ISSCR Updates Guidelines for Stem Cell Research

The International Society for Stem Cell Research (ISSCR) recently issued 2016 Guidelines for Stem Cell Research and Clinical Translation.  The new Guidelines update and expand the 2006 and 2008 guideline “topic areas and bring all guidance together under common principles of research integrity, patient welfare, respect for research subjects, transparency, and social justice.”  A new recommendation is “a specialized human embryo research oversight (EMRO) process capable of evaluating the unique aspects of the science.”  Because they are not derived from embryos, induced pluripotent stem (iPS) cells are exempted from an EMRO process, but iPS cells should still be reviewed under existing human subject protection requirements for donor cell recruitment.  The new Guidelines support “laboratory-based research that entails modifying the nuclear genomes of gametes, zygotes and/or preimplantation human embryos,” but recommend prohibiting the application of such modification techniques to human reproduction.  Several recommendations address transparency and research results:  “All trials should be prospectively registered in public databases, Investigators should report adverse events…, and Researchers should promptly publish aggregate results regardless of whether they are positive, negative or inconclusive.”  The ISSCR recognizes that “guidelines do not supersede local laws and regulations,” but “they can inform the interpretation and development of local laws and provide guidance for research practices not covered by legislation.  For additional information, see the 5/12/16 ISSCR news release page.