Environmental Mutagenesis and Genomics Society

Financial Conflict of Interest (FCOI) Policy

Introduction

This Environmental Mutagenesis and Genomics Society (EMGS) Financial Conflict of Interest (FCOI) policy provides guidance for Principal Investigators (PIs), directors, faculty, staff, and other planners involved in the design, conduct, or reporting of EMGS projects seeking or receiving PHS-funded grants, subawards, or cooperative agreements. This policy only applies to projects that are applying for or have received PHS-funded grants, subawards, or cooperative agreements.

The purpose of this policy is to meet the requirements stated in 42 CFR Part 50, Subpart F, for promoting objectivity in research and ensuring that the design, conduct and reporting of PHS-funded research is free from bias that may arise from an individual’s perceived or real FCOI and applies to all individuals who submit PHS applications or receive PHS-funded grants, subawards, or cooperative agreements administered by the EMGS.

It should be emphasized that conflicts of interest are not inherently illegal or unethical, nor should they be interpreted as reflection upon the integrity of the conflicted individual.

Procedure

Principal Investigators (PIs), directors, faculty, staff, and other planners who are involved in the design, conduct, or reporting of PHS applications or PHS-funded grants, subawards, or cooperative agreements must:

  1. Disclose financial interests at the time of the PHS application by completing the EMGS Financial Conflict of Interest Disclosure Form.
  2. Submit an EMGS Financial Conflict of Interest Disclosure Form on an annual basis for each PHS-funded grant, subaward, or cooperative agreement administered by the EMGS.
  3. Provide notice to the EMGS within 30 (thirty) days of any changes (acquisition, purchase, inheritance, etc.) to their EMGS Financial Conflict of Interest Disclosure Form.
  4. Complete the NIH tutorial and submit a Certificate of Completion prior to engaging in PHS-funded grant, subaward, or cooperative agreement administered by the EMGS.

Disclosures

Principal Investigators (PIs), directors, faculty, staff, and other planners who are involved in the design, conduct, or reporting of PHS-funded grants, subawards, or cooperative agreements must disclose to the EMGS any financial interest consisting of one or more of the following interests (including those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the responsibilities related to PHS applications or PHS-funded grants, subawards, or cooperative agreements:

  1. Regarding 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.
  2. Regarding 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 or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
  3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  4. The occurrence of any reimbursed or sponsored travel (i.e., that which is paid on their behalf and not reimbursed so that the exact monetary value may not be readily available), related to PHS-funded grants, subawards, or cooperative agreements responsibilities (applications or funded projects); 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 EMGS requires that Principal Investigators (PIs), directors, faculty, staff, and other planners provide the information requested on the disclosure form for EMGS projects seeking or receiving PHS-funded grants, subawards, or cooperative agreements. Those who fail to provide the information will not be permitted to participate in these EMGS projects.

Review

The EMGS Board of Directors (BOD) will review all disclosures for compliance with 42 CFR 50, Subpart F, and the guidelines above. If a FCOI is identified by the EMGS BOD that could directly and significantly affect the design, conduct, or reporting of the PHS-funded research or application, the EMGS BOD may request additional information for the disclosure to manage the FCOI. FCOIs may be approved with certain restrictions or conditions or may be prohibited at the discretion of the EMGS BOD.

EMGS will document the retrospective review including but not limited to the following:

  1. Project number
  2. Project title
  3. PD/PI or contact PD/PI if a multiple PD/PI model is used
  4. Name of the Investigator with the FCOI
  5. Name of the entity with which the Investigator has a financial conflict of interest
  6. Reason(s) for the retrospective review
  7. Detailed methodology used for the retrospective review
  8. Findings of the review
  9. Conclusions of the review

All FCOI-related records, including the Principal Investigator’s SFI disclosures, EMGS’s review of, and response to, disclosures (whether resulting in a FCOI) and all actions taken under EMGS’s FCOI policy or retrospective review, will be retained for at least 3 years from the date the final report is submitted to NIH.