Virtual Stakeholder Engagement Meeting on USG Policies for the Oversight of Life Sciences Dual Use Research of Concern

Location: NIH Videocast:

* Please note that this meeting was originally intended to be a hybrid meeting held in person in Tempe, AZ. However, to ensure the health and safety of all invitees and to get maximum stakeholder feedback NIH has decided to make this meeting fully virtual.*

NIH is moving to an all-virtual stakeholder engagement meeting on June 29, 2022, to discuss the U.S. Government policies for the oversight of Dual Use Research of Concern (DURC).    

The purpose of this meeting is to gather feedback from stakeholders about their experiences implementing these policies, the effect of these policies in terms of achieving their stated goals, the overarching definition of DURC, and possible alternative approaches for the oversight and responsible conduct of DURC.

 This feedback will also be used to inform the discussions of the National Science Advisory Board for Biosecurity (NSABB) in fulfillment their current charge to evaluate and analyze the DURC policies. 

Registration is not required to view the webcast.  

Webcast

https://videocast.nih.gov/watch=45698

Agenda

Draft Virtual DURC Stakeholder Engagement Meeting Agenda

Public Comments: 

NIH welcomes comments from the public. For those interested in making oral comments at the June 29th Virtual DURC Stakeholder Engagement Meeting, please sign up at SciencePolicy@od.nih.gov by June 27, 2022.  For those interested in submitting written comments, please send your submission to SciencePolicy@od.nih.gov by July 8, 2022. Other than name and contact information, please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your comments.   Please note that any written comments NIH receives may be posted unredacted to the OSP website.

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

*Note: The NExTRAC working group’s report is a draft, pre-decisional document. The NExTRAC publicly discussed and endorsed the draft findings and recommendations with minor modifications to the report at the June 25, 2021, meeting. The final NExTRAC report can be found here.

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)