EDICTS-M V1.0
Research type
Research Study
Full title
Ethical Determination In sequenCing diagnosTics developmentS-Metagenomics (EDICTS-M)
IRAS ID
346310
Contact name
Rachel Fay
Contact email
Sponsor organisation
Guy's & St Thomas' NHS Foundation Trust
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
The COVID-19 pandemic has demonstrated the urgent need for new diagnostic techniques to be created and evaluated in a rapid fashion. In order for this to occur, researchers must have access to multiple sample types from different patient populations to establish and test the accuracy of new diagnostics. Therefore, they must have the ability to use surplus or discarded samples with a subset of clinical information collected by the direct care team and provided to the researchers in a linked-anonymised or anonymised fashion in order to develop new pathogen agnostic assays. Given these requirements it is usually not possible to consent patients for the use of these types of samples given that the time to discard or to be deemed surplus is usually outside the standard admission time of the patient. This fact has been recognised by the governing bodies as the use of anonymised surplus or discarded samples does not always require consent.
This framework protocol will ensure that these studies can be delivered quickly and safely, under one standardised ethical and governance framework. The platform design will allow for rapid development and testing of new assays and the appropriate flexibility in the evaluation methodologies to be able to meet clinical questions as they arise.
REC name
HSC REC B
REC reference
24/NI/0133
Date of REC Opinion
19 Nov 2024
REC opinion
Further Information Favourable Opinion