Guidelines for Stem Cell Research and Clinical Translation

The International Society for Stem Cell Research (ISSCR) produces research guidelines every five years with the intention of promoting responsible advances in research and clinical applications of stem cell biology. The 2016 guidelines provide a number of recommendations on clinical and ethical principles, including protocols for provision of biomaterials, informed consent processes, documentation, safety and efficacy, privacy, reporting of clinical trials, and other matters for clinical practice. The attention placed on research oversight bodies is noteworthy, such as the expansion of the stem-cell research oversight (SCRO) committees to encompass all forms of embryo research in humans. For our purposes, these guidelines provide a point of reference for ISSCR’s later 2021 guidelines, which abandon strict observation of the 14-day rule in 2021. In the 2016 guidelines, the culture of embryos beyond 14 days remained in category 3: prohibited research (the same three categories have persisted since ISSCR released its first guidelines in 2006). Of importance, at the time of publication (2016), there were already debates about the relaxation of the 14-day rule (e.g., Hyun et al 2016), given the scientific advances that took place in 2016. The task force that produced the 2016 guidelines was chaired by bioethicist Jonathan Kimmelman.