Legis
Healthcare
Executive order · Monday 5 May 2025

Improving The Safety And Security Of Biological Research

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  • The executive order addresses concerns regarding dangerous gain-of-function research on biological agents and pathogens.
  • It emphasizes that such research poses significant risks to American citizens, including potential widespread mortality, impaired public health, and threats to national security.
  • The Biden Administration's previous approach allowed dangerous gain-of-function research with insufficient oversight and authorized life-science funding in foreign countries with limited U.S. oversight.
  • The order prioritizes U.S. federally funded research benefiting citizens without compromising national security, public health, or economic stability.
  • Key directives include:
    • Immediate cessation of federal funding for dangerous gain-of-function research abroad, particularly in countries of concern (like China).
    • Suspension of federally funded dangerous gain-of-function research until new policy guidance is developed.
  • The Office of Science and Technology Policy (OSTP) must revise existing guidelines to:
    • Enhance oversight, accountability, transparency, and define research scope while maintaining U.S. leadership in health research.
    • Incorporate enforcement mechanisms in federal funding agreements.
  • Within specified timelines, further actions must be taken to limit and track dangerous gain-of-function research, even outside federal funding.
  • Institutions receiving federal funding must report on their gain-of-function research activities and comply with new contractual requirements.
  • “Dangerous gain-of-function research” is defined broadly to encompass activities that enhance infectious agents' harmfulness or transmissibility and could lead to significant societal consequences.
  • Clauses specify that the order does not infringe on existing legal authorities of departments and agencies.