Introduction

People may experience impaired decision-making due to a sudden illness or accident, progressive conditions such as dementia, or an intellectual or learning disability. Research involving adults who have impaired capacity to consent can raise ethical, legal, and practical issues.

Difficulties overcoming these issues mean that people who lack capacity are generally under-represented in research, resulting in a lack of evidence base for their care. Greater understanding about how we can appropriately involve them in research, whilst protecting their interests and welfare, is needed.

Our previous research has shown that knowing when and how to include adults with impaired capacity in research can be challenging in practice. This includes understanding the ethical and legal justification, how to design inclusive studies, who should be involved in making decisions about participation, what documents are required and what information they should contain.

Aim of these resources

These pages contain a range of information and resources to support the design and conduct of research involving adults with impaired capacity to consent that have been collated under a number of themed areas. The information and resources can be accessed by clicking on the theme headings below or using the menu bar. Brief summaries of the consent processes can also be found below.

Designing inclusive studies

Resources on designing studies to be inclusive of adults with impaired capacity to consent, including legal frameworks, outcomes and data collection, and participatory approaches​

Research
​ethics

Resources to support ethical aspects of research involving adults lacking capacity and processes for seeking ethical approval, including the requirements for ethical review of studies including adults lacking capacity and emergency research ​

Communication and capacity

Resources to help ensure that communication about research is accessible, information about assessment of capacity​, and supporting adults with impaired capacity to make decisions

Consent and
​consultation

Resources to support consent and consultation processes, including a summary of consent arrangements and examples of associated ​documents​

Research
​​conduct

Resources for the duration of a research project such as ongoing consent, loss and regaining of capacity during a study, and dissemination of results​ at the end of a study

Commonly used
​terms

Downloadable table of terms that are commonly used in research involving adults lacking capacity

Brief summaries of consent processes

Non-CTIMPs involving adults lacking capacity

Brief flow diagram of the consent process for intrusive research governed by the Mental Capacity Act 2005 in England and Wales

CTIMPs involving adults lacking capacity

Brief flow diagram of the consent process for clinical trials governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 in England and Wales 

Emergency research involving adults lacking capacity

Brief flow diagram of the process for emergency research (CTIMPs and non-CTIMPs) conducted without prior consent or consultation in England and Wales

Case studies

A randomised controlled trial with care home residents: the PRINCESS trial

Case study: Background and summary of the challenges and solutions

Protocol

Participant consent form

Consultee declaration form

RANDOMISED CONTROLLED TRIAL OF COMPUTERISED SPEECH AND LANGUAGE THERAPY FOR APHASIA: BIG CACTUS

Case study: Background and summary of the challenges and solutions

Protocol

Consent Support Tool

Research Pathway

Resources mapped according to the stage of the research pathway

Research Pathway