Novel and Exceptional Technology and Research Advisory Committee

Virtual Meeting

Federal Register Notice

Webcast

Agenda

Minutes

Draft Report of the Gene Drives in Biomedical Research Working Group

This is the draft report of the Gene Drives in Biomedical Research Working Group, which was prepared in response to the charge given by the NIH Director at the December 2019 NExTRAC meeting to:

  • “Consider whether existing biosafety guidance is adequate for contained laboratory research utilizing gene drive technology
  • Outline conditions (if any) under which NIH could consider supporting field release of gene drive modified organisms

and to provide advice on the following issues:

  • Given the diverse applications and species that may be used in gene drive research with different risks, is the current landscape of biosafety guidance adequate for contained research?
  • What knowledge and conditions should be in place to help ensure that field release research of gene drive modified organisms could be conducted safely and ethically?”

Additional Meeting Materials

This material contains content that is not fully supported by assistive technology. For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.

Public Comments

Novel and Exceptional Technology and Research Advisory Committee

Virtual Meeting

Federal Register Notice

Webcast

Agenda

Meeting

Draft Report of the Working Group to Establish a NExTRAC Framework

  • Draft Report of the Working Group to Establish a NExTRAC Framework
  • The draft report of the Working Group to Establish a NExTRAC Framework was prepared in response to the charge given by the NIH Director at the December 2019 NExTRAC meeting to:
    • “Describe effective approaches for prospectively identifying emerging biotechnologies or specific applications with reasonable potential to have important scientific, safety, or ethical considerations
    • Conceptualize a framework for NExTRAC deliberation of issues surrounding emerging biotechnologies and applications, including:
      • Guiding principles for when an emerging biotechnology or its applications would significantly benefit from further public deliberation
      • A potential process by which the NExTRAC will consider or evaluate any given emerging biotechnology or its applications”

Additional Meeting Materials

Slides

This material contains content that is not fully supported by assistive technology. For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.

SESSION I: GENE DRIVES IN BIOMEDICAL RESEARCH

SESSION II: BIOSAFETY GUIDANCE FOR CONTAINED RESEARCH

SESSION III: SCIENCE OF BIOLOGICAL AND ENVIRONMENTAL RISK MITIGATION APPROACHES

SESSION IV: STRATEGIES FOR ASSESSING RISK AND BENEFIT FOR GENE DRIVE FIELD RELEASE

SESSION V: US AND INTERNATIONAL POLICY DISCUSSIONS AND OVERSIGHT FRAMEWORKS FOR RESEARCH INVOLVING GENE DRIVE FIELD RELEASE

SESSION VI: PUBLIC ENGAGEMENT- INPUT FROM LOCAL COMMUNITIES

SESSION VII: STRATEGIES FOR STAKEHOLDER AND PUBLIC ENGAGEMENT

SESSION VIII: DRAFT REPORT OF THE WORKING GROUP TO ESTABLISH A NEXTRAC FRAMEWORK

Public Comments

NExTRAC Meeting

Virtual Meeting

Federal Register Notice

Webcast

Agenda

  • NIH NExTRAC June 2021 Meeting Agenda (Needs Link)

Draft Report of the Gene Drives in Biomedical Research Working Group

  • Draft Report of the Gene Drives in Biomedical Research Working Group (Needs Link)

This is the draft report of the Gene Drives in Biomedical Research Working Group, which was prepared in response to the charge given by the NIH Director at the December 2019 NExTRAC meeting to:

  • “Consider whether existing biosafety guidance is adequate for contained laboratory research utilizing gene drive technology
  • Outline conditions (if any) under which NIH could consider supporting field release of gene drive modified organisms

and to provide advice on the following issues:

  • Given the diverse applications and species that may be used in gene drive research with different risks, is the current landscape of biosafety guidance adequate for contained research?
  • What knowledge and conditions should be in place to help ensure that field release research of gene drive modified organisms could be conducted safely and ethically?”

Additional Meeting Materials

This material contains content that is not fully supported by assistive technology. For accessibility assistance with these files, please contact: SciencePolicy@od.nih.gov.

  • NExTRAC Roster (Needs Link)
  • Gene Drives in Biomedical Research Working Group Roster (Needs Link)
  • NExTRAC Gene Drives in Biomedical Research Working Group, Cinnamon Bloss, Ph.D. and Zach Adelman, Ph.D. June 25, 2021 (Needs Link)
  • Charge to the NExTRAC, Lawrence A. Tabak, D.D.S., Ph.D. June, 25 2021 (Needs Link)

Public Comments (Needs Link)