Human Tissue Act 2004: Primary legislation governing the storage, use and disposal of human tissue samples in England, Wales and Northern Ireland. Establishes the Human Tissue Authority and licensing requirements.
Data Protection Act 2018: UK's implementation of data protection requirements, working alongside UK GDPR. Crucial for handling personal data in biobanking.
UK GDPR: Post-Brexit version of GDPR, providing framework for processing personal data, including genetic and biometric data.
Mental Capacity Act 2005: Legislation relevant for consent procedures, particularly regarding individuals who may lack capacity to consent.
Human Rights Act 1998: Ensures respect for privacy and other fundamental rights in research context.
Human Tissue Regulations 2007: Specific regulations on quality and safety standards for human tissue intended for human application.
GCP Guidelines: Good Clinical Practice guidelines providing international quality standards for clinical research.
MRC Guidelines: Medical Research Council guidelines specific to biobank governance and operation.
Common Law Duty of Confidentiality: Legal obligation to maintain confidentiality of personal information obtained in professional context.
Caldicott Principles: Guidelines for handling patient-identifiable information in healthcare settings.
HTA Codes of Practice: Detailed guidance from Human Tissue Authority on implementing legal requirements.
UK Biobank Ethics Framework: Established ethical guidelines specific to UK biobank operations and governance.
OECD Biobank Guidelines: International guidelines for human biobanks and genetic research databases.
WHO Biobanking Guidelines: World Health Organization's standards for biobanking practices.
ISBER Best Practices: International Society for Biological and Environmental Repositories' comprehensive best practice standards.
Research Ethics Requirements: Mandatory ethical approval procedures from relevant Research Ethics Committees.
NHS Research Governance: Framework for conducting research within or in partnership with the NHS.
Declaration of Helsinki: Fundamental principles of ethical research involving human subjects.
