Prime Genomics, Inc. Financial Conflict of Interest Policy
Purpose of this policy
The Financial Conflict of Interest (FCOI) regulation, 42 CFR Part 50 Subpart F, promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest. This policy establishes the process by which Prime Genomics, Inc. will comply with the regulation.
Investigator refers to any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of NIH-funded research, including subgrantees, contractors, consortium participants, collaborators, or consultants.
Disclosure refers to the investigator’s disclosure of Significant Financial Interests (SFIs) to their institution.
Report refers to the institution’s report of identified FCOIs to the NIH.
Significant Financial Interest (SFI) 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 reasonably appears to be related to the investigator’s institutional responsibilities:
- 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 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 includes any stock, stock option, or other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value;
- 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 or dependent children) holds any equity interests (e.g., stock, stock option, or other ownership interest) or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- 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, medical center, or research institute that is affiliated with an Institution of higher education. The institution’s FCOI policy will specify the details of this disclosure, which 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, the institutional official(s) will 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 NIH-funded research.
- The term Significant Financial Interest does not include the following types of financial interests: salaries, 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 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.
Prime Genomics investigators are required to complete training relating to Financial Conflicts of Interest:
- Prior to engaging in research related to any NIH-funded grant
- At least every 4 years
- Immediately, if:
- Prime Genomics revises its FCOI policy that affects requirements of investigators.
- An investigator is new to Prime Genomics.
- An investigator is not in compliance with the policy or management plan.
Disclosure, Review, and Monitoring Process
Each investigator involved in NIH-funded research is required to disclose SFIs (and those of the investigator’s spouse and dependent children) related to the investigator’s institutional responsibilities that meets or exceeds the regulatory definition of SFI.
SFIs must be disclosed, using the Prime Genomics SFI Disclosure Form:
- No later than at the time of application for NIH-funded research
- At least annually during the period of the award
- Within 30 days of discovering or acquiring a new SFI
Prime Genomics’ designated official(s) will review all disclosures and evaluate whether they contain any FCOIs. If a FCOI is identified, reporting to NIH will follow, as outlined below.
Reporting to NIH
Initial, annual, and revised FCOI reports, if any FCOIs are found, will be submitted to the NIH, via eRA Commons as required by the regulation:
- Prior to the expenditure of funds
- Within 60 days of identification for an investigator who is newly participating in the project
- Within 60 days for new, or newly identified FCOIs for existing investigators
- At least annually (at the same time as when Prime Genomics is required to submit the annual progress report, if applicable, or at time of extension) to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project.
- Following a retrospective review to update a previously submitted report, if appropriate.
In addition, the NIH will be notified promptly if:
- Bias is determined in the design, conduct, or reporting of NIH-funded research by submission of a Mitigation Report.
- If an investigator fails to comply with Prime Genomics’ FCOI policy or a FCOI management plan appears to have biased the design, conduct or reporting of NIH-funded research.