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Mitochondria Replacement Annex IV Questionnaire Medical frontiers: debating mitochondria replacement Annex IV: Summary of the 2012 open consultation questionnaire Report to: Human Fertilisation and Embryology Authority February 2013 Prepared by Dialogue by Design Dialogue by Design 252B Gray’s Inn Road London WC1X 8XG Telephone: 020 7042 8000 Email: [email protected] Website: www.dialoguebydesign.net Company registration no. in England and Wales: 3856988 VAT registration no. 123 4151 58 Annex IV: Medical frontiers: Dialogue by Design 1 of 158 debating mitochondria replacement Contents Executive Summary 4 Chapter 1 Introduction 8 Chapter 2 The consultation process 10 2.1 Summary of consultation activities 10 2.2 Responses 10 2.3 About the respondents 11 Chapter 3 Methodology 14 3.1 Receiving responses 14 3.2 Analysing responses 14 3.3 About this report 16 Chapter 4 Question 1: permissibility of new techniques 19 4.1 Headline findings 19 4.2 Summary of comments 20 4.2.1 Arguments for the introduction of the techniques 20 4.2.2 Arguments against the introduction of the techniques 23 4.2.3 Other considerations 25 Chapter 5 Question 2: changing the germ line 29 5.1 Headline findings 29 5.2 Summary of comments 30 5.2.1 Uncertainty and risk 30 5.2.2 Social implications 32 5.2.3 Ethical implications 34 5.2.4 The science of the germline 35 Chapter 6 Question 3: implications for identity 39 6.1 Headline findings 39 6.2 Overview of comments 40 6.2.1 Reflections on identity 40 6.2.2 Ethical implications 42 6.2.3 Social implications 43 6.2.4 Comparing with other procedures 49 Chapter 7 Question 4a: the status of the mitochondria donor 51 7.1 Headline findings 51 7.2 Summary of comments 51 7.2.1 Comparing mitochondrial donation 51 7.2.2 The mitochondrial donor 55 Annex IV: Medical frontiers: Dialogue by Design 2 of 158 debating mitochondria replacement Chapter 8 Question 4b: the status of the mitochondria donor 58 8.1 Headline findings 58 8.2 Summary of comments 60 8.2.1 Option 1 (no information) & option 2 (some information but not identity) 60 8.2.2 Option 3 (information and ability to contact once child is 18) 62 8.2.3 Option 4 64 8.2.4 Option 5 66 8.2.5 Other comments 66 Chapter 9 Question 5: regulation of mitochondria replacement 67 9.1 Headline findings 67 9.2 Overview of comments 69 9.2.1 Responses to option 1 (clinics and patients to decide) 69 9.2.2 Responses to option 2 (regulatory framework; clinics and patients decide) 71 9.2.3 Responses to option 3 (regulator decides) 73 9.2.4 Responses to option 4 (mitochondria replacement should not be permitted) 74 Chapter 10 Question 6: should the law be changed? 76 10.1 Headline findings 76 10.2 Overview of comments 78 10.2.1 Arguments against a change in law 78 10.2.2 Arguments in favour of a change in law 80 10.2.3 Other legal and regulatory considerations 82 10.2.4 Other considerations 84 Chapter 11 Question 7: further considerations 85 11.1 Headline findings 85 11.2 Overview of comments 86 11.2.1 Arguments against the introduction of the techniques 86 11.2.2 Arguments for the introduction of the techniques 88 11.2.3 Other considerations 89 11.2.4 Context and decision making 92 Appendix 95 A.1 Consultation questions 95 A.2 Responding organisations 97 A.3 Analysis: List of themes 100 A.4 Analysis: List of codes applied per question 101 Annex IV: Medical frontiers: Dialogue by Design 3 of 158 debating mitochondria replacement Executive summary About the consultation The Office for Public Management (OPM), in partnership with Forster and Dialogue by Design (DbyD), was commissioned by the Human Fertilisation and Embryology Authority (HFEA) to conduct a multi-method research and engagement project looking at the possible social and ethical issues relating to two techniques for the avoidance of mitochondrial disease: pronuclear transfer (PNT)1 and maternal spindle transfer (MST)2. As part of this research and engagement, Medical Frontiers: debating mitochondria replacement, an open consultation ran from 17 September to 7 December 2012. Respondents were invited to consider a range of information presented on the consultation website, and to respond to seven questions using the online questionnaire. A total of 1,836 responses were received, the majority of which were via the consultation website. Respondents include stakeholder organisations, individuals with personal experience of mitochondrial disease, as well as many members of the public. The consultation process was managed by Dialogue by Design (DbyD), a company specialising in managing large or complex consultation processes. DbyD received, processed and analysed all responses to the consultation in close liaison with the HFEA. It is important to note that the open consultation provided an opportunity to participate for individuals and organisations keen to have their views heard. As anyone who wanted to could participate, the views expressed cannot be considered representative of the wider population. Emerging themes The consultation questionnaire asks respondents to consider a number of questions relating to making MST and pronuclear transfer PNT techniques available to people at risk of passing on mitochondrial disease to their child. Throughout responses to all consultation questions a number of themes are highlighted repeatedly, mostly as part of a narrative that is either supportive of the introduction of the techniques, or one that articulates opposition. Respondents who argue against the introduction of mitochondria replacement techniques often express concern that such a move would cross an ethical boundary or amount to inappropriate interference with the natural or spiritual aspect of reproduction. Many specify that they believe it is problematic that children born as a result of the techniques will carry DNA from three people, for a range of reasons further discussed below. Another strand to some respondents’ opposition is the creation and destruction of embryos as part of PNT, which in their view is unethical. 1 Pronuclear transfer involves transferring the pronuclei from an embryo with unhealthy mitochondria and placing them into a donor embryo which contains healthy mitochondria and has had its pronuclei removed. A pronucleus is a small round structure containing nuclear DNA seen within an embryo following fertilisation. A normal embryo should contain two pronuclei, one from the egg (maternal pronucleus) and one from the sperm (paternal pronucleus). 2 The maternal spindle is a structure within the egg containing the mother’s nuclear DNA. Maternal spindle transfer involves transferring the spindle from the intended mother’s egg, with unhealthy mitochondria, and placing it into a donor egg with healthy mitochondria. Annex IV: Medical frontiers: Dialogue by Design 4 of 158 debating mitochondria replacement Respondents who argue in favour of the introduction of mitochondria replacement techniques often emphasise the benefits of the techniques to families affected by mitochondrial disease. Many say they believe it is important - some say there is an ethical imperative - to avoid or eradicate the disease, sometimes referring to the suffering that patients may endure. Respondents who support the techniques also tend to employ arguments about the genetic significance of donated mitochondria (or mitochondrial DNA), which they believe is limited and therefore not a great concern. This is further explored in the sections below. An additional theme emerging both in responses arguing against the techniques and in responses arguing in favour is the management of risk. For many respondents supporting mitochondria replacement in principle it is crucial that sufficient evidence is available about the safety of the techniques before they are allowed in a clinical setting. Other respondents highlight that risks cannot be fully managed and that this is part of the reason why they oppose the introduction of mitochondria replacement techniques. Consultation questions Responses to each of the seven consultation questions are discussed below, focusing on issues specific to those questions. Question 1 Asked for their views on offering MST and PNT to people at risk of passing on mitochondrial disease to their child, just over 500 respondents say they do not think the techniques should be permitted, while almost 500 say that they support the introduction of both techniques. Most respondents with direct or indirect experience of mitochondrial disease argue in favour of the introduction of the techniques. Where respondents support one technique in particular, they tend to prefer MST because this technique replaces mitochondria in eggs rather than embryos. Question 2 Respondents are asked in question 2 whether they think there are social and ethical implications to changing the germline. Those in favour of the techniques argue that there are no negative implications or that these are outweighed by the positives. Respondents who oppose the introduction of the techniques specify a range of potential implications, highlighted below. With regard to the germline the most prominent concern expressed is that consequences of the techniques will affect many generations down the line, and that these consequences are to some extent unknown. Another potential implication outlined in some respondents’ views is that making changes to the germline for this purpose could lead to other changes becoming more acceptable: many respondents identify the idea of germline change with cloning or the creation of designer babies. Others argue that any change to the germline is inappropriate because there is no way for all those affected to give consent; a view contradicted by a few who see making choices for subsequent generations as a very ordinary part of being a parent. Question 3 When asked in question 3 whether they think the techniques have social or ethical implications relating to a person’s sense of identity, respondents’ comments differ widely.
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