No, it is up to you to decide whether you want to take part in this study. If you agree to take part, you will be asked to complete a consent form. You will be given a copy of your signed consent form, which is yours to keep. If you choose not to take part, your care will not be affected.
You will receive the usual care you would expect to receive from your IBD team.By signing a consent form, this means that you fully understand what taking part in the study means for you. That’s why it is really important that you take as much time as you want to read this information sheet and ask lots of questions.
Pregnancy: If you are pregnant or become pregnant while in the study, you can still take part. You will be asked to complete a page in the REDCap database 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.
Surgery: If you undergo surgery to remove a section of bowel during this study, we will ask your local study team for information about this operation.
Obtaining further information about your health: In the future, we may want to obtain further information about your health to compare to the findings from this study. Information will be gathered from UK organisations across the four nations, including the NHS, and those providing health research services for the NHS. You will have the option to allow us to store your name, date of birth and NHS number (or CHI number in Scotland) for 10 years after the end of the study so that we can obtain this information. We will contact you again after 8 years to extend your permission if we decide to obtain information for a longer time period. You will be able to remove your consent for this at any time, for any reason.
Benefits: In the short term this study will not help you directly as the results will not change the treatment you receive. However, the information we get from this study will help to improve our understanding of the links between gut microbes, genes, diet and IBD. Our goal is to better understand the complicated relationship between these different factors and IBD. Our aim is to use this information to create a tool that can predict response to treatment in IBD. In the future, we hope it will benefit lots of IBD patients, potentially including you, by helping to select the best drug at the right time for individual patients.
Risks: By joining the study, we will ask you to donate some blood samples and biopsies (only if you have an endoscopy during the study period). These samples will be collected by qualified and trained staff. Blood sampling can cause discomfort and may cause a small bruise. Biopsies are taken as part of routine clinical care. When a biopsy is taken, there is a small risk of bleeding and there is a very small risk, that the procedure could create a hole in the bowel (perforation). The specific risks of undergoing a colonoscopy or flexible sigmoidoscopy will be discussed with you in line with the NHS consent process for each endoscopic procedure you undergo; this is part of standard NHS practice.
Even if you agree to take part, you can change your mind at any time. Your care will not be affected, and you will continue to receive the usual care you would expect from your IBD 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 and may collect data recorded in your NHS medical records during the study period. This is because this information is still very useful to us.
You will not receive any payments for taking part in the study. As this study will be completed at home or during routine clinical appointments, travel and parking expenses are not covered and will not be reimbursed.
You will continue to receive standard care like any other patient with your condition under the care of your doctors and specialist nurses.
If you have a concern about any aspect of this study, you can speak to a member of your hospital’s IBD-RESPONSE team 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.cas.org.uk or phone 0800 917 2127.
If you live in Northern Ireland, you can contact the Patient and Client Council, website www.patientclientcouncil.hscni.net or phone 0800 917 0222. 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.
Chief Investigator: The doctor in charge of the study is Dr Chris Lamb, a Consultant Gastroenterologist and Clinician Scientist. He works for Newcastle University and at the Newcastle upon Tyne Hospitals NHS Foundation Trust.
Study Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust is the study Sponsor and has responsibility for the study. The study is managed by the Newcastle Clinical Trials Unit, Newcastle University, on behalf of the Sponsor.
Study Funders: The Medical Research Council (MRC), the Leona M. and Harry B. Helmsley Charitable Trust and the Wellcome Sanger Institute are the funders of this study.
This study was reviewed and approved by the Research Ethics Committee (Ref: 21/WA/0228) and the Health Research Authority (HRA). The Newcastle Upon Tyne Hospitals NHS Foundation Trust has reviewed all the study documentation and assessed the risks of this study as part of their responsibility as study Sponsor. This is to ensure that we are not doing anything harmful to you during the study and that your data is collected safely and stored securely.
If during the course of the study new information becomes available that is relevant to you, we will tell you about it. We will discuss whether you should or would like to withdraw from the study.
· The results will be written in medical journals and presented in meetings to other doctors, nurses, researchers and patients.
· A report will be written for the study funders.
· All study data that is published will be anonymous. Your identity will always be protected.
· Fully anonymised data and samples collected during the study, will be made available to other researchers to help inform other research studies.
Individual results will not be fed back to you.
Yes. You will not be named in any results, reports or on websites.All the information that you provide during the course of this study will be securely stored. Paper copies of your study information will be stored in locked files or rooms at your local hospital. Electronic copies of your study information will be stored on a secure, password-protected computer database provided by REDCap.
Only authorised members of the study team at the hospital and Newcastle Clinical Trials Unit will be granted access to the database.Some parts of your medical records and the data collected for the study will be looked at by authorised persons from the Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle University and/or the Newcastle Clinical Trials Unit to check that the study is being conducted to the correct standards. All will have a duty of confidentiality to you as a research participant.The study team at your hospital will have access to your information during the study to organise planned visits as well as for ongoing safety.
Very occasionally, information might be given during the study that we would have a legal obligation to pass on to others, for instance information which suggested you or others were at risk of harm. In this case, confidentiality would be broken so that we could pass this information to the relevant people. You would be informed of this.At the end of the study, all study information will be kept in a secure storage area (this is called archiving) for at least 5 years. This makes sure any queries about the running of the study have been answered. All information will be held securely to make sure we protect your confidentiality, after which it will be safely destroyed. Anonymised data and samples from this study may be stored indefinitely to answer additional research questions and to benefit future research studies.
We will need to use information from you and from your medical records for this research project. This information will include your name, initials, date of birth, postcode and contact details. People will use this information to carry out the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number (study ID) instead. We will keep all information about you safe and secure.Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
What are your choices about how your information is used?
· You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
· If you choose to stop taking part in the study, we would like to collect information about your health from the IBD BioResource and/or your medical records. If you do not want this to happen, tell us and we will stop.
· We need to manage your records in specific ways for the research to be reliable.
This means that we won’t be able to let you see or change the data we hold about you.
Where can you find out more about how your information is used?
You can find out more about how we use your information:
· at www.hra.nhs.uk/information-about-patients/
· our leaflet available from www.hra.nhs.uk/patientdataandresearch
· by asking one of the research team
· by sending an email to the Sponsor Data Protection Officer at nuth.dpo@nhs.net
If you have any further questions or would like any further information about the study or the rights of participants, please feel free to contact the people at your local site.
They are also who you or your doctor should contact in the event of an emergency, if your study participation is in any way involved.
