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
   9. Information Governance
   10. 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
6. Research Ethics and Research Ethics Committees
   2. The Declaration of Helsinki (2008 version)
   3. International Conference on Harmonisation of Technical Requirements for Registration of
      Pharmaceuticals for Human Use Guideline for Good Clinical Practice (‘ICH GCP’) 1996
   4. 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
   5. International Ethical Guidelines for Biomedical Research Involving Human Subjects
   6. Operational Guidelines for Ethics Committees that Review Biomedical Research
   8. Good Clinical Practice Directive 2005/28/EC
7. Consent
8. Genetics
9. Other Established Standards
   2. Health Protection Agency. Standards Unit
   3. HSE Research Ethics Committee
10. Codes of Professional Conduct
    3. GCP Lab Guidance Issue 1
11. 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
12. Registration of Trials
    1. International Clinical Trials Registry Platform (ICTRP)
    2. UK PubMed Central
    3. UKCRN Portfolio Database
13. Publication
    1. The CONSORT statement
14. Research Misconduct
    1. Research Integrity Office: Procedure for the Investigation of Misconduct in Research