This is a resource of all relevant trial legislation and guidelines.

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1. General
1. Research Governance Framework, 2nd ed
2. Legislation & Regulation
1. Human Rights Act 1998
2. Health and Social Care Act 2008
3. Patient Information
1. The Health Service (Control of Patient Information) Regulations 2002
2. The Data Protection Act 1998
3. The Data Protection (Processing of Sensitive Personal Data) Order 2000
4. Access to Health Records Act 1990 (c. 23)
5. The Human Fertilisation and Embryology (Disclosure of Information) Act 1992
6. Personal Information in Medical Research
7. Information Governance
8. Security of NHS patient data shared for research purposes
4. Use of Human Organs and Tissues
1. Human Tissue Act 2004
2. The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of
   Information about Transplants) Regulations 2006
3. The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants)
   Regulations 2006
4. Human Tissue (Scotland) Act 2006
5. The Approval of Research on Organs No Longer Required for Procurator Fiscal Purposes
   (Specified Persons) (Scotland) Order 2006
6. Code of Practice – Post mortem examination
7. Code of Practice – The removal, storage and disposal of human organs and tissue
8. Human tissue and biological samples for use in research – Operational and ethical
   guidelines
5. Animals
1. Home Office. Animals in scientific procedures
6. Research Ethics and Research Ethics Committees
1. The Declaration of Helsinki (2008 version)
2. International Conference on Harmonisation of Technical Requirements for Registration of
   Pharmaceuticals for Human Use Guideline for Good Clinical Practice (‘ICH GCP’) 1996
3. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine
4. Good Clinical Practice Directive 2005/28/EC
5. NRES guidance on the approval of research involving ionising radiation, v2.0, Issued September 2008
6. MHRA guidance on approval of medical devices
7. Revisions to the Medical Devices and Active Implantable Devices Directive
8. Gene Therapy Advisory Committee (GTAC)
7. Consent
1. NRES guidance on information sheets and consent forms, Version 3.5,
   Issued May 2009
8. Adults unable to consent for themselves
1. Adults lacking capacity – on-line toolkit An on-line toolkit on research involving adults lacking capacity to consent for themselves. The toolkit 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.
2. Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002
3. Adults with Incapacity (Scotland) Act 2000
4. DH Mental Capacity Act 2005 guidance page
5. Guidance on nominating a consultee for research involving adults who lack capacity to consent
6. Informed consent in CTIMPs
   NRES information paper on informed consent in clinical trials of investigational medicinal products
7. MCA1 – Supplementary Information Form for approval under Section 30 of the Mental Capacity Act
8. MCA2 – Supplementary Information Form for approval under Section 34 of the Mental Capacity Act
9. Mental Capacity Act (MCA) 2005
10. Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007
11. Mental Capacity Act 2005 (Loss of Capacity during Research Project) (Wales) Regulations 2007
12. Mental Capacity Act 2005 Questions and Answers
    Questions and answers on the Mental Capacity Act 2005, including principles, scope of the research provisions, applying for approval under the Act, approval criteria, consultees, loss of / regaining capacity during research.
13. Mental Capacity Act Code of Practice
14. Mental Capacity Act Factsheet for Social Scientists
15. Criteria for approving research under sections 30-33 of the Mental Capacity Act 2005
16. Criteria for approving research under section 34 of the Mental Capacity Act 2005
9. Genetics
1. Guidance on Making Proposals to Conduct Gene Therapy Research on Human Subjects
10. Other Established Standards
1. Health Protection Agency. Standards Unit
2. HSE Research Ethics Committee
11. Codes of Professional Conduct
1. Good Clinical Practice (GCP)
2. Good Manufacturing Practice (GMP)
3. GCP Lab Guidance Issue 1
12. Clinical Trials
1. Medicines for Human Use (Clinical Trials) Regulations 2004
2. The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
3. The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006
4. The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008
5. EU directive on Good Clinical Practice in clinical trials
6. International Conference on Harmonisation of Technical Requirements for Registration of
   Pharmaceuticals for Human Use
7. Inspection: The United Kingdom Good Laboratory Practice Monitoring Authority (UK GLP MA)
13. Registration of Trials
1. International Clinical Trials Registry Platform (ICTRP)
2. UK PubMed Central
3. UKCRN Portfolio Database
14. Publication
1. The CONSORT statement
15. Research Misconduct
1. Research Integrity Office: Procedure for the Investigation of Misconduct in Research

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