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Financial Conflict of Interest and Prospective Subrecipients

The US Public Health Service (PHS) 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.  The US Department of Energy also has an Interim Conflict of Interest Policy which is similar to the PHS regulations. In order to comply with the new requirements, the following procedures should be followed prior to submission of the proposal:

  1. As soon as you know of a proposed subrecipient under a PHS prime award , 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. At this time, the Clearinghouse does not track institutions’ COI policies with respect to the DOE requirements.
  2. 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- or DOE-compliant FCOI policy, according to the prime sponsor, 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 coinsadmin@psu.edu.
  3. Also included with Form A and Form B is a training document required to be read as part of Form B, if applicable (see #5, below). 
  4. 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 coinsadmin@psu.edu 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.  Penn State’s COI Program will forward FCOI reports to DOE in cases where the conflict is deemed unmanageable, and also in cases where the conflict is managed when the DOE award terms and conditions specify that a FCOI report is required. 
  5. If the prospective subrecipient does not have a PHS- or DOE-compliant FCOI 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 coinsadmin@psu.edu 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. 
  6. It is important that the ORP be notified of the names of subrecipient investigators required to submit Form B, in order to be able to follow-up with those individuals if the form is not received. The COI Program in the ORP does not have a way of identifying such individuals aside from the Form A and Form B process.

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 or DOE. 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 subawards under a PHS-Agency or DOE prime are subject to these requirements.   In summary:

1.    If a PHS prime award, check the FDP Clearinghouse to confirm that the subrecipient is registered.

2.    If subrecipient is not listed in the FDP Clearinghouse, or if the prime award is from DOE, proceed with sending Form A and Form B to the subrecipient.