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

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

Keywords

Informed consent
Clinical Trials
Ethics
Undeserved populations

Access to Document

10.1186/s13063-023-07159-6Licence: CC BY

Russell_etal_T_Complex_And_Alternate_VoR
© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. T
Final published version, 994 KBLicence: CC BY

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), [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

@article{32fe18b34c464d42af9f89a9a1c0cae4,

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

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.",

keywords = "Informed consent, Clinical Trials, Ethics, Undeserved populations",

author = "Russell, {Amy M.} and Victoria Shepherd and Kerry Woolfall and Bridget Young and Katie Gillies and Anna Volkmer and Mark Jayes and Richard Huxtable and Alexander Perkins and Noor, {Nurulamin M.} and Beverley Nickolls and Julia Wade",

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{\textquoteright}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.",

year = "2023",

month = feb,

day = "28",

doi = "10.1186/s13063-023-07159-6",

language = "English",

volume = "24",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

}

TY - JOUR

T1 - Complex and alternate consent pathways in clinical trials

T2 - methodological and ethical challenges encountered by underserved groups and a call to action

AU - Russell, Amy M.

AU - Shepherd, Victoria

AU - Woolfall, Kerry

AU - Young, Bridget

AU - Gillies, Katie

AU - Volkmer, Anna

AU - Jayes, Mark

AU - Huxtable, Richard

AU - Perkins, Alexander

AU - Noor, Nurulamin M.

AU - Nickolls, Beverley

AU - Wade, Julia

N1 - 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.

PY - 2023/2/28

Y1 - 2023/2/28

N2 - 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.

AB - 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.

KW - Informed consent

KW - Clinical Trials

KW - Ethics

KW - Undeserved populations

U2 - 10.1186/s13063-023-07159-6

DO - 10.1186/s13063-023-07159-6

M3 - Article

VL - 24

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 151

ER -

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

Abstract

Keywords

Access to Document

Fingerprint

Cite this