Joint Statement of Ethics Councils from France, Germany and the United Kingdom on the Ethics of Human Germline Intervention

The ethics councils of three major European nations—France, Germany, and the UK—jointly authored this statement on the ethics of human germline genome editing. The statement identifies momentum toward allowing the clinical use of heritable genome editing but argues that this use would require “a level of public ethical reflection that is not yet met by current initiatives.” Accordingly, the three ethics bodies call for broad societal debate and deliberation and argue that this deliberation must focus more on ethical questions and principles.

Human Fertilisation and Embryology: a Framework for Legislation (Cm.: 259)

This report follows the recommendation of the Warnock Report (1984) in creating an independent government body to regulate and oversee assisted reproduction. In the following years, given the diversity of views on the subject, the government made a series of public consultations. By the time the consultation period ended in June 1987, the British Government reaffirmed its intention to have legislation on assisted reproduction, a task for the British parliament.

Report of the IBC on updating its reflection on the Human Genome and Human Rights

Following a UNESCO meeting in Paris, the International Bioethics Committee (IBC) released this report, which clarifies its stance on recent research related to human genomics. It includes special considerations for heritable genome editing and specifically calls for a moratorium on such applications. The reasoning the IBC provides is that such interventions raise “serious concerns,” including threats to human dignity and the prospect of eugenic applications.

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention)

This treaty is more commonly known as the “Oviedo Convention,” after the city in Spain where it was ratified. The Oviedo Convention is based on the European Convention of Human rights and is the only legally binding international instrument for protecting human rights in biology and medicine, covering both clinical and research settings and giving special consideration to human dignity. It lays out the rights of patients and research subjects for Europe, focusing largely on individual rights of informed consent and privacy but also mandating consideration of equitable access to health care.

Intervention on the Human Genome: Re-examination Process of Article 13 of the Oviedo Convention - Conclusions and Clarifications

In 2021, the Council of Europe determined that it was necessary to clarify the provisions of the Oviedo Convention pertaining to human genome editing. These clarifications were designed to clear up ambiguity surrounding the applicability of Article 13 of the Oviedo Convention to research and in particular, the use of the terms “preventive, diagnostic and therapeutic.” The clarifications approved by the Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO) specify that Article 13’s restrictions apply to human genome editing for both clinical and research purposes.

Report of the First Meeting

The World Health Organization established an international and multi-disciplinary expert panel, composed largely of biomedical researchers, clinicians, and bioethicists, to assess the “scientific, ethical, social, and legal challenges with human genome editing (both somatic and germline)" (2019:1).

Report of the Committe of Inquiry into Human Fertilisation and Embryology (Warnock Report)

Known as the Warnock Report, this document primarily deals with issues surrounding in-vitro fertility treatments in the UK. However, it also includes recommendations on related matters of research on human gametes and embryos. One of the many consequential features of the Warnock Report was its advocacy of a fourteen-day limit on the culture of human embryos, the “14-day rule” that eventually made its way into UK law.

HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer: Report and Conclusions

This U.S. government report is widely acknowledged to contain (on pages 106-107) the first imposition of a two-week limit on culturing human embryos. It reads "The Ethics Advisory Board finds that it is acceptable from an ethical standpoint to undertake research involving human in vitro fertilization and embryo transfer provided that . . .

Agricultural Biotechnology: The U.S.-EU Dispute

In a US Congressional Research Service report, Charles Hanrahan recounts a dispute between the United States (along with Argentina and Canada) and the EU over the subject of genetically modified crops. The EU had kept a de facto moratorium on the import of genetically engineered foodstuffs, which the US argued was in violation of World Trade Organization rules and was causing economic harm to the United States both directly and through the global influence of EU policy.

ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update

This document was written by the 45 members of the International Society for Stem Cell Research (ISSCR) task force charged with revising the Society’s guidelines for stem cell and related biological research. Such revision was necessary, as the task force put it, to “evolve[e] with the science” (2021:1399). They explain their deliberative procedure and highlight the differences between the 2016 and 2021 editions of the guidelines.

Human Genome Editing: Science, Ethics, and Governance

The National Academies of Sciences and Medicine convened a committee to summarize the important considerations for the future of human gene editing, including both somatic and germline editing. They lump these considerations into three categories: the scientific, the medical, and the ethical. They note that public engagement is especially important in the case of germline editing.

Heritable Human Genome Editing

Produced by a joint commission of leading science advisory bodies in the USA and UK, this was the first major advisory report to be spurred by news that gene-edited twins had been born in China in 2018. While cautioning that relevant criteria for safety had not yet been met, the report sought to define a "responsible translational pathway" by which heritable human genome editing (HHGE) could be applied in a clinical setting. This pathway emphasizes a risk/benefit framework, balancing risks to individuals against the potential benefits of treating monogenic diseases.

Genome editing: an ethical review

This report from the independent UK Nuffield Council on Bioethics takes a broad view of the practical and ethical significance of genome editing. It responds in part to the development of CRISPR/Cas9 and examines applications of genome editing well beyond the human. It divides its analysis into several different “fields of activity” in which CRISPR/Cas9 and genome editing more broadly have anticipated impacts.

Human Embryo Culture: Discussions concerning the statutory time limit for maintaining human embryos in culture in the light of some recent scientific developments

The UK’s independent Nuffield Council of Bioethics convened an expert workshop to respond to the question of whether the 14-day rule should be reevaluated in the wake of new technological developments. The Council explains the logic underlying the initial establishment of the rule and the UK’s specific legal mechanisms providing licensed exceptions for research on embryos younger than two weeks.

Genome editing and human reproduction: social and ethical issues

The UK’s independent Nuffield Council on Bioethics prepared this 2018 report in response to recent developments in biological genome editing techniques. The report provides background, speculation on future directions of the technology, an analysis of a range of ethical considerations, and recommendations for governance of human germline genome editing. The report broadly determines that the important ethical considerations limit the range of applications for germline editing.