e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence

Trials

Research

L. Culliford¹  K. Hood²  H. Evans³  A. J. Farrin³  K. Gillies⁴  A. Bravery⁵  S. B. Love⁶  M. R. Sydes⁷  P. R. Williamson⁸  N. Wakefield⁹  E. J. Mitchell⁹  D. Appelbe^1,10 

[1] Bristol Trials Centre, University of Bristol, Bristol Medical School, 1-5 Whiteladies Road, BS8 1NU, Bristol, UK;Centre for Trial Research, College of Biomedical & Life Sciences, Cardiff University, Neuadd Meirionnydd, Heath Park, CF14 4YS, Cardiff, UK;Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, LS2 9NL, Leeds, UK;Health Services Research Unit, Health Sciences Building, University of Aberdeen, AB25 2ZD, Foresterhill, Aberdeen, UK;Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, W12 7RH, London, UK;MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, 90 High Holborn, WC1V 6LJ, London, UK;MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, 90 High Holborn, WC1V 6LJ, London, UK;BHF Data Science Centre, Health Data Research UK, 215 Euston Road, NW1 2BE, London, UK;MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK;Nottingham Clinical Trials Unit, School of Medicine, Applied Health Research Building, University Park, NG7 2RD, Nottingham, UK;Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK;

关键词: Clinical trial;    e-Consent;    Consent;   

DOI  :  10.1186/s13063-023-07656-8

 received in 2023-05-16, accepted in 2023-09-15,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundDuring the COVID-19 pandemic, in-person healthcare visits were reduced. Consequently, trial teams needed to consider implementing remote methods for conducting clinical trials, including e-Consent. Although some clinical trials may have implemented e-Consent prior to the pandemic, anecdotes of uptake for this method increased within academic-led trials. When the increased use of this process emerged, representatives from several large academic clinical trial groups within the UK collaborated to discuss ways in which trialists can learn from one another when implementing e-Consent.MethodsA survey of UKCRC-registered Clinical Trials Units (CTUs) was undertaken in April–June 2021 to understand the implementation of and their views on the use of e-Consent and experiences from the perspectives of systems programmers and quality assurance staff on the use of e-Consent. CTUs not using e-Consent were asked to provide any reasons/barriers (including no suitable trials) and any plans for implementing it in the future. Two events for trialists and patient and public involvement (PPI) representatives were then held to disseminate findings, foster discussion, share experiences and aid in the identification of areas that the academic CTU community felt required more research.ResultsThirty-four (64%) of 53 CTUs responded to the survey, with good geographical representation across the UK. Twenty-one (62%) of the responding CTUs had implemented e-Consent in at least one of their trials, across different types of trials, including CTIMPs (Clinical Trial of Investigational Medicinal Product), ATIMPs (Advanced Therapy Medicinal Products) and non-CTIMPs. One hundred ninety-seven participants attended the two workshops for wide-ranging discussions.Conclusione-Consent is increasingly used in academic-led trials, yet uncertainties remain amongst trialists, patients and members of the public. Uncertainties include a lack of formal, practical guidance and a lack of evidence to demonstrate optimal or appropriate methods to use. We strongly encourage trialists to continue to share their own experiences of the implementation of e-Consent.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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