CONSENTOR
Research type
Research Database
IRAS ID
323912
Contact name
J William L Brown
Contact email
Research summary
Combined One-off Neuroimmunological conditions Study and trial Eligibility Notification Tool and Observational Research consent form (CONSENTOR)
REC name
London - Bromley Research Ethics Committee
REC reference
23/LO/0144
Date of REC Opinion
14 Apr 2023
REC opinion
Further Information Favourable Opinion
Data collection arrangements
We propose a simple unified consent form which anyone with a neuroimmunological condition in the UK can complete from home (electronically or on paper) without input from healthcare professionals. This form – to be presented in multiple languages - will combine the consent forms from multiple existing registries, and allow people to indicate how much information they are comfortable sharing. People can additionally indicate whether they consent for their data to be used in ethically-approved studies being performed at their hospital (or the hospital’s research partner’s), preventing the need for multiple consents. For those interested in hearing about trials, their details will be compared against the ‘entry’ criteria for new trials. If a person is found to be eligible, they will be sent the trial Participant Information Sheet plus the contact details of trial staff if they wish to find out more or participate.
This will (i) markedly increase the number of people contributing detailed information to registries and local studies, expediting answers to the most important questions; (ii) improve the speed of trial recruitment; and (iii) improve access to both trials and registries for under-served populations, thereby improving their representation in each.Research programme
This study is about people with neuroimmunological conditions such as multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein (MOG) antibody disorder and myasthenia gravis. A neuroimmunological condition is one where the body’s own immune system becomes “mis-programmed” and attacks the brain, spinal cord, nerves or muscles. These conditions are common and cause significant disability. While some conditions have treatments that can reduce worsening, much remains unknown. Hospital records contain copious real-world data (e.g. information from clinics, results from blood tests and MRI scans); and people with these conditions – and their healthcare professionals - are often keen to contribute such data to registries to enable important questions to be answered. But this is not happening, largely due to clinician time constraints that preclude entering the data into registries (being addressed in a separate project) and consenting people. Consequently, registries contain the minimum necessary hospital-level information from around 1% of those with neuroimmunological conditions in the UK, preventing key questions from being answered.
Research database title
Combined One-off Neuroimmunological conditions Study and trial Eligibility Notification Tool and Observational Research consent form (CONSENTOR)
Establishment organisation
Cambridge University Hospitals
Establishment organisation address
Addenbrooke's Hospital
Cambridge Biomedical Campus
CB2 0QQ