Financial Conflict of Interest (FCOI) Policy GLC Biotechnology, Inc.
This Policy is established by GLC Biotechnology, Inc. (“Company”) for compliance with the regulations set forth in 42 CFR Part 50, Subpart F regarding Promoting Objectivity in Research. The objective of this Policy is to maintain the integrity and transparency of financial relationships as they may relate to Investigators’ research funded by federal Public Health Service (“PHS”) agencies (e.g. the National Institutes of Health (“NIH”)) at the Company. This policy also applies to the research funded by other federal agencies that follow the same regulations.
To accomplish our purpose, all Investigators (defined below) must file all of their Significant Financial Interest (“SFI”, defined below) disclosures in a timely manner. These SFI disclosures enable the Company to initiate its financial conflict of interest review, as needed. The Company’s designated Financial Conflict of Interest (“FCOI”) officer (“Officer”) determines whether the disclosed SFI is related to the Investigator’s PHS-funded research, and, if related, whether the SFI creates an FCOI. If a conflict exists, the Officer will work with the Investigator to develop and implement a management plan to eliminate, reduce, or manage the conflict.
Definitions DHHS
The U.S. Department of Health and Human Services (“DHHS”). Investigator
Investigator means the Project Director or Principal Investigator and any other person, regardless of title or position (e.g., collaborators, consultants), who is responsible for the design, conduct, or reporting of research.
Financial Conflict of Interest (FCOI)
A financial conflict of interest exists when an Investigator’s SFI could directly and significantly affect the design, conduct, or reporting of the Investigator’s research.
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External Organization
An external organization means any domestic or foreign (i.e., not within the United States), for-profit or not-for-profit, public or private organization (excluding a Federal agency) from or in which an Investigator (and/or his/her spouse and/or dependent children) receives payments or remuneration, income from intellectual property rights and interests, and/or reimbursed or sponsored travel; and/or has an ownership or equity interest.
Institutional Responsibilities
Institutional responsibilities mean an Investigator’s professional responsibilities on behalf of the Company which include activities such as research, research consultation, teaching, professional practice, and institutional committee memberships.
Significant Financial Interest (SFI)
A significant financial interest means a financial interest consisting of one or more of the following interests, subject to the monetary thresholds below, of the Investigator (and/or her/his spouse and/or dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
- Payments or Remuneration (e.g., salary, consulting fees, honoraria, paid authorship, prizes, board service payments) from an external organization. Monetary Threshold for Disclosure for Payments or Remuneration:
- (i) With regard to a publicly traded external organization, any payment or remuneration received in the 12 months prior to the date of disclosure and the value of any equity interest in the organization as of the date of disclosure, when aggregated, that exceed $5,000, must be disclosed;
- (ii) With regard to a non-publicly traded external organization, any payment or remuneration received in the 12 months prior to the date of disclosure that exceeds $5,000, and/or any equity interest, regardless of value, must be disclosed. Equity Interest means publicly traded or non-publicly traded stock, stock options, or other ownership interest in an external organization, which is held as of the date of disclosure.
- Intellectual Property Rights and Interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. Monetary Threshold for
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Disclosure for Intellectual Property Rights and Interests: Income from such intellectual property rights and interests that exceed $5,000, received from an external organization in the 12 months prior to the date of disclosure, must be disclosed.
- Reimbursed or Sponsored Travel paid by an external organization. Sponsored travel includes travel that is paid on behalf of the Investigator but not reimbursed directly, so that the exact monetary value may not be known by the Investigator. In such circumstances, an estimate of the sponsored travel must be disclosed. Investigator disclosures must specify the purpose of the trip, the identity of the sponsor/organizer, the destination, and the trip’s duration. Monetary Threshold for Disclosure for Reimbursed or Sponsored Travel: Direct or indirect payments and/or reimbursement for travel that exceed $5,000, received from an external organization in the 12 months prior to the date of disclosure, must be disclosed.
- SFI associated with (i) a foreign government, which includes local, provincial, or equivalent governments of another country (i.e., not within the United States) or (ii) a foreign institution of higher education, must be disclosed.
- SFI does not include: (i) Any ownership or income in mutual funds or retirement accounts so long as the Investigator does not directly control these vehicles’ investment decisions; and (ii) Income from, or reimbursed or sponsored travel relating to, seminars, lectures, teaching engagements, service on advisory committees, honoraria, or review panels for a U.S. federal, state, or local government agency; a U.S. institution of higher education, academic teaching hospital, or medical center; or a research institute that is affiliated with a U.S. institution of higher education. Company’s Designated Financial Conflict of Interest Officer (Officer) The Officer has the authority to determine whether an Investigator’s SFI creates an FCOI. If so, the Officer works with the Investigator to eliminate, reduce, or manage the conflict by developing and implementing a management plan.
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Policy
Investigator Disclosures
Each Investigator must update his or her SFI disclosures:
• at least annually;
• within 30 days of acquiring a new SFI, including reportable travel; • within 30 days of discovering a previously unreported SFI; and
• in connection with newly awarded PHS-funded research projects, or when an Investigator is added to the list of investigators on an ongoing PHS-funded research.
As a pre-condition to submitting a grant application to a PHS awarding agency, each Investigator named on the application must have completed a certification within the prior 12 months.
Sub-Recipient Disclosures
If research is done on behalf of the Company through institutional sub-recipients, the Company will incorporate, as part of a written agreement with the sub- recipient, terms that establish whether the Company’s or the sub-recipient’s FCOI policy will apply to the sub-recipient’s investigators. Additionally, the written agreement should address the time frames within which the sub-recipient must provide either (i) FCOI information necessary to ensure that the Company is able to meet its FCOI reporting obligations to the PHS awarding agency, or (ii) financial disclosure information to enable the Company to comply timely with its review, management, and reporting obligations under the Regulation.
- If a sub-recipient defers to the Company’s FCOI Policy, the individuals at the sub-recipient involved in the design, conduct, or reporting of the research are considered Investigators as defined in the Company’s FCOI Policy.
- If a sub-recipient’s policy applies, the sub-recipient must certify that its policy complies with the Regulation.
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Procedures for Determining and Addressing FCOI
No funds from a PHS awarding agency can be expended until all FCOI related to the awarded grant have been eliminated, reduced, or managed.
The Officer oversees and manages implementation of this Policy.
The Officer will review each SFI disclosure to determine whether it reasonably appears to be related to the Investigator’s PHS-funded research. An Investigator’s SFI is related to the PHS-funded research when the Company, through the Officer, reasonably determines the SFI: could be affected by the PHS-funded research or is in an organization whose financial interest could be affected by the research. An Investigator may be involved in making the determination of SFI relatedness to the research, although the ultimate determination of this rests with the Officer. If there is a finding of relatedness, and a finding that the SFI could directly and significantly affect the design, conduct, or reporting of the research an FCOI may be found to exist.
If the Officer determines that the Investigator has an FCOI, the Officer will work with the Investigator on a management plan to eliminate, reduce, or manage the conflict. Management plan elements may include, but are not limited to, requiring the Investigator to disclose the potential FCOI to study all team members working on the research, to research participants, and/or to publishing journals; establishing independent review of research data; and/or requiring the Investigator to relinquish the SFI. The Company will monitor the Investigator’s compliance with each imposed management plan on an ongoing basis until completion of the PHS-funded research project.
To the extent that a new or previously unreported SFI is disclosed during the course of PHS-funded research (e.g., an Investigator who is new to the research project discloses SFI or a previously named Investigator discloses new or previously unreported SFI), the Officer will, within 60 days from the date of
the disclosure, determine whether an FCOI exists, and, if so, will implement a plan to eliminate, reduce, or manage the conflict.
If an FCOI is not identified or managed as required, due to (i) a failure by an Investigator to timely disclose SFI that is later determined by the Officer to constitute an FCOI, (ii) the Company’s failure to review or manage such an FCOI, or (iii) an Investigator’s failure to comply with a FCOI management plan, the Company will, within 120 days of its determination of noncompliance, complete a retrospective review of the Investigator’s activities and PHS-funded
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research to determine whether the design, conduct, or reporting of the research has been affected by bias. The Company will document the retrospective review, including, at a minimum: (i) the project number and title, (ii) the Investigator’s name and the external organization creating the FCOI, (iii), the Principal Director/Principal Investigator contact information, (iv) the reason(s) for the review, (v) the detailed methodology used for the review, and (vi) the findings and conclusions. The Company will notify the PHS awarding agency of any bias found in the PHS-funded research and will submit a mitigation report that addresses the impact of the bias on the research project and the Company’s plan to eliminate or mitigate the effect of the bias.
The Company will maintain records of all Investigator disclosures of financial interests and all actions under this FCOI Policy. Records will be kept for at least three years from the date that the final expenditure report is submitted to the PHS awarding agency, or, when applicable, as specified in 45 C.F.R. Sections 75.361 and 2 CFR 200.334 for different situations.
If DHHS determines that a PHS-funded clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by any Investigator with a FCOI that was not managed or reported as required by the Regulation, the Company will require the Investigator to disclose the FCOI in each public presentation of the results of the research and to request an addendum to her or his previously published presentations.
Reporting FCOI
Prior to the Company’s expenditure of awarded funds, the Company is required to report to the PHS awarding agency the existence of any FCOI, including FCOI of sub-recipient Investigator’s management plan(s). The Company also must submit annual FCOI reports to the PHS awarding agency during the award period. These annual reports must address the status of the FCOI, e.g., whether the FCOI is being managed, any changes to the management plan, and/or if the FCOI no longer exists. Annual reports must be made for the duration of the research project period (including extensions with or without funds) in the time and manner specified by the PHS awarding agency.
The Company must also submit FCOI reports to the PHS awarding agency within sixty days of identifying any previously unreported FCOI.
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Within five (5) business days of receiving a written request from the public for information about PHS-funded research involving an Investigator with a FCOI, the Company will respond to the request in writing, providing the name of the Investigator, the external organization in which the Investigator holds SFI, the nature of the SFI, and the approximate value of the SFI, in dollar ranges, if known.
Training
Each Investigator must be trained on this Policy, the Investigator’s responsibilities regarding SFI disclosure, and the requirements of the Regulation. Each Investigator must complete this training (i) prior to engaging in any PHS- funded research, (ii) at least every four (4) years, and (iii) immediately, in any of the following circumstances:
• the Investigator is new to the Company;
• the Company revises this Policy in any manner that affects the requirements
applicable to Investigators; or
• the Company finds that an Investigator is not in compliance with this Policy or with the Investigator’s FCOI management plan.
Noncompliance and Sanctions
In the event an Investigator fails to comply with this Policy or a previously imposed FCOI management plan, the Officer shall recommend appropriate sanctions that may include, for example, imposing a stricter management plan, withholding a PHS grant application, suspending an ongoing PHS-funded research project, freezing PHS-funded research project funds, and/or other appropriate sanctions.
Public Accessibility
The Company will maintain a publicly accessible FCOI policy by posting the Company FCOI policy on the Company’s public Web site at www.glcbiotechnology.com and provides any related information to the public upon request.
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Policy Review
This policy will be reviewed annually to ensure its effectiveness and relevance. Changes will be made as needed to reflect regulatory updates and organizational requirements. Changes to the policy will be communicated to all relevant personnel and the updated policy will be submitted to the PHS awarding agency in a timely manner.