Questions & Answers

Gut Reaction is a project aiming to make health data (such as genetic information, medications and treatment plans) from people with IBD more accessible to doctors, scientists and pharmaceutical companies to use for research into possible causes and treatments.

Gut Reaction builds on the health data already securely held in the NIHR BioResource (within the NIHR IBD BioResource cohort), combining it with additional data from participating NHS trusts, organisations such as the IBD Registry and genetic information provided by the Wellcome Trust.

Researchers can apply to investigate selected datasets in a secure environment. Applications for data access are overseen by an expert panel, including patients.

Gut Reaction is funded by a grant from Health Data Research UK (HDR UK), it is not a company and has no owners or shareholders. Our funding covers all or some of the costs of the research team working on it, as well as other costs such as data storage, communications materials etc.

Researchers and organisations are charged for access to the data, but these charges cover costs and drive investment in further research and the NHS; they are not to be used to benefit team members or any other individual associated with the project.

Gut Reaction enables approved researchers to access and use linked patient data in order to answer a pre-approved research question, and our standard approach is to use our trusted research environment (TRE). The TRE is protected so that it is not possible to download the datasets in order to be able to share or sell them.

We also have legal contracts in place with the researchers before they start their studies to further ensure that data is only used in the approved way.

We may charge researchers a fee for providing secure access to the data, in order to recover costs and invest further in research. Our standard charges are between £8,000 and £50,000, depending on how much data is required. If additional requests (such as specialist computing or genetic analysis) are made, we would also ensure that our costs were covered.

There are a number of safeguards protecting the data within Gut Reaction. The data are stored at specialist facilities, with significant commercial and technical expertise in data protection. We only allow researchers to access de-identified data; this is where any information that could link the data to an individual such as birth date or NHS number has been removed.

We are partnered with specialist technology firms, including Privitar and AIMES to ensure that this is done to the highest standard.

Gut Reaction only contains health data from people who are participating in health research through the NIHR BioResource. People who sign up to the BioResource to take part in research provide a small biological sample (usually a blood sample), complete a health and lifestyle survey and give permission for researchers to access their health records for research purposes.

Gut Reaction builds on the data from the NIHR BioResource (for example, genetic data) safely combining it with data that comes from their usual treatment for IBD (for example, scans, prescriptions, hospitalisations). People who are not participants in the NIHR BioResource are not included in Gut Reaction.

If you have IBD and would like to take part in Gut Reaction, you can join the NIHR IBD BioResource. Recruitment to the NIHR IBD BioResource takes place in outpatient clinics in participating NHS hospitals (you can find a participating hospitals here).

When you join you will be asked to sign a consent form, fill in a health questionnaire and provide a blood sample (which will be taken as part of your routine clinic bloods). Once enrolled, IBD BioResource members may receive invitations to participate in research studies Participants are always free to decide which (if any) studies they wish to take part in. More information about the NIHR IBD BioResource can be found here.

You can also join the IBD Registry so that data from your hospital record can be linked with your health information held in the IBD BioResource. When you join, you can also tell the Registry if you would like to be contacted about new studies that are relevant to you and you may want to take part in. You can find out more about joining the IBD Registry here.

The NIHR BioResource (or the NIHR BioResource for Translational Research in Common and Rare Diseases, to give it its full name) is a partnership of patients, researchers and clinicians working together to learn more about the causes of disease, and find new treatment options. To help make this vital research possible, the NIHR BioResource securely collects and holds consented health information from its participants.

Gut Reaction will build on this data by bringing in further data for the same participants and linking it together to give a detailed picture of their treatment and symptoms. The rules and procedures (known as governance) that cover how data in Gut Reaction can be accessed and used are the same as those used for the NIHR BioResource.

Crohn’s & Colitis UK is the leading charity for Crohn’s Disease and Ulcerative Colitis in the UK, whose 40,000-strong membership represent people living with Crohn’s and colitis as well as their families, friends, medical professionals and researchers.

Their mission is to work with all those affected by these conditions to achieve a better quality of life, improve services, and ultimately find a cure. As a partner in Gut Reaction, they bring their expertise in IBD, research and working with patients and communities as well as ensuring that the voices of patients are central to our work.

The IBD Registry collects health data from NHS hospitals and analyses this information to help improve services for people in the UK with Crohn’s disease, ulcerative colitis and other forms of inflammatory bowel disease (IBD). It also supports new research into these conditions. If you have IBD, you can join the Registry to agree to your data being used to support this valuable resource. You will also have the option to agree to your data being used for research, and to tell the Registry if you want to be contacted about new studies that are relevant to you and you may want to take part in. The IBD Registry is a partner in Gut Reaction, which means health data collected from people who participate in both the Registry and the IBD BioResource can be linked and united to create a rich dataset for research.

If you are a member of the IBD BioResource and you are not comfortable with Gut Reaction using your data for research you can withdraw your consent. Leaving the IBD BioResource is very straightforward, you do not need to give a reason for your decision and withdrawing will not affect the quality of healthcare that you receive. You can find more information about withdrawing here.

You can find out more about withdrawing from the IBD Registry here.

The data held in Gut Reaction is de-identified – it has all of the obviously identifying information (such as name and NHS number) removed, but it is not anonymised. This is because we need to be able to identify individuals within Gut Reaction to make sure that all of the different pieces of data about them are correctly joined together – that information coming from different sources about the same person is all put together as part of one record.

However, the information we need to identify people (and so link the information together) is held separately and securely by the NIHR BioResource. You can read more information about how the NIHR BioResource keeps data confidential. There is a small, but real, risk that under the wrong conditions individuals could be identified from this data. However, we believe that the potential benefits from this research outweigh this risk and have strict procedures in place to ensure that this is very unlikely.

To request a copy of the data we hold on you, please email us or write to:

NIHR BioResource
F49, Department of Haematology
University of Cambridge & NHS Blood and Transplant
Long Road
Cambridge
CB2 0PT

Email: nbr@bioresource.nihr.ac.uk

We will confirm receipt of your request as soon as possible. We have a lot of data and may need to ask you whether you can narrow down your request. However, the data we hold should be with you within 30 days.