Genome editing and human reproduction: social and ethical issues

Throughout 2017 the Nuffield Council on Bioethics undertook a range of evidence-gathering activities to inform the deliberations of its working group examining the ethical issues raised by genome editing and human reproduction.

To inform our discussions about genome editing and human reproduction, we commissioned two reviews of the literature and evidence relating to this area:

Background paper

The regulatory and legal situation of human embryo, gamete and germ line gene editing research and clinical applications in the People’s Republic of China

Written by Dr Achim Rosemann, University of Warwick, Coventry, UK; Li Jiang, Soochow University, Suzhou, China; Xinqing Zhang, Peking Union Medical College / Chinese Academy of Medical Sciences, Beijing, China

This paper provides an overview of the regulatory and legal landscape for human gamete, embryo and germ line genome editing in the People’s Republic of China. The paper reviews the situation for basic, preclinical and clinical research and potential commercial applications. Relevant policies and provisions are discussed in relation to some of the historical, socio-economic, political and cultural factors that shape bio-medical innovation in China, and that influence issues such as implementation, enforcement, levels of compliance, as well as public opinions and debates on human germ line research.

Report

The regulation of genome editing and human reproduction under international Law, EU law and comparative law

Written by Dr Rumiana Yotova, Lecturer and Director of Studies in Law, Lucy Cavendish College, University of Cambridge

The aim of this report is to identify and analyse the relevant legal frameworks governing the research and possible clinical applications of human genome editing on the levels of public international law, EU law and the comparison between selected domestic jurisdictions. The report will focus in particular on the requirements andrestrictions imposedby these legal frameworks, as well ason theexisting mechanisms for oversight, compliance and sanctions in cases of violations. Together with the black letter law, the report will also assess the soft law instruments, including guidelines, recommendations and non-binding declarations of competent international and domestic agencies.

Fact-finding meetings and panel interviews

Three fact-finding meetings and four panel interviews were conducted with experts in reproductive genetics, embryology, genome sequencing, bioinformatics, genomics research and ethics between March and October 2017.

Public survey (closed on 14 July 2017)

The Council wanted to hear as wide a range of views as possible on ethical questions about these potential uses of genome editing and how far we, as a society, should go in altering fundamental aspects of human biology.

The survey set out three scenarios to that could plausibly arise in the future, each followed by a set of questions to explore the ethical considerations and was open between 15 May and 14 July 2017.

• Download a document containing the survey questions
• Download a summary of responses from the public survey

The survey can also be used as a tool for anyone facilitating discussion about genome editing technologies. If you would be interested in using it for this purpose, please contact us at bioethics@nuffieldbioethics.org.

Call for evidence

Alongside the public survey, we issued a call for evidence, which aimed to gather more in-depth information from organisations and individuals with an existing interest in or knowledge about genome editing. The consultation ran from 15 May – 14 July 2017. The questions were similar to those in our 2015-2016 call for evidence on genome editing but focussed on human reproductive uses.

• Download the consultation document

Consultation responses

The Nuffield Council on Bioethics has decided that, in the spirit of openness, it will post consultation responses on its website where possible. Only the submissions of those respondents who have given their consent have been made available.

Individuals

• Hillie Haker
• Richard Hayes, PhD
• Amarpreet Kaur
• Dr Helen O'Neill
• Dr Kenneth Taylor, Dr Ilke Turkmendag, Dr Matthias Wienroth and Dr Simon Woods
• Maggie Zhou, PhD

Organisations

• Academy of Medical Sciences (AMS)
• Association of Medical Research Charities (AMRC)
• Center for Genetics and Society
• COST Action CHIP ME (IS1303)
• Medical Research Council (MRC) and Biotechnology and Biological Sciences Research Council (BBSRC)
• PHG Foundation

Research interviews

A series of six research interviews with scholars, activists and clinicians on the potential impacts on disabled people of human reproductive applications of genome editing was conducted between May and August 2017.

Review of literature

A review of the philosophical and ethical literature relevant to genome editing and human reproduction was conducted by Council Executive staff members between June and October 2017.