Exai Bio Financial Conflict of Interest Policy (FCOI)

Code of Federal Regulations

Exai Bio

Individual(s) at the institution who is(are) responsible for reviewing SFI disclosure and making determination of FCOI per the regulatory criteria in 42 CFR 50.604(f)

Disclosure of significant financial interest

When investigators have a significant financial interest that may compromise or have the appearance of compromising professional judgement in the design, conduct or reporting of research related to the PHS funded research.

Exai Bio’s report of a Financial Conflict of Interest to a PHS Awarding Components

Anything that has monetary value, whether or not the value is readily ascertainable

United States Department of Health and Human Services.

Any domestic or foreign, public, or private, entity, or organization (excluding a federal agency). 

Program Director/Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, including subgrantees, contractors, consortium participants, collaborators, and consultants. Exai Bio will consider the role, rather than the title, of those involved in the research and the degree of independence with which those individuals’ when considering who meets the definition of “investigator”

Taking action to address a financial conflict of interest, which can include reducing or elimination the financial conflict of interest to ensure, to the extent possible, that the design, conduct and reporting of research will be free from bias.

National Institute of Health

Project Director or Principal Investigator of a PHS-funded research project. The PD/PI is included in the definitions of senior/key personnel and investigator under this subpart. 

Public Health System

Systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research.  The term encompasses basic and applied research and product development. 

• A Financial Interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s Company responsibilities:

  • Regarding 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. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
  • Regarding any non-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, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest), or a management or governance position; or
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income in excess of $5,000 related to such rights and interests.

• Significant Financial Interests do not include:

  • Salary, royalties, or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to such rights.
  • Regarding any non-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, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest), or a management or governance position; or
  • Any ownership interest in the Company held by the Investigator since the Company is a for-profit organization.
  • Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency located in the United States, a United States 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 a United States Institution of higher education.
  • Income from service on advisory committees or review panels for a Federal, state, or local government agency located in the United States, a United States 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 a United States Institution of higher education.
  • 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.

  Note: Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received any foreign entity, including foreign Institution of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).

• Reimbursed or Sponsored Travel:

  • Investigators also must disclose the occurrence of any foreign or domestic reimbursed or sponsored travel that exceeds $5,000 (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Company responsibilities.
  • provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency located in the United States, a United States 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 a United States Institution of higher education. Reimbursed or sponsored travel received from a foreign government, or a foreign institution of higher education is required to be disclosed if such income exceeds $5,000.
  • Disclosure for travel shall include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The Company will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
  • The initial disclosure must include reimbursed or sponsored travel received over the previous twelve-months. Investigators must submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.

  Note: the Foreign Disclosure Requirements Related to the Exclusions: Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received any foreign entity, including foreign Institution of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).

SFI Disclosure Form

Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought

Retention requirements for records