Instructions for managing financial conflicts of interest in research projects funded by US federal health agencies

National Institutes of Health (NIH) in the United States (US) provides research grants through the federal government agencies within U.S. Public Health Services (PHS).

In cases where researchers at Karolinska Institutet (KI) receive grants from PHS, far-reaching demands are placed on researchers' objectivity and independence from commercial ties to companies that could influence the design, implementation and reporting of the research. Since KI is the grant recipient of PHS, the university has

  • Diary number: 1-106/2024
  • Dnr preg. version: 1-852/2020
  • Decision date:
  • Validity period: Until further notice
  • Decision: President
  • Document type: Instructions
  • Handled by department/unit: CDO
  • Preparation with: Legal office
  • Revision with respect to: Committee members, changing from Grants Office to Compliance & Data Office and linguistic adjustments without change in substance.

Summary of the instructions

These instructions correspond to US federal regulations set forth in “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contracts (Section of 42 CFR part 50 subpart F) to identify, manage and report financial conflicts of interest”.

These rules apply specifically to grants funded by PHS and should be followed in parallel with other reporting requirements of conflict of interest at KI. 

Purpose

The purpose of these instructions is to ensure the objectivity of the research so that the design, implementation and reporting of funded research, grants or collaboration agreements shall be free from the influence of the researcher's financial conflicts of interest (including the researcher's spouse and/or minor children).