Financial Conflict of Interest (FCOI) Policy

Last Revision Date: 6/10/2022

 

Purpose:

This FCOI policy was developed to:

 

  1. Promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research, including research funded under grants or cooperative agreements, will be free from bias resulting from investigator financial conflicts of interest;

 

  1. Promote transparency in the disclosure and management of any actual or perceived FCOIs; and

 

  1. Adhere to Federal and State laws and regulations relating to FCOIs, specifically 42 CFR Part 50 Subpart F.

 

 

Scope:

This FCOI policy applies to any employee or appointee of Aerodyne Microsystems Inc. (AMI) who meets the definition of an “Investigator” on a federal or state grant or cooperative agreement.

 

An Investigator, as defined in 42 CFR Part 50 Subpart F, 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 funded research, or proposed for such funding, which may include, for example, collaborators or consultants

 

Disclosure of FCOIs:

The principal investigator(s) and participants who are responsible for the design, conduct and reporting of research funded by the PHS must disclose any financial conflict of interest. A financial conflict of interest may exist if the investigator, or the investigators’ spouse and dependents hold a significant financial interest in the following:

  • Ownership of stock, equity, or other financial interest in a company/entity which has products that might be used in or benefit from or harmed by the results of the project

  • Employment, office or directorship in any company/entity involved or potentially involved

  • Personal compensation from any company/entity involved or potentially involved

  • Consulting/advisory arrangements with any company/entity involved or potentially involved

  • Involvement with grants, contracts, research, training or other support (restricted or unrestricted) from any company/entity involved or potentially involved

  • Travel grants to attend educational symposia provided by any company/entity involved or potentially involved

  • Intellectual property rights (i.e. copyright, patent, trademark) related to the activities of the project

  • Relationship with a company/entity that may affect academic advancement or status

Disclosure, Training, Review, and Monitoring

Prior to starting work on a PHS funded grant, all participants will be provided a copy of this policy and will undergo FCOI training at least once every 4 years. Investigators must also provide the following information in a Disclosure Form, which will then be submitted to the designated Institutional Official (IO) for FCOI policy.

  1. Name of the individual(s)

  2. Name of the entity with which the investigator(s) has a financial conflict of interest

  3. The nature of the significant financial interest

  4. The value of the financial interest

  5. Description of how the financial interest relates to the research project

This information must be disclosed prior to the funding of a project/grant and should be disclosed prior to beginning funding solicitation.  An investigator will also be required to immediately complete FCOI training if:

  1. AMI revises its FCOI policy that affects the requirements of investigators

  2. They are newly hired to AMI

  3. An investigator is not in compliance with the policy or management plan

The IO will review disclosure forms prior to the research start date to determine whether there is a Significant Financial Interest (SFI) as described in 42 CFR Part 50 Subpart F Section 50.603(1), and whether the SFI is related to the PHS funded research. If the IO determines the existence of an FCOI, the IO will implement appropriate measures to restrict or eliminate the FCOI.

If a new SFI develops during the research period, or if the Investigator did not previously  disclose an existing SFI prior to the research start date, the Investigator must submit a disclosure form within 30 days of acquiring or discovering a new SFI. The IO will review the disclosure form and make an FCOI determination within 60 days of receipt of the form.

The IO will periodically monitor investigator compliance under this policy throughout the research period. Questions or concerns regarding this policy should be directed to the IO.

Significant Financial Interest Exclusions:

As provided by the NIH 2011 Revised Regulations, the term significant financial interest does not include the following types of financial interests: salary, 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 retirement 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, or a 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.

 

Reporting Requirements to NIH

AMI’s designated official shall send initial, annual (i.e., ongoing) and revised FCOI reports, including all the following information:

  • Project number;

  • Project title;

  • PD/PI or Contact PD/PI if a multiple PD/PI model is used;

  • Name of the Investigator with the FCOI;

  • Name of the entity with which the Investigator has a FCOI;

  • Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);

  • Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000- $9,999; $10,000- $19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;
    A description of how the financial interest relates to the NIH-funded research and why the Institution 3 determined that the financial interest conflicts with such research;

  • A description of the key elements of the Institution’s management plan, including:

  • Role and principal duties of the conflicted Investigator in the research project;

  • Conditions of the management plan

  • How the management plan is designed to safeguard objectivity in the research project; o Confirmation of the Investigator’s agreement to the management plan;

  • How the management plan will be monitored to ensure Investigator compliance; and

  • Other information as needed.

 

These reports shall be provided to the NIH or other granting agency: prior to the expenditure of funds; within sixty (60) days of identification for an Investigator who is newly participating in the project; within sixty (60) days for new, or newly identified, FCOIs for existing Investigators; at least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension). The annual report will provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project; and, after a retrospective review to update a previously submitted report, if new information is discovered following completion of the review. AMI will also promptly notify the NIH if bias is found with the design, conduct or reporting of PHS/NIH-funded research and include the requirement to submit a Mitigation Report to explain what action(s) have been or will be taken to mitigate the effects of the bias in accordance with the regulation or at any time if an Investigator fails to comply with the Institution’s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research. AMI shall notify the NIH promptly and take corrective action for noncompliance with this policy or the management plan.

 

Maintenance of Records:

 AMI shall maintain all FCOI-related records relating to all Investigator disclosures of financial interests and AMI’s review of, and response, to such disclosures (whether or not a disclosure resulted in a determination of an FCOI) and all actions under this policy or retrospective review, if applicable, for at least three (3) years from the date the final report is submitted to the PHS (NIH).

 

Enforcement, Remedies, and Noncompliance:

Violations of this policy will be addressed with applicable Company policies and procedures, which may include disciplinary actions up to and including suspension and termination from the Company and/or criminal prosecution.

 

In the event that an Investigator does not disclose SFIs timely, that SFIs are not reviewed timely, or whenever an FCOI is not identified or managed in a timely manner, the Company will complete and document a retrospective review within 120 days consistent with FCOI laws and regulations of its research funding agreements.

 

Subrecipient Requirements:

FCOI regulations apply to subrecipients, consultants, and subcontractors used in any PHS funded research. Subrecipients, consultants, or subcontractors must have their own FCOI policy or use AMI’s policy if none exists. The contracting agreement should certify that the subcontractor shall comply with FCOI regulations. The agreement should also specify the time period to submit disclosure forms and FCOI reports to AMI

 

Public Accessibility:

As required by 42 CFR 50.604(a), the Company’s FCOI policy will be made publicly accessible from its website. The Company will make available information concerning identified FCOIs held by senior/key personnel (as defined by the regulation), publicly accessible:

1) prior to the expenditure of funds;

2) within 5 calendar days of a written request; or

3) within 60 days of a newly identified FCOI.

The information concerning identified FCOIs will include the minimum elements as provided by 42 CFR 50.605(a)(5)(i)-(iv), be updated at least annually, and remain available for three years from the date the information was most recently updated.