If you agree to take part in the study, we will ask your permission to access and store images or video recordings from scans (e.g. MRI, CT or ultrasound) or endoscopy procedures (e.g. colonoscopy, flexible sigmoidoscopy, gastroscopy, enteroscopy or capsule endoscopy) performed prior to, or during the study. These images/video recordings will be stored securely and used for research purposes only.
If you are pregnant or become pregnant while taking part in the study, you can still take part. You will be asked to let the study team know that you are pregnant, and to let us know about any changes that may be made to your medications during or after pregnancy.
If you undergo any IBD-related surgery while taking part in the study, we will ask your local study team for information about this operation.
If you are admitted to hospital on account of your symptoms you may still be eligible to take part in the study even if you have already received some treatment or had an endoscopy test.
If you agree to take part, with your consent we will send your GP a letter informing them that you are participating. This is so that your medical records at your GP practice and in the hospital contain documentation that you are taking part in a research study. Any clinical test results from taking part in the study will be added to your medical notes at the hospital.
We may also collect further information from your GP medical records after 3, 6, 9, 12, 18, 24, 36 and 48 months if not available from your medical notes at the local hospital.
You will continue to receive standard care in line with any other patient with your condition, under the care of your doctors and specialist nurses. For most study participants this will be at the same hospital and with the same clinical team.
Even if you agree to take part, you can change your mind and withdraw from the study at any time by getting in touch with your site team. Your treatment will not be affected, and you will continue to receive the usual care you would expect from your Crohn’s and Colitis team. You do not need to explain the reasons, but it is helpful to the study if you do. If you do withdraw from the study, we will keep the information and samples collected from you up to the point of withdrawal. We will ask for your consent to continue to collect data recorded in your NHS medical records until the study ends. This is because this information is still very useful to us.
If you have a concern about any aspect of this study, you can speak to a member of the Open-IBD study team at your hospital, who will do their best to answer your questions. Further contact details are included at the end of this information sheet.
If you are still unhappy and wish to raise your concerns with someone who is not directly involved in your care and you are based in England or Wales, you can contact your local Patient Advice and Liaison Service (PALS). You can find your nearest PALS office on the NHS website, or ask your GP surgery, hospital or phone NHS 111 for details of your nearest PALS. If you live in Scotland, you can contact the Patient Advice & Support Service (PASS), website www.pass-scotland.org.uk or phone 0800 917 2127.
In the unlikely event that you are harmed during the study and this is due to someone’s negligence (they were careless) you may have grounds for legal action and compensation, but you may need to meet your own legal costs.
The Newcastle Clinical Trials Unit, part of Newcastle University, are managing the study on behalf of The Newcastle upon Tyne Hospitals NHS Foundation Trust. Newcastle University also has insurance arrangements in place to cover Newcastle University staff involved in designing and managing the study.