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

• Published in: BMC medical ethics Vol. 18; no. 1; p. 4
• Main Authors: Budin-Ljøsne, Isabelle, Teare, Harriet J. A., Kaye, Jane, Beck, Stephan, Bentzen, Heidi Beate, Caenazzo, Luciana, Collett, Clive, D’Abramo, Flavio, Felzmann, Heike, Finlay, Teresa, Javaid, Muhammad Kassim, Jones, Erica, Katić, Višnja, Simpson, Amy, Mascalzoni, Deborah
• Format: Journal Article
• Language: English
• Published: London BioMed Central 25.01.2017; BioMed Central Ltd
• Subjects: Beliefs, opinions and attitudes; Biobank; Biomedical Research - ethics; Biomedical Research - methods; Clinical research; Clinical trials; Communication; Data Collection - methods; Dynamic consent; Education; Ethical aspects; Ethics; Ethics in Biomedical Research; Ethics, Research; Follow-Up Studies; Forecasts and trends; Humans; Information Dissemination; Informed Consent; legal; Management; Medical research; Medical research volunteers; Participant engagement; Patient Selection; Philosophy; Philosophy of Medicine; Professional-Patient Relations; Research Article; Research communication; Research Design; Research Personnel; Research Subjects; social implications; Software tools; Theory of Medicine/Bioethics; Translation in healthcare: ethical; Ethics; Dynamic consent; Biobank; Research communication; Clinical trials; Participant engagement; Clinical research; Software tools
• ISSN: 1472-6939; 1472-6939
• DOI: 10.1186/s12910-016-0162-9

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.