The Data Access Process for Research (DAP-R) enables UCLH to approve certain projects internally. Research not falling within the criteria will require the usual approvals process via the Health Research Authority (Link). The Data Concierge will help the researcher to define the required data items, explore what data is available within UCLH, and to determine a suitable method of delivery.
Research proposals will be reviewed on a weekly basis by the Research Data Access Committee. Once ready, they will be submitted for review at the Data Trust Committee, which convenes monthly.
The Data Trust Committee comprises patient representatives, as well as UCLH staff. It provides the transparency and ethical review for proposed research projects. If the DTC is satisfied, the JRO will then formally confirm Capacity & Capability, and the extraction and delivery of data can begin.
Refer to the criteria below to determine whether your research proposal is eligible for this process. For more information please contact email@example.com.
Applications begin with the DEX form and are reviewed at a series of clearly defined stages by the RDAC and DTC committees
Simplicity of service
Apply once via this service, rather than completing and sending multiple forms to various external bodies
Speed of service
Successful applications are approved in weeks rather than months
One point of contact
The Data Concierge is available throughout the process to update progress and connect your team to the right people
Scope of the DAP-R
Studies must be:;
- Data-only studies, that require access to routinely collected anonymous data for patients and staff.
- (This includes references to staff activities within the Patient Health Record, or rostering and Electronic Staff Record (ESR) data)
- Sponsored by UCL or UCLH;
- In the public interest;
- For the benefit of UCLH and the service it offers, its patients and staff.
Any pseudonymised data shared for research will not include direct links between a study ID and direct identifiers like NHS Number. These linking tables will be retained by UCLH such that data will be anonymous when accessed and processed by research.
Studies may involve industry partnerships and collaborations and where appropriate, other NHS Trusts in line with their own approvals and subject to the inclusion and exclusion criteria. Note that, in line with NHS policy and process, the National Data Opt Out would not be applied because the data-only studies will be limited to using anonymous data.
Studies that require access to anonymous children's and young adults’ data can also be included, and those that involve submission to other research registries.
Examples of studies excluded from this process are those that:
- require Medicines and Health Regulatory Authority (MHRA) Approvals;
- are classified as “research” under the UK Policy Framework for Health and Social Care Research with the exception of data only studies;
- require live participant access or where there is a significant risk to patients or substantial changes to clinical operations and care provision;
- require data to inform databases and data studies which involve records relating to abortion, criminal records and Female Genital Mutilation (FGM);
- require data to inform or are collected as part of requirements for any of the above listed exclusions;
- are data driven studies that require consent or Confidentiality Advisory Group (CAG) support;
- use Occupational Health Records data for staff.
Those studies that fall outside the scope of the DAP-R will be handled in line with the existing processes for IRAS submission, Health Research Authority (HRA) and, where appropriate, Research Ethics Committee (REC) or CAG approvals.
Q: Where can we find DEX?
DEX is available here. It can only be accessed from within the UCLH network. The recommended browser is Chrome.
Q: Can the DEX form template be downloaded?
Yes. From within DEX, you can use the PRINT PDF button to download the form.
Q: Does each project need a protocol?
A protocol is not mandatory for DAP-R applications. The DEX form covers the key points. However, if you already have a protocol, you can upload this to the DEX form as an attachment, in support of the data request. Information submitted as a whole is considered when reviewing an application.
Q: If there are problems, who resolves them / follows up?
Please contact the Data Concierge firstname.lastname@example.org if you have any problems during the application.
Q: How do you get sponsorship without ethical approval?
Sponsorship will be arranged as part of the approvals process. Final approval of a DAP-R study will include both ethical approval and confirmation of appropriate sponsorship by the JRO.
Q: What does C&C mean?
Confirmation of C&C (Capacity & Capability) means that the Joint Research Office has reviewed a Research study and determined that UCL or UCLH can support the project. It is the final approval stage after an assessment of contracts, sponsorship, feasibility and so on.
Q: Should my study be defined as Research, or another purpose such as a service evaluation or audit?
The key thing to consider is whether the study will produce generalisable findings (or transferable findings in the case of a qualitative study). If so, it should be considered Research. The HRA decision tool may provide a quick answer. For more information, please contact the Joint Research Office email@example.com.
Q: How can I access or share data for a service evaluation or audit?
Please contact your Business Information Partner for data requirements relating to service evaluation, audit, or other non-Research purposes. For advice on sharing this data outside the trust, please contact Information Governance firstname.lastname@example.org.
Q: Can DAP-R be used for data requiring CAG approval?
No. The scope of DAP-R does not cover studies that need approval from the Confidentiality Advisory Group. Please contact the JRO for further advice.
Q: Are requirements for data sharing agreements embedded within this process?
Yes. For more information please contact the data concierge.
Q: Does this process cover data from other Trusts?
No. The scope of DAP-R is limited to studies using only anonymised UCLH data.
Q: Does this cover studies with researchers from other Trusts?
Yes. The research team does not need to be limited to UCL/H employees. However, the CI of the study must be principally employed by UCL or UCLH due to sponsorship requirements.
Q: What if we have our own analysts / data managers who can perform the data extraction and delivery side?
This is fully supported by DAP-R and will reduce costs. The request will require a clear data management plan to ensure that data is extracted and anonymised appropriately, and that the research team will only have access to anonymous data as specified in the request.
Q: Is there a possibility of linking the source data with other data sets?
Yes. This will often require patient-level IDs. The linking will need to be done by the data extraction teams before anonymising and then delivering the data to the research team.
Q: Can imaging studies go through the DAP-R process?
Yes. Imaging data can be requested using DAP-R, so long as the data can be anonymised.
Q: Who can access the Data Safe Haven?
The DSH is a UCL-owned platform which can be used for conducting research on data within a secure environment. It may be possible for non-UCL employees to access. Please contact the Data Concierge for further information.
Q: Can DAP-R be used to provide data for global surveillance projects or network studies?
The scope of DAP-R is limited to research studies using anonymised UCLH data. Multi-site studies do not fall within the scope. For more information please contact the data concierge.
Q: Are there resources to help with data extraction?
Yes, we can support data extraction. A charge will apply in most cases. Resource requirements are determined on a case-by-case basis.
Q: What are the timeframes?
This will vary from project to project. For a data request with strong supporting information, we expect 4-6 weeks from submission to approval. The time frame for data delivery will vary based on factors such as complexity of the data extraction and available resources.