Medicines for Human Use (Clinical Trials) Regulations 2004: Primary UK legislation governing the conduct of clinical trials, including requirements for authorization, good clinical practice, and safety reporting
UK Clinical Trials Regulations (Post-Brexit): Updated regulations governing clinical trials in the UK following Brexit, maintaining alignment with international standards while establishing UK-specific requirements
Human Medicines Regulations 2012: Regulations controlling the sale, supply, manufacture, distribution, and marketing of medicines in the UK
Data Protection Act 2018: UK's implementation of data protection standards, governing how personal information must be handled and protected
UK GDPR: Post-Brexit version of GDPR incorporated into UK law, setting standards for data protection and privacy
NHS Research Governance Framework: Framework setting standards for health research in the NHS, ensuring quality, safety, and ethical conduct
HRA Requirements: Health Research Authority's standards and approval requirements for conducting research in the UK healthcare system
Good Clinical Practice Guidelines: International ethical, scientific, and practical standards for conducting clinical trials
MHRA Guidelines: Regulatory guidance from the Medicines and Healthcare products Regulatory Agency for conducting clinical trials
Human Tissue Act 2004: Legislation regulating the storage, use, and disposal of human tissue in research
Mental Capacity Act 2005: Law protecting and empowering people who may lack capacity to make certain decisions, including participation in research
Research Ethics Committee Requirements: Ethical review and approval requirements for clinical research protocols and procedures
ICH Guidelines: International Council for Harmonisation guidelines providing global standards for clinical research
Declaration of Helsinki: Fundamental principles for medical research involving human subjects
Common Law Contract Principles: Basic principles of English contract law including offer, acceptance, consideration, and intention to create legal relations
Unfair Contract Terms Act 1977: Legislation regulating unfair terms in contracts, particularly regarding limitation of liability
Clinical Negligence Scheme: Insurance and liability coverage requirements for clinical research, particularly within NHS settings
Caldicott Principles: Guidelines for handling patient-identifiable information in healthcare settings
NHS Information Governance: Framework for handling information in health and social care organizations, including research data
