Subcontractors and PHS Sponsored Research Responsibilities

Effective August 24, 2012, the Public Health Service (PHS) including the National Institute of Health (NIH) and other funding organizations that have adopted the PHS policy and regulations, changed its policies regarding financial conflict of interest (FCOI).  The University is now required to obtain information related to proposed and current PHS-sponsored research subrecipients, which includes subcontractors and consortium members.

The Principal Investigator (PI) must obtain written documentation from each proposed subrecipeint that the organization, their investigators, and their key personnel are in compliance with the PHS FCOI regulations.  The subrecipient has two options available:

  • Abide by their own PHS-compliant FCOI policy, or
  • Will abide by the Universities’ policy on FCOI if they do not have their own policy.

Documentation of compliance with this part of the regulations will need to be submitted with the Internal Clearance Form as the proposal is being routed for approval.

To assist Universities and subrecipients to document compliance with PHS FCOI rules and regulations, the Federal Demonstration Partnership (FDP) Institutional Clearinghouse  has created an Institutional Clearinghouse where Universities and subrecipients can register their respective institutions and organizations as compliant with the regulations.  The PI can access the List of Compliant Institutions and Entities.  If the subrecipient is on the list, then the PI can document on the Internal Clearance Form that the subrecipient is listed and certified in the FDP Institutional Clearinghouse.

If the subrecipient organization is not on the list with the FDP Institutional Clearinghouse the PI will send out the Subrecipient Financial Conflict of Interest Documentation Form, Notice to Subrecipient, and the Subrecipient Disclosure of Financial Conflict of Interest Form to the authorized organizational official for completion.