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The ethics of clinical applications of germline genome modification: A systematic review of reasons Ivy Van Dijke1, Lance Bosch2, Annelien Bredenoord3, Martina Cornel4, Sjoerd Repping2, Saskia Hendriks2
1PhD student at VU University Medical Center Amsterdam (VUMC) and Academic Medical Center University of Amsterdam (AMC), Amsterdam, Netherlands 2Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands 3UMC Utrecht, Utrecht, Netherlands 4VU University Medical Center, Amsterdam, Netherlands Objectives Germline genome modification is still unsafe and insufficiently effective for clinical purposes. However, the recent progress made using CRISPR-Cas has led scientists to expect to overcome the technical hurdles in the foreseeable future. This has invited a fierce debate on the socio-ethical and legal implications of germline genome modification. A systematic overview of the reasons presented in the literature in favour or against germline genome modification is missing. We aimed to identify all reasons that have been presented for or against the future clinical application of germline genome modification. Methods The database ‘Medline/Pubmed’ was systematically searched for articles published between January 2011 and June 2016 Articles were selected based on eligibility, and the reference lists of eligible studies were hand searched. All types of articles (e.g. reviews, opinion articles), except for original biological research were eligible. Articles covering reasons for or against clinical application of intentional modification of the nuclear DNA of the germline (i.e. embryo, zygote, gametes or precursor cells of gametes) were included. Results A total of 169 reasons were identified: 90 reasons for, and 79 reasons against clinical application of germline genome modification. None of the included articles mentioned more than 60/169 reasons. The reasons could be categorised into: (i) quality of life of affected individuals; (ii) safety; (iii) effectiveness; (iv) existence of a clinical need or alternative; (v) costs; (vi) effects on homo sapiens as a species; (vii) social justice; (viii) potential for misuse; (ix) special interests exercising influence; (x) parental rights and duties; (xi) comparability to acceptable processes; (xii) rights of the unborn child; (xiii) human life and dignity. Conclusions Clinical introduction of germline genome modification should only be considered based on reassuring outcomes of appropriate preclinical effectiveness and safety studies. In the meantime, there is an evident need for a proper pre-implementation process which should address all reasons provided. Such a pre-implantation process is essential for a responsible introduction of germline genome modification or any other new medical technique with potential large scale socio-ethical and legal implications. The provided overview of all reasons will aid in allowing for a systematic and thorough debate on the introduction of germline genome editing.
