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University of Colorado Denver

Office of Regulatory Compliance

Office of Regulatory Compliance

Office of Regulatory Compliance

PHS Regulations relating to conflict of interest

  • You must have updated or submitted a new COI disclosure after 8/24/12 to submit a grant to NIH;
  • The definition of investigator has been broadened to include key personnel who may potentially bias the design, conduct or analysis of a study – so can include consultants, PRAs and statisticians depending on the scope of work outlined in the grant
  • You must disclose any financial remuneration from professional organizations as well as financial remuneration provided by a commercial sponsor;
  • You must disclose any travel remuneration from professional organizations or a commercial sponsor;
  • Institutions named as sub-recipients must certify that they will follow PHS regulations or named investigators will need to complete a disclosure with UC Denver I Anschutz Medical Campus
  • If an investigator named on an award declares a financial interest that meets the definition of a significant financial interest then no money can be drawn on a PHS award until the Conflict of Interest Office determines whether or not the significant financial interest potentially could conflict with the project. If the latter is determined then a management plan developed, signed by the investigator and submitted to NIH before funds can be released.
  • The Conflict of Interest Office must make approved management plans available to a member of the public within 5 days of the request for a plan;
  • There is a mandatory training requirement – in the new disclosure form there will be a training section and electronic quiz to determine understanding of the new requirements.