Conflict of interest policy for U.S. funded research

Any studies funded by the United States Government and National Institutes of Health must follow U.S. Department of Health and Human Services and Public Health Services Regulations

The policy

This policy sets out requirements to be followed by senior and key staff at CPFT participating in research funded by a Public Health Service (PHS) funder in the United States (U.S.), 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 staff required to administer the policy

  • All Investigators
  • Each Investigator’s Director of Research and Development or Head of Department (Head of School if the Head of Department is an Investigator)
  • Each Investigator’s Departmental Administrator
  • The Research and Development Office: The relevant research governance manager has authorised access to submit forms through the eRA Commons Financial Conflict of Interest Module and hence will submit the Conflict of Interest disclosure report.

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 U.S. Department of Health and Human Sciences (HSS) regulations:
Title 42 – Public Health, Part 50– Policies of General Applicability, Subpart F – Promoting Objectivity in Research

Further information

Flowchart for Conflict of Interest regulations - What to do and when
NIH Frequently Asked Questions (FAQs)

 

 

The page was last updated on 26 August 2020 by lmarshall.

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