Guidelines for Stem Cell Research and Clinical Translation

The ISSCR is an international body founded in 2002 that harmonizes global ethical standards and regulation for research with embryos, stem cells and gametes. The organization updated its 2016 guidelines to accommodate scientific advances in embryo research, embryo models, organoids, chimeras, genome editing, and mitochondrial replacement techniques. Of particular interest is the relaxation of the 14-day rule for in vitro embryo culture. Recommendation 2.2.2.1 of the report puts into question whether certain circumstances justify culture of embryos beyond 14 days. The relaxation of the rule has sparked debate regarding the establishment and maintenance of limits surrounding embryo research. This is reflected in the recategorization of embryo research from Category 3 (“not allowed”) to Category 2 (“reviewed by a specialized oversight process”). Notably, heritable genome editing remains in Category 3A, “not allowed,” due to being “currently unsafe”). The task force that produced the report was chaired by British scientist Robin Lovell-Badge, an influential figure in recent discussions about ethics and norms of embryo and stem cell biology.