NB: needs re-formatting as a folding set of Q and As
What is the Gut Reaction Hub?
The Gut Reaction Hub is a programme of work, funded by a grant from HDR UK, that aims to enrich the genotyping and sequencing data already collected by the NIHR IBD BioResource with linked longitudinal health records from participating Trusts and the IBD Registry, and national hospital activity data from NHS Digital (HES). The integrated data will be stored by the NIHR BioResource and made available via a Trustworthy Research Environment. We also aim to demonstrate that this model is scalable to other disease areas and financially sustainable.
Do I apply to the Gut Reaction Hub to access the data?
No. The Gut Reaction Hub is the programme of work bringing together integrated data from multiple sources. The IBD BioResource, part of NIHR BioResource, holds the data and is the data controller. You must therefore apply to the BioResource to access the data. An application form can be found on the BioResource website. See section 10 of this document.
Which organisation would a commercial contract be with, and therefore be responsible for providing data access and meeting contractual obligations such as quality checks and timelines?
All contracts would be between Cambridge University Hospitals, the host organisation for the NIHR BioResource, and the institution which employs the applicant(s). The NIHR BioResource would provide access to the data.
Who can request access to the data?
Both academic and commercial researchers can request access to the data. International collaborations may be proposed.
What is meant by a ‘data access only’ study?
This is a study which only requires existing data which is already held by the NIHR BioResource. Any study requiring additional data will need to apply to recall participants from the IBD BioResource panel to a new study which will gather the additional data. These applications are done through the NIHR BioResource website <url>
Can I extract / download the data to analyse it within my own systems?
No. Existing data held by the NIHR BioResource will remain within the Trusted Research Environment for analysis. A variety of tools will be available within the TRE to help you analyse the data. If you have bespoke tools which you require, we can work with you to include these within the TRE. Any data generated by the research team as part of a participant recall study and the results of any study may be held securely by the researchers in question within their own systems.
Are proof-of-concept studies possible?
Yes, you may apply to run a proof-of-concept study.
What regions of the UK have you collected data from?
The IBD BioResource has consented patients across England, Scotland and Wales.
Will the datasets being provided by NHS Trusts and NHS Digital be available for all causes of hospital admission, or only those relating to IBD?
Health Episode Statistics (HES) from NHS Digital will be available for all causes of hospital admission.
Will mortality data be collected?
Patient activity data in HES can be used to identify if a patient died in hospital. Deaths recorded in HES may be analysed by the main diagnosis for which the patient was being treated, however these data alone cannot be used to determine the underlying cause of death. Data concerning mortality subsequent to discharge are not (currently) available, although we are investigating with NHS Digital whether it will be possible to use the Personal Demographics Service (PDS) for this purpose – but only where BioResource participants are being contacted about a potential recall study.
Will the data be curated?
Please see section 4 of this document for curation status and anticipated timelines.
Are all applications from industry automatically routed through the Steering Committee?
Yes. All commercial access requests will be reviewed by the NIHR BioResource Steering Committee, regardless of how ‘straightforward’ the request is. Ensuring we have patients’ support for the governance process is one of our highest priorities. We have collected extensive feedback from our Patient Advisory Committee. This tells us that patients would feel more comfortable with their pseudonymised data being used by commercial companies if the study has undergone a full review by a Steering Committee, which includes patient representatives, who will assess the application for both patient and scientific benefit.
Can I submit a single data access request which would allow repeated access to the data?
No. An application must be submitted for each proposed study. Each application must have a clear aim and specify the datasets which you would like access to. The data must only be used for the purpose specified in the study application. Applications requesting access to all the data for a non-specific study aim will be declined. We continue to work closely with our Patient Advisory Committee, who have provided extensive feedback from which it is clear the conditions above are imperative to continued patient support for the project.
Is it possible to obtain counts prior to application, using top level inclusion & exclusion criteria, to gauge pre-study feasibility? Will this cost industry to do so?
A cohort discovery tool is available for this purpose. Please see section 6.1. If significant costs are incurred in undertaking work before a project starts, these may need to be recovered in the contract for the project.
With regards to intellectual property ownership, who is classed as owner of the data following a study?
Ownership of participant level data will remain with the NIHR BioResource. Results of a study will belong to the organisation undertaking the research. If participants are recruited into a study by another organisation, that data set will be owned by the organisation.
Is sharing of commercial revenues agreed pre-study on an ad hoc basis or is there a fixed pricing structure & duration where this cost to industry is applied?
Any revenue share will be agreed once the input of the data into a commercial product is known. Factors to be considered will be:
- Intellectual Property: who is contributing the background IP, and who is/are creating the Foreground IP
- How the data contributes to the final product.
- Granularity of data requested; (increased granularity or specificity of a data set (Depth of phenotyping, number of data points) increases its value.