Abstract
Background
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 across both adults and children, a cross-disciplinary approach is
required.
Discussion
A UK-wide collaboration, a sub-group of the Trial Conduct Working Group in the MRC-NIHR Trial
Methodology Research Partnership, was formed to collectively address these challenges. Members are
drawn from disciplines including bioethics, qualitative research, trials methodology, healthcare
professions, and social sciences. This commentary draws on our collective expertise to identify key
populations where particular methodological and ethical challenges around consent are encountered,
articulate the specific issues arising in each population, summarise ongoing and completed research, and
identify targets for future research. Key populations include people with communication or other
disabilities, people whose capacity to consent fluctuates, adults who lack capacity to consent, and adults
and children in emergency and urgent care settings. Work is ongoing by the sub-group to create a
database of resources, update NIHR guidance and to develop proposals to address identified research
gaps.
Conclusion
Collaboration across disciplines, sectors, organisations, and countries is essential if the ethical and
methodological challenges surrounding trials involving complex and alternate consent pathways are to
be addressed. Explicating these challenges, sharing resources, and identifying gaps for future research is
an essential first step. We hope that doing so will serve as a call to action for others seeking ways to
address the current consent-based exclusion of underserved populations from trials.
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 across both adults and children, a cross-disciplinary approach is
required.
Discussion
A UK-wide collaboration, a sub-group of the Trial Conduct Working Group in the MRC-NIHR Trial
Methodology Research Partnership, was formed to collectively address these challenges. Members are
drawn from disciplines including bioethics, qualitative research, trials methodology, healthcare
professions, and social sciences. This commentary draws on our collective expertise to identify key
populations where particular methodological and ethical challenges around consent are encountered,
articulate the specific issues arising in each population, summarise ongoing and completed research, and
identify targets for future research. Key populations include people with communication or other
disabilities, people whose capacity to consent fluctuates, adults who lack capacity to consent, and adults
and children in emergency and urgent care settings. Work is ongoing by the sub-group to create a
database of resources, update NIHR guidance and to develop proposals to address identified research
gaps.
Conclusion
Collaboration across disciplines, sectors, organisations, and countries is essential if the ethical and
methodological challenges surrounding trials involving complex and alternate consent pathways are to
be addressed. Explicating these challenges, sharing resources, and identifying gaps for future research is
an essential first step. We hope that doing so will serve as a call to action for others seeking ways to
address the current consent-based exclusion of underserved populations from trials.
| Original language | English |
|---|---|
| Article number | 151 |
| Journal | Trials |
| Volume | 24 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 28 Feb 2023 |
Bibliographical note
Funding Information: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.
Publisher Copyright:
© 2023, The Author(s).
Keywords
- Informed consent
- clinical trials
- ethics
- underserved populations