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Regenerative Medicine

Disclosure and management of research findings in stem cell research and banking: policy statement

    Rosario Isasi

    * Author for correspondence

    Center of Genomics & Policy, Faculty of Medicine, Department of Human Genetics, McGill University, Montreal, QC, Canada; Centre of Genomics & Policy, McGill University, QC, Canada.

    ,
    Bartha M Knoppers

    Center of Genomics & Policy, Faculty of Medicine, Department of Human Genetics, McGill University, Montreal, QC, Canada

    ,
    Peter W Andrews

    Department of Biomedical Science, University of Sheffield, Sheffield, UK

    ,
    Annelien Bredenoord

    Julius Center, Department of Medical Ethics, University Medical Center Utrecht, Utrecht, The Netherlands

    ,
    Alan Colman

    Singapore Stem Cell Consortium, Institute of Medical Biology, Singapore

    ,
    Lee Eng Hin

    Division of Graduate Medical Studies, Faculty of Medicine, National University of Singapore, Singapore

    ,
    Sara Hull

    NHGRI Bioethics Core, NIH, MD, USA

    ,
    Ock-Joo Kim

    Department of Medical History & Medical Humanities, College of Medicine Seoul National University, Seoul, Korea

    ,
    Geoffrey Lomax

    California Institute for Regenerative Medicine, CA, USA

    ,
    Clive Morris

    National Health & Medical Research Council, Canberra, Australia

    ,
    Douglas Sipp

    Research Unit for Science Policy & Ethics Studies, RIKEN Center for Developmental Biology, Kobe, Japan

    ,
    Glyn Stacey

    Division of Cell Biology & Imaging, National Institute for Biological Standards & Control, UK Stem Cell Bank, Potters Bar, UK

    ,
    Jan Wahlstrom

    Department of Medical Genetics, University of Gothenburg, Göteborg, Sweden

    &
    Fanyi Zeng

    Shanghai Institute of Medical Genetics, Shanghai Stem Cell Institute, Shanghai, China

    ;
    for the International Stem Cell Forum Ethics Working Party

    International Stem Cell Forum Ethics Working Party: McGill University & Génome Québec Innovation Center, 740 Dr Penfield, Suite 5206, Montreal, QC, H3A 1A4, Canada

    Published Online:https://doi.org/10.2217/rme.12.23

    Prompted by an increased interest of both research participants and the patient advocacy community in obtaining information about research outcomes and on the use of their biological samples; the international community has begun to debate the emergence of an ethical ‘duty’ to return research results to participants. Furthermore, the use of new technologies (e.g., whole-genome and -exome sequencing) has revealed both genetic data and incidental findings with possible clinical significance. These technologies together with the proliferation of biorepositories, provide a compelling rationale for governments and scientific institutions to adopt prospective policies. Given the scarcity of policies in the context of stem cell research, a discussion on the scientific, ethical and legal implications of disclosing research results for research participants is needed. We present the International Stem Forum Ethics Working Party’s Policy Statement and trust that it will stimulate debate and meet the concerns of researchers and research participants alike.

    Papers of special note have been highlighted as: ▪▪ of considerable interest

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