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©2021 by The International Society for Stem Cell Research. All rights reserved.

No part of this document may be produced in any form without written permission of The International Society for Stem Cell Research.

2. Laboratory-based Human Embryonic Stem Cell Research, Embryo Research, and Related Research Activities

Stem cell and embryo research show great promise for advancing our understanding of human development and disease, including research to address issues pertinent to the earliest stages of human development, such as: the causes of miscarriage; epigenetic, genetic and chromosomal disorders; and human reproduction. Furthermore, the derivation of some types of stem cell lines necessitates the use of human embryos. 

Scientific research on and with human embryos and embryonic stem cell lines in culture is viewed as ethically permissible in many countries when performed under rigorous scientific and ethical oversight. This is consistent with policy statements of other organizations, most notably, the American Society for Reproductive Medicine (Ethics in Embryo Research Task Force and Ethics Committee of the American Society for Reproductive Medicine, 2020), the European Society of Human Reproduction and Embryology (ESHRE Taskforce on Ethics and Law, 2001), the American College of Obstetricians and Gynecologists (2006) and the United Kingdom (UK) Human Fertilisation and Embryology Authority (2019). Creating embryos for research, which is permitted in relatively few jurisdictions, is required to develop and ensure both standard and novel methods involving IVF (including the use of mitochondrial replacement techniques, in vitro derived gametes, etc.) are safe, efficient, and effective as well as to give information about the first steps of human development.

This section of the Guidelines pertains to:

  1. The banking, derivation, distribution, and preclinical use of human pluripotent stem cells, including human embryonic stem cells (hESCs).
  2. The procurement of human embryos, gametes, and somatic cells for stem cell research and in vitro embryo studies not explicitly entailing stem cell derivation.
  3. The transfer of human pluripotent stem cells into animal host embryos in vitro.
  4. Generation of stem cell-based models of human development. 
  5. Animal research that involves the transfer of human stem cells or their direct derivatives into animal hosts.

Institutions and researchers conducting basic research with these human cells and tissues should follow the guidelines insofar as they pertain to the categories of review discussed below.

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