Approved: 07/01/2021
Effective: 07/01/2021
PURPOSE: Under this policy, GlycoT strives to ensure that all work performed under PHS Awards meets the highest standard of integrity and is free of any real or perceived conflicts of interest. This policy governs the disclosure of individual financial interests and the management and reporting of individual financial conflicts of interest in PHS Awards. It is intended to comply with the requirements of federal regulations, including, but not limited to, the conflict of interest regulations of the U.S. Department of Health and Human Services Public Health Service (“the PHS FCOI Rules”) as found in 42 CFR Part 50 Part F (titled Promoting Objectivity in Research) and 45 CFR Part 94 (titled Responsible Prospective Contractors) and the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of Interest Rules”).
SCOPE: Company Wide. The PHS Awards Compliance Program covers all projects conducted with PHS funds in GlycoT and is applicable to all employees, sub recipients, consultants, or any other covered organizations or persons involved in PHS awards.
RESPONSIBILITY
It is the Company's responsibility to assure the integrity of all aspects of sponsored research. The purpose of this document is to identify situations where potential conflicts of significant financial interest are likely to arise and to establish a process whereby such conflicts are either avoided or at least managed equitably to the satisfaction of all concerned parties. This document articulates Company policy on the management or elimination of conflicts of significant financial interest between outside constituencies and the associated funded activities carried out by Company. While this policy focuses upon avoiding, or at least managing conflicts of significant financial interest, its primary purpose is to promote compliance with the standards of Objectivity in Research.
DEFINITIONS
A) Conflict of Significant Financial Interest is considered to occur whenever a Company employee, or a family member of the Company employee, has an existing or potential financial or other material interest that impairs, or appears to impair, the Company employee's independence and objectivity in the discharge of his/her responsibilities to and/or for the Company; or, alternatively, conflict of significant financial interest is considered to occur whenever a Company employee receives financial or other material benefit through inappropriate use of knowledge or information confidential to the Company.
B) Company Employee is any individual employed on a full- or part-time basis by GlycoT and is receiving, or will receive, compensation for such employment, including Consultants, Agents and Research Collaborators of the Company.
C) Investigator is the principal investigator, co-principal investigators, or any other Company employee responsible for the design, conduct, or reporting of externally funded scientific research activities.
D) Family member includes the Company employee's spouse and children or other adults who qualify as dependents under the Internal Revenue Code definitions.
E) Project implies any externally funded activity such as basic, applied, or developmental research, or other activity conducted by Company employees on behalf of the Company.
F) Remuneration: salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorships).
G) Significant Financial Interest (SFI): the value of remuneration received by the employee, employee’s spouse or dependent children that reasonably appear to be related to the employee’s responsibilities exceeds $5000.
(1) A financial interest consisting of one or more of the following interests of the Investigator or their Immediate Family Member that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
(a) the value of any remuneration received from a public 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; or
(b) the value of any remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or their immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities. The disclosure will include, at a minimum, the following details:
(a) the purpose of the trip;
(b) the identity of the sponsor/organizer;
(c) the destination; and
(d) the trip duration. However, 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
(3) A significant financial interest does not include the following:
(a) Salary, royalties, or other remuneration paid by GlycoT to the Investigator if the Investigator is currently employed or otherwise appointed by GlycoT;
(b) Intellectual property rights assigned to GlycoT and agreements to share in royalties related to such rights;
(c) 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;
(d) Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined in 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; and
(e) Income from service on advisory committees or review panels for a federal, state, or local government agency, or 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.
Negative Finding means a determination has been made that no conflict of significant financial interest exists.
Positive Finding means a determination has been made that a conflict of significant financial interest does exist and, therefore, appropriate administrative action will be required as given under III.D. below.
III. POLICY STATEMENT)
A) MANDATORY DISCLOSURE OF SIGNIFICANT FINANCIAL INTERESTS.
In accord with relevant Federal and State regulations, the Company is required to manage, eliminate, or reduce any potential conflicts of significant financial interests that may be inherent in the personal financial interest of an investigator. Company, therefore, requires investigators to disclose to the Company, any significant financial interest, including those of his/her family members, which would reasonably appear to be affected by the project being funded by external government agencies. Investigators are required to provide updated disclosure information during the time period in which the proposal is pending, annually during the time period of an award, or whenever new significant financial interests are obtained by the investigator.
B) IDENTIFICATION OF CONFLICTS OF SIGNIFICANT FINANCIAL INTEREST.
In conjunction with the administrative review of applications for grants, the President will review each Financial Disclosure submitted and shall make the determination of whether or not a conflict of significant financial interest exists. If the President determines that no conflict of significant financial interest exists, the resulting negative finding will be filed in the Company's Legal/Human Resource files. For negative findings no further review is required. When a related party engages in the selection, award, and administration of contracts, the President will review the transactions, and determine whether there is an apparent conflict of significant financial interest. The determination will be sent to the related party in a signed letter.
C) APPEAL OF POSITIVE FINDINGS.
Investigators may appeal a resulting positive finding to the Board of Directors for a review of the conflict of significant financial interest determination reached by the President. The review of an appealed positive finding must be completed prior to the expenditure of any funds under an award. In reviewing positive findings, the Board of Directors will be guided by the following principles: 1) Assure adherence to all relevant Company policies; 2) Give full consideration to the nature and extent of the financial interests in the relationship of the investigator, and/or the investigator's family members, with the external constituencies; 3) Give special consideration to the terms and conditions of sponsored project agreements that mitigate or complicate the given situation; and 4) Consult fully with the investigator and obtain additional information from the investigator, as deemed appropriate to the management of the apparent conflict of significant financial interest.
D) MANAGING POSITIVE FINDINGS OF SIGNIFICANT FINANCIAL INTEREST.
Following the determination of a positive finding, or upon receipt of the review by the Board of Directors, the President shall make a final determination involving one of the administrative actions: 1) Accepting the sponsored project award; 2) Not accepting the sponsored project award; or 3) Accepting the sponsored project award subject to suitable modifications in the award documentation or in the investigator’s, or his/her family's, affiliation with the external constituencies involved. Reasonable modifications under option 3) above might include one or more of the following actions; 1) Requiring that public disclosure of the identified financial interests be made; 2) Requiring that the data and research results be reviewed by independent reviewers identified by the Board of Directors/President and the investigator; 3) Requiring that the research plan be modified; 4) Requiring that the investigator be disqualified from participation in a portion of the research; 5) Requiring that the investigator and/or her/his family member(s) divest certain significant financial interests related to the positive finding; or 6) Requiring that the investigator and/or his/her family members(s) sever relationships that create the conflict of significant financial interest.
E) COMPLIANCE.
If an investigator who is required under this policy to file a conflict of significant financial interest disclosure fails to do so or fails to disclosure a significant financial interest on the disclosure form, the investigator may be subject to company and legal procedures. If an unreported significant financial interest involves a research project administered by the Company, appropriate administrative action required by the funding agency will also be taken. GlycoT will promptly notify the funding agency if it is determined that the company is unable to manage satisfactorily any conflict of significant financial interest. Intentional disregard for this policy, including non-adherence to the agreed upon management plan, shall constitute serious misconduct and may be the basis for further administrative or legal inquiry.