Financial Conflict of Interest and Prospective Subrecipients
The US Public Health Service (PHS) has adopted new regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) pertaining to Financial Conflict of Interest (FCOI) compliance which will impact proposals being submitted to the National Institutes of Health (NIH) and other PHS agencies. In order to comply with the new requirements, the following procedures should be followed prior to submission of the proposal:
- As soon as you know of a proposed subrecipient, check the FDP Clearinghouse to see if that subrecipient is registered. If it is, it has a PHS-compliant policy on Conflicts of Interest and no further action is required. There is no requirement to keep records of which institutions are on the Clearinghouse, as the FDP will keep permanent records of institutions on the Clearinghouse, including dates they were added and removed, if applicable.
- If the prospective subrecipient is NOT on the FDP Clearinghouse, you must forward Form A and Form B to the subrecipient to complete. On Form A, the subrecipient must indicate whether or not it has a PHS-compliant FCOI policy, and return the completed Form A to the “return to” address entered on the form by the Penn State pre-award office. When the returnee receives Form A from the subrecipient, the form must also be forwarded to email@example.com.
- Also included with Form A and Form B is a copy of the FDP Model FCOI Policy, which the subrecipient can choose to adopt if it does not have its own, as well as a training document required to be read as part of Form B, if applicable (see #5, below).
- If the subrecipient checks “Yes” on Form A, then the subrecipient will follow its own policy. In this case, if the subrecipient identifies any FCOI related to the specific research project in question, it will forward its FCOI report(s) to firstname.lastname@example.org by the time specified in Form A. Penn State’s COI Program will then submit all required FCOI reports to the PHS awarding component prior to execution of the subagreement.
- If the prospective subrecipient does not have a PHS-compliant FCOI Policy and chooses not to adopt the FDP Model FCPO Policy, then the subrecipient will be required to follow Penn State’s policy RP06. In this case, the names of all Investigators expected to work on the subaward project must be entered on Form A, and each one must complete Form B and return it to email@example.com by the time specified on the form. Penn State’s COI Program will then review the forms for potential FCOI prior to execution of the subagreement.
- In each instance where the ORP receives a form from a subrecipient institution, the ORP will immediately notify the research office responsible for the project.
A flowchart has also been prepared to provide guidance through the above steps.
Please note that all FCOI requirements must be met prior to spending being authorized on a subaward. Checks for compliant policies and/or receipt of disclosures from a prospective subrecipient must occur no later than the time of submitting a proposal to a PHS agency. If a prospective subrecipient is identified subsequent to submitting the proposal, receipt of disclosures and all other FCOI requirements must be met before spending is authorized on the subaward.
FCOI and Existing Subrecipients
The same type of review that is described above should be performed when considering an amendment to an existing subaward (FCOI review has not yet been done), as all subwards under a PHS-Agency prime are subject to the new rules. In summary:
1. Check the FDP Clearinghouse to confirm that the subrecipient is registered.