FCOI Policy Notice

Introduction

GlycoMira is dedicated to maintaining public trust in the integrity of its research activities. This document establishes policies on individual conflicts of interest. It is the policy of GlycoMira to ensure that personnel avoid situations in which personal interests may affect, or have the appearance of affecting, their professional judgment in exercising their duties or responsibilities, or in conducting or reporting research. This policy provides guidance to help personnel manage situations in their personal affairs, employment outside GlycoMira, and financial activities that may appear to conflict with their responsibilities and to ensure that GlycoMira and its employees comply with applicable federal laws when participating in research funded by the Public Health Service (PHS). GlycoMira’s personnel should promptly disclose the circumstances of any situation that might be covered by this policy. This policy applies to any member acting as Investigator or as a Senior/Key personnel on any PHS research project and any Sub-recipient of that project.

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 regulation was developed to promote objectivity in research by establishing standards that provide a reasonable expectation ensuring the design, conduct and reporting of research funded under National Institutes of Health (NIH) grants will be free from bias resulting from Investigator financial conflicts of interest.  

GlycoMira’s Signing Official (SO) is the person responsible for the procedures under this FCOI Policy but may designate one or more individuals to assist in any or all of these responsibilities.

Availability of the Policy

GlycoMira will maintain an up-to-date written, enforced policy on financial conflicts of interest (FCOI) that complies with applicable regulations, including any federal financial conflict of interest regulations. The policy will be posted and available via GlycoMira’s publicly accessible website. GlycoMira will inform covered individuals of the policy and of their responsibilities regarding disclosure. GlycoMira will inform covered individuals in the event the policy is revised and updated.

Who is Covered by this Policy?

The conflict of interest policy applies to all investigators and key personnel that are involved in PHS-funded research projects or are applying for PHS funding.

Disclosure Requirements

By the time a proposal is submitted to PHS, all investigators, senior or key personnel requesting PHS funding—whether grant, cooperative agreement, or contract—are required to have submitted to GlycoMira’s Signing Official (SO) a Financial Interest Disclosure Form. These completed forms either indicate that the investigators, senior or key personnel, has no significant financial interests (SFI) or includes a listing of known SFIs (and those of the spouse and dependent children) in entities whose financial interests would reasonably appear to be affected by the research for which PHS funding is sought. Financial disclosures must be updated by all investigators, senior or key personnel on an annual basis during the award period or as new reportable SFIs are obtained, whichever occurs first.

Responsibilities

PHS-Funded Investigators/Senior/Key Personnel:

  • Must complete FCOI training prior to engaging in a PHS research project and thereafter, every four years.
  • Must complete and submit to the SO a Financial Interest Disclosure Form prior to working on PHS-funded projects.
  • Must update the Financial Interest Disclosure Form annually or within 30 days of a change in financial status (acquisition of new financial interest), whichever occurs first.
  • Must follow management plan as prescribed by the SO for FCOIs.

Sub-Recipient:

  • Must complete and submit to the SO a Sub-Recipient FCOI disclosure form prior to working on PHS funded projects.
  • Sub-recipient organization will certify that it has a PHS FCOI compliant policy in place or that it intends to have one in place at the time of the award or that it will abide by GlycoMira’s policy.
  • Sub-recipient organization will certify that the investigators, senior and/or key personnel will complete required training.

Signing Official (SO):

  • Must record and review all Financial Interest Disclosure forms from PHS-funded researchers to determine whether a FCOI exists.
  • Must provide required information concerning FCOIs to the expenditure of PHS funds, and must update such information at least annually and within 60 days of changes to Statement of Financial Interest Disclosure forms, whichever occurs first.
  • Must prepare the Public Financial Conflict of Interest Disclosure Form, including the following information, for reported FCOIs such that it can be made publicly available upon request:
    • Project/Contract number
    • Investigator’s name
    • Investigator’s title and role with respect to the research project
    • Name of the entity in which the relevant significant financial interest (SFI) is held
    • Nature of the relevant SFI (e.g., equity, consulting fees, travel reimbursement, honoraria, etc.)
    • Approximate dollar value of the relevant SFI (dollar ranges are permissible: $5,000-$9,999; $10,000-$19,999; etc.)
  • For reported FCOIs, must develop a FCOI management plan to include: role and principal duties of the Investigator with the FCOI; how the FCOI Management Plan is designed to safeguard objectivity in the PHS research project; confirm that Investigator agrees with the FCOI Management Plan; and how the FCOI Management Plan will be monitored. The FCOI Management Plan must be completed in advance of the Company’s spending PHS funds and a summary of the management plan must be included in the FCOI Report.
  • Must maintain for three years records of all Statement of Financial Interest Disclosure form records and FCOI Management Plans.
  • Maintains the FCOI Policy and Procedure on GlycoMira’s external website.
  • Must ensure compliance with FCOI policy and procedures.

Training

The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education training on what constitutes financial conflict of interest. This course is required for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of GlycoMira engaged in NIH-funded research or its compliance.

The course is accessible at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html.

Upon completion of the training, a certificate of completion must be turned into the SO. This training is required prior to engaging in research relating to any NIH-funded grant or as deemed necessary by GlycoMira due to changes in the FCOI policy, non-compliance of the Investigator/Key Personnel or new hires to the Company.  At a minimum, the FCOI training shall be taken every four (4) years.

SFI Review Process

The SO reviews each SFI received from GlycoMira personnel. If necessary, the SO collects additional information from the disclosing individual and/or from other individuals who possess relevant information. The SO determines whether the disclosed financial interests are significant, whether they are related to the individual’s research responsibilities at GlycoMira, and whether a management plan is required. In conducting this review, the SO considers factors such as the value of the individual’s financial interest and how it could affect their ability to objectively complete the research. A financial conflict of interest exists when the SO reasonably determines that the SFI could directly and significantly affect the design, conduct or reporting of the PHS-funded research.

If a significant financial interest is deemed to be a financial conflict of interest, the SO will develop a management plan in consultation with the Investigator. The goal of the management plan is to reduce or eliminate the financial conflict of interest, which can include reducing or eliminating the financial conflict of interest and to ensure that the design, conduct and reporting of research will be free from bias. The management plan may include, but is not limited to:

  • Requiring the individual to recuse himself/herself from particular decisions or activities related to the research,
  • Public disclosure of financial conflicts of interests (e.g., relevant review bodies, research sponsors, co-investigators, journals to which manuscripts about the research are submitted, media, etc.),
  • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;
  • Modification of the research plan;
  • Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research;
  • Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
  • Severance of relationships that create financial conflicts.

For all management plans, the SO shall (1) monitor ongoing investigator compliance and (2) submit annual updates to the PHS Awarding Component at the time and in the manner specified by the PHS Awarding Component, until the completion of the PHS-funded research project to which the FCOI relates.

With respect to FCOI related to research sponsored by the NIH, annual FCOI reports will be submitted through the eRA Commons FCOI Module for the duration of the project period (including extensions with or without funds) at the same time annual progress reports are required to be submitted and at the time of extension (if any).

If the FCOI is identified and eliminated prior to the expenditure of any PHS-awarded funds, no FCOI report need be submitted.

Reporting

GlycoMira will comply with federal regulations regarding reporting of financial conflicts of interest (e.g. by submitting FCOI reports to the awarding institution, as required). The Company will comply with federal FCOI regulations regarding making publicly available information on identified FOCIs held by investigators and key personnel on PHS-funded research projects.

Record Keeping

GlycoMira complies with federal regulations regarding maintaining records relating to all disclosures of financial interests and the Company’s review of, and response to, such disclosures. GlycoMira shall maintain all disclosure forms and related records of determinations made and actions taken for a period of three years from the date of submission of the final expenditures report to the NIH.

Confidentiality

All disclosures or information obtained in reviewing a potential FCOI is kept confidential, except where disclosure is required by federal regulations.

Sanctions

Failure to comply with GlycoMira’s FCOI policy includes failing to submit a required disclosure, providing false information, omitting required information, failing to maintain confidentiality, failure to carry out duties prescribed by these policies, and refusal or failure to comply with a management plan adopted under these policies. A failure to comply with these policies may result in a decision by the SO to suspend the research project or to refuse to approve a new research project for the individual who fails to comply.

A failure to comply is also subject to: (1) formal admonition, (2) ineligibility of the individual to apply for federal research grants, (3) additional sanctions per research funding agency (such as requiring investigator financial conflict of interest training), up to and including sponsor suspension of function per applicable federal regulations (note: GlycoMira will comply with federal financial conflict of interest requirements regarding non-compliance retrospective review and corrective action), and/or (4) termination of employment

Definitions:

For the purposes of this procedure, the following definitions apply:

  • Signing Official means the individual within GlycoMira that is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s family related to the Investigator’s Company Responsibilities.
  • Company Responsibilities means the Investigator’s responsibilities associated with his or her Company appointment or position, such as research, teaching, administration, and internal and external professional committee service.
  • Financial Interest means anything of monetary value, whether or not the value is readily ascertainable, including remuneration, salary, other payments for services (e.g., consulting fees, paid authorship or honoraria), equity interests (e.g., stocks, stock options, or other ownership interest), intellectual property rights (e.g., patents, copyrights, and royalties from such rights), and reimbursed or sponsored travel unless the sponsored travel is paid for 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.
  • Investigator means the Project Director (PD) or Principal Investigator (PI) 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.
  • Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by GlycoMira in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.
  • Sub-recipient means any party that has entered into an Agreement with GlycoMira as a sub-grantee, subcontractor, collaborator, contractor, or consultant.
  • Significant Financial Interest (SFI) means a Financial Interest that reasonably appears to be related to the Investigator’s Company Responsibilities, and is:
    • if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure, and the value of any equity interest during the 12-month period preceding or as of the date of disclosure, exceeds $5,000; or
    • if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure exceeds $5,000; or
    • if with a non-publicly-traded company, is an equity interest of any value during the 12-month period preceding or as of the date of disclosure; or
    • income related to intellectual property rights and interests not reimbursed through GlycoMira.

The term Significant Financial Interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by GlycoMira to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to GlycoMira and agreements to share in royalties related to such rights; any ownership interest in GlycoMira held by the Investigator; 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.