In August 2012 new regulations went into effect regarding research funded by the US Public Health Service (PHS).
The regulations require specific information to be reported at specific time points; summaries are below, but all affected parties are strongly advised to read the CHA policy on COI in PHS-Funded Research, A-COM-0015.
The regulations require disclosure of significant financial interests by investigators who participate in PHS-funded research either directly or via sub-award. Links will list all PHS institutions.
All CHA employees, collaborators, or contractors, regardless of title or position, who are responsible for the design, conduct, or reporting of research activities that are funded by the PHS, and any of its components.
The CHA Summary Guidance on PHS COI regulations may assist researchers.
Please also reference the CHA COI Reporting Requirement Reminders for PHS-Funded Grants for a quick summary about the "who, what, and when" of PHS COI reporting.
The CHA Office of Sponsored Research will determine if a financial conflict of interest exists and develop a proposed resolution. The CHA COI Committee will make final determinations on the resolution of financial COIs. The CHA IRB retains authority to make final determinations to disapprove research involving human subjects based on the existence of financial COIs.
This is a summary of Investigator significant financial interest (SFI) disclosure and Institutional FCOI reporting requirements for PHS-funded research:
| When Investigators, including sub-recipients, are to disclose a known SFI to CHA |
When CHA designated official reviews SFI disclosure and reports identified FCOIs to the PHS Awarding Component |
| At the time of application |
Prior to fund expenditure |
| Within 30 days of acquiring or discovering SFI |
Within 60 days of identification |
| Annually at the time period prescribed by the Institution during the award period |
Annually: At the same time as when the grantee is required to submit the annual progress report, including multi-year progress report, or at the time of extension. Annual FCOI reports are submitted through the eRA Commons FCOI module. |
This is a summary of types of reports, information to be included in each report and the reporting time points:
| Type of Report |
Information in Report |
When Required |
| Initial FCOI report |
Grant number, PD/PI name or contact PD/PI if a multiple PD/PI model is used, name of the Investigator with the FCOI, name of the entity with which the Investigator has a FCOI, nature of the FCOI, value of the financial interests, description how the financial interest related to the PHS-funded research and the basis of CHA’s determination that the financial interest conflicts with the research, and key elements of the Institution’s management plan. |
- Prior to fund expenditure.
- Within 60 days of any subsequently identified FCOI.
|
| Annual FCOI report |
Status of the FCOI and any change(s) to the management plan. |
Due at the same time as when the grantee is required to submit the annual progress report, a multi-year progress report, or at the time of award extension. |
| Revised FCOI report |
If applicable, update a previously submitted FCOI report to describe actions that will be taken to manage a FCOI going forward. |
After completion of a retrospective review, if needed. |
| Mitigation report |
Project number, project title, PD/PI or contact PD/PI if a multiple PD/PI model is used, name of Investigator with the FCOI, name of the entity with which the Investigator has a FCOI, reason(s) for the retrospective review, detailed methodology used for the retrospective review, findings of the review, conclusions of the review, description of the impact of the bias on the research project, and the plan of action(s) to eliminate or mitigate the effect of the bias. |
When bias is found after a retrospective review. |