Am J Hum Genet. 2017 Aug 3;101(2):167-176. doi: 10.1016/j.ajhg.2017.06.012.

Human Germline Genome Editing.

Ormond KE1, Mortlock DP2, Scholes DT3, Bombard Y4, Brody LC5, Faucett WA6, Garrison NA7, Hercher L8, Isasi R9, Middleton A10, Musunuru K11, Shriner D12, Virani A13, Young CE3.

Author information

1

Department of Genetics and Stanford Center for Biomedical Ethics, School of Medicine, Stanford University, Stanford, CA 94305, USA. Electronic address: kormond@stanford.edu.

2

Vanderbilt Genetics Institute and Department of Molecular Physiology and Biophysics, Vanderbilt University, Nashville, TN 37232, USA.

3

American Society of Human Genetics, Bethesda, MD 20814, USA.

4

Li Ka Shing Knowledge Institute of St. Michael's Hospital, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON M5B 1W8, Canada.

5

Division of Genomics and Society, National Human Genome Research Institute, Bethesda, MD 20892, USA.

6

Genomic Medicine Institute, Geisinger Health System, Danville, PA 17822, USA; National Society of Genetic Counselors.

7

Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital and Research Institute, Seattle, WA 98101, USA; Division of Bioethics, Department of Pediatrics, University of Washington, Seattle, WA 98101, USA.

8

National Society of Genetic Counselors; Joan H. Marks Graduate Program in Human Genetics, Sarah Lawrence College, Bronxville, NY 10708, USA.

9

Dr. John T. Macdonald Foundation Department of Human Genetics and Institute for Bioethics and Health Policy, University of Miami Miller School of Medicine, Miami, FL 33136, USA.

10

Society and Ethics Research Group, Connecting Science, Wellcome Genome Campus, Hinxton, Cambridge CB10 1SA, UK; Association of Genetic Nurses and Counsellors.

11

Cardiovascular Institute, Departments of Medicine and Genetics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.

12

Center for Research on Genomics and Global Health, National Human Genome Research Institute, Bethesda, MD 20892, USA; International Genetic Epidemiology Society.

13

Provincial Health Service Authority of British Columbia and Department of Medical Genetics, University of British Columbia, BC V6H 3N1, Canada; Canadian Association of Genetic Counsellors.

Abstract

With CRISPR/Cas9 and other genome-editing technologies, successful somatic and germline genome editing are becoming feasible. To respond, an American Society of Human Genetics (ASHG) workgroup developed this position statement, which was approved by the ASHG Board in March 2017. The workgroup included representatives from the UK Association of Genetic Nurses and Counsellors, Canadian Association of Genetic Counsellors, International Genetic Epidemiology Society, and US National Society of Genetic Counselors. These groups, as well as the American Society for Reproductive Medicine, Asia Pacific Society of Human Genetics, British Society for Genetic Medicine, Human Genetics Society of Australasia, Professional Society of Genetic Counselors in Asia, and Southern African Society for Human Genetics, endorsed the final statement. The statement includes the following positions. (1) At this time, given the nature and number of unanswered scientific, ethical, and policy questions, it is inappropriate to perform germline gene editing that culminates in human pregnancy. (2) Currently, there is no reason to prohibit in vitro germline genome editing on human embryos and gametes, with appropriate oversight and consent from donors, to facilitate research on the possible future clinical applications of gene editing. There should be no prohibition on making public funds available to support this research. (3) Future clinical application of human germline genome editing should not proceed unless, at a minimum, there is (a) a compelling medical rationale, (b) an evidence base that supports its clinical use, (c) an ethical justification, and (d) a transparent public process to solicit and incorporate stakeholder input.