An ad hoc committee will plan and conduct a public workshop to examine challenges facing the use of animals in scientific research stemming from the widespread use of gene editing technologies, such as CRISPR/Cas9, TALENS and “zinc fingers”. Among the issues that invited speakers will address are:

• How could gene editing be applied in various animal species and what factors go into selecting the optimal species as research models?
• What are the risks of gene editing and how should these be addressed for animals used in research? What are the efficiencies of and obstacles to gene editing using these new technologies?
• What regulatory, policy, and/or accreditation issues will need to be considered when applying gene editing to derive animal models for pre-clinical research?
• How could this technology enable the improvement of animal models for preclinical research by recapitulating human genetic variants underlying disease processes? In what ways and how much could gene-edited animals contribute to the goals of precision medicine and be more predictive of the human condition compared to current strategies?
• Will gene editing provide capabilities that cannot be achieved through other means? What are the implications for more traditional strategies to manipulate the genome of research animals? What new technologies are foreseen coming after TALENS, zinc fingers, and CRISPR/Cas9, and will they have similar impacts on the derivation and use of genetically-altered animals for research?
• What are the ethical issues stemming from using gene editing in research animals? In particular:
  • What is the potential effect gene editing could have on expanding the numbers of animals and variety of species that can be used in biomedical research?
  • What ethical issues should be considered before expanding the use of these technologies in animal species that are not currently used in biomedical research and what would our obligations be toward the quality of life of these animals?
  • Do these modified species require protection under existing policies and guidelines? What methods are required to ensure the humane and ethical care and use of these animals, both in the editing phase of their genome as well as in the production and procreation phase of their, and their descendants’, lives?

The ad hoc committee will develop the workshop agenda, select and invite speakers and discussants, and moderate the discussions. A summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.