Special FCOI Requirements for PHS Researchers

The Department of Health and Human Services has its own financial conflict of interest regulation - Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractor. The regulation, which took effect on August 24, 2012, governs research sponsored by NIH, CDC, AHRQ, and other Public Health Service (PHS) agencies (see below) and applies to all investigators on new awards, new proposals, non-competing renewals, and no cost extensions received or submitted on or after that date.  The regulation, which is incorporated as an appendix to the University's FCOI and Research Policy, includes specific requirements for all PHS investigators, including:

A. Mandatory Training: All PHS researchers must complete training in Financial Conflicts of Interest in Research at least once every four years. PHS researchers have two options for completing their initial FCOI training in Rascal:

  1. Completing Rascal training for human subjects research – TC0087, which includes an FCOI component; or
  2. Taking Rascal course TC1450 - Financial Conflicts of Interest for PHS Researchers, a stand-alone FCOI course for researchers who do not take human subjects protection training.
  • To remain compliant with the PHS FCOI 4-year training requirement, researchers whose training is expiring have two options:
  1. Staying up to date on human subjects protection training, TC0087, which is required every 3 years; OR
  2. Completing Rascal course TC1455 - Refresher FCOI Training for PHS Researchers, an abbreviated FCOI refresher course. [Note that TC1455 is refresher training only and does not satisfy the initial FCOI training requirement.]

B. Broader disclosure requirements of all financial interests that relate to an individual's institutional responsibilities, including compensation from non-profit entities and sponsored travel

C. A lower threshold of $5,000 for "significant financial interests"

PHS Agencies*

  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control (CDC)
  • Food and Drug Administration (FDA)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Services (IHS)
  • National Institutes of Health (NIH)
  • Office of the Assistant Secretary for Health (OASH)
  • Office of Assistant Secretary for Planning and Evaluation
  • Office of the Assistant Secretary for Preparedness and Response (ASPR)
  • Office of Global Affairs (OGA)
  • Office of Public Health and Science
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

*Check with the funding agency for most up-to-date information on FCOI policies. Source: FDP FCOI Agency list

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