New JHSPH FCOI Policies (Part Two)

Last week, we detailed our new FCOI policies with respect to JHSPH personnel and their PHS proposals and awards.  Today, we’ll focus on the procedures with respect to any of our subrecipients performing similar work.

Under 42 C.F.R. 50(F), institutions carrying out PHS-funded sponsored activities must maintain an up-to-date, written, enforced policy on financial conflict of interest.  In addition, if an institution carries out such activities through a subrecipient (e.g., subcontractor or consortium member), the institution must take reasonable steps to ensure that any subrecipient investigator complies with the regulation.  The institution must require that subrecipient investigators comply with their own institution’s existing policy, or, if no such policy exists, the subrecipient must create its own regulations in keeping with the standards of PHS and certify that it will comply with them during the course of its efforts.

These requirements apply to subawards or subcontracts issued under all PHS-funded awards, and affect new awards, competing renewals, and non-competing renewals.  Modifications at the next funding increment must be issued for all outstanding subawards affected by this regulation.

1.       When a proposal includes one or more subrecipients, a determination must first be made regarding whether the subrecipient has their own compliant COI policy.

a.       Check the FDP COI Clearinghouse to see if subrecipient has confirmed that they have a compliant policy. The department should check PRIOR to creation of COEUS PD.

b.       If the subrecipient is not in the FDP Clearinghouse, the department should contact the subrecipient and ask if they have a compliant policy.

c.       If the subrecipient is not in the FDP Clearinghouse, but has a compliant policy, send a copy of the FDP Clearinghouse Invitation and ask that they confirm their compliance in the Clearinghouse.

2.            For subrecipients who DO have a compliant COI policy, the department should send the subrecipient the “Statement of Intent to Establish a Collaboration” (FORM 4). The subrecipient should complete, sign and return FORM 4 to department for upload into COEUS prior to proposal submission.

3.            For subrecipients who DO NOT have a compliant COI policy:

a.            The department should send the subrecipient the “Statement of Intent to Establish a Collaboration with Non-PHS Grantee Subrecipients” (FORM 5), along with a copy of the Conflict of Interest Model Policy and Subrecipient COI Disclosure Form (FORM 7b).

b.            Ask the subrecipient to implement a policy based on the model prior to award issuance. Subrecipients should complete, sign and return FORM 5 to the department for upload into COEUS prior to proposal submission.

c.             All identified subrecipient Investigators (as determined by the subrecipient PI and listed on FORM 4), including subrecipient PI, must complete and sign the “Subrecipient Investigator Certification Form for Use with PHS Proposals” (FORM 6). All forms must be submitted to department for upload into COEUS prior to proposal submission.

d             Any subrecipient PI or subrecipient Investigator who has identified a conflict on the forms described in Section 3(c) above must also complete and sign the “Subrecipient COI Disclosure Report” (FORM 7a or 7b) and attach it to the Subrecipient Certification Form (FORM 6).  All forms must be uploaded into COEUS prior to proposal submission. ORA will forward Disclosure Forms to Marla Hallacy for COI management.

e.            For subrecipients who DO NOT have a compliant COI policy and refuse/are unable to implement the FDP model policy by award issuance, departments should contact ORA immediately for instructions.

As a reminder, all forms mentioned are available via our portal, as well as from your department administrator.

For more information, visit JHU’s website, or, for more general questions, be sure to read NIH’s online repository of all things COI.  And don’t forget that all JHSPH faculty must complete the online Conflict of Interest training course by October 31, 2012, regardless of whether they are submitting a PHS proposal or we are accepting a PHS award on their behalf.