Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction

Following a meeting at the Brocher Foundation in Switzerland, a group of public interest advocates released this statement on heritable human genome editing. They viewed this statement as a corrective to the many statements released by experts in the sciences and bioethics. The authors object to endorsements from these groups to proceed with heritable genome editing research.

Universal Declaration on the Human Genome and Human Rights

UNESCO reacted to developments in genomics by releasing this declaration, which draws on the tradition of the United Nations’ 1948 Universal Declaration on Human Rights and is similarly framed in terms of human dignity, human rights, and fundamental freedoms. The declaration asserts that the human genome is the common heritage of humanity and establishes individual rights regarding the genome, including nondiscrimination, informed consent, and confidentiality. It identifies specific applications of genomics, namely human cloning, as contrary to human dignity.

Statement by the Organizing Committee of the Second International Summit on Human Genome Editing

This statement was released by the organizing committee of the Second International Summit on Human Genome Editing in Hong Kong in 2018, immediately following the revelation of He Jiankui’s heritable genome editing experiments. Though a scandal was emerging, the statement does not repeat the language from the first summit statement about the need for “broad societal consensus” to proceed with heritable genome editing. Instead, it says that its clinical use “remains irresponsible at this time” and beings the work of anticipating a path forward.

Statement from the Organising Committee of the Third International Summit on Human Genome Editing

This statement was released by the organizing committee of the Third International Summit on Human Genome Editing in London in 2023. It continues the trend from the second summit statement of laying out a path to clinical applications of human genome editing. One of the ways in which the organizers accomplish this is by making a distinction between heritable genome editing for reproductive purposes and germline genome editing for research purposes.

Statement on Human Germline Genome Modification

ISSCR released this statement shortly before the publication of CRISPR research on nonviable human embryos. It suggests a moratorium on clinical germline genome editing research. The statement asserts that in addition to the lack of understanding of safety and risk, more social and ethical deliberation are necessary in order to determine whether the clinical use of germline editing will ever be permissible.

Summary statement of the Asilomar conference on recombinant DNA molecules.

Several of the molecular biologists who gathered at the Asilomar Conference Grounds reported back on the conference shortly after its conclusion. They stated their general agreement that the voluntary moratorium called for the previous year need not continue. The researchers laid out the criteria for responsible research, focusing on managing risks (which remained largely unknown) with technical forms of containment rather than limits on risky research.

On Human Gene Editing - International Summit Statement

This statement followed the first three-day International Summit on Human Gene Editing convened by the National Academies of Sciences and Medicine. It summarizes the Organizing Committee’s conclusions, including the conclusion that “it would be irresponsible to proceed with any clinical use of germline editing." It identifies the need for “broad societal consensus” before such research should be pursued and suggests that the subject should be revisited regularly.

Notice Announcing the Removal of the Funding Pause for Gain-of-Function Research Projects

This brief notice announced to researchers and the public that the funding moratorium on gain-of-function research instituted in 2014 would be lifted. This announcement came after the U.S. Government conducted a risk/benefit analysis on such research. Based on this analysis, the Department of Health and Human Services (HHS) established a new framework for the review of dual-use gain-of-function research with potential pandemic pathogens (PPPs). In effect, the U.S.

U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses - October 17, 2014

In 2014, the White House Office of Science and Technology Policy (OSTP) made the decision to pause funding on certain types of gain-of-function research. Gain-of-function research alters pathogenic organisms to test the ability of pathogens to acquire additional virulence. OSTP decided that the biosafety and biosecurity risks of such experiments were too great and decided to impose a moratorium on new federal funding for such research focused on pathogens with high pandemic potential: influenza, MERS, and SARS viruses.

NIH supports call for moratorium on clinical uses of germline gene editing

At the same time Lander et al. published their call for a voluntary moratorium on heritable human germline editing, two leaders of the US National Institutes of Health (NIH) voiced their support. In this brief Nature correspondence on behalf of NIH, Wolinetz, the acting Chief of Staff, and Collins, the Director, also voice support for a process of “substantive debate” and allow that this may result in a ban of human germline editing in the future. The authors also note that NIH is presently prohibited from supporting research on human germline gene editing.