each new grant submitted, the Angion FCOIC will identify the subcontractors and confirm that they have FCOI assurance in their agreements. If language is not in a subcontract or master agreement by any name with a subcontractor, an agreement addendum will be completed adding the requirements of PHS grant policy and published regulations for FCIO to the controlling agreement. If new subcontractors are added the FCOIC will ensure FCOI language is included in the contract. When new grants are submitted a list of participants and subcontractors will be kept in the FCOI binder.
  4. The Angion FCOIC will review all “disclosure forms” and evaluate whether they contain any conflict of significant financial interest.
  5. If no conflict of significant financial interest is found, the “disclosure forms” will be filed in the FCOI binder. For negative finding no further review is required.
  6. If a Financial Conflict of Interest is identified it will be evaluated by the Angion FCOIC who will work with the principal investigator or researcher to prepare a resolution plan that will reduce, minimize or eliminate the conflict of interest. The resolution plan must be approved by the FCOIC before any expenditures are incurred against the federal grant.
  7. If the Angion  FCOIC is unable to satisfactorily manage a financial conflict of interest, Angion will notify the appropriate official at the funding agency within sixty (60) days of identifying the FCOI, in the manner required by agency regulations such as 42 C.F.R Part 50, Subpart F.
  8. In the event circumstances change, regarding a significant financial interest of an investigator engaged in a sponsored project, the investigator must notify Angion’s FCOIC as soon as the change becomes known and a revised disclosure form must be completed. The revised form will undergo the same review process as the original form. The new disclosure must be completed within 30 days of discovery.
  9. Angion will maintain the confidentiality of the disclosure statements except as required by federal law or agency award terms. In no case will a disclosure statement be released to a federal agency without prior notification to the affected individual.

Federal Compliance and Record Retention:

  1. Upon hire and on an annual basis, all Angion employees shall be provided with a copy of this policy and be required to complete and sign the disclosure form - Attachment A. All completed forms as well as all other conflict information shall be provided to and reviewed by the FCOIC.
  2. All completed forms shall be retained by the FCOIC for a period of not less than 3 years after date of submission of the final expenditures report submitted to PHS under an award.
  3. Violations:
    1. If the Angion FCOIC has reasonable cause to believe any person (employee, agent, consultant, student, trainee, or subcontractor) has failed to disclose actual or possible conflicts of interest, it shall inform the person of the basis for such belief and afford the person an opportunity to explain the alleged failure to disclose.
    2. If, after hearing the person’s response and after making further investigation as warranted by the circumstances, the Angion FCOIC determines the person has failed to disclose an actual or possible conflict of interest, the FCOIC will report the failure to the COO who shall take appropriate disciplinary and corrective action up to and including termination of employment, subcontracts, or consulting agreements.
  4. Training on the Financial Conflict of Interest Regulations and Angion policy will be required:
    1. Upon hire;
    2. When the Angion policy is changed such that it affects the requirements of
      the investigator;
    3. If an investigator is not in compliance with the policy;
    4. No less than every 4 years.

Publication

FCOIC will ensure accessibility of Angion ’s Policy by making it available to the public on Angion’s Web site.

Forms: Financial Conflict of Interest Disclosure Form – Attachment A