Financial Conflict of Interest (FCOI) Policy PHS Regulations

The Policy

This Policy implements the 2011 U.S. Public Health Service (PHS) regulations on Promoting Objectivity in Research. The Policy is applicable to all PHS Research Activities with an award issue date of August 24, 2012, or later, and to proposals for research activities submitted to PHS on or after August 24, 2012. PHS Research Activities that are ongoing as of August 24, 2012 will become subject to this policy as additional funds are requested through submission of a progress report, competing renewal application, or proposal for supplemental funding. This Policy applies to the Principal Investigator and all other Investigators (regardless of position or title) who are responsible for the design, conduct or reporting of a PHS Research Activity. The Policy is applicable to all research activities supported by a PHS funder, most notably the National Institutes of Health (NIH), through a grant or cooperative agreement (either directly or via another institution as a sub-awardee), and by other sponsors and programs that specifically request review consistent with the PHS regulations on objectivity in research.

A summary of the PHS FCOI Policy is as follows:

  • all Investigators must disclose any Significant Financial Interest (SFI) with respect to their Institutional Responsibilities to their Head of Department who will determine whether such interest constitutes a Financial Conflict of Interest (FCOI)
  • where an SFI is determined to be an FCOI, a management plan will be drawn up to help manage, reduce or eliminate the FCOI
  • a disclosure of the FCOI and management plan must be submitted to the PHS-funder
  • adherence to the management plan must be monitored
  • all PHS-funded Investigators are required to take training on conflicts of interest
  • annual (and in some circumstances more regular) reporting of FCOIs to the PHS-funder is required
  • before any expenditure of PHS funds, information concerning any disclosed SFI which has been determined to be an FCOI relating to PHS-funded research, must be made publicly accessible by written response within 5 working days of request

The complete PHS FCOI Policy implemented at Politecnico di Milano is available for download at the link below.

POLIMI PHS FCOI Policy, Procedures & Process

An overview of the PHS FCOI disclosure process is set out in this:

REFERENCE REGULATIONS

This Policy is drawn from the original U.S. Department of Health and Human Services (HSS) regulations:

Title 42 Public Health, Part 50 Policies of General Applicability, Subpart F Promoting Objectivity in Research http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf