"Staged-and-Tailored" Informed Consent
International Symposium
Wednesday 13th September 2023
This symposium brings together triallists, clinicians, patients/ public, bioethicists, and health regulators to share perspectives and experiences of staged-and-tailored approaches to informed consent for individually randomised pragmatic trials (including those 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, mini presentations and posters.
.png)
Call for Abstracts
Submission deadline: Monday 3rd July 2023
Scientific & Organising Committee
-
Dr Julia Wade: Senior Lecturer Qualitative Health Science, Bristol University, TMRP Complex & Alternate Consent Pathways Working Group Chair
-
Professor Julius Sim: Statistician &Ethicist, School of Medicine, Keele University, UK
-
Dr Andrew Vickers: Biostatistician & Research Methodologist – Memorial Sloan Kettering Cancer Centre, USA
-
Beverley Nickolls: (Lead Co-ordinator) PhD Research Student – Centre for Evaluation and Methods, Queen Mary University, London, UK
-
Dr Clare Relton: Senior Lecturer Clinical/Public Health Trials – Centre for Evaluation and Methods, Queen Mary University London, UK
-
Dr Alain Amstutz: Physician Researcher, CLEAR Methods Center, Division of Clinical Epidemiology, University Hospital Basel, Switzerland
-
Dr Roxanne Gal: Clinical Epidemiologist & Post-doctoral researcher, University Medical Centre, Utrecht, The Netherlands
-
Dr Lois Daamen: Clinical Epidemiologist & Post-doctoral researcher, University Medical Centre, Utrecht, The Netherlands
-
Dr Danny Young-Afat, Plastic and Reconstructive surgeon & Clinical Epidemiologist, Amsterdam University Medical Center, The Netherlands
-
Dr Indrani Manoharan: Senior Clinical Trial Manager, UK
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?
Background
A growing number of triallists are using alternative approaches to informed consent for trials with usual care comparators. Triallists argue that these approaches reduce or avoid expectation and disappointment bias, improve recruitment efficiency and enhance representativeness.
Trials which use a stage-and-tailored approach to informed consent processes can result in detailed information about the experimental intervention being given to the experimental intervention group (not the usual care group).
Examples of these staged-and-tailored approaches include the Patient-Centred approach used in the Trials within Cohorts (TwiCs) design [1, 2] and Just-in-time consent [3, 4].
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 needed.
This symposium addresses 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?
.png)
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
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 development of guidance on these approaches to informed consent for pragmatic trials.
To submit an abstract please email it to b.nickolls@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
State whether you would prefer to be considered for Oral or Poster Presentation or Either.
If awarded, an Oral Presentation would be a talk (likely 8 to 12 minutes) plus an allowance for Q&A, accompanied by a presentation (PowerPoint).
If awarded, a Poster would be displayed electronically during the conference for delegates to view.
There will be a session of quick Poster talks (5 mins each).
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.
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.
For any queries please email Beverley Nickolls (b.nickolls@qmul.ac.uk)