PHS/PHHS Guidance

The U.S. Department of health and Human Services (DHHS) has issued a final rule in the Federal Register that amends the Public Health Services (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50 Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). An institutional applying for or receiving PHS funding from a grant or cooperative agreement must comply with all of the revised regulatory requirements. Major changes to the previous regulations from 1995 include:

  • Lower financial disclosure thresholds ($5000 minimum threshold)
  • New conflict of interest training (every 4 years for investigators receiving PHS funds)
  • New public accessibility requirements
  • Increased transparency for travel reimbursement

Funding agencies that have adopted the DHHS and PHS Regulation change:

Department of health and Human Services Agencies

 

Non-PHS Agencies

Office of Global Affairs (OG   Administration for Children and Families (ACF)
Office of the Assistant Secretary for Health (OASH   Alliance for Lupus Research (ALR
Office of the Assistant Secretary for Preparedness and Response (ASPR)   American Cancer Society (ACS
Agency for Health Care Research & Quality (AHRQ)   American Heart Association (AHA)
Agency for Toxic Substances and Disease Registry (ATSDR)   American Lung Association (ALA)
Centers for Disease Control and Prevention (CDC)   Arthritis Foundation (AF)
Food and Drug Administration (FDA)   Juvenile Diabetes Research Foundation (JDRF)
Health Resources and Services Administration (HRSA)   Lupus Foundation of America (LFA)
Indian Health Service (IHS)   Susan G. Komen for the Cure
National Institutes of Health (NIH)   CurePSP
Substance Abuse and Mental Health Services Administration (SAMHSA)