Dynamic Consent: a potential solution to some of the challenges of modern biomedical research
Isabelle Budin-Ljøsne,Harriet Teare,Jane Kaye,Stephan Beck,Heidi Beate Bentzen,Luciana Caenazzo,Clive Collett,Flavio D'Abramo,Heike Felzmann,Teresa Finlay,Muhammad Javaid,Erica Jones,Višnja Katić,Amy Simpson,Deborah Mascalzoni +14 more
TL;DR: 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.
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Abstract: Background 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. Methods 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. Results 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. Conclusions 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.
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Citations
Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process
Deborah Mascalzoni,Roberto Melotti,Cristian Pattaro,Peter P. Pramstaller,Martin Gögele,Alessandro De Grandi,Roberta Biasiotto +6 more
TL;DR: The experience with the CHRIS study dynamic consent is described, providing an overview of its conceptualization and implementation, and of the participant-centered strategies used to assess and improve the process, directly linked to participation and communication.
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Terje B. Holmlund,Peter W. Foltz,Alex S. Cohen,Håvard D. Johansen,Randi Sigurdsen,Pål Fugelli,Dagfinn Bergsager,Jian Cheng,Jared Bernstein,Elizabeth Rosenfeld,Brita Elvevåg +10 more
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Remote monitoring of cardiac implanted electronic devices: legal requirements and ethical principles - ESC Regulatory Affairs Committee/EHRA joint task force report.
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