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OPTIMISE recommendations for designing inclusive consent processes in trials |
Background
Informed consent is a fundamental principle of ethical research. People with conditions that affect their ability to communicate and/or make decisions may require additional support to decide whether to take part in a study and provide consent. However, informed consent processes in clinical trials are often not designed to take account of additional communication and/or decision-making needs. This can lead to people being unfairly excluded from trials or, for some, it may mean that they are deemed to lack capacity to consent and an alternative person is involved on their behalf.
With more accessible information and the right support in place, people with communication and/or decision-making needs will be better able to make, or contribute to, decisions about participating in research. This protects their right to make their own decisions, and ensures their views are heard.
OPTIMISE project
In conjunction with a group of researchers and a lay advisory group, the OPTIMISE project is developing recommendations to improve the design of informed consent methods in clinical trials to ensure they are equitable and accessible for people with additional communication and/or decision-making needs.
This will be achieved through:
1. Reviewing existing evidence about enhanced consent processes
2. Expert stakeholder consultation to develop a set of recommendations
3. Mapping existing resources (including from CONSULT) onto the recommendations
4. Developing a toolkit to help researchers and others use the recommendations
Join us for the OPTIMISE launch webinar
We will be launching the OPTIMISE recommendations at a webinar in December 2025. At this webinar, we will discuss why inclusive consent matters, introduce the OPTIMISE recommendations and supporting resources, and outline how they can help researchers address challenges in recruitment and consent.
This will be followed by a live Q&A with our expert panel on the theme: “What are the key challenges in designing inclusive consent processes, and how can we address them?” Attendees are invited to submit questions ahead of the webinar or during the event.
Everyone is welcome to attend. The event might be of particular interest to researchers who design and conduct research involving populations with communication and decision-making needs, anyone interested in how we can deliver more inclusive research, and those with a role in reviewing or supporting research including REC members, funders, and public involvement contributors.
Date: 1st December 2025
Time: 2-3pm
Registration: https://app.onlinesurveys.jisc.ac.uk/s/cardiff/optimise-webinar-registration
Informed consent is a fundamental principle of ethical research. People with conditions that affect their ability to communicate and/or make decisions may require additional support to decide whether to take part in a study and provide consent. However, informed consent processes in clinical trials are often not designed to take account of additional communication and/or decision-making needs. This can lead to people being unfairly excluded from trials or, for some, it may mean that they are deemed to lack capacity to consent and an alternative person is involved on their behalf.
With more accessible information and the right support in place, people with communication and/or decision-making needs will be better able to make, or contribute to, decisions about participating in research. This protects their right to make their own decisions, and ensures their views are heard.
OPTIMISE project
In conjunction with a group of researchers and a lay advisory group, the OPTIMISE project is developing recommendations to improve the design of informed consent methods in clinical trials to ensure they are equitable and accessible for people with additional communication and/or decision-making needs.
This will be achieved through:
1. Reviewing existing evidence about enhanced consent processes
2. Expert stakeholder consultation to develop a set of recommendations
3. Mapping existing resources (including from CONSULT) onto the recommendations
4. Developing a toolkit to help researchers and others use the recommendations
Join us for the OPTIMISE launch webinar
We will be launching the OPTIMISE recommendations at a webinar in December 2025. At this webinar, we will discuss why inclusive consent matters, introduce the OPTIMISE recommendations and supporting resources, and outline how they can help researchers address challenges in recruitment and consent.
This will be followed by a live Q&A with our expert panel on the theme: “What are the key challenges in designing inclusive consent processes, and how can we address them?” Attendees are invited to submit questions ahead of the webinar or during the event.
Everyone is welcome to attend. The event might be of particular interest to researchers who design and conduct research involving populations with communication and decision-making needs, anyone interested in how we can deliver more inclusive research, and those with a role in reviewing or supporting research including REC members, funders, and public involvement contributors.
Date: 1st December 2025
Time: 2-3pm
Registration: https://app.onlinesurveys.jisc.ac.uk/s/cardiff/optimise-webinar-registration
