Legal frameworks

These resources provide further information about the legal frameworks that govern research in the UK and Ireland.

General resources

MHRA algorithm

Different 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 website

Different legislation applies across the UK. The HRA website has an interactive map of the UK in which you can select the area the study is to be conducted in, with links to the relevant  legislation

Summary of legislation

This table summarises some of the differences between legislation governing research with adults lacking capacity across the UK, including the different terminology

Clinical trials of medicines (CTIMPs)

Medicines for Human Use (Clinical Trials) Regulations 2004

The Medicines for Human Use (Clinical Trials) Regulations 2004 covers clinical trials involving investigational medicinal products in the UK. It transposed the EU Clinical Trials Directive 2001/20EC (which also applies to Ireland) into UK law. Together with its amendments, it is often referred to as the Clinical Trial Regulations. Schedule 1 Part 5 refers to the conditions and principles which apply in relation to adults who lack capacity to consent.

Non-CTIMP research studies

Mental Capacity Act 2005
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The Mental Capacity Act 2005 (MCA) provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves in England and Wales. Sections 30-34 cover invasive research that is not classed as a clinical trial of an investigational medicinal product (i.e applies to non-CTIMP research studies) 

National Consent Policy HSE
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There are currently no legal regulations in Ireland for research involving adults lacking decision-making capacity that is not a clinical trial of an investigational medicinal product. However, Section 4 of the National Consent Policy covers adults lacking decision-making capacity and consent for research (i.e policy applies to non-CTIMP research studies).

Adults with Incapacity (Scotland) Act 2000​

The 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) 2016

The 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).

Codes of Practice

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.
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