Legislations

1. Mental Capacity Act 2005, Sections 30-34 (England and Wales)
2. Northern Ireland: Adults with Incapacity (Scotland) Act 2000, Section 51
3. Medicines Act (1968)
4. Data Protection Act (1998) [A number of Statutory Instruments have been developed to implement the Data Protection Act]

Regulations

1. Northern Ireland: Adults with Incapacity (Ethics Committee) (Scotland) Regulations (2002)
   MHRA:
2. The Medicines for Human Use (Clinical Trials) Regulations, Statutory Instrument No. 1031 (2004)
3. Amendment Regulations (SI 2006/1928)
4. Amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 and
5. Adults with Incapacity (Scotland) Act 2000 to Facilitate Clinical Research in Emergency Settings (SI 2006/2984)

Guidelines
DH:

1. Governance Arrangements for NHS Research Ethics Committees (2001)
2. Research Governance Framework for Health and Social Care (2005)

NRES:

1. NRES Guidance on Information Sheets and Consent Forms (2007)
2. NRES Guidance on Research Involving Adults Unable to Consent for Themselves (Including Guidance on the Mental Capacity Act 2005) (2007)
3. Guidance for Applicants to NRES (2007)
4. Standard Operating Procedures for Research Ethics Committees in the United Kingdom (2008)
5. NRES Leaflets (2008):
   •Building on Improvement
   •Research Ethics Timeline
   •Defining Research
   •Explaining Research Integrated Research Application System (2008)
6. NRES: Memorandum of Understanding between MHRA, COREC, and GTAC (2006)  
7. NRES: Ethical Review of Research Databases (2008):
8. NHS Information Governance: Security of NHS Patient Data Shared for Research Purposes (2008)

MRC:

1. MRC Guidelines for Good Clinical Practice in Clinical Trials (1998)
2. Good Research Practice (2000)
3. Personal Information in Medical Research (2000)
4. Research Involving Human Participants in Developing Societies (2004)
5. Medical Research Involving Children (2004)
6. MRC Policy on Antiretroviral Therapy for People Infected with HIV and Involved in AIDS Research in Developing Countries (2003)
7. MRC:  Personal Information in Medical Research (2000)

MHRA:

• Consultation Letter on the Medicines for Human Use (Clinical Trials) Regulations (2003)

RCP:

• Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants (2007)

ESRC:

• Research Ethics Framework

Northern Ireland:

• Research Governance Framework for Health and Community Care (2006)
  

Wales:

• Research Governance Framework for Health and Social Care in Wales (2001)
  

Scotland:

• Protecting Patient Confidentiality (2002)