Purpose

The purpose of this policy articulated herein is intended to promote objectivity by establishing guidance in the management of formal relationships between employees of EydisBio, Inc. (EydisBio) and any of their external conflict of interest to ensure that the design, conduct, and reporting of sponsored research will be free of bias as a result of an Investigator’s financial interests. 

This policy complies with the following federal regulations under Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought.

Scope:

The policy described herein is intended to provide guidance in the management of formal relationships between EydisBio and their external constituencies applicable to all Investigators involved in the design, execution, and reporting of research funded by Public Health Service (PHS) or National Institutes of Health (NIH). This policy is applicable to all EydisBio employees, sub-recipients, consultants or any other organizations or persons involved in government awards. 

Definitions:

  1. Financial Interest means anything of monetary value or potential monetary value held by the Investigator, or the Investigators immediate family, independent of whether or not the value is readily ascertainable. 
  2. Investigator is the project director, principal investigator, co-principal investigators, or any other person responsible for the design, conduct, or reporting of externally funded scientific research activities. 
  3. Company Employee is any individual employed on a full- or part-time basis by EydisBio and is receiving, or will receive, compensation for such employment, including consultants, agents and research collaborators of the company.
  4. Immediate Family Member includes a person’s spouse, children or other adults who qualify as dependents under the Internal Revenue Code definitions. 
  5. Project implies an investigation, study, or experiment designed to develop scientific knowledge relating to public health.
  6. Public Health Service (PHS) describes the division of the Department of Health and Human Services, consisting of the following agencies: Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).
  7. Financial Conflict of Interest exists when EydisBio reasonably determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of research
  8. Significant Financial Interest is defined by the regulations as:
    1. A financial interest consisting of one or more of the following interests of the Investigator or their immediate family that reasonable appears to be related to the Investigator’s institutional responsibilities:
      1. With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the 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. 
      2. the value of any payment 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
      3. Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
    2. For PHS-funded Investigators, any reimbursed or sponsored travel related to an Investigator’s institutional responsibilities, including that which is paid on behalf of the Investigator so that the exact monetary value may not be readily available. The PHS-Investigator will specify the details of this disclosure, which include i. the purpose of the trip; ii. identity of the sponsor/organizer; iii. destination iv. duration.
    3. The term significant financial interest does not include the following types of financial interests including i. salary or consulting fees paid by EydisBio to the Investigator if the Investigator is currently employed or otherwise appointed by EydisBio; ii. income from seminars, lectures, or teaching engagements sponsored by a federal, state or local 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; iii. 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; iv. travel by a PHS-funded investigator 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; v. income from investment vehicles, such as mutual funds and retirements accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles

Policy Statement:

  1. Disclosure and Reporting Process. It is the policy of EydisBio to ensure that all work performed under government awards is performed in a means that is free of any bias that may be a result of financial conflict of interest. Therefore, EydisBio requires all Investigators to disclose any significant financial interest, including those of their family members. Investigators will be required to complete or update annual disclosures during the period of the award and must disclose any new SFI’s within thirty days of discovering or acquiring the SFI.  Investigators also must ensure that the disclosure survey is completed or updated no later than the time of application for a Government Award as per 42 CFR 50.603 and 42 CFR 50.604 (e)(1)-(3). All records of financial disclosures will be reported to the FCOI appointed representative and CEO and actions taken by EydisBio will be retained for a minimum of 3 years following the final expenditure report.
  2. Compliance.If an Investigator who is required under this policy to file a conflict of significant financial interest disclosure fails to do sowithin 120 days, EydisBio shall complete a retrospective review of the Investigator’s activities to determine bias. If an unreported SFI involving a research project administered by EydisBio is found, appropriate administrative action required by the funding agency will also be taken. 
  3. Identification of FCOI, management and penalties for non-performance.A designated EydisBio representative in conjunction with the CEO/President will do an administrative review of each Financial Disclosure submitted and shall make the determination of whether or not a conflict of significant financial interest exists. If an SFI is found, EydisBio shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that will address the potential impact of the FCOI on the research project and describe a mitigation plan developed to limit any bias. EydisBio will develop a mitigation plan with the Investigator to reduce bias. Company-wide, EydisBio requires all investigators to disclose the FCOI in each public presentation with research results if it was not reported initially. 
  4. External Partners. Any individual or organization acting as a consultant, subcontractor, or subrecipient (“External Partner”) to EydisBio on a government-funded award must either: i. have a FCOI policy that meets the requirements of the PHS FCOI regulations, or ii. follow this policy.
  5. Training Requirement. EydisBio Inc. and Investigators associated with PHS funded grants are required to complete training on FCOI policy at EydisBio as per 42 CFR 50.604(b). All investigators will undergo training at the following times: i. upon becoming an Investigator at EydisBio; ii. prior to performing work on a government award; iii. following any major policy revision; iv. at least every 4 years; v. if any Investigator is non-compliant with the company FCOI policy. Information regarding the NIH FCOI policy compliance can be accessed at https://grants.nih.gov/grants/policy/coi/index.htm.
  6. Public Posting of Policy. This policy will be posted on a publicly accessible internet site for EydisBio This policy will be updated annually and updates appropriately posted to a publicly available website. Additionally, this policy will be made available within 5 calendar days to anyone who requests it.