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Human embryo research policy update

Ethics standards for studies that report human embryo and stem cell research.

Ethics regulations governing research with human embryos, gametes, and embryonic stem cells vary considerably among countries. The International Society for Stem Cell Research (ISSCR) has long sought to raise and harmonize ethical standards in the field, and two years ago published recommendations for scientists in its Guidelines for Stem Cell Research and Clinical Translation. In support of efforts by the ISSCR and other stakeholders to promote the ethical conduct of stem cell research, Nature journals have released an updated policy (https://www.nature.com/authors/policies/experimental.html). The policy, which formalizes and refines longstanding editorial practices, encourages scientists to adopt the ISSCR guidelines. For manuscripts submitted to Nature Biotechnology and other Nature journals, it defines the types of study requiring an ethics statement and a smaller group of studies requiring both an ethics statement and review by an ethicist.

The ISSCR guidelines prescribe categories of research that warrant specialized review through a “human embryo research oversight (EMRO) process.” In line with this objective, our policy requires an ethics statement, backed by EMRO-type review, for manuscripts in the following areas: (i) research on human embryos and gametes, (ii) research on animal–human chimeras where human cells may contribute significantly to the host central nervous system or gametes, and (iii) clinical studies in which human subjects are donors or recipients of embryos, gametes, or cells derived from pluripotent stem cells. The ethics statement should report the review boards that monitored the research and the conditions of cell donation and transplantation, including informed consent.

The editors will consult an ethicist reviewer alongside the scientific peer review for papers describing especially sensitive research, such as genome engineering of human embryos or gametes, culture of human embryos or embryo-like structures for around 14 days (Nat. Biotechnol. 35, 1029–1042, 2017), and clinical studies with cells derived from pluripotent stem cells. As in the past, research prohibited according to current ethical consensus (e.g., human reproductive cloning) will not be sent for peer review or published.

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Human embryo research policy update. Nat Biotechnol 36, 477 (2018). https://doi.org/10.1038/nbt.4171

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