"Disclosure of Significant Financial Interests" means an Investigator's disclosure of significant financial interests (defined below) to the Institution or to its designated agents, e.g. via the submission of a Conflict of Interest in Research questionnaire via a web-based COI declaration management system such as COI-SMART. Disclosures by an investigator must be made annually, and updated within 30 days of discovering or acquiring a new significant financial interest.

"DHHS/PHS"--DHHS means the United States Department of Health and Human Services and any components of the Department to which the authority involved may be delegated. PHS means Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH), 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), and Substance Abuse and Mental Health Services Administration (SAMSHA).

"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.

"Financial Conflict of Interest (FCOI)" means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of sponsored or unsponsored research, or have an inappropriate influence, or appear to have such an influence an investigator's responsibilities to Mount Sinai Health System or to an individual Institution.

"FCOI report" means an Institution's report of an FCOI to an awarding component (sponsor).

"Financial Interest" means anything of monetary value, whether or not the value is readily ascertainable.

"Investigator" means the project director or principal investigator or any other person, regardless of title or position, including but not limited to program directors, Research coordinators, collaborators and consultants who is responsible for the design, conduct or reporting of research, sponsored or unsponsored, or proposed.

"Investigator's Institutional Responsibilities" mean an Investigator's professional responsibilities on behalf of the Institution, such as research, research consultation, teaching, professional practice, Institutional committee memberships, and service on panels such as the Institutional Review Board or Data and Safety Monitoring Boards.

"Manage" means taking action to address an FCOI, to ensure to the extent possible, that the design, conduct, and reporting of research will be bias-free.

"Research" means a systematic investigation, study or experiment 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 (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used herein, the term includes any research activity, unsponsored or sponsored. "Federally-sponsored research" means research for which funding is available from any sponsoring entity or a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project or research resources award.

"Remuneration" means salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

"Senior/Key Personnel" means the Program Director/Principal Investigator and any other person identified as senior/key personnel by the Institution in a grant application, progress report, or any other report submitted to the sponsor by the Institution.

"Significant Financial Interest (SFI)" means one or more of the following interests of the Investigator, and /or those of the Investigator's spouse and dependent children, that reasonably appear to be related to any of the Investigator's Institutional responsibilities, including but not limited to research.

For a publicly traded entity:

  • An SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure plus the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.

For a non-publicly traded entity:

  • An SFI 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)

For Property rights and interests (e.g., patents and copyrights, including copyrights on books, chapters and teaching materials)

  • An SFI exists upon receipt of any income related to such rights and interest.

Other SFI that must be disclosed

  • Any reimbursed or sponsored travel (i.e., that which is paid for 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 Institutional 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, 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. The disclosure must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The Institutional Conflict of Interest in Research (COIR) Committee will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes FCOI related to the research.

SFI does not include the following interests:

  • Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights
  • Any ownership interest in the Institution 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 institution 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.

testtubes