TY - JOUR
T1 - Dynamic Consent
T2 - A potential solution to some of the challenges of modern biomedical research
AU - Budin-Ljøsne, Isabelle
AU - Teare, Harriet J.A.
AU - Kaye, Jane
AU - Beck, Stephan
AU - Bentzen, Heidi Beate
AU - Caenazzo, Luciana
AU - Collett, Clive
AU - D'Abramo, Flavio
AU - Felzmann, Heike
AU - Finlay, Teresa
AU - Javaid, Muhammad Kassim
AU - Jones, Erica
AU - Katić, Višnja
AU - Simpson, Amy
AU - Mascalzoni, Deborah
N1 - Publisher Copyright:
© 2017 The Author(s).
PY - 2017/1/25
Y1 - 2017/1/25
N2 - 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.
AB - 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.
KW - Biobank
KW - Clinical research
KW - Clinical trials
KW - Dynamic consent
KW - Ethics
KW - Participant engagement
KW - Research communication
KW - Software tools
UR - https://www.scopus.com/pages/publications/85010755533
U2 - 10.1186/s12910-016-0162-9
DO - 10.1186/s12910-016-0162-9
M3 - Article
SN - 1472-6939
VL - 18
JO - BMC Medical Ethics
JF - BMC Medical Ethics
IS - 1
M1 - 4
ER -