Conflict of Interest for US Funded Research

Conflict of interest policy to meet U.S. Dept of Health and Human Services and Public Health Services Regulations (of which the NIH is part)

The Policy

This policy consists of a set of requirements to be followed by senior and key personnel participating in research funded by a Public Health Service (PHS) funder, most notably the National Institutes of Health (NIH).

The policy applies to any institution (foreign or U.S. domestic) that is applying for or receives research funding from a PHS funder through a grant or cooperative agreement (either directly or via another institution as a sub-awardee) and, consequently, any investigator planning to or who is already participating in such research.

Key requirements

• 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.
• See also Key Definitions

This policy is drawn from the original HSS regulations:

Title 42 – Public Health, Part 50– Policies of General Applicability, Subpart F – Promoting Objectivity in Research