Table 1

Recent organisational or expert body statements on the ethics of heritable gene editing (HGE)*

YearBodyTitleKey points
2018Nuffield Council on BioethicsGenome editing and human reproductionApplications of HGE may be morally permissible if they are consistent with the welfare of the future person and social justice. This may allow for applications beyond preventing disease. Further research must be done into efficacy and safety and a broader societal debate must be facilitated, as well as ensuring adequate governance.
2018Génome Québec & Centre of Genomics and PolicyHuman genome editing: ethical and policy considerationsThe modification of human germ cells and embryos should be permitted in a basic or preclinical research context, any future clinical germline modifications should be for serious diseases only (and criteria need to be outlined) and an inclusive approach to policymaking should be encouraged.
2017National Academy of Sciences, Engineering and MedicineHuman genome editing: science, ethics and governanceIf technical challenges relating to safety and efficacy were overcome, clinical trials for HGE should only be permitted if there is an absence of reasonable alternatives, be restricted to genes that clearly cause or predispose to a severe disability or disease, with conversion only to genes that currently exist in the population. Regulatory oversight and public debate is essential. No trials for purposes other than the prevention of disease should be permitted at this time, but public debate on the matter should be facilitated.
2017American Society of Human Genetics (ASHG)†Human germline genome editing: ASHG position statement
  1. At this time, it is not appropriate to conduct HGE that results in human pregnancy.

  2. As long as there is appropriate oversight, there is no reason to prohibit or not use public funds for in vitro germline gene editing for research into clinical applications.

  3. Future clinical applications should only proceed if there is: (i) a medical rationale, (ii) strong evidence base, (iii) an ethical justification and (iv) a transparent public process.

2017Opinion Group of the Bioethics and Law Observatory, University of BarcelonaDeclaration on bioethics and gene editing in humansA moratorium is useless in an international and competitive scientific world. Regulatory frameworks are needed to govern any clinical application of germline genome editing, and it should not be used for enhancement.
2017Council of EuropeRecommendation 2115: the use of new genetic technologies in human beingsDeliberate germline editing in human beings would cross a line viewed as ethically inviolable. A regulatory framework needs to be developed and a broad and informed public debate should be fostered.
2017Federation of European Academies of Medicine (FEAM)The application of genome editing in humansThere are major ethical, safety and efficacy issues that must be resolved before clinical applications of HGE can be considered. There is no broad societal consensus in Europe. Generally, FEAM does not support genome editing for non-medical interventions (including somatic genome editing), but anticipates a wide-ranging public discussion on this matter.
2017European Academies Science Advisory CouncilGenome editing: scientific opportunities, public interests and policy options in the European UnionIt would be irresponsible to proceed with germline editing until the numerous safety and efficacy concerns have been resolved. There is a need for an ongoing forum.
2017American College of Medical Genetics and GenomicsGenome editing in clinical genetics: points to considerThere are technical concerns (eg, the risk of off-target effects or epigenetic effects that may affect many future generations) as well as ethical concerns (which variants that are to be edited needs to be discussed at a societal level).
2015National Academy of Sciences, Engineering and MedicineInternational summit on human gene editingIt would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application.
2015Academy of Medical Sciences (UK)‡Genome editing in human cells—initial joint statementEthical and regulatory questions must be debated before clinical applications of editing germ cells can be considered.
2015Hinxton Group§Statement on genome editing technologies and human germline genetic modificationWhen all safety, efficacy and governance needs are met, there may be morally acceptable uses for HGE for reproductive purposes. Further debate as to what specific uses are morally acceptable is required.
2015American Society for Gene and Cell Therapy (ASGCT) and Japan Society of Gene Therapy (JSGT)ASGCT and JSGT joint position statement on human genomic editingAs available genome editing technologies are inadequately understood, and because the results of such manipulation could not be understood for decades or generations, these safety and efficacy concerns are sufficiently serious to support a strong stance against HGE.
2015Alliance for Regenerative Medicine¶Do not edit the human germlineThe scientific community is urged to engage in dialogue and put in place a voluntary moratorium to discourage human germline modification. This is due to scientific and ethical risks such as that permitting even unambiguously therapeutic interventions could start down a path towards non-therapeutic genetic enhancement.
2015IGI Forum on Bioethics, Napa, California**A prudent path forward for genomic engineering and germline gene modification
  1. Any attempts at clinical applications of germline gene editing are strongly discouraged.

  2. Expert forums of scientists and bioethicists must be held to further discuss these issues.

  3. Transparent research should be encouraged and supported.

  4. A globally representative group of a wide range of stakeholders (including the general public and government bodies) should be assembled to further discuss these issues and make policy recommendations.

2015International Society for Stem Cell Research (ISSCR)††The ISSCR statement on human germline genome modificationAny consideration of applying nuclear genome editing to the human germline in clinical practice raises significant ethical, societal and safety considerations. Therefore, the ISSCR calls for a moratorium on germline genome editing in clinical practice (excepting mitochondrial replacement therapy), although in vitro research is supported.
2015National Institutes of Health (NIH)Statement on NIH funding of research using gene-editing technologies in human embryosSafety, ethical and regulatory issues means that altering the human germline in embryos is ‘a line that should not be crossed’. NIH will not fund any use of gene editing in embryos.
(N.B.: as of 2018, NIH is funding research into somatic cell genome editing).
  • *Organisational recommendations are included here. A search was conducted using a branched strategy, beginning with the use of search terms in databases such as PubMed and Google Scholar using search terms such as ‘human heritable genome editing’, ‘germline gene editing’, ‘genome editing embryos’, ‘germline engineering’, ‘human germline editing’+‘ethics’, ‘policy’ and/or ‘recommendations’. Furthermore, citations and references were examined to generate further results. A large number of papers were identified discussing these issues, including a number of recommendations. Results were limited to those from 2008 onwards (ie, the past decade at time of writing); all papers by individuals or groups of individuals not representing an organisation, body or conference were discarded, as well as empirical research into opinions on germline editing by specific sectors of society (eg, general public, healthcare professionals). The final group of results was limited to organisations whose remit includes human genetics, genetics policy, bioethics, reproductive technologies and/or emerging technologies. Organisational responses to statements and journal editorials were not included. This list is not exhaustive.

  • †Statement endorsed by UK Association of Genetic Nurses and Counsellors, Canadian Association of Genetic Counsellors, International Genetic Epidemiology Society, US National Society of Genetic Counselors, 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. The Alliance for Regenerative Medicine (an international multistakeholder group, including commercial stakeholders), released a statement supporting this position.

  • ‡Joint statement with the Association of Medical Research Charities, the Medical Research Council and the Wellcome Trust.

  • §A group consisting of an international collection of academics from disciplines such as the life sciences, philosophy, medicine and economics, from universities including John Hopkins, Oxford and London School of Economics.

  • ¶A group consisting of commercial companies, research institutions, non-profit organisations and patient advocacy groups. Corporations comprise 73% of stakeholders and thus this organisation should be primarily considered to represent the views of corporations such BD Biosciences, GE Healthcare, GSK, MilliporeSigma, Novartis and Pfizer, among many others. They later released a statement supporting the ASHG position statement (see footnote 1).

  • **A large number of expert stakeholders attended and made this position statement, including the inventors of CRISPR-Cas9.

  • ††A non-profit organisation encouraging research into the use of stem cells.