One small edit for humans, one giant edit for humankind? Points and questions to consider for a responsible way forward for gene editing in humans

Abstract

Gene editing, which allows for specific location(s) in the genome to be targeted and altered by deleting, adding or substituting nucleotides, is currently the subject of important academic and policy discussions. With the advent of efficient tools, such as CRISPR-Cas9, the plausibility of using gene editing safely in humans for either somatic or germ line gene editing is being considered seriously. Beyond safety issues, somatic gene editing in humans does raise ethical, legal and social issues (ELSI), however, it is suggested to be less challenging to existing ethical and legal frameworks; indeed somatic gene editing is already applied in (pre-) clinical trials. In contrast, the notion of altering the germ line or embryo such that alterations could be heritable in humans raises a large number of ELSI; it is currently debated whether it should even be allowed in the context of basic research. Even greater ELSI debates address the potential use of germ line or embryo gene editing for clinical purposes, which, at the moment is not being conducted and is prohibited in several jurisdictions. In the context of these ongoing debates surrounding gene editing, we present herein guidance to further discussion and investigation by highlighting three crucial areas that merit the most attention, time and resources at this stage in the responsible development and use of gene editing technologies: (1) conducting careful scientific research and disseminating results to build a solid evidence base; (2) conducting ethical, legal and social issues research; and (3) conducting meaningful stakeholder engagement, education and dialogue.

Civil liability for damages related to germline and embryo editing against the legal admissibility of gene editing

“…2 of the new Regulation no. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, repealing Directive 2001/20/EC that was not yet transposed to the member states of the European Union (Howard et al, 2018). However, this article does not seem to ban all types of gene editing but only those that alter "the subject's germ line genetic identity".…”

Precision medicine in the era of CRISPR-Cas9: evidence from Bosnia and Herzegovina

“…Use of genome editing to amend human genomes, today facilitated by the technology of CRISPR-Cas9, raises serious health and ethical concerns, particularly if changes are made to genes in egg or sperm cells (germline cells) or in the genes of an embryo through CRISPR-Cas9 that could be passed to future generations (Howard et al, 2018). Tinkering with the reproductive cells constitutes inherently unsafe human experimentation also effectively irreversible that could put any resulting children at risk of harm.…”

CRISPR: Challenges to South African biotechnology law

“…The United Nations Educational, Scientific and Cultural Organization (UNESCO) has taken a conservative stance, calling for a temporary ban on any use of germline gene editing. [3] The US National Academy of Sciences and the National Academy of Medicine released a report entitled Human Genome Editing: Science, Ethics, and Governance, in which a slightly more flexible approach is adopted that allows for clinical trials of germline gene editing if ten criteria are met. [15] Internationally, according to a survey of 39 countries -including the UK, USA, China and SA -conducted by Araki and Ishii, [16] there is dissidence regarding the ban on human germline editing.…”

“…Actors involved recognise the need to advance this technology to maximise benefits to society, but also the need to apply caution so as to protect public and environmental health. [3] Central to these debates is the fact that CRISPR-Cas9 is a relatively nascent technology, the potential of which to impact on human, animal and environmental health cannot be determined with perfect clarity. This echoes the sentiments in the debate on genetically modified organisms (GMOs).…”