The UK's COVID Inquiry praised the speed with which the Oxford/AstraZeneca COVID vaccine was developed and the rapid set-up of the Oxford-led RECOVERY trial, which identified the first effective treatment for COVID. It said the infrastructure established by the National Institute for Health and Care Research (NIHR) was critical to the successful delivery of clinical trials during the pandemic.
17.1. Research governance refers to the framework to manage the research process from end to end, to ensure that research is undertaken in a safe, appropriate and ethical manner, in accordance with national guidance and applicable laws to ensure that maximum benefit is derived from research for public and patients. Compliance with the legislation is overseen nationally by the Health Research Authority. This includes:
17.2. UK Policy Framework for Health and Social Care 2017 - The UK policy framework sets out principles of good practice in the management and conduct of health and social care research that take account of legal requirements and other standards.
17.3. ICH Good Clinical Practice (GCP) – GCP is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting research that involves human participation. Compliance provides public assurance that the rights, safety and wellbeing of participants are respected and protected, and that the data generated are credible and accurate. In the first major overhaul in nearly a decade, ICH-GCP E6 (R3) was implemented globally during 2025-26. The updates modernise structure and terminology, promote a more proportionate, quality-by-design approach to trial design, accommodate decentralisation and digital readiness, adopt a participant-centred approach to informed consent, and streamline operations and reporting.
17.4. EU Directives - The EU Clinical Trials Directive (EUCTD – 2001/20/EC) sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted. It includes medicinal trials with healthy volunteers and small scale or pilot studies. The Good Clinical Practice (GCP) Directive (2005/28/EC) supplements the EUCTD, strengthening the legal basis for requiring member states to comply with the principles and guidelines of good clinical practice. After leaving the EU the UK implemented the EUCTD