(which become an EU Regulation on 31 January 2022), into domestic legislation.
17.5. Medicines for Human Use (Clinical Trials) Regulations 2025 has been approved and will come into effect from 28^{th} April 2026. The aim of the updated legislation is to streamline approvals, enhance patient safety, and accelerate access to innovative treatments.
17.6. Human Tissue Act - The Human Tissue Act 2004 repealed and replaced the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they related to England and Wales, and the corresponding orders in Northern Ireland. The Human Tissue Authority regulates the removal, storage, use and disposal of human bodies, organs and tissue.
17.7. Declaration of Helsinki - The Declaration of Helsinki was developed by the World Medical Association as 'a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data' (Para 1, Declaration of Helsinki).
17.8. General Data Protection Regulation (GDPR) - Most clinical research requires the processing and/or storage of personal and sensitive information. The General Data Protection Regulation (GDPR) legislates for the control and protection of personal information relating to living individuals including both facts and opinions about the individual.
17.9. Mental Capacity Act - Research studies involving adults aged 16 or over who lack capacity must comply with the Mental Capacity Act 2005. This includes persons with dementia, learning disabilities, mental health problems, stroke or head injuries who may lack capacity to make certain decisions, including consenting to participate in a research study. The act does not apply to studies falling under the Clinical Trials Regulations (CTIMPs).
17.10. OUH Frameworks for R&D Governance, Training and Monitoring – Locally, clinical research is governed by the following OUH policies: