Call for Evidence - The International Commission on the Clinical Use of Human Germline Genome Editing

9/5/2019

The Royal Society and the U.S. National Academies of Sciences and Medicine have convened an international commission to develop a framework for considering technical, scientific, medical, regulatory, and ethical requirements for human germline genome editing, should society conclude such applications are acceptable.

To inform its deliberations, the Commission is engaging with external expertise and has launched a call for evidence, open until Friday, 27 September 2019. They would appreciate input from members of the Society for Developmental Biology.

The full list of questions is available as a PDF and on the commission websites, while responses can be submitted through an online form. Several questions in the call invite broad input, while others are more technical in nature. Members are encouraged to address those questions most relevant to their particular areas of expertise. When appropriate, providing citations and/or links to evidence in support of responses is greatly appreciated.

Given members’ expertise, the Commission would be particularly interested in thoughts on the following questions:

1. Which diseases and conditions, if any, do you see as appropriate for human germline genome editing? Explain.

2. If there were to be an appropriate use case for human germline genome editing, what evidence would be needed to proceed to first in human use? 

3. What is the status of editing mechanisms for early stage human embryos (e.g., using different editing techniques, improving homology directed repair, etc.)? What are the factors that predict whether single nucleotide changes or other intended modifications in human embryos will be correct? To what extent will genome editing affect the viability of embryos?

4. What is the status of the technology for validating that a correct edit (on target characterization) has been made and that unintended edits (e.g., off target effects, mosaicism, etc.) have not occurred in a range of cell and tissue types? If possible, please provide evidence drawn from work on early stage human embryos.

7. To what extent do different genetic backgrounds affect success and phenotypic outcomes after genome editing?

8. What is the success rate of full term pregnancies following pre-implantation genetic diagnosis? What affects this (e.g., age, number oocytes harvested, technique used, etc.)?

The Commission would also welcome the circulation of this call to any of your colleagues who may be interested in contributing to the discussion.

The U.S. National Academies will list all written submissions in a Public Access File (PAF) established for the International Commission. These submissions will be made available to the public upon request. If respondents prefer that personally identifiable details not be included in the PAF, they must not include their name, contact information, or other such specifics in their comments.

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Thank you very much in advance for your time, and the Commission looks forward to receiving member responses.

Last Updated 09/05/2019