A number of overarching regulations are in place which are not specifically concerned with the conduct of research but impact upon it. This list presents the most common regulations which may affect your study, though it is not exhaustive.
Protection of and access to personal data
The Data Protection Act (1998) covers the whole of the UK. Further information is available on the Information Commissioners Office website.
The Freedom of Information Act (2000) covers the whole of the UK. Further information is available on the Information Commissioners Office website.
Use of Human Tissue
The Human Tissue Act (2004) covers England, Wales and Northern Ireland. Further information is available on the Human Tissue Authority website.
The Human Tissue (Scotland) Act (2006) covers Scotland. Further information is available on the Human Tissue Authority website
Adults lacking capacity
The Medicines for Human Use (Clinical Trials) Regulations (2004) include requirements for the conduct of CTIMPs involving adults lacking capacity to research.
The Mental Capacity Act (2005) covers England and Wales. Further information is available on the Directgov website.
- The NRES e-learning toolkit 'Adults Lacking Capacity to consent to Research' covers the provisions of the Mental Capacity Act 2005 and the separate provisions for medicinal trials under the Medicines for Human Use (Clinical Trials) Regulations 2004. It includes a specific module on research in emergency medicine.
The Adults with Incapacity (Scotland) Act (2000) covers Scotland. Further information is available on the Scottish Government website.
There is no specific legislation regarding adults lacking capacity to make their own decisions in Northern Ireland, though common law principles do apply.
Further information about involving adults lacking capacity to consent in research is also available.
Children
The Medicines for Human Use (Clinical Trials) Regulations (2004) include requirements for the conduct of CTIMPs involving children.
European Regulations apply directly in all the Member States without requiring a national act to transpose them. The Paediatric Regulations (EC/1901/2006) are applicable to, and enforceable within, the UK without the need to transpose them into an Act or a Statutory Instrument. Further information about the EU Paediatric Regulations is available on the NIHR Medicines for Children Research Network (MCRN) website.
Further information about involving children in research is also available.
The
Children Act (2004) covers the whole of the UK, though much of the act covers England and Wales only.
The Children (Scotland) Act (1995) covers Scotland. The Children (Northern Ireland) Order (1995) covers Northern Ireland.
