UKHSA Pathogen Evaluation Framework - v1
Research type
Research Study
Full title
UK Health Security Agency (UKHSA) standardised protocol for clinical studies evaluating pathogen characterisation of public health interest
IRAS ID
339824
Contact name
Tom Fowler
Contact email
Sponsor organisation
UK Health Security Agency (UKHSA)
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Establishing and monitoring the epidemiological, clinical and biological characteristics of an emerging pathogen is essential for the development of national policies and guidance underpinning the UK’s public health response. A flexible and multifaceted framework approach is required to achieve this objective to ensure the UK is prepared to respond to any future public health threats.
The overall aim of this framework protocol is to provide a standardised approach for establishing and updating the key epidemiological, clinical and biological characteristics of new and emerging pathogens through the collection and analysis of comprehensive data and biological materials from suspected and confirmed cases.
This framework protocol describes the epidemiological methods to be used to generate this evidence and will ensure that these studies can be delivered rapidly and safely in response to new and emerging public health threats, under one standardised scientific, ethical and governance framework. While new and emerging infections may require specific and slightly varying approaches to epidemiological assessment, core considerations remain similar. As speed of implementation is often vital, these transferrable factors support a framework protocol approach that can be pre-approved and as long as specific responses are within the remit and guidelines of the framework protocol, a rapid and ethically robust research response is able to be implemented. The evidence produced will inform key policy decisions, support the development and evolution of UK Health Security Agency (UKHSA) public health interventions and provide assurance of their clinical effectiveness and impact.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0115
Date of REC Opinion
4 Aug 2025
REC opinion
Further Information Favourable Opinion