NELOA version 1.0
Research type
Research Study
Full title
Northeast London Early Osteoarthritis Cohort
IRAS ID
335751
Contact name
Xavier L Griffin
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
9 years, 11 months, 31 days
Research summary
Barts BioResource (BBR) is an existing study at Barts Health NHS Trust which provides for the collection of consented participants' human samples and healthcare data, as well as the opportunity for recall into other studies. The new cohort study described in this application (NELOA) is approved as a potential recall study. Those aspects of NELOA that will require collection, processing and storage of human samples will operate under the regulatory approvals of BBR and the procedures laid out in that protocol.
NELOA is an observational cohort framework, designed to efficiently deliver multiple embedded observational substudies of patients who are at risk of developing arthritis in the joint(s) of their lower limb. It is based upon experience derived from the planning and delivery of several previous related groups of studies.
The purpose of the overarching cohort is to simplify the patient pathway through research in this field and capture efficiencies in the reduction of documents and clinical reporting forms duplication. We intend to make this operational through enrolment of participants into a large-scale observational cohort following standard care with low burden research procedures made in addition to routine clinical data collection. This cohort will act as a foundation for more detailed substudies to be added.
This will simplify the patient pathway through research in this field and produce efficiencies in the reduction of documents and clinical reporting forms duplication. Furthermore, the proposed platform is more coherent with a single set of ethical and regulatory approvals and an explicit legal basis and processing purpose for the use of patient-level data.
Future substudies within the overarching cohort will be detail further subsidy specific eligibility criteria and procedures. Future substudies will go through an approval process as amendments to this platform approval.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0039
Date of REC Opinion
27 Feb 2024
REC opinion
Favourable Opinion