Course

We need to be confident that an individual, regardless of their mental capacity, is supported to understand and/or engage with information about our research in ways that are personally meaningful.

Including adults who may lack capacity and may have communication difficulties in research can present challenges to:

• The person invited to participate in a study
• The researcher recruiting to a study
• The reviewer of the study on a Research Ethics Committee

This guidance advises on the use of strategic adjustments and supports to promote the participation of adults with communication difficulties, regardless of their mental capacity, in ethically sound research.

The Mental Capacity Act (2005) provides a legal framework for protecting the rights of adults who may lack capacity to make specific decisions, including decisions about research participation. It is accompanied by a Code of Practice that provides guidance on applying the Act.

In this section, you will explore the legal and ethical principles underpinning research involving adults who may lack capacity, including consent, decision-making and the importance of balancing potential benefits and risks.

Section objectives

By the end of this section, you will be able to:

• outline the key principles of the Mental Capacity Act (2005) and its relevance to research involving adults who may lack capacity
• explain the importance of valid consent, presumed capacity and supporting individuals to make their own decisions
• identify the legal and ethical considerations involved in including adults who may lack capacity in research
• recognise the importance of balancing potential benefits, risks and burdens when considering research participation

Capacity to make decisions about research participation can vary depending on the individual, the decision being made and the adjustments and supports available.

In this section, you will explore how to recognise and respond to different capacity and communication needs, assess capacity in the context of research, and understand the role of personal and nominated consultees.

You will also consider how to support meaningful engagement in research, including recognising and respecting expressions of assent and dissent.

Section objectives

By the end of this section, you will be able to:

• recognise how cognitive and communication difficulties may affect a person's ability to make and communicate decisions about research participation
• explain how capacity is assessed in relation to a specific research decision, including the importance of adjustments and supports
• describe the roles of personal and nominated consultees in advising on a person's likely wishes and feelings about research participation
• outline the decision-making process for involving adults who may lack capacity in research
• explain the continuum of engagement and the importance of recognising and respecting expressions of assent and dissent

Providing appropriate adjustments and supports is essential to enabling adults with capacity or communication difficulties to engage meaningfully in research and make decisions about participation wherever possible.

In this section, you will explore four key areas of adjustment: language, media, context and relevance. You will consider how information can be made more accessible, how the environment and communication methods can influence engagement, and how involving people with lived experience can improve research materials and processes.

Section objectives

By the end of this section, you will be able to:

• identify barriers that may affect an individual's ability to understand, retain, weigh up and communicate information about research participation
• describe adjustments to language and media that can make research information more accessible and meaningful
• explain how context, including timing, environment and the involvement of familiar people, can influence decision-making and engagement
• recognise the importance of collaboration and co-production with people with lived experience in developing accessible and relevant research materials

Please use the following case studies to put your learning into practice. After each case study, make notes about what you think would be useful adjustments and supports in relation to:

• Language
• Media
• Context
• Relevance

Section objectives

By the end of this section, you will be able to:

• apply learning from the course to practical research scenarios
• identify potential communication and decision-making barriers within the case studies
• suggest appropriate adjustments and supports to promote meaningful participation in research

ASSENT Project

The guidance in this course is based on a multi-disciplinary project (2018–2022) that looked at:

• Law and ethics for research with adults who may lack capacity and may have communication difficulties in England and Wales
• Practice and experiences of stakeholders in research, including persons who may lack capacity and may have communication difficulties, their supporters, practitioners, researchers and members of research ethics committees
• Feedback from our stakeholders on a pilot version of the web-based guidance

Principal Investigator

Karen Bunning, School of Health Sciences, University of East Anglia, UK.

Co-Investigators

Rob Heywood, School of Law, University of East Anglia, UK.

Anne Killett, School of Health Sciences, University of East Anglia, UK.

Peter E. Langdon, Centre for Educational Development, Appraisal and Research, University of Warwick, UK.

Advisor

Ciara Shiggins, The Queensland Aphasia Research Centre, The University of Queensland, and The Centre of Research Excellence in Aphasia Recovery and Rehabilitation, Australia.

Research Associates

Oluseyi F. Jimoh, University of East Anglia, UK.

Hayley Ryan, University of East Anglia, UK.

Marcus Redley, University of East Anglia, UK.

Alex Tiseo, University of East Anglia, UK.

With thanks to

• All our participants who were so willing to share their views and experiences with us
• Our working group members who contributed their expertise at every stage of the project
• Our project advisory group who reviewed our progress at strategic points and gave timely feedback
• Our project art group at the Broadland Clinic
• Our funders, the Nuffield Foundation