I. Purpose
This Policy applies to all research funded or proposed for funding by the Public Health Service of the U.S. Department of Health and Human Services (“PHS”), including the National Institutes of Health (“NIH”). The purpose of this policy is to implement the requirements of the federal regulations set forth in 42 CFR Part 50 (Subpart F), 45 CFR Part 94, and any additional regulations that may be in effect from time to time, governing investigators’ responsibilities for promoting objectivity in PHS‐Funded Research. This policy shall be construed in accordance with such regulations and shall be deemed to include any requirements set forth in such regulations that are not expressly set forth below.
II. Covered Parties
This Policy applies to all persons responsible for designing, conducting or reporting PHS‐Funded Research under the auspices of the American Geriatrics Society (“AGS”).
III. Defined Terms
A. “Financial Conflict of Interest” (“FCOI”) means a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of PHS‐Funded Research.
B. “Designated Official” means an institutional official designated to solicit and review disclosures of Significant Financial Interests from Investigators. The Designated Official shall be the AGS Chief Executive Officer (CEO) and/or such other individual(s) as the Institution may designate in writing. All references herein to the CEO shall be deemed to refer to such other Designated Official(s) as appropriate.
C. “Institutional Responsibilities” means an Investigator’s professional responsibilities on behalf of AGS including but not limited to research, research consultation, teaching, professional practice, and administration such as service on committees, boards and panels.
D. “Investigator” means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS‐Funded Research. This may include, for example, graduate students, post‐doctoral fellows, technicians, collaborators or consultants if they have such responsibilities.
E. “Manage” means taking action to address a Financial Conflict of Interest, which can include reducing or eliminating the Financial Conflict of Interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
F. “PHS‐Funded Research” means Research funded by or proposed to be funded by the PHS, including without limitation NIH awards. The term includes any Research for which funding is available from 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.
For purposes of this Policy, the term shall not include Phase 1 Small Business Innovative Research (“SBIR”) or Small Business Technology Transfer (“STTR”) applications or awards.
G. "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).
H. "Senior/key personnel" means the project director or principal investigator and any other person identified as senior/key personnel in the grant application, contract proposal, contract, progress report, or any other report submitted to the PHS for PHS‐Funded Research.