"Staged-and-Tailored" Informed Consent
Symposium
Wednesday 13th September 2023
This online international symposium brought together trialists, clinicians, members of the public, bioethicists to share perspectives and experiences of staged-and-tailored approaches to informed consent for individually randomised pragmatic trials (including studies using the TwiCs design approach.
Dr Clare Relton opened the symposium with an Introduction to Staged & Tailored Informed Consent and the Informed Consent Decisions and Choices Tool. This was followed with two Reviews of published studies using staged and tailored informed consent.
Key note speaker Professor Lenny Verkooijen opened the Real World Examples session with her talk about the pioneering work using this design approach in a hospital setting at UMC in the Netherlands in oncology. This was followed by five presentations on studies in hospital settings and then five presentations on real world examples in community and criminal justice settings.
The Thinking about Staged and Tailored Informed Consent session began with twin keynote talks on the ethics of the staged and tailored approach to informed consent from Dr Scott Kim and Professor Julius Sim. This session continued with presentations on interviews with professionals , layered patient information sheets and refining the Estimand framework for TwiCs. The day concluded with a short panel discussion.
REAL WORLD EXAMPLES - REVIEWS
Randomized controlled trials using the Trials within Cohorts (TwiCs) design: A scoping review
Dr Christof Schönenberger, University Hospital Basel, Switzerland
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Use of Staged Informed Consent in Trials within Cohorts (TwiCs): a scoping review
Bev Nickolls, Queen Mary University of London, UK
REAL WORLD EXAMPLES - HOSPITAL SETTINGS
Europe
Dr Beatrice Fournier, European Organisation for Research and Treatment of Cancer (EORTC)
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UK
Dr Cheney Drew, Cardiff University Centre for Trials Research
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Canada
TargetKids cohort
Dr Curtis D'Hollander, St Michael's Hospital, Toronto, Canada
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Internal pilot study evaluating the feasibility and acceptability of a staged consent model within a primary care embedded randomized controlled trial to determine the effect of a childcare navigator on child health and development
Dr Michaela Kucab, St Michael's Hospital, Toronto, Canada
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USA
Dr Andrew Vickers, Memorial Sloan Kettering Cancer Center, USA
REAL WORLD EXAMPLES - COMMUNITY SETTINGS
Lesotho
ComBaCal cohort
Dr Felix Gerber, University of Basel, Switzerland
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Implementing Trials within Cohorts (TwiCs) in Lesotho and Switzerland: Preliminary lessons learnt
​Dr Alain Amstutz, University of Basel, Switzerland
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UK
Born in Bradford’s Better Start Cohort
Dr Rachael Moss, Bradford Institute of Health Research, University of York
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Dr Kate Mooney, Bradford Institute of Health Research , University of York
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Gateway Hampshire Constabulary
Design and implications of a two-stage consent process for an RCT in the criminal justice setting
Dr Alex Mitchell, York Trials Unit, UK
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THINKING ABOUT INFORMED CONSENT
Bev Nickolls, Queen Mary University of London, UK
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Guiding principles and acceptability tests for ‘layered’ clinical trial patient information sheets
William Cragg, Clinical Trials Unit, University of Leeds, UK
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Dr Lois Daamen & Dr Roxanne Gal, University Medical Centre, Utrecht, The Netherlands
KEYNOTE TALKS ​
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Tailoring informed consent within hospital settings
In this talk, Lenny Verkooijen demonstrated how oncologic care can be organized in such a way that that it is possible to learn from each patient and that randomized trials can be embedded in routine care. At the so-called innovation clinic, (new) cancer patients are systematically invited and offered broad informed consent, including consent to be randomized into (cohort) based trials. Using this approach, several innovations have been evaluated efficiently in highly generalizable trial populations, and the ones that have proven to be effective, were quickly employed in routine care.
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Staged-and-tailored informed consent: what are the ethical challenges?
The standard formulation of consent, as typically demonstrated in the conventional RCT, requires adequate disclosure by the researcher and a corresponding level of comprehension on the part of the potential participant, in order for consent to be autonomously given or refused. Alternative clinical trial designs that involve different models of consent must demonstrate that such consent meets an equivalent ethical standard. This talk outlined some of the challenges that this may pose to staged models of consent.
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Staged-and-tailored informed consent: what makes it ethical?
RCTs embedded in clinical settings with high fidelity to pragmatic principles can be impossible to conduct if a traditional informed consent is required. This talk addressed how staged consent models can be conducted ethically by: (1) reviewing the conditions under which altered/modified consent or waivers of consent are usually considered to be ethical; and (2) engaging the key ethical challenges and objections to staged consent.
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Scientific & Organising Committee
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Dr Julia Wade: Senior Lecturer Qualitative Health Science, Bristol University, TMRP Complex & Alternate Consent Pathways Working Group Chair
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Professor Julius Sim: Statistician & Ethicist, School of Medicine, Keele University, UK
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Dr Andrew Vickers: Biostatistician & Research Methodologist – Memorial Sloan Kettering Cancer Centre, USA
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Beverley Nickolls: (Lead Co-ordinator) PhD Research Student – Centre for Evaluation and Methods, Queen Mary University, London, UK
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Dr Clare Relton: (Chair) Senior Lecturer Clinical/Public Health Trials – Centre for Evaluation and Methods, Queen Mary University London, UK
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Dr Alain Amstutz: Physician Researcher, CLEAR Methods Center, Division of Clinical Epidemiology, University Hospital Basel, Switzerland
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Dr Roxanne Gal: Clinical Epidemiologist & Post-doctoral researcher, University Medical Centre, Utrecht, The Netherlands
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Dr Lois Daamen: Clinical Epidemiologist & Post-doctoral researcher, University Medical Centre, Utrecht, The Netherlands
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Dr Indrani Manoharan: NIHR Senior Programme Manager, UK
Background
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Some trialists are using alternative approaches to informed consent for intervention trials with usual care comparators.
In the stage-and-tailored approach to informed consent initial broad consent to take part in research is sought from all potential participants.
After random allocation to groups, detailed/specific information about the experimental intervention is provided only to the experimental intervention group and specific consent to be in the experimental group sought, and no detailed/ specific information about the experimental intervention is offered to the usual care group.
Staged-and-tailored approaches to informed consent have been variously described. The most common examples are found in studies using the Trials within Cohorts (TwiCs) design [1, 2, and 3]. A more recent example of this approach is Just-in-time consent [4, 5]. It is thought that these stage-and tailored approaches reduce or avoid expectation and disappointment bias, improve recruitment efficiency and enhance representativeness. Although growing in use there is limited knowledge of these alternative structured approaches.
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Guidance on when (and when not) to use these type of alternative informed consent approaches in pragmatic trials is now needed.
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By bringing together a wide range of stakeholders in pragmatic trial design the purpose of this symposium was to help address the James Lind Priority Setting Partnership on Recruitment in Randomised Trials Top Priority Question: "What are the best approaches to optimise the informed consent process (who should take consent, timing of consent, method and format of consent) to improve recruitment of members of the public to randomised trials?"
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