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When is it Safe to Edit the Human Germline?

Janella Baxter1

  • 1Department of Philosophy, Washington University, Campus Box 1073 One Brookings Drive, St. Louis, MO, US. baxterj@wustl.edu.

Science and Engineering Ethics
|July 7, 2021
PubMed
Summary

Human germline gene editing (GGE) requires better policy. Current proposals inadequately address disability community input and disease selection criteria for GGE applications.

Area of Science:

  • Bioethics
  • Genetics
  • Biotechnology Regulation

Background:

  • The 2018 announcement of CRISPR-Cas9-edited babies highlighted safety concerns and the need for robust human germline gene editing (GGE) regulation.
  • Existing policy proposals aim to integrate safety and public input for GGE, but their frameworks are criticized as insufficient.
  • The ethical implications of GGE necessitate careful consideration of scientific, societal, and community perspectives.

Purpose of the Study:

  • To critically evaluate current policy proposals for human germline gene editing (GGE).
  • To propose an improved framework for incorporating disability community perspectives into GGE policy-making.
  • To refine criteria for identifying suitable diseases for GGE, moving beyond a monogenetic disease model.

Main Methods:

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  • Analysis of existing policy proposals regarding human germline gene editing (GGE).
  • Critique of strategies for including disability community input in GGE policy.
  • Development of alternative criteria for disease selection based on genetic causal control and desirable trait variants.

Main Results:

  • Current policy proposals for human GGE are deemed inadequate in their approach to disability community engagement.
  • The focus on monogenetic diseases in policy proposals is insufficient for determining GGE viability.
  • Essential criteria for GGE candidate diseases include high genetic causal control and identified desirable sequence variants, which are currently unspecified in policy.

Conclusions:

  • An iterative, deliberative process is superior for integrating disability community insights into GGE policy.
  • GGE policy must consider genetic causal control and the identification of desirable genetic variants, not solely monogenetic disease classifications.
  • Clearer guidelines are needed to prevent individual scientists from unilaterally deciding on GGE applications and desirable outcomes.