Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

Amy M. Russell; Victoria Shepherd; Kerry Woolfall; Bridget Young; Katie Gillies; Anna Volkmer; Mark Jayes; Richard Huxtable; Alexander Perkins; Nurulamin M. Noor; Beverley Nickolls; Julia Wade

doi:10.1186/s13063-023-07159-6

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

Amy M. Russell, Victoria Shepherd^* (Corresponding Author), Kerry Woolfall, Bridget Young, Katie Gillies, Anna Volkmer, Mark Jayes, Richard Huxtable, Alexander Perkins, Nurulamin M. Noor, Beverley Nickolls, Julia Wade

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. This may be due to participants having communication or other disabilities, their capacity to consent fluctuates or they lack capacity, or in emergency situations where their medical condition or the urgent nature of the treatment precludes seeking consent from either the participant or a representative. These challenges, and the subsequent complexity of designing and conducting trials where alternative consent pathways are required, contribute to these populations being underserved in research. Recognising and addressing these challenges is essential to support trials involving these populations and ensure that they have an equitable opportunity to participate in, and benefit from, research. Given the complex nature of these challenges, which are encountered by both adults and children, a cross-disciplinary approach is required.

Original language	English
Article number	151
Number of pages	12
Journal	Trials
Volume	24
Issue number	1
Early online date	28 Feb 2023
DOIs	https://doi.org/10.1186/s13063-023-07159-6
Publication status	Published - 28 Feb 2023

Bibliographical note

Acknowledgements
We would like to thank the wider contributors to the Complex and Alternate Consent Pathways group and the MRC-NIHR Trials Methodology Research Partnership who have participated in the discussions at various stages of this work. JW would like to acknowledge the support of the QuinteT research group, University of Bristol.

Funding
No funding was received for this work. VS is supported by a National Institute of Health Research Advanced Fellowship (CONSULT) funded by the Welsh government through Health and Care Research Wales (NIHR-FS(A)-2021). AMR is supported by a Wellcome Trust Fellowship (Capacity, Consent and Autonomy https://capacityconsent.leeds.ac.uk/) (219754/Z/19/Z). AV is supported by a National Institute for Health Research Advanced Fellowship (NIHR302240). KG is supported by funding from the Chief Scientist Office of the Scottish Government’s Health and Social Care Directorate (CZU/3/3). This work was supported by the MRC-NIHR Trials Methodology Research Partnership (MR/S014357/1). RH is supported in part by the Wellcome Trust (209841/Z/17/Z and 223290/Z/21/Z), EPSRC (EP/T020792/1), and the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. RH also serves on various local, regional, and national ethics committees and related groups. None of the organisations played a role in the drafting of this article, and the opinions stated are those of the authors.

Keywords

Informed consent
Clinical Trials
Ethics
Undeserved populations

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Cite this

Russell, A. M., Shepherd, V., Woolfall, K., Young, B., Gillies, K., Volkmer, A., Jayes, M., Huxtable, R., Perkins, A., Noor, N. M., Nickolls, B., & Wade, J. (2023). Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action. Trials, 24(1), Article 151. https://doi.org/10.1186/s13063-023-07159-6

Russell, AM, Shepherd, V, Woolfall, K, Young, B, Gillies, K, Volkmer, A, Jayes, M, Huxtable, R, Perkins, A, Noor, NM, Nickolls, B & Wade, J 2023, 'Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action', Trials, vol. 24, no. 1, 151. https://doi.org/10.1186/s13063-023-07159-6

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abstract = "Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. This may be due to participants having communication or other disabilities, their capacity to consent fluctuates or they lack capacity, or in emergency situations where their medical condition or the urgent nature of the treatment precludes seeking consent from either the participant or a representative. These challenges, and the subsequent complexity of designing and conducting trials where alternative consent pathways are required, contribute to these populations being underserved in research. Recognising and addressing these challenges is essential to support trials involving these populations and ensure that they have an equitable opportunity to participate in, and benefit from, research. Given the complex nature of these challenges, which are encountered by both adults and children, a cross-disciplinary approach is required.",

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Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

Abstract

Bibliographical note

Keywords

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