The federal Public Health Service (PHS) has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research.
Each Investigator who is participating in research under an award or a subaward where the prime award originates from PHS must submit an updated disclosure of Significant Financial Interest (SFI) at least annually, during the period of the award. Such disclosure must include any information that was not disclosed initially to Hospital, pursuant to this policy, or in a subsequent disclosure of SFI (e.g., any financial conflict of interest identified on a PHS-funded project directly as a PHS Grantee and/or indirectly through a subaward) that was transferred from another Institution), and must include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).
Each Investigator who is participating in research under an award or a subaward where the prime award originates from PHS must submit an updated disclosure of SFI (including reimbursed travel) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.
Each Investigator must receive a copy of this policy and complete training on Hospital Conflict of Interest Policy Applicable to Public Health Services Prime Award(s) and Subawards prior to engaging in research related to any PHS-funded subaward and at least every four years, and immediately (as defined below) when any of the following circumstances apply:
In fulfillment of the training requirement, Hospital requires its investigators to complete the National Institutes of Health’s Financial Conflict of Interest tutorial, or some subsequently Hospital-approved training, in accordance with the requirements and expectations of this Policy. All investigators must print a certification of completion at the end of training and supply a copy to COIC/designated official for audit purposes.
These requirements apply under the policy and federal regulations to the project director (PD) or principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS by an award or a subaward, or proposed for such funding, which may include, for example, collaborators or consultants.
