UK Changes Section 251 Consent Waiver Requirements

From 18 January 2024, applicants seeking Section 251 support for the use of confidential patient data without consent will be expected to attend the CAG meeting at which their application is being discussed. This is in line with recommendations made in the?Department of Health and Social Care (DHSC) Goldacre?review [Read Full Details].

Separately the Health Research Authority (HRA) closing the CAG phone number from 29 December 2023. All CAG meeting bookings and any queries should now be made by email to [email protected].

Real World Research Context:

Consent can be waived under section 251 of the?National Health Service Act 2006?and its current Regulations, the?Health Service (Control of Patient Information) Regulations 2002?(as per the?Health Research Authority Guidelines – Confidential Patient Information and the Regulations – February 2023).

Applies to research where it was not possible to use anonymised information and obtaining consent was not practical (as per the?Health Research Authority Guidelines – Confidential Patient Information and the Regulations – February 2023).

• Germany?– Germany’s Draft Health Data Usage Act [Link] [LinkedIn]
• EU?– EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation [Link] [LinkedIn]
• China?– China’s Emerging Trend: Embracing Real-World Evidence in Drug Development and Regulation [Link] [LinkedIn]
• Japan?– Revolutionizing Healthcare in Japan: The Rise of Real-World Evidence in Drug Development [Link] [LinkedIn]
• Taiwan?– Integrating Real-World Evidence for Drug Development and Policy Making [Link] [LinkedIn]
• South Korea?– South Korea’s Pioneering Approach: Integrating Real-World Evidence in Healthcare and Drug Development [Link] [LinkedIn]
• Australia?– Advancing Healthcare in Australia: Embracing Real-World Evidence and Data in Medicine Regulation and Development [Link] [LinkedIn]
• RWE Event Horizon?[Link] [LinkedIn]
• THE END?– A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU [Link] [LinkedIn]

Real World Research (RWR) refers to the collection of patient-related data in a real-world environment (real-world data) and obtaining clinical evidence (real-world evidence) of the value and potential benefits or risks of the medical products through analysis [Link].

ABOUT STUART MCCULLY

Stuart is a real world research (RWR) regulatory scientist and thought leader.?With his background as a pharmacologist working on traditional pre-approval clinical trials, he became frustrated with the operational inefficiencies and support gaps for non-interventional (observational) studies. As a result, Stuart created CHCUK which became a global leader in supplying regulatory and operational intelligence for non-interventional studies. Currently, Stuart is a co-founder of RWR-Regs, a regulatory compliance solutions platform for real world research.