NIH FCOI POLICY

SureMed Compliance (Clarity, LLC) Company Policy - Financial Conflict of Interest (FCOI) Policy

Purpose: Objective research is of the utmost importance to SureMed Compliance to ensure public trust in research and to meet the highest scientific, program, and ethical goals of our National Institutes of Health (NIH) grant efforts. SureMed Compliance believes we have fully addressed the requirements of the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) final rules related to the financial interests held by biomedical and behavioral researchers. We will continue to update this policy upon further HHS guidance or any changes in personnel FCOI issues.

As SureMed Compliance makes expenditures with government awards, this policy governs the disclosure of individual financial interests and the management and reporting of individual conflicts of interest. Under this policy, SureMed Compliance strives to ensure that all work performed under government awards meets the highest standard of integrity and is free of any real or perceived conflicts of interest that could harm patients, research participants, and/or the reputation of SureMed Compliance, the NIH, and any external partners. SureMed Compliance policy requires each investigator, subrecipient, subgrantee, and collaborator affiliated with SureMed Compliance via NIH or any other applicable grant or contract, be in compliance with the government regulations listed in 42 CFR Part 50, Subpart F for grants and cooperative agreements and 45 CFR Part 94 for contracts. 

The following are key term definitions and SureMed Compliance’s policy guidance for principal or program investigators, subrecipients, subgrantees, and collaborators affiliated with SureMed Compliance. This policy is posted on our website and in our employee handbook so that all interested parties, including the general public, have access to the policy.

Conflict Management Plan: the document specifying actions to be taken to manage a Financial Conflict of Interest.

External Partner: a consultant, subcontractor, or sub-recipient performing work under a Government Award who is not employed by SureMed Compliance.

Government Award: government grants and cost reimbursement contracts including research grants or contracts, and other types of government financial assistance (e.g., cooperative agreements, loans, loan guarantees, property, donated supplies, and direct appropriations) that SureMed Compliance receives directly from government agencies or indirectly from pass through entities. Government Awards do not include procurement contracts, payments for health care services provided under government healthcare programs (e.g., Medicare, Medicaid) or Medical Education and Research Costs (MERC).

Financial Conflict of Interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct, or reporting of a research study or other government-funded project.

Investigator:

(1) For PHS-funded research: the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

(2) For other Government Awards: project staff directly involved in management of the project or who hold key responsibilities on the Government Award. Typically, these would be individuals specifically named to a Government Award or whose participation is key to the success of the project.

Institutional Responsibilities: an Investigator’s professional responsibilities on behalf of SureMed Compliance, which may include, but is not limited to: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Public Health Service (PHS): a division of the Department of Health and Human Services, consisting of the following eight agencies - (1) Agency for Healthcare Research and Quality (AHRQ), (2) Agency for Toxic Substances and Disease Registry (ATSDR), (3) Centers for Disease Control and Prevention (CDC), (4) Food and Drug Administration (FDA), (5) Health Resources and Services Administration (HRSA), (6) Indian Health Service (IHS), (7) National Institutes of Health (NIH), and (8) Substance Abuse and Mental Health Services Administration (SAMHSA).

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.  This does not include applications for Phase 1 support under the Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) programs.

Remuneration: salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorships, 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.

Training Requirements: SureMed Compliance and all defined sub-level vendors are required to complete training related to Financial Conflict of Interest. If any possible conflicts of interest are found or known, they must be disclosed. The training must be updated at least every four years or as designated by the grant. Training can either be completed using the NIH FCOI tutorial found at: https://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm or CITI COI training found at: https://about.citiprogram.org/en/homepage/ . Training must be documented by submitting the Government Award FCOI Training Certification form to SureMed Compliance HR Official. The required training is valid for four years; however, Investigators are required to certify annually that they understand and have complied with their responsibilities under SureMed Compliance’s Government Awards FCOI Policy. 

Significant Financial Interest (SFI): 

  1. 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 Investigators institutional responsibilities:

    A. Public Entity - A significant financial interest exists if the value of any remuneration received from a public entity in the 12 months preceding the disclosure and the value of any equity interest in that entity as of the date of disclosure, when aggregated, exceeds $5,000 or

    B. Non-Public 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

    C. Intellectual Property and Interests - A significant financial interest exists upon receipt of income related to such rights and interests (e.g. patents, copyrights, etc.).

  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. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, 1) the purpose of the trip, 2) the identity of the sponsor/organizer, 3) the destination, and 4) 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 PHS-funded research.

  3. The term significant financial interest does not include the following types of financial interests: A) salaries, royalties or other remuneration paid by SureMed Compliance to the Investigator if the Investigator is currently employed or otherwise appointed by SureMed Compliance, including intellectual property rights assigned to SureMed Compliance and agreements to share in royalties related to such rights; B) any ownership interest in SureMed Compliance held by the investigator, if SureMed Compliance is a commercial or for profit organization; C) 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; D) 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 research institute that is affiliated with an Institution of higher education; or E) 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.

Policy:

It is the policy of SureMed Compliance to comply with the Financial Conflict of Interest Rules (“FCOI Rules”) to ensure that the work performed under Government Awards is carried out in a manner that is free from any bias which may result from financial conflicts of interest. All Investigators for Government Awards must disclose any Significant Financial Interests (SFI) to SureMed Compliance. Investigators must complete or update a disclosure survey at least annually during the period of the award and must disclose any new SFI’s within thirty days of discovering or acquiring the SFI. SureMed Compliance will then report it to the PHS awarding component that has issued the award within 60 days. Investigators also must ensure that the disclosure survey is completed or updated no later than the time of application for a Government Award.

If SureMed Compliance’s designated official determines that no SFI are found or that SFI do not constitute a Financial Conflict of Interest (FCOI), “disclosure forms” will be filed in the SFI binder. If, however, SureMed Compliance’s designated official determines that an SFI constitutes an FCOI, SureMed Compliance will enter the FCOI report through the eRA Commons FCOI module prior to expending any funds.

If an investigator fails to comply with SureMed Compliance’s FCOI policy, SureMed Compliance shall complete a retrospective review of the Investigator’s activities within 120 days to determine bias. If a bias is found, SureMed Compliance will submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions SureMed Compliance has taken to mitigate the bias. SureMed Compliance will work with the Investigator to set up an FCOI management plan to mitigate the situation. If any PHS-funded project is conducted by an investigator or SO with a conflict of interest that was not disclosed or managed, SureMed Compliance is required to disclose the conflict in each public presentation related to the results of the research. In extreme cases of bias, the Investigator may lose the right to work on the project or receive future funding from the NIH.

Investigators must complete training on this policy and the applicable regulations at the following time points: 1) upon becoming an Investigator for SureMed Compliance, 2) before performing work under a Government Award, 3) upon the release of a revised copy of this policy that alters the responsibilities of an Investigator, and 4) at least every four years.

This policy will be posted on a publicly accessible website for SureMed Compliance.

Any individual or organization acting as a consultant, subcontractor, or subrecipient (“External Partner”) to SureMed Compliance on a PHS-funded award must either: (1) have a FCOI policy that meets the requirements of the PHS FCOI Rules or (2) follow this policy.


Organizations with their own policy will certify that the policy meets the requirements of the PHS FCOI Rules by submitting an External Partner Financial Conflict of Interest Disclosure form or registering with the FDP Clearinghouse https://thefdp.org/default/fcoi-clearinghouse/ before submission of the Government Award. The designated official will verify registration with the FDP Clearinghouse before submission. The contract with SureMed Compliance will contain language requiring compliance with SureMed Compliance’s FCOI Policy.