Co Leads: Julia Wade, University of Bristol, Amy Russell, University of Leeds, Victoria Shepherd, University of Cardiff
This group is a sub group of the TMRP Trial Conduct Working Group. To join the Complex and Alternative Consent Working Group please download and fill in our TCWG Expressions of Interest Form and return to methodologyhubs@liverpool.ac.uk
Objectives
The MRC-NIHR TMRP Complex and Alternative Consent Trials Working Group is a sub-group of the MRC-NIHR TMRP Trial Conduct Working Group. The aim of this group is to focus on the methodological and ethical challenges which are encountered by underserved groups and/or arise from study design during information provision and consent processes required for trial participation. The group facilitates networking and collaborative research to optimise informing and receiving consent from people where complex consent pathways or alternative consent processes are required to take part in the research.
Examples of complex and alternative consent pathways include but are not limited to:
- Children’s transition from competence to give assent to giving consent;
- Consent for children in care;
- Consent for adults who lack capacity to consent;
- Situations where adults may lose or gain capacity during a research project;
- Fluctuation in adults’ capacity to consent;
- Emergency research without prior consent (‘deferred consent’) and/or consultation for children and adults;
- Involvement of professionals acting as consultee/legal representative;
- Waiver of consent (e.g. cluster RCTs);
- Supporting consent for people with additional cognitive, speech, language or sensory needs;
- Staged and tailored consent, e.g. during Trials within Cohorts - TWiCs;
- Other situations in which research design requires tailoring of the usual consent process.
Potential research areas
- Impact of interpretation of regulatory frameworks in different contexts;
- Balancing regulatory requirements and person-centred practice in trials;
- Identifying and addressing training needs for methodological guidance across the research community;
- How can the process of consent respond to new and emerging study designs and procedures whilst maintaining its moral authority?
Membership
The group welcomes members that are included in (but not limited to) the groups outlined below:
- Individuals with a professional or academic interest in complex and alternative consent pathways and processes within trials research;
- Patient partners and patient representatives;
- International partners interested in complex and alternative consent pathways and processes.
Collaborations
This special interest area was identified as a target for a sub-group from within the TMRP Qualitative Research in Trials group. However, there is general recognition that the subject area cuts across the following TMRP sub-groups (‘sibling groups’)
- Recruitment WG
- Inclusivity WG
Basecamp/meetings of the above WGs will be used to maintain communication with these larger WGs and advertise short- and long-term objectives to members of these ‘sibling’ groups who may want to support these.
Sub group ways of working
The sub-group meets to agree the scope of its activities, and targets for short- and long-term outputs. Work on these outputs is then delegated and undertaken by members of the group with meetings normally restricted to 2-3 a year. Wherever possible, work will be moved forward between meetings. All members of the group will be invited to contribute in some way (e.g. minute taking, commenting on written drafts of proposals, liaising with potential speakers for webinars).
Outputs to date
SYMPOSIUM: Staged and Tailored Informed Consent, September 2023 - Clare Relton, Beverley Nickolls, Julius Sim, Roxanne Gal, Lois Daamen, Helena Verkooijen, Andrew Vickers, Alain Amstutz, Indrani Manoharan, Julia Wade, Petter Viksveen, Curtis D’Hollander, Ratna Sohanpal, Xavier Griffin, James Hogg, Sandra Phair,Monica Jefford
Russell AM, Shepherd V, Woolfall K, Young B, Gillies K, Volkmer A, Jayes M, Huxtable R, Perkins A, Noor NM, Nickolls B, Wade J. Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action. Trials. 2023; 24: 151. doi: /10.21203/rs.3.rs-2123156/v1.
MRC-NIHR Clinical Trials Routemap section on Informed Consent. The Clinical Trials Toolkit is an interactive colour-coded routemap to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMPT).
WEBINAR: Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups – Dr Amy M. Russell, Dr Victoria Shepherd, Dr Kerry Woolfall, Dr Mark Jayes, Dr Julia Wade & Dr Anna Volkmer, April 2023
Relevant related groups
Practical Informed Consent Guidance for Trials with Usual Care Groups Purpose: To develop and disseminate practical guidance for researchers and ethics committees on the design, review and reporting of informed consent process for trials with usual care groups and pragmatic aims.
