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

Isabelle Budin-Ljøsne^{1

2}, Harriet J A Teare³, Jane Kaye³, Stephan Beck⁴, Heidi Beate Bentzen^{5

6

7}, Luciana Caenazzo⁸, Clive Collett⁹, Flavio D'Abramo¹⁰, Heike Felzmann¹¹, Teresa Finlay³, Muhammad Kassim Javaid¹², Erica Jones⁴, Višnja Katić¹³, Amy Simpson¹⁴, Deborah Mascalzoni^{15

16}

Affiliations

¹ 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.
² Norwegian Cancer Genomics Consortium, cancergenomics.no, Oslo, Norway. i.b.ljosne@medisin.uio.no.
³ Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
⁴ UCL Cancer Institute, University College London, London, United Kingdom.
⁵ Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Blindern, P.O. Box 1130, NO-0318, Oslo, Norway.
⁶ Norwegian Cancer Genomics Consortium, cancergenomics.no, Oslo, Norway.
⁷ Norwegian Research Center for Computers and Law, Faculty of Law, University of Oslo, Oslo, Norway.
⁸ Università degli Studi di Padova, Padova, Italy.
⁹ Health Research Authority, London, United Kingdom.
¹⁰ Focus Area DynAge, Freie Universität, Berlin, Germany.
¹¹ Centre of Bioethical Research & Analysis, NUI Galway, Galway, Ireland.
¹² NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
¹³ School of Medicine, University of Rijeka, Rijeka, Croatia.
¹⁴ Genetic Alliance UK, London, United Kingdom.
¹⁵ Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.
¹⁶ Centre for Biomedicine, EURAC, Bolzano, Italy.

PMID: 28122615
PMCID: PMC5264333
DOI: 10.1186/s12910-016-0162-9

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

Isabelle Budin-Ljøsne et al. BMC Med Ethics. 2017.

. 2017 Jan 25;18(1):4.

doi: 10.1186/s12910-016-0162-9.

Authors

Affiliations

¹ 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.
² Norwegian Cancer Genomics Consortium, cancergenomics.no, Oslo, Norway. i.b.ljosne@medisin.uio.no.
³ Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
⁴ UCL Cancer Institute, University College London, London, United Kingdom.
⁵ Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Blindern, P.O. Box 1130, NO-0318, Oslo, Norway.
⁶ Norwegian Cancer Genomics Consortium, cancergenomics.no, Oslo, Norway.
⁷ Norwegian Research Center for Computers and Law, Faculty of Law, University of Oslo, Oslo, Norway.
⁸ Università degli Studi di Padova, Padova, Italy.
⁹ Health Research Authority, London, United Kingdom.
¹⁰ Focus Area DynAge, Freie Universität, Berlin, Germany.
¹¹ Centre of Bioethical Research & Analysis, NUI Galway, Galway, Ireland.
¹² NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
¹³ School of Medicine, University of Rijeka, Rijeka, Croatia.
¹⁴ Genetic Alliance UK, London, United Kingdom.
¹⁵ Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.
¹⁶ Centre for Biomedicine, EURAC, Bolzano, Italy.

PMID: 28122615
PMCID: PMC5264333
DOI: 10.1186/s12910-016-0162-9

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.

Keywords: Biobank; Clinical research; Clinical trials; Dynamic consent; Ethics; Participant engagement; Research communication; Software tools.

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Figures

**Fig. 1**
Dynamic Consent’s contribution to phases of research

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources