NIH, with the Midwest Area Biosafety Network (MABioN), will be hosting the third in a series of public listening sessions to obtain stakeholder feedback on NIH’s effort to modernize and strengthen biosafety oversight.

Priority for this meeting will be given to stakeholders located in: Minnesota, Wisconsin, Iowa, Illinois, Indiana, Michigan, and Ohio

NIH Videocast

https://videocast.nih.gov/watch=57218

Draft Agenda

Listening Session 3 Draft Agenda

Meeting Flyer

Listening Session 3 Flyer

Introductory Slides

Coming Soon

Public Comments

NIH and its partners encourage any interested individual to sign up to provide oral comments during the listening session.  All comments offered at the listening session are welcome and will be considered, including on topics covered at previous sessions. Feedback on the following topic is particularly encouraged.  

There are different levels of NIH or IBC oversight that could be required under a biosafety policy, which would be tiered based on the risk of the research. NIH is interested in hearing individual opinions regarding what levels of oversight should be required under the policy and what categories of research should fall under those levels based on risk and safety data.  

As a starting point, NIH is interested in hearing feedback on these potential options:  

• NIH review and approval required before initiation 
  • Lowering containment for research involving wild type or genetically modified RG3 or RG4 agents (e.g., experiments with attenuated or replication defective constructs) 
  • Research involving emerging or zoonotic agents for which the RG classification or containment level in the BMBL is not available 
  • Other higher risk research 

• IBC review and approval required before initiation, including potential expedited review 
  • Research involving RG2, 3, or 4 wild type agents 
  • Research involving genetically modified organisms, cells or viruses (e.g., certain vectors, replicons, gene editing, gene drives, transgenic animals) 
  • Research involving other biohazards (e.g., prions, toxins, certain emerging technology products) 
  • Other 

• IBC notification simultaneous with initiation 
  • Research involving RG1 or RG1 and RG2 wild type agents 
  • Research involving reporter constructs or other low risk expression vectors 
  • Research involving certain transgenic organisms 
  • Other 

• No IBC oversight 
  • Research with RG1 wild type agents, or BL1 transgenic animals 
  • Research involving reporter constructs or other low risk expression vectors (e.g., RG1 or RG1/2 vectors/replicons with lower risk modifications) 

• Other

NIH welcomes individuals to offer additional ideas for how NIH should approach levels of oversight under the policy. 

Registration

The listening session is open to the public and there is no cost to attend. Registration is required, using the form below, if you are planning to make an oral statement at the listening session.  Those planning to only view the listening session are kindly requested, but not required, to register below.