Dynamic Consent: a potential solution to some of the challenges of modern biomedical research

BMC Medical Ethics

Research Article

Teresa Finlay¹  Jane Kaye¹  Harriet J. A. Teare¹  Isabelle Budin-Ljøsne²  Heidi Beate Bentzen³  Deborah Mascalzoni⁴  Heike Felzmann⁵  Flavio D’Abramo⁶  Amy Simpson⁷  Clive Collett⁸  Muhammad Kassim Javaid⁹  Višnja Katić^1,10  Erica Jones^1,11  Stephan Beck^1,11  Luciana Caenazzo^1,12 

[1]Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom

[2]Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Blindern, P.O. Box 1130, NO-0318, Oslo, Norway

[3]Norwegian Cancer Genomics Consortium, cancergenomics.no, Oslo, Norway

[4]Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Blindern, P.O. Box 1130, NO-0318, Oslo, Norway

[5]Norwegian Cancer Genomics Consortium, cancergenomics.no, Oslo, Norway

[6]Norwegian Research Center for Computers and Law, Faculty of Law, University of Oslo, Oslo, Norway

[7]Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden

[8]Centre for Biomedicine, EURAC, Bolzano, Italy

[9]Centre of Bioethical Research & Analysis, NUI Galway, Galway, Ireland

[10]Focus Area DynAge, Freie Universität, Berlin, Germany

[11]Genetic Alliance UK, London, United Kingdom

[12]Health Research Authority, London, United Kingdom

[13]NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom

[14]School of Medicine, University of Rijeka, Rijeka, Croatia

[15]UCL Cancer Institute, University College London, London, United Kingdom

[16]Università degli Studi di Padova, Padova, Italy

关键词: Dynamic consent;    Participant engagement;    Research communication;    Ethics;    Biobank;    Clinical trials;    Clinical research;    Software tools;   

DOI  :  10.1186/s12910-016-0162-9

 received in 2016-06-09, accepted in 2016-12-26,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundInnovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.MethodsAn interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.ResultsDynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.ConclusionsDynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.

【 授权许可】

CC BY   
© The Author(s). 2017