title: Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines.
abstract: The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.
authors.affiliation: Division of Hematology/Oncology, Boston Children's Hospital and Dana Farber Cancer Institute, Boston, MA 02115, USA. Electronic address: george.daley@childrens.harvard.edu.
authors.forename: George Q
authors.initials: GQ
authors.lastname: Daley
authors.affiliation: Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA.
authors.forename: Insoo
authors.initials: I
authors.lastname: Hyun
authors.affiliation: Centre for Hematology, Imperial College, Hammersmith Hospital, Du Cane Road, London W12 0NN, UK.
authors.forename: Jane F
authors.initials: JF
authors.lastname: Apperley
authors.affiliation: John van Geest Centre for Brain Repair, Department of Clinical Neuroscience, Cambridge CB2 0PY, UK.
authors.forename: Roger A
authors.initials: RA
authors.lastname: Barker
authors.affiliation: Department of Genetics, The Azrieli Center for Stem Cells and Genetic Research, The Hebrew University of Jerusalem, Jerusalem 91904, Israel.
authors.forename: Nissim
authors.initials: N
authors.lastname: Benvenisty
authors.affiliation: Department of Medical Humanities, Julius Center, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, the Netherlands.
authors.forename: Annelien L
authors.initials: AL
authors.lastname: Bredenoord
authors.affiliation: Center for Cardiovascular Research, Nationwide Children's Hospital, Columbus, OH 43215, USA.
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Breuer
authors.affiliation: Health Law Institute, University of Alberta, Edmonton, AB T6G 2H5, Canada.
authors.forename: Timothy
authors.initials: T
authors.lastname: Caulfield
authors.affiliation: University of California San Francisco School of Medicine, San Francisco, CA 94158, USA.
authors.forename: Marcelle I
authors.initials: MI
authors.lastname: Cedars
authors.affiliation: Frey-Vasconcells Consulting, Sykesville, MD 21784, USA.
authors.forename: Joyce
authors.initials: J
authors.lastname: Frey-Vasconcells
authors.affiliation: Center for Cell & Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital and Texas Children's Hospital, Houston, TX 77030, USA.
authors.forename: Helen E
authors.initials: HE
authors.lastname: Heslop
authors.affiliation: Institute of Health Science, Shanghai JiaoTong University School of Medicine/Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences, Shanghai, 200025, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Jin
authors.affiliation: Harvard Department of Stem Cell and Regenerative Biology, Harvard University, Cambridge MA 02138, USA.
authors.forename: Richard T
authors.initials: RT
authors.lastname: Lee
authors.affiliation: Department of Emergency Medicine, University of Alberta, Edmonton, AB T6G 2B7, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: McCabe
authors.affiliation: Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, Department of Anatomy and Neuroscience, University of Melbourne, Melbourne, Parkville, VIC 3010, Australia.
authors.forename: Megan
authors.initials: M
authors.lastname: Munsie
authors.affiliation: Departments of Pathology, Bioengineering and Medicine/Cardiology, Institute for Stem Cell and Regenerative Medicine, Center for Cardiovascular Biology, University of Washington, Seattle, WA 98109, USA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Murry
authors.affiliation: Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Piantadosi
authors.affiliation: The New York Stem Cell Foundation Research Institute, New York, NY 10023, USA; Q Therapeutics, Salt Lake City, UT 84108, USA.
authors.forename: Mahendra
authors.initials: M
authors.lastname: Rao
authors.affiliation: International Society for Stem Cell Research, Skokie, IL 60077, USA.
authors.forename: Heather M
authors.initials: HM
authors.lastname: Rooke
authors.affiliation: RIKEN Center for Developmental Biology, Kobe, 650-0047 Japan; Keio University School of Medicine, Tokyo, 160-8582 Japan.
authors.forename: Douglas
authors.initials: D
authors.lastname: Sipp
authors.affiliation: Center for Stem Cell Biology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
authors.forename: Lorenz
authors.initials: L
authors.lastname: Studer
authors.affiliation: Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
authors.affiliation: Center for Developmental Biology, RIKEN, Kobe, Hyogo 650-0047, Japan.
authors.forename: Masayo
authors.initials: M
authors.lastname: Takahashi
authors.affiliation: ViaCyte, San Diego, CA 92121, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Zimmerman
authors.affiliation: Biomedical Ethics Unit, McGill University, Montreal, QC H3A 1X1, Canada. Electronic address: jonathan.kimmelman@mcgill.ca.
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mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D007258:Informed Consent; D012958:Societies, Scientific / Q000941:ethics / Q000331:legislation & jurisprudence; D057905:Stem Cell Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D013234:Stem Cells / Q000166:cytology / Q000502:physiology*; D057170:Translational Research, Biomedical / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000379:methods
keywords: EMRO; clinical translation; clinical trials; communication; embryo research; guidelines; stem cells