The results will be analysed and written up in medical journals and presented in meetings to other doctors, nurses, researchers and patients. A report will also be written for the study funders. Individual feedback will not be able to be provided at the end of the study, however a summary of the study findings will be completed and available to all participants. All study data that is published will be anonymous so your identity will always be protected. An easy to understand summary of our findings will be published here on our website.
While you and your care team may be able to access some of the results of assessments carried out during the study, Open-IBD will not routinely provide feedback on individual genetic, or other results from samples taken for research purposes. The research analyses we undertake in this study can take many years to complete. They are not designed to make clinical diagnoses or influence your care. In the unlikely event that an abnormality is identified through analyses carried out on your samples or questionnaires during the study or later, which the study team believes is important for your Crohn’s or Colitis management, or that indicates you may be at increased risk of a disease relevant to your future health, your clinical care team or GP may be notified. You may then be asked to provide further information or additional samples to be sent to an accredited NHS diagnostic laboratory to seek confirmation of the result discovered on your research sample.
We want to know how your human cells in blood and in the gut and how gut microbes and other components of stool influence the behaviour of Crohn’s and Colitis and other gut conditions. We want to know how these factors influence the start of disease, how well you respond to different treatments and to see if this knowledge can help develop new treatments. As your genes, immune system, microbes, the environment you live in and the foods you eat may all be important, it is crucial to look at the whole picture, and in a large number of people.
Genes are made up of DNA codes which we can find in your body’s cells. RNA, a molecule similar to DNA, converts this code to control how cells behave. When you give us a blood, stool or biopsy sample, we separate out the DNA and RNA from the samples, analyse it, and store this information safely. This allows us to identify genes in human and microbe cells that may be important in determining how you respond to a treatment.
We may also look for other things in your blood, stool and biopsy samples now or in future using stored samples. Examples of other research includes looking at:
· Different types of cells such as those involved in the immune system and stem cells
· Proteins such as antibodies
· Metabolites (molecules that form from chemical reactions in your body)
We may also grow some cells from your biopsies, called organoids. Organoids are 3D models of cells that grow from the cells present in biopsy samples collected during colonoscopy, they imitate the environment inside of the gut. These may be used to study how different cells of the intestine behave and interact with one another and/or other microbes, metabolites, medications or food. Future research with organoids could help us to better understand the causes of Crohn’s and Colitis and how to develop or test new treatments. Studying organoid models also helps avoid the use of animals for medical research.
We hope this study will provide valuable information about how Crohn’s and Colitis behaves over time. Therefore, if at the end of the current study period, further funding can be obtained we may apply to extend the study period, perhaps for at least 10 years. If this occurs, we will continue to have access to your medical records, scans, endoscopy images and to any biopsy or surgical samples taken as part of your routine care. You would not need to be involved in further research sampling or questionnaires.
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 Ennov. 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.
Data about you e.g. personal details and information about your health, will be stored in secure electronic databases. You will be given a unique study ID code, which will be used to identify your samples and data without using any personal details. Any information from analysis (genetic and other tests) will be stored separately from your personal details using the unique study ID. Access to your personal details will be available to authorised members of the local study team (for example, your treating clinician and research nurses at site).
Data collected to confirm your consent to participate will be stored in a secure electronic database called REDCap. Data collected as part of the study itself will be stored in a secure electronic database called Ennov, using your unique study ID. The staff responsible for managing the REDCap database at The Newcastle upon Tyne NHS Foundation Trust and the Ennov database at Newcastle Clinical Trials Unit will also have access to some parts of your personal details. Paper copies of questionnaires (if used) will only include your unique study ID and never any personal details.
One of the health questionnaires used in this study asks you to record your current level of anxiety/depression. Should you record being severely or extremely anxious/depressed, staff within the Newcastle Clinical Trials Unit will notify the Principal Investigator at your hospital site, using your unique study ID in order to support you. These investigators have access to the data collected, however this notification is to ensure this is brought to their attention swiftly.
The data collected during the study (which cannot be linked to you personally) will be transferred to Open Targets study partners periodically during the study. These partners include research institutions including universities and hospitals and commercial institutions including pharmaceutical companies. This may include transferring data to partners based in other countries. UK data protection regulations will be adhered to at all times during this process.
Data may also be requested by external researchers during or after the study. Before any of your anonymised data is given to external researchers, the request will need to be considered by the study oversight committee. Under no circumstances will information that identifies you personally, be disclosed.
Every few months and at the end of the study, anonymised study data, including genetic sequencing data, will be uploaded to a public online archiving platform to allow researchers to access anonymised data for any future research and so help the scientific and clinical community to benefit as many people as possible using the data from Open-IBD. Online archiving is considered best practice by funding bodies and research journals.
You can find out more about howwe use your information:
▪ In our leaflet available from www.hra.nhs.uk/patientdataandresearch
▪ By asking one of the research team
▪ By sending an email tothe Sponsor Data Protection Officer at nuth.dpo@nhs.net
Chief Investigator
The doctor in charge of the study is Professor Chris Lamb, aConsultant Gastroenterologist and Clinician Scientist. He works for theNewcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University.
Study Sponsor
The Newcastle upon Tyne Hospitals NHS Foundation Trust isthe study Sponsor and has responsibility for the study. The study is managed bythe Newcastle Clinical Trials Unit, Newcastle University, on behalf of the
Sponsor.
Study Funder
The study is funded by Open Targets (https://www.opentargets.org/), apublic-private partnership that includes funding from charities andpharmaceutical companies. Open Targets aims to use genetic data to identifytargets for new drugs with the goal of discovering new medicines.
Open-IBD team
The Open-IBD study team includes doctors, nurses and scientists from hospitals, universities across the UK and other research institutions, like the Wellcome Sanger Institute. We will work closely with our funder, Open Targets and the scientists who work at Open Targets partners (https://www.opentargets.org/) so the research undertaken in Open-IBD has the greatest chance of benefiting patients in the future.
The study has been reviewed by an NHS Research Ethics Committee and the Health Research Authority (HRA). They need to be satisfiedthat your rights will be respected, that any risks are balanced againstpossible benefits, and that you have been given sufficient information on which to make an informed decision to take part or not. The committee agreed that itis ethical to proceed.
The Newcastle Upon Tyne Hospitals NHS Foundation Trust hasreviewed all the study documentation and assessed the risks of this study aspart of their responsibility as study Sponsor.
If you have any further questions or would like any moreinformation about the study or the rights of participants, please contact your local research nurse.