Legal frameworks
These resources provide further information about the legal frameworks that govern research in the UK and other jurisdictions.
MHRA algorithmDifferent legal frameworks apply to different types of research involving adults lacking capacity. This MHRA algorithm can be used to clarify if a study is a clinical trial or not
|
HRA websiteDifferent legislation applies across the UK. The HRA website has an interactive map of the UK to check which applies, and NHS Scotland hosts a 'Carrying Out Research Across Borders' toolkit
|
Summary of legislationThis table summarises some of the differences between legislation governing research with adults lacking capacity across the UK, including the different terminology
|
Mental Capacity Act 2005
|
Adults with Incapacity (Scotland) Act 2000The Adults with Incapacity (Scotland) Act 2000 provides a framework for safeguarding the welfare and managing the finances of adults (aged 16 or over) who lack capacity. Section 51 covers research not classed as a clinical trial of an investigational medicinal product (i.e applies to non-CTIMP research studies)
|
Mental Capacity Act (Northern Ireland) 2016The Mental Capacity Act (Northern Ireland) 2016 legislation governs decisions across health and social care for adults with incapacity in Northern Ireland. Part 8 covers research that is not a clinical trial of an investigational medicinal products (i.e applies to non-CTIMPs). It is closely aligned to the MCA in England & Wales, and there is a scheme of mutual recognition of NHS/HSC REC review.
|
Code of practice giving guidance for decisions made under the Mental Capacity Act 2005 in England and Wales. Chapter 11 covers how the Act affects research projects involving a person who lacks capacity (applies to non-CTIMPs).
|
The Code provides an overview of the relevant provisions of the Act to help those who need to work with persons who lack, or may lack, capacity in relation to money and valuables and research in Northern Ireland. Chapter 3 covers research (applies to non-CTIMPs).
|
Guidance for health practitioners authorised to carry out medical treatment or research under the Adults with Incapacity (Scotland) Act. Part 4 covers authority for research.
|
HSE National Policy for Consent in Health and Social Care Research (Ireland)This policy covers the Health Service Executive (HSE) requirements for obtaining consent for participation in health and social care research from patients, their families, and carers. Section 4 covers capacity to consent in adults (CTIMPs and non-CTIMPs), and 6.9 covers emergency research.
|