Maximising the value of the UK IBD Registry
Research type
Research Study
Full title
Maximising the value of the UK IBD Registry for service delivery, audit and research: Prospective Evaluation Of The Consent Model
IRAS ID
210568
Contact name
Keith Bodger
Contact email
Sponsor organisation
Aintree University Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
The Inflammatory Bowel Disease Registry (IBD Registry) is a condition-specific chronic disease registry. It was established with a primary aim of supporting service delivery at point-of-care and facilitating audit and service evaluation at local and national level. However, the registry also has great potential to support future IBD research.
The registry currently operates an 'opt-out' model of participation for its core functions, having been granted a period of exemption from requiring informed consent (section 251). The relative merits of ‘opt-out’ versus ‘consent-based’ models for the sharing of health-related data for secondary uses are subject to ongoing review and public consultation in the UK.
Anticipating the potential transition from an opt-out to a consent-based model of registry participation and the opportunity to capture consent for future research, the IBD Registry has worked with NHS Digital to develop a consent process. This gives patients an opportunity to actively consent to basic registry participation and also to approve additional options, including the use of anonymized data for research and permission to be contacted for future research studies. If the registry is to serve as a future vehicle for research, it is vital to understand whether the proposed consent process is capable of achieving high rates of participating and gain insight into potential recruitment bias for different research options.
Our primary aim is to determine the acceptability of each of the IBD Registry consent options, as indicated by the proportion of eligible patients willing to consent to basic registry participation and to each of the subsequent research-related options. A secondary aim is to support the establishment of hospital sites with well-characterised cohorts of patients who have provided informed consent for future research. This study will provide a proof-of-concept that the registry's infrastructure and consent model is capable of providing a platform for UK-wide IBD research participation.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0496
Date of REC Opinion
6 Oct 2017
REC opinion
Favourable Opinion