title: Dynamic Consent: a potential solution to some of the challenges of modern biomedical research.
abstract: Innovations 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.
  
  
  
  An 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.
  
  
  
  Dynamic 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.
  
  
  
  Dynamic 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.
authors.affiliation: Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Blindern, P.O. Box 1130, NO-0318, Oslo, Norway. i.b.ljosne@medisin.uio.no.|Norwegian Cancer Genomics Consortium, cancergenomics.no, Oslo, Norway. i.b.ljosne@medisin.uio.no.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Budin-Ljøsne
authors.affiliation: Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
authors.forename: Harriet J A
authors.initials: HJ
authors.lastname: Teare
authors.affiliation: Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
authors.forename: Jane
authors.initials: J
authors.lastname: Kaye
authors.affiliation: UCL Cancer Institute, University College London, London, United Kingdom.
authors.forename: Stephan
authors.initials: S
authors.lastname: Beck
authors.affiliation: Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Blindern, P.O. Box 1130, NO-0318, Oslo, Norway.|Norwegian Cancer Genomics Consortium, cancergenomics.no, Oslo, Norway.|Norwegian Research Center for Computers and Law, Faculty of Law, University of Oslo, Oslo, Norway.
authors.forename: Heidi Beate
authors.initials: HB
authors.lastname: Bentzen
authors.affiliation: Università degli Studi di Padova, Padova, Italy.
authors.forename: Luciana
authors.initials: L
authors.lastname: Caenazzo
authors.affiliation: Health Research Authority, London, United Kingdom.
authors.forename: Clive
authors.initials: C
authors.lastname: Collett
authors.affiliation: Focus Area DynAge, Freie Universität, Berlin, Germany.
authors.forename: Flavio
authors.initials: F
authors.lastname: D'Abramo
authors.affiliation: Centre of Bioethical Research & Analysis, NUI Galway, Galway, Ireland.
authors.forename: Heike
authors.initials: H
authors.lastname: Felzmann
authors.affiliation: Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
authors.forename: Teresa
authors.initials: T
authors.lastname: Finlay
authors.affiliation: NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
authors.forename: Muhammad Kassim
authors.initials: MK
authors.lastname: Javaid
authors.affiliation: UCL Cancer Institute, University College London, London, United Kingdom.
authors.forename: Erica
authors.initials: E
authors.lastname: Jones
authors.affiliation: School of Medicine, University of Rijeka, Rijeka, Croatia.
authors.forename: Višnja
authors.initials: V
authors.lastname: Katić
authors.affiliation: Genetic Alliance UK, London, United Kingdom.
authors.forename: Amy
authors.initials: A
authors.lastname: Simpson
authors.affiliation: Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.|Centre for Biomedicine, EURAC, Bolzano, Italy.
authors.forename: Deborah
authors.initials: D
authors.lastname: Mascalzoni
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000379:methods*; D003142:Communication; D003625:Data Collection / Q000379:methods*; D032984:Ethics, Research; D005500:Follow-Up Studies; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent; D018579:Patient Selection; D011369:Professional-Patient Relations; D012107:Research Design; D012108:Research Personnel; D035842:Research Subjects
keywords: Biobank; Clinical research; Clinical trials; Dynamic consent; Ethics; Participant engagement; Research communication; Software tools