Subrecipients and Consultants
As with many other federal regulations, Northwestern must flow down Sponsored Research COI requirements to subrecipient institutions. For some sponsors that requires:
- Verifying that the subrecipient has a conflict of interest policy that is compliant with the sponsor's requirements, and if not,
- Having the subrecipient Investigators follow Northwestern's conflict of interest policy.
Public Health Service (PHS) and National Science Foundation (NSF) always require this. If you are working on a PHS or NSF proposal, or a proposal for any other organization that requires this, please refer to the instructions and resources below.
Other sponsors, however, may not require this step. Sponsor requirements are discussed below, and the guide to COI at proposal time covers general requirements for subrecipients by sponsor. Reach out to firstname.lastname@example.org if you have questions.
Please use the Subrecipient COI Decision Matrix Tool as a quick reference for subrecipient COI compliance at proposal submission.
At the proposal stage, if required by the sponsor, the subrecipient must indicate whether or not it has a COI policy that is consistent with applicable federal requirements. In general, PHS and NSF always require this; for other sponsors, please read below or consult our guide to COI at proposal time.
How do we know whether an institution has a compliant policy?
- Check whether the subrecipient is listed in the Federal Demonstration Partnership (FDP) FCOI Clearinghouse. If so, no further action is required and the subrecipient may follow its own policy.
- If the institution is not in the FDP FCOI Clearinghouse, but either includes language in the subrecipient Letter of Intent (LOI) or completes a Subrecipient Commitment Form certifying that the institution has a COI policy compliant with applicable federal requirements and is a U.S. institution of higher education or academic medical center, then no further action is required and the subrecipient may follow its own policy.
- If the institution is not in the Clearinghouse and not a US institution of higher education or academic medical center, but certifies to having a compliant policy, please send to NUCOI for verification. NUCOI maintains a list of institutions that have compliant policies, for reference (requires login). If verified, the subrecipient may follow its own policy.
What if the institution does not have a compliant policy?
If, and only if, the subrecipient is:
- Not in the FDP COI Clearinghouse, and
- Is unable to certify to a COI policy compliant with applicable requirements in the LOI or Subrecipient Commitment Form, and
- The sponsor requires it,
Then the Investigators from that institution will need to follow Northwestern's COI policy for the project.
To have an Investigator at an outside institution follow Northwestern's policy, they will need to be added in CERES. Once submitted for department review in CERES, the Investigator's eDisclosure profile is generated, allowing them to complete their training and disclosure requirements.
Any and all consultants that have the role of Investigators on Northwestern research -- if required by the sponsor for the Northwestern research in which they are engaged -- must adhere to Northwestern's COI requirements, which is facilitated by being set-up in eDisclosure following the instructions above.
This is because the individual's institution will not have any record of the project -- the institution would have no research project to review -- and consequently could not ensure compliance for that project.
Please see the section on deciding who on a project meets the definition of Investigator under Proposal Preparation for guidance on determining whether a consultant is an Investigator.
For PHS agencies and agencies that specifically adhere to PHS COI regulations, these COI requirements flow down to subrecipients: 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 94
For NSF, these COI requirements flow down to subrecipients: the current National Science Foundation Proposal and Award Policies and Procedures Guide.
For other agencies with COI requirements: COI requirements identified in sponsor solicitation or project terms and condition are those that flow down to subrecipients. The guide to COI at proposal time provides an overview of general requirements for subrecipients by sponsor. Reach out to email@example.com with questions about whether Northwestern must verify a subrecipient's policy at the time of proposal.
When issuing a subagreements, Northwestern will flow down applicable sponsor COI requirements to subrecipients. All applicable sponsor COI requirements must be met prior to award set-up, contract or subcontract execution, and/or expenditure of funds.
Key Tools and Resources
Subrecipient COI Decision Matrix Tool - provides quick reference for determining whether investigators at a proposed subrecipient institution need to follow Northwestern's COI policy for the project, or can follow their own.
FDP FCOI Clearinghouse - a list of institutions that have publicly certified to having a COI policy that is compliant with PHS regulations (42 C.F.R. Part 50, Subpart F). Institutions on this list never need to follow Northwestern's COI policy.
Compliant Institutions Verified by NUCOI - a list of institutions that NUCOI has verified as having COI policies that are compliant with PHS or NSF regulations (as noted). Those institutions compliant with PHS regulations are also compliant with NSF regulations.
COI at Proposal Time (by Sponsor) - an overview of requirements for conflict of interest by sponsor, including whether or not sponsors (generally) require policy verification and/or asking subrecipient Investigators to disclose to Northwestern prior to proposal submission.