Declaration of Helsinki and clinical trial regulations – alignment

13th January 2026

Declaration of Helsinki and clinical trial regulations – alignment

Summary: The MHRA guidance sets out how the UK’s clinical trial regulatory framework reflects and supports the ethical standards of the Declaration of Helsinki, the internationally recognised set of principles for medical research involving human participants. It explains how UK requirements — including informed consent, scientific validity, risk–benefit assessment, respect for participants’ rights and welfare, and independent ethics committee review — align with the Declaration’s core provisions. The guidance helps sponsors, investigators and ethics committees understand how ethical considerations are integrated into legal and regulatory expectations for clinical trials in Great Britain.

Link: https://www.gov.uk/government/publications/declaration-of-helsinki-and-clinical-trial-regulations-alignment

Back to Recent News