Person(s) responsible for the implementation of the FCOI Policy, designated by Atelerix.
Any stock, stock option or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
Anything of non-trivial monetary value, regardless of whether the value is readily ascertainable.
Financial Conflict of Interest (FCOI):
A significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.
Investigator/senior/key personnel’s spouse or domestic partner and dependent children.
The project director or principal investigator (PD/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 subgrantees, contractors, consortium participants, collaborators or consultants.
Any domestic or foreign, public or private, entity or organization (excluding a federal agency), including Biotechnology and Pharmaceutical companies, that submits a proposal, or that receives, PHS research funding. Atelerix is considered an “Institution” for the purposes of this policy.
Any key/senior personnel/investigator’s professional responsibilities conducted on behalf of Atelerix and as defined by Atelerix, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards (IRB) or Data and Safety Monitoring Boards (DSMB).
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).
Regulation or FCOI regulation:
42 CFR Part 50 Subpart F, Promoting Objectivity in Research, which applies to both grants and cooperative agreements.
Salary and any payment for services, including consulting fees, honoraria, and paid authorship.
A systematic investigation, study, or examination designed to develop or contribute to generalizable knowledge relating broadly to public health including behavioral and social-sciences research. basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). The term includes any such activity for which research funding is available from PHS but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
The Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel by the Atelerix in the grant application, progress report, or any other report submitted to the PHS/NIH by Atelerix under the regulation.
Significant Financial Interest (SFI):
Financial interest consisting of one or more of the following interests of the investigator/senior/key personnel (and those of the investigator/senior/key personnel ’s spouse and dependent children) that reasonably appears to be related to the Investigator/senior/key personnel s institutional responsibilities:
- With regard to any publicly traded entity a SFI 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 the 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 in stock, stock options or other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value;
- With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remunerations from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator/senior/key personnel (or the Investigator/senior/key personnel ’s spouse or dependent children) holds any equity interests (e.g. stock, stock options, or other ownership interest) or
- Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
- Investigator/senior/key personnel s also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator/senior/key personnel and not reimbursed to the investigator/senior/key personnel so that the exact monetary value may not be readily available) related to their responsibilities to Atelerix; 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, medical center, or research institute that is affiliated with an Institution of higher education. Atelerix’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with Atelerix’s FCOI policy, Atelerix Designated Official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI with the PHS-funded research.
- The term significant financial interest (SFI) does not include the following types of financial interests: salaries, royalties or other remuneration paid by Atelerix to the investigator/senior/key personnel if the investigator/senior/key personnel is currently employed or otherwise appointed by Atelerix, including intellectual property rights assigned to Atelerix and agreements to share in royalties related to such rights; any ownership interest in Atelerix held by the investigator/senior/key personnel; income from investment vehicles, such as mutual funds and retirements accounts, as long as the investigator/senior/key personnel 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, 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.
Small Business Innovation Research (SBIR):
The extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.