CommunityHealth IT Purpose
CommunityHealth IT, hereafter designated CommHIT, works to improve community health, patient safety, and quality care through the support of quality community engaged research. For health-related PHS or NSF research studies, CommHIT and its personnel who work as Investigators serve as subrecipients of PHS- or NSF-funded research received by awardee Institutions. CommHIT Investigators carefully follow the Financial Conflict of Interest policies of the respective awardee Institution (primary organization) under which Investigators perform PHS- or NSF-funded research.
Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS- or NSF-funded research.
Investigator means the PI/PD, co-PI/co-PDs, and any other person identified on the proposed project who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by PHS or NSF.
Significant Financial Interest means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).
Financial Conflict of Interest Applicable Federal Laws
CommHIT complies with all applicable laws in 45 CFR Part 94 – RESPONSIBLE PROSPECTIVE CONTRACTORS. In large part, 45 CFR Part 94 deals with FCOI.
As a subrecipient to the awardee Institute, CommHIT will inform each of its Investigator about FCOI, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded contract and at least every four years, and immediately when any of the following circumstances apply:
- CommHIT revises its FCOI policies or procedures in any manner that affects the requirements of Investigators;
- An Investigator is new to CommHIT; or
- CommHIT finds that an Investigator is not in compliance with the applicable FCOI policy or management plan.
Reporting FCOI to CommHIT
Each Investigator who is participating in the PHS- or NSF-funded research will submit an updated disclosure of Significant Financial Interests to CommHIT at least annually during the period of the award as according to 45 CFR Part 94. This disclosure should also include Significant Financial Interests of the Investigator’s spouse and dependent children
The disclosure must include Significant Financial Interests : (i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by PHS or NSF; or (ii) in entities whose financial interests would reasonably appear to be affected by such activities.
Investigators must report significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.
CommHIT’s designated official reviews disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS- or NSF-funded research. If FCOI is identified by the CommHIT official, the official also develops and implements a management plan and, if necessary, a retrospective review and mitigation report pursuant to §94.5(a).
CommHIT maintains records relating to all Investigator disclosures of financial interests and actions taken regarding these conflicts for three years after the relevant PHS or NHS award.
Reporting FCOI to Awardee Institution
CommHIT will report all identified financial conflicts to the lead Institution with sufficient time to enable the awardee Institution to comply timely with its review, management, and reporting obligations (prior to the expenditure of funds and within 60 days of any subsequently identified FCOI).
CommHIT understands that the awardee Institution follows all PHS and NHS FCOI policies. CommHIT will comply with the awardee Institution’s financial conflicts of interest policies.
CommHIT must review and approve travel related to PHS and NSF research. Investigators must report to CommHIT the following items regarding PHS- or NSF-related reimbursed or sponsored travel: purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.