"Staged-and-Tailored" Informed Consent Symposium
Wednesday 13th September 2023
10am-4pm GMT, 11am-5pm CEST, 5am-11am EST
Online
This symposium brings together trialists, clinicians, patients, members of the public, bioethicists, and health regulators to share perspectives and experiences of staged-and-tailored approaches to informed consent for individually randomised pragmatic trials
(including studies using the Trials within Cohorts (TwiCs) design approach).
The objectives are to share and explore what is known about the use, acceptability and efficiency of staged-and-tailored approaches to informed consent and to provide a forum for discussion.
Outputs from this symposium will support the future development of guidance on staged-and-tailored approaches to informed consent for pragmatic trials.
This one-day free online symposium will include invited keynote talks interspersed with discussions and presentations.
REGISTRATION NOW OPEN - Click here to register
This symposium brings together trialists, clinicians, patients, members of the public, bioethicists, and health regulators to share perspectives and experiences of staged-and-tailored approaches to informed consent for individually randomised pragmatic trials
(including studies using the Trials within Cohorts (TwiCs) design approach).
The objectives are to share and explore what is known about the use, acceptability and efficiency of staged-and-tailored approaches to informed consent and to provide a forum for discussion.
Outputs from this symposium will support the future development of guidance on staged-and-tailored approaches to informed consent for pragmatic trials.
This one-day free online symposium will include invited keynote talks interspersed with discussions and presentations.
REGISTRATION NOW OPEN - Click here to register
KEYNOTE TALKS
Tailoring informed consent within hospital settings
Staged-and-tailored informed consent: what are the ethical challenges?
Staged-and-tailored informed consent: what makes it ethical?
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: 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: Senior Clinical Trial Manager, UK
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 this symposium will 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?"
This international symposium is supported by a Public Involvement grant from the NIHR Research Design Service (London)
Abstract Submission Guidelines
"Staged-and-tailored" approaches to informed consent
for individually randomised trials: perspectives and experiences
International online Symposium
Wednesday 13th September 2023
10am-4pm GMT, 11am-5pm CEST, 5am-11am EST
We welcome abstracts on staged-and-tailored approaches to informed consent.
We especially welcome abstracts on their use, acceptability and efficiency.
To submit an abstract please email c.relton@qmul.ac.uk. The deadline to submit an abstract for this symposium is Monday 3rd July 2023. The word limit for each abstract is 400 words (excluding title and references). Maximum 5 references. All abstracts to be written and presented in English.
Presentation Type
If awarded, talks will be between 5 to 12 minutes plus an allowance for Q&A, accompanied by a presentation (PowerPoint).
Affiliations
Please list all authors and their affiliations as per this example.
Jennifer Taylor1, Stefan Polanski2, Juliet Stein1
1 Department of…., UK
2 Center for…., USA
Suggested structure
*Introduction (covering aims/objectives/settings)
*Methods/Approach (making clear the approach e.g. applications and implementation, mixed methods, opinion, qualitative, quantitative, review, simulation, survey, SWATs)
*Results (or the form that the results will take)
* Discussion including potential relevance and impact
Unstructured abstracts are welcome for non-empirical work.
References
Surname(s) and initial(s) of author(s) of the article. Title of article. Title of journal. Date of publication as year month day; volume (issue): page numbers (not preceded by p.).
Perry C, Barron A. Honey bees selectively avoid difficult choices. Proceedings of the National Academy of Sciences. 2013; 110 (47): 19155-19159.
Review Process
Each abstract will be reviewed by at least 2 reviewers appointed by the Scientific Committee. Authors will be notified about the outcome of their submission(s) by 14th August 2023. Notification will be sent to the submitting author only. All symposium presenters will be invited to contribute to a report on the symposium. Details on how to register for the symposium will be sent out in August.
For any queries or discussions re potential abstracts please contact Clare Relton (c.relton@qmul.ac.uk)
CALL FOR ABSTRACTS
Prospective authors of presentations are invited to submit abstracts.
Submission deadline: Monday 3rd July 2023