Purpose
To ensure research integrity by managing financial interests that could bias the design, conduct, or reporting of PHS-funded research.
Policy:
CHR, along with any identified investigator will remain in compliance with the expectations under 42 CFR, Part 50 Subpart F and 45 CFR Part 94 while participating in any PHS- funded research.
Definitions:
• Institutional (Organizational) Responsibilities: Means an Investigator’s professional responsibilities on behalf of the Institution, which may include :
o activities such as research
o research consultation
o institutional committee memberships, and
o service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
• Investigator: Any individual responsible for the design, conduct, or reporting of PHS-funded research.
• Public Health Service (PHS): Means the 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).
• Significant Financial Interest (SFI): Includes income >$5,000, equity in non-public entities, or intellectual property rights.
• Financial Conflict of Interest (FCOI): An SFI that may directly and significantly affect the research.
This policy applies to all investigators involved in PHS-funded grants, cooperative agreements, and contracts, including subrecipients and collaborators.
Procedure:
1. Disclosure Requirements:
a. Any investigators are required to disclose any Significant Financial Interest (SFI):
• Before submitting a PHS application
• At least annually
• Within 30 days of discovering a new SFI
b. This disclosure must include interests of spouse and dependent children.
2. Organizational Responsibilities:
a. CHR will maintain and enforce this written FCOI policy
b. CHR will assign an institutional official to review disclosures
c. CHR will implement management plans for FCOIs
d. All records will be maintained for at least 3 years
e. CHR will monitor Investigator compliance, and will oversee and manage any identified willful noncompliance
f. In the event an FCOI is not identified and managed in a timely manner, CHR will conduct a retroactive review of research done during the period of noncompliance to ensure that the design, conduct, or reporting of the research was not biased, will document this review, and will update FCOI reporting if necessary. The review will follow 42 CFR, Part 50, Subpart F (50.605, 3(ii, B).
3. Public Accessibility:
CHR will make this policy publicly available on its website.
4. Reporting to PHS:
a. Submit initial, annual, and updated FCOI reports through appropriate systems (e.g., eRA Commons)
b. Include conflict details, value, and mitigation strategy
5. Travel:
a. Investigators must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities.
b. The disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
6. Training:
a. Any investigators will complete the identified training prior to engaging in PHS-funded research, and then every four years there after while participating in an identified project.
b. Any investigator will complete retraining required for policy updates or if found to be in noncompliance.
References:
• 42 CFR Part 50 Subpart F
• 45 CFR Part 94