RAE Health FCOI Policy

RAE Health FCOI Policy

March 2, 2021

I. POLICY


RAE Health, LLC’s purpose of the Financial Conflict of Interest Policy is to document our commitment and responsibility to identify, manage, and ensure that RAE Health’s research that is funded by the National Institute of Health (“NIH”), is conducted and based in objectivity, without bias, and with the highest ethical integrity. This policy has been developed to address and comply with the specific federal agency requirements as defined in the 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F).


This policy is applicable to each Investigator (and those of the Investigator’s spouse and dependent children) who are responsible for the design, conduct, or reporting of research funded by NIH, or proposed for such funding. An Investigator may be an employee, subcontractor, and/or consultant who is planning to, or is participating in research activity that is supported by NIH funds. Each such Investigator must:

 

  1. Disclose any significant financial interests (SFI) 

  2. Comply with a FCOI policy and management plan; and

  3. Complete FCOI training, at least once every four years.

 

Disclosure of SFI is essential for RAE Health to determine if a FCOI exists, and in cases of FCOI determine how it will be managed and reported in full compliance with government regulation. Non-disclosure of SFI or non-compliance with FCOI management plan may subject the employee, subcontractor or consultant without limitation, suspension or termination of employment and/or contract.

 

With respect to subcontractors, RAE Health shall establish via a written agreement whether a subcontractor will follow the FCOI policy of RAE Health or the FCOI policy of the subcontractor. RAE Health shall obtain FCOI documentation which details compliance to regulations, identification, investigating, management, and reporting from the subcontractor. 

 

This policy is available on www.raehealth.com,the employee handbook, and associated contracts with any consultant or potentially any subcontractor who is responsible for any NIH funded research. 

 

II. DEFINITIONS

 

The following definitions apply to this policy: 

 

  1. Training Requirement means training related to Financial Conflict of Interest (FCOI) and required under law. The training must be updated every four years or as designated based on grant or role circumstances. All NIH funded Investigators are required to complete training. Information and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site: (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm).

  2. Investigator means 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 NIH, or proposed for such funding, which may include, for example, collaborators or consultants.

  3. Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS funded research.

  4. Significant Financial Interest (SFI) 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.

    1. Including:

      1. 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). Equity interests (e.g., stocks, stock options or other ownership interests) in a non-publicly traded entity, no matter the amount, constitutes an SFI; and,

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

      3. 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 excluded sources provided in regulation.   

    1. Excluding:

      1. Salary, royalties, stock options or other remuneration from if employed by RAE Health;

      2. Income from seminars, lectures, teaching engagements, service on advisory committees or review panels, derived from excluded sources;

      3. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions; and,

      4. Intellectual property owned by RAE Health and agreements to share in royalties related to those rights.

      5. Any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization

  1. SFI Disclosure is a report that each Investigator shall submit: annually to the Policy Coordinator and within thirty (30) days of an Investigator discovering or acquiring any significant financial interest; and no later than at the time of application for NIH research.
     

 

III. PROCEDURE

 

  1. Identification of Persons Required to Disclose a Significant Financial Interest - It shall be the responsibility of the designated FCOI official at RAE Health to identify all individuals that are required to disclose SFI under this policy and to ensure that an SFI Disclosure Form is prepared and submitted. In addition, the designated FCOI official shall be responsible for ensuring that training is completed, annual updates and disclosures of new or increased financial interests are disclosed.   

  2. Submission and Review of Financial Conflict of Interest Disclosure Form - Every individual having a SFI requiring disclosure under this policy shall prepare a fully-completed SFI Disclosure Form that shall be submitted to RAE Health’s designated FCOI official. An initial review of the SFI Disclosure Form will be conducted by the designated FCOI official to; determine if any SFIs relate to funded research, determine if an FCOI exists, and develop and implement management plans as needed to manage FCOIs. The management plan may require one or more of the following actions (but not limited to) to be taken in order to manage, reduce or eliminate any actual or potential conflict of interest:   

    • Public disclosure of significant financial interests;  

    • Review of research protocols;  

    • Monitoring of research;  

    • Modification of research plan;  

    • Divesture of significant financial interests;  

    • Potential severance of relationships, contracts or employment that create actual or potential conflicts.  All management plans are required to be signed by the Investigator and the CEO. Compliance of the management plan shall be monitored by the designated FCOI official.  

  1. Reporting of Significant Financial Interests – All Investigators shall provide annual FCOI disclosure reports. Any Investigator who acquires a new or increased SFI shall promptly submit a new FCOI Disclosure Form(s) within 30 days of discovering or acquiring the new SFI. It is the Investigator’s responsibility to ensure that FCOI disclosure reports are reported to the designated FCOI official.   

  2. Violations – Investigators are expected to comply fully and promptly with this policy. If violated this policy occurs, including failure to make a required SFI disclosure or failure to comply to this policy, the Designated FCOI official shall make recommendations to the CEO regarding the impositions of sanctions or disciplinary proceedings against the violating individual. In addition, the Company shall follow Federal regulations regarding the notification to the NIH in the event an Investigator has failed to comply with this policy. The NIH may take its own action as it deems appropriate, including the suspension of the funding for the Investigator until the matter is resolved.   

  3. Record Management – Records of FCOI Disclosure forms, and of actions taken to manage actual or potential conflicts of interest, shall be retained by RAE Health under the designated FCOI official’s guidance for three (3) years from the date the final expenditure report is submitted to the NIH, or as required by 45 CFR 74.53(b) and 92.42(b).   

  4. Subcontractor’s Requirements – Sub-award must comply with this policy or provide certification that their organization is in compliance with the Federal policy, 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F) and that their portion of the research project, as detailed in the sub-award agreement, is in compliance with their institutional policies. If a SFI is identified by the subcontractor, they are required to notify RAE Health’s Designated official of the existence of the conflicting interest within 30 days of the identification of the interest.  In addition, the subcontractor must certify and assure that any reported conflicting interest has been managed, reduced or eliminated in accordance with federal regulations.   

  5. Federal Reporting – The Designated FCOI official is responsible for all SFI and FCOI reporting in accordance with applicable federal requirements. The following reports are required by the NIH:  

  1. Prior to Expenditure of NIH Funds –the Company must provide a FCOI report regarding any Investigator SFI found by the Company to be a financial conflict of interest in accordance with the regulation.  

  2. During NIH-Funded Research – the Company shall submit an FCOI report within 60 days after its determination that a new FCOI exists.  If a FCOI was not disclosed timely, the Company shall submit a FCOI report to the NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance.  

  3. Annually – For any FCOI previously reported to the NIH, the Company shall provide an annual FCOI report addressing the status of the FCOI and any changes to its related management plan.    

  1. SFI disclosures must include the following information:

    1. Grant number;

    2. PD/PI or contact PD/PI;

    3. Name of Investigator with the FCOI; 

    4. Name of the entity with which the Investigator has an FCOI;

    5. Nature of FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria);

    6. Value of the financial interest $0-4,999; $5K-9,999; $10K-19,999; amts between $20K-100K by increments of $20K; amts above $100K by increments of $50K or a statement that a value cannot be readily determined;

    7. A description how the financial interest relates to NIH-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research; and

    8. Duration.

FCOI Training

Investigators must undergo training with respect to this Policy and NIH FCOI rules and regulations, as follows:

  1. When a new investigator joins NIH funded research;

  2. Prior to participating in NIH funded research, and at least once every four years;

  3. When RAE Health has a FCOI policy changes in a manner that effects NIH funded Investigator disclosure or compliance requirements; and,

  4. If the designated FCOI official determines that a NIH funded Investigator is not compliant with the FCOI Policy.

NIH web-based training (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm) will be used. All who are required to have training must save and print the FCOI Certificate as proof of completion and submit to the designated FCOI official.