The following definitions apply to terms as they are used in the Policy and Guidelines for Financial Conflicts of Interests and Commitments in Research and Sponsored Programs of the University of Puerto Rico (Certification No. 8 [2012-2013]).
Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible and has the authority to make independent decisions related to the design, conduct, reporting or direct administration of University research funded by the federal sponsor, or proposed for such funding, which may include, for example, sub grantees, contractors, collaborators or consultants. Phase I SBIR/STTRs are exempt.
Refers to the research project director or principal investigator an any other individual who contributes to the scientific development or execution of a project in a substantive, measurable way, and who is included in the grant application, progress report, or any other report submitted by the institution.
Financial Interests means anything of monetary value, whether or not the value is readily ascertainable, in any one of the following categories: compensation, compensation for management, advisory, or consulting roles; gifts, services, loans; payments or in-kind gifts for services; licensing, patent, royalty, and other intellectual property agreements; equity interests in a public or private company (e.g., stocks, stock options, bonds, property interests, dividends, convertible securities, or other ownership interest); a position in an external entity giving rise to a fiduciary duty such as director, officer, partner, trustee, employee or any position of management; or, for researchers with funding from the Public Health Service, any reimbursed or sponsored travel.
Significant Financial Interest (SFI)
Encompasses remuneration and anything of monetary value or potential monetary value held by an investigator (and by the investigator's spouse and dependent children), and that reasonably appears to be related to the investigator's institutional responsibilities, as follows:
1. With regard to any publicly traded entity, 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. With regard to any non-publicly traded entity, the value of any remuneration received from the entity in the calendar year preceding the disclosure, when aggregated, exceeds $5,000, or any equity interest (e.g., stock, stock option, or other ownership interest).
3. Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests
4. A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any position of management.
5. For Investigators applying for or conducting research funded by the PHS, any reimbursed or sponsored travel related to the investigator's institutional responsibilities (i.e., travel is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available). Disclosure of this interest will include the purpose and duration of the trip, the identity of the sponsor/organizer, and the travel destination.
Financial Conflict of Interest (FCOI)
An Apparent Conflict of Interest arises when there is a reasonable apprehension, which reasonably well-informed persons are likely to have, that an individual's opportunity for personal financial gain could compromise or influence the design, conduct, reporting, or direct administration of research.
A Real Financial Conflict of Interest arises when a financial interest, or other opportunity for personal financial gain, is likely to comprise or influence the objective design, conduct, reporting, or direct administration of research.
Conflict Management Plan
The designed actions or plan of measures delineated and strategically to address the risk of real or apparent financial conflict of interest to protect research subjects, and maintain public trust in the University's research and its personnel.
Conflict of Commitment
When an employee of the university engages in an outside activity that burdens or interferes with their fulfillment of primary responsibilities, commitments and obligations to the university, even if the outside activity is valuable to the university or contributes to their professional development and competence.
Design, Conduct, or Reporting of Research
Oversight, decision-making, or participation in research that includes, but not limited to, creating the structure, roles, and/or protocol of a research project; the execution of the research roles and protocol; and/or the publishing, presentation, or discussion of the research results.
Direct Administration of Research
Oversight or decision-making impacting research that includes, selection of vendors, determining the allocation of funds, sponsor negotiations for the research project, protocol review and approval, or managing resulting intellectual property and licensing opportunities.
An entity or organization other than the University, whether public or private, such as, a company, partnership, professional associations, and voluntary health organizations, among others.
An obligation or activity (e.g., management, employment, advisory, or consulting role) that is not related to primary responsibilities, commitments or obligations to the University.