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"Staged-and-Tailored" Informed Consent 

Symposium

Wednesday 13th September 2023 

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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 (video).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

Video

Use of Staged Informed Consent in Trials within Cohorts (TwiCs): a scoping review

Bev Nickolls, Queen Mary University of London, UK

Video

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KEYNOTE TALK

Tailoring informed consent within hospital settings

Professor Lenny Verkooijen

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.

Video

REAL WORLD EXAMPLES - HOSPITAL SETTINGS

Europe

A Trials within Cohorts (TwiCs) approach in a pan-European setting – The EORTC experience with OligoCare 

Dr Beatrice Fournier, European Organisation for Research and Treatment of Cancer (EORTC)

Video

UK

Evaluating the utility and acceptability of a structured consent process in a cell replacement therapy trial

Dr Cheney Drew, Cardiff University Centre for Trials Research

Video

Canada

TargetKids cohort

NUtrition Recommendation Intervention trialS in children’s Healthcare (NuRISH) Breastfeeding Support Internal Pilot Study:

Feasibility of a modified staged informed consent model in a Trial within Cohort design   

Dr Michaela Kucab & Dr Curtis D'Hollander, St Michael's Hospital, Toronto, Canada

Video

USA

Low-stakes intervention in cancer centre - A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial

Dr Andrew Vickers, Memorial Sloan Kettering Cancer Center, USA

Video

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KEYNOTE TALK

Staged-and-tailored informed consent: what are the ethical challenges?

Professor Julius Sim

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.

Video

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KEYNOTE TALK

Staged-and-tailored informed consent: what makes it ethical?

Dr Scott Kim 

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.

Video

Ethics & terminology discussion video

PANEL DISCUSSION

Andrew Vickers, Alain Amstutz, Helena Verkooijen, Julius Sim, Monica Jefford, Clare Relton
Topics covered: Verbal vs written consent, Changing trends in ethical norms, Impact of too much/ little information for patients, Lessons learned at UMC, Need for empiricism in ethics, Importance of context, Need for RECs/IRBs to take a less rule based approach and take context more into consideration.

Video

Scientific & Organising Committee

Background

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.

Guidance on when (and when not) to use these type of alternative informed consent approaches in pragmatic trials is now needed.

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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