The Data Access Process for Research (DAP-R) is a Health Research Authority-devolved internal UCLH approvals process, providing a streamlined approvals process for in-house research studies that fulfil certain criteria and enables UCLH to approve certain projects internally. Research not falling within the criteria will require the usual approvals process via the Health Research Authority. A SAFEHR Team member 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 every fortnight by the Research Data Access Committee (RDAC). Once ready, they will be submitted for review at the Data Trust Committee (DTC) 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.
DAP-R Express is an expedited branch of DAP-R for more straightforward and standardised data access, extraction and delivery. Eligible research requests must fit within the standard DAP-R criteria, in addition to our fixed Express requirements.
Refer to the criteria below to determine whether your research proposal is eligible for either the DAP-R or DAP-R Express process. For more information or if you believe you are eligible please contact the team via email.
To apply for DAP-R / DAP-R Express please visit the SAFEHR data website.
Streamlined service
Applications begin with a brief request form and are responded to within one week. A triage call is set up to review the request, discuss next steps, and assign a SAFEHR ‘buddy’ to the project.
Simplicity of service
Apply directly via this service, rather than completing and sending multiple forms to various external bodies.
Speed of service
Successful applications can be approved in weeks rather than months.
One point of contact
A SAFEHR team member is available throughout the process to update progress and connect your team to the right people.
Is it research?
Projects using hospital data may not be research. For example, service evaluations and audits are not defined as research, and the route for gaining data access is different.
As a general rule, projects"...which the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods..." fall under the Research remit, (Defining Research Table, HRA).
Non-research
For non-Research projects, please contact your divisional Business Information Partner or the central Information Services. If it is not clear whether your project is research, the MRC HRA Decision Tool can help. Alternatively, please contact the Joint Research Office via email for assistance, uclh.randd@nhs.net.
Research
For Research, the route to obtaining access will vary depending on context:
Researchers from within UCL / UCLH proposing a data-only study using exclusively anonymised data can apply via the Data Access Process for Research (DAP-R). For more information, including the criteria governing this process, please visit the DAP-R webpage.
To begin this process, please visit the SAFEHR data website.
Researchers from within UCL / UCLH whose study does not fall within the criteria of the DAP-R will need to obtain ethical approval from the HRA or related external bodies.
Please contact the JRO (uclh.randd@nhs.net) for assistance.
Researchers based outside UCL / UCLH may have an existing study sponsored externally, and wish to add UCLH as a site.
To begin this process, please contact the JRO (uclh.randd@nhs.net) for help with registration and contracts.
To be eligible for 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.
The study may be eligible for our DAP-R Express process if it also meets the following criteria:
- The data extraction is done by--or with direct supervision from--our SAFEHR team to comply with our anonymisation protocols
- The research IP will be owned by UCL or UCLH
- The data will be held in a secure environment within UCL or UCLH
- The request is in line with our data specification guidelines
- Structured data exists in OMOP-CAT
- Up to a 1,000 patients with imaging
- Up to 10,000 patients without
The above criteria will be discussed in our initial meeting to determine if you qualify.
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.
Electronic Health Record data is primary accessed via the Epic data warehouse, which receives daily extracts from the live system. Data can also be drawn from other systems, such as Onbase, PACS, and the Archive Data Store. Theoretically, any data stored by UCLH can be the subject of research, but some data sets are more commonly sought than others.
Only authorised UCLH staff have direct access to these data. Researchers will be provided a subset of data – the minimum required to answer the research question. This data must be clearly and unambiguously defined before work on extraction can begin.
No confidential or personal identifiable data will be included by default. To be included, any potentially identifiable data would need to be essential for the research initiative. Extractions inclusive of such data will need to be ethically approved by an appropriate governing body, as well as reviewed and permitted by the Information Governance team.
Data Items
Examples of data items may include:
- Inpatient admission, outpatient appointments, day cases.
- Medication & procedure orders.
- Diagnoses, problem list, reason for admission.
- Lab results, vital sign measurements.
Defining your cohort
This can depend on your project, but typically, you would specify:
- A date range attached to a specific date item.
- For example: admission date or discharge date; the date a test was taken or the date of its result.
- Inclusion / exclusion criteria for the study subjects.
Data Delivery
Once the data has been defined and is ready to be extracted, it must be stored for analysis. The storage solution must be approved by the Information Governance team.
UCL and UCLH support research using multiple platforms, such as:
Q: Where can we find the request form?
The request form can be found on the SAFEHR data website, along with more detailed documentation about our process and other SAFEHR services.
Q: If there are problems, who resolves them / follows up?
Please contact the SAFEHR team about your data request via email - uclh.research-dataconcierge@nhs.net.
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.
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 uclh.igqueries@nhs.net.
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 SAFEHR team via email - uclh.research-dataconcierge@nhs.net.
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 done via PIXL, an advanced imaging pipeline which allows streamlined access to structured, unstructured, and imaging data, including MRI and CT scans.
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 SAFEHR team via email for further information - uclh.research-dataconcierge@nhs.net.
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 SAFEHR team via email - uclh.research-dataconcierge@nhs.net.
Q: Are there resources to help with data extraction?
Yes, the SAFEHR team can provide assistance with data extraction. Costs will apply.
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.
HRA - Health Research Authority
The HRA is the external body responsible for overseeing, reviewing and approving health research in England.
REC - Research Ethics Committee
RECs “review research applications and give an opinion about whether the research is ethical”. Usually this is done as part of the HRA application process.
CAG - Confidentiality Advisory Group
The CAG “provides independent expert advice to the Health Research Authority and Secretary of State for Health on whether an application to process patient information without consent should or should not be approved”.
The NDG “advises and challenges the health and care system to help ensure that citizens’ confidential information is safeguarded securely and used properly”.
ICO - Information Commissioner’s Office
The ICO is an “independent authority set up to uphold information rights in the public interest, promoting openness by public bodies and data privacy for individuals”.
5 Safes framework
The Five Safes model is a popular framework for designing, describing and evaluating access systems for data, used by data providers, data users, and regulators.
- “What is the Five Safes framework?” by the UK Data Service
- Working paper
