Background to OPTIMISE

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. 

This could be achieved through incorporating a range of strategies known to effectively support people with communication and/or decision-making needs. Researchers called for clear, practical guidance about how to incorporate these strategies into the design of clinical trials to ensure they are more inclusive.

As part of the ​CONSULT research programme, the OPTIMISE project has developed a set of recommendations to help researchers design more inclusive consent processes in clinical trials. They were developed through combining evidence and key stakeholder consultation with experts in inclusive research, trials methodology and ethics, and with clinicians and public contributors. 

Who are the OPTIMISE recommendations for?

The OPTIMISE recommendations are intended for researchers to help with the design of consent processes (which span from being initially informed about a study, through to consent discussions, and recording/evidencing consent). They are intended to be generic and high level, recognising that accessibility and support needs vary between populations and individuals, and the exact consent processes will depend on the study design and context. They focus on consent processes as this often acts as the ‘gatekeeper’ to research, however all components of a study should be inclusive (e.g data collection, safety reporting, dissemination). Whilst they have been developed for trials, they are applicable to other types of research more broadly.

The OPTIMISE recommendations will also be useful for those reviewing and supporting research, such as members of research ethics committees and funding panels, to understand how researchers have (or have not) considered accessibility.
The key message is that even small, achievable adaptations can meaningfully improve accessibility. For example, by providing accessible or easy read versions of documents, offering information in video or audio format, or allowing more time for consent discussions
On this page you will find information about when and how the OPTIMISE recommendations should be considered and what the recommendations are. We suggest you download the detailed recommendations as this contains links to further reading and resources.

Towards the bottom of the webpage you will also find links to resources that have been developed to help you to use the OPTIMISE recommendations, including easy read versions which may be useful to support public involvement. We will be adding to these resources over time and would welcome your feedback and any examples or experiences you are happy to share. Please use the contact form or email address below to get in touch.

We have also created a OPTIMISE policy brief to outline how the recommendations can help organisations such as funders to achieve their commitments to improving research inclusion.

​When should the recommendations be considered?

Inclusive consent should be considered throughout the lifecycle of a study, including:

Developing a research idea

  • to plan adequate time and resources (e.g community outreach, inclusive design)
  • identify costs to be included in the funding application (e.g developing accessible materials such as easy read, translations)
  • identify and build relationships with key stakeholders and early involvement of public involvement contributors

Designing the protocol

  • when designing consent process to ensure accessibility (e.g flexible approaches to consent, use of decision-support tools)
  • developing participant information materials (including piloting the materials and seeking feedback)
  • drafting an ethics application
  • identifying research sites (e.g translation needs, research delivery staff time)

Approaching participants

  • help inform assessment of the individual’s communication needs
  • appropriate tailoring of information using communication strategies (e.g staged approaches to consent) and supported decision-making, with adaptations as required
  • inform assessment of capacity to consent if there are concerns.
  • revisiting consent during the study if concerns about changes in capacity

How should the OPTIMISE recommendations be used?

Recommendations

1. Consider these guiding principles for inclusive consent

Collaboration

Work together with organisations (e.g voluntary and third sector), multi-disciplinary teams (e.g speech and language therapists, mental capacity teams), funders, research governance teams, patients, carers and members of the public who all have a role in facilitating inclusive consent.

Ethics

Embed ethical practices and principles, such as building and maintaining trust between researchers and communities and individuals, being respectful, and promoting autonomy. Reflexively engage with ethical review processes which can act as a barrier or facilitator to inclusive consent practices.

Reflection

Review whether consent processes are effectively meeting peoples’ needs or if additional support is needed, whether collaborations are working (for everyone involved), and if there is an appropriate balance between burden and benefit for participants and any carers, consultees/legal representatives.

2. Review accessibility and consent requirements for trials

3. Improve accessibility by considering OPTIMISE domains

Consent processes can be made more accessible by taking action across one, more, or all of the domains:

Content

Participants (and consultees/legal representatives where needed) should be provided with clear and concise information about the purpose of the study, what is involved (and what it might mean for them), how the findings will be shared, and contact details for any questions or more information. Attention should be paid to how key concepts (e.g randomisation, data protection) are introduced and explained, and the order in which they are presented, to ensure the information is understandable (‘cognitively accessible’).

Language

​Plain and accessible language should be used (e.g avoiding complex words, using shorter sentences with a simplified sentence structure) with careful consideration about the literacy level of the information and how it corresponds with that of the population, as well as the tone of the language being used. Consideration should also be given to any translation and interpretation needs and how those can be met throughout the study.

Format

​Consider the best choice of format for participant information materials. This may depend on the study design (e.g decentralised trial), setting (e.g primary or emergency care), recruitment pathways, and study population. Information could be provided in written, audio, pictorial, easy read or video formats, through various modes of delivery such as physical (e.g paper, touch) or electronic/digital (e.g website, animation), with routes to delivery such as in person or remotely. Consider having multiple options available for both providing information and seeking/recording consent, and ensure the format, mode and route can be tailored to meet individuals’ communication and decision-making needs.

Design

​​Accessible design principles should be used to design informational materials, and the layout should be kept simple. Use of images can be an important way of supporting the accompanying text, but care must be taken to decide which images help support understanding, are appropriate (e.g culturally), and are accessible (e.g with alt text).

Support

​Communication and decision-making can be supported through layering of participant information (e.g brief summary of information alongside more detailed versions), use of communication strategies (e.g keywords/cards, memory aids), technology (e.g hyperlinks to more detail or explanation), including assistive technology (e.g screen reader), and use of tools to support communication and/or decision-making (e.g Talking Mats, Consent Support Tool). Those involved in caring for or supporting the person (e.g family members, support workers) can help facilitate communication. As communication behaviour has a key role, consider who will be involved and whether they have the appropriate skills and training to communicate effectively and assess capacity if needed. For participants who lack capacity to consent, consultees/legal representatives should be provided with their own information and should be involved in exploring the person’s preferences, potentially prior to any loss of capacity.

Timing

​Considerations around timing can help support inclusive consent processes. This includes identifying the best time to engage with the person that maximises their ability to make an informed decision (e.g in emergency situations, during fluctuations in capacity, prior to any loss of capacity). It includes the time taken to deliver information such as staging of information (e.g providing information at multiple timepoints), support to retain information (e.g use of memory aids), and revisiting consent. It also includes ensuring there is sufficient time for discussions with public contributors when designing a study and to develop and tailor information and approaches.

Environment

​Consider the environment (including digital environment) in which participants are approached and consent is being sought. This includes whether the environment is accessible and safe, it is somewhere the person feels comfortable (e.g a familiar place), is a place that they trust, and where there are appropriate levels of sound, lighting and other sensory stimuli.

 Resources to help support uptake of OPTIMISE:

Case study 

Easy read guide

Easy read summary

OPTIMISE launch webinar


We launched the OPTIMISE recommendations at a webinar in December 2025. At this webinar, we discussed why inclusive consent matters, introduced the OPTIMISE recommendations and supporting resources. Dr Mark Jayes presented on how to reduce exclusion of people with communication needs from your research, and Max and Mary-Lou from Thinklusive shared their practical experience of co-producing accessible participant information materials.

It was followed by a live Q&A with our expert panel (the presenters plus Dr Amy M Russell, Dr Julia Wade, Dr Anna Volkmer, and Martina Svobodova) on the theme: “What are the key challenges in designing inclusive consent processes, and how can we address them?” 

The event was intended for 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.

Access the webinar recording: https://youtu.be/9aEMD7mQRR0
OPTIMISE is funded by a UKRI Impact Accelerator Award. ​CONSULT is part of an NIHR Advanced Fellowship funded by Health and Care Research Wales. 

​With many thanks to the Researcher Advisory Group members (Amy M Russell, Julia Wade, Mark Jayes, Anna Volkmer, Shaun Treweek), the Lay Advisory Group members (Sian Jones, Jane Barnett, Ian Hill, Rashmi Kumar, Aysha Choudhury, Marie-Clare Hunter) and Thinklusive Advisory Group members for their support with the OPTIMISE project. Thanks also to all those who contributed to the stakeholder workshop.

For more information, please contact: Dr Victoria Shepherd [email protected]
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