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Data pathways at UCLH

There are numerous types of projects which need access to health data

A project using patient or staff data from the NHS may fall into one of 3 categories:

  1. Service evaluation or audit
  2. Research
  3. Research database

You will need to obtain the appropriate approvals before you can access data or the data is released to you. Researchers should not attempt to access or utilise data before  obtaining the correct approval.

To get the appropriate approval you will need to contact the relevant UCLH Department

To determine which of the 3 categories your project falls in, you should use the HRA decision making tool. You should the follow the guidance and approval pathway (PDF).

1. Service evaluation and audit

Service evaluations and audits using data from UCLH are managed through the audit lead in the relevant UCLH clinical division. Before the project starts, you will need to approach the audit lead who will tell you what information you need to provide. The audit lead for each division can be found on UCLH intranet.

Note: each NHS trust will have their own requirements around the registration and approval of service evaluations and audit. The appropriate procedure should be followed at each trust.

2. Research

Projects considered “research” and taking place at UCLH can be managed through 3 routes depending on the nature of the data requested and the type of approval required.

Research Route A - the DAP-R process

  • Research Route A Studies that can go through the DAP-R process
  • new standalone data- only research project
  • requires only UCLH anonymised data (no other sites, no other forms of data)
  • Chief Investigator is substantively employed by either UCL or UCLH
  • study sponsor would be either UCL or UCLH

The DAP-R (data access process for research) process combines processes for gaining sponsorship and local permissions at UCLH

To use the DAP-R process, you will need to  submit a request via an online system called UCLH DEX. The request is then handled by the UCLH Data concierge. The Data concierge will screen the request and if suitable, the study will move through the DAP-R approvals process.

The process includes review by the research data access committee (RDAC) and then onto the UCLH Data Trust Committee (DTC).  Any study approved by DTC would then receive final approval from the JRO to begin data collection at UCLH. Contracts and agreements maybe required in cases where there is a movement of data between UCL and UCLH.

 Further information about DAP-R can be found on the DAP-R pages.

Research Route B  - the standard review procedure for Sponsorship

  • Research Route B Studies which cannot go through the DAP-R process and need UCLH or UCL sponsorship.
    • new study does not fulfil the criteria for research route A
    • Chief Investigator is substantively employed by either UCL or UCLH

The project is likely to require sponsorship, NHS ethics, HRA approval and local permissions (AAC).  These studies follow the standard review procedure for sponsorship through the JRO, followed by site approvals.

Research Route C – studies that require site approval at UCLH (only)

  • Research Route C Studies that need site approval at UCLH (only)
    • study already has a sponsor (UCL, UCLH or other)
    • researcher from UCLH
    • study is to be placed at UCLH

The project is likely to require local permissions (AAC). The sponsor will have already (or be in the process of obtaining) obtained sponsorship, NHS ethics, HRA and other permissions outside of UCL and UCLH. These studies will need to be reviewed by the JRO for UCLH site approval.

3. Research databases

A research database is defined as “a structured collection of individual-level personal information, which is stored for potential research purposes beyond the life of a specific research project with defined endpoints. Research purposes in this context refers to analysis of data to answer research questions in multiple projects” (Research tissue banks and research databases - Health Research Authority (hra.nhs.uk).

HRA approval is not required for the establishment of research databases. Organisations managing these databases can apply for voluntary ethical approval.

From March 2023, all research databases led through and/or hosted within UCL or UCLH must be registered with the UCLH/UCL Joint Research Office (JRO) prior to initiation. Researchers should submit the database protocol or application to the JRO via uclh.randd@nhs.net.  In some cases, the database maybe suitable for a review through the DAP-R process. The JRO will advise if this is the case. As some databases involve the movement of data between UCLH and UCL (and potentially other sites), there may be a requirement for a data sharing agreement (or equivalent). The JRO will advise if this is  the case and will provide support to establish the correct agreement.

Resources:

 

Contacts:

Joint Research Office Leads:

Data Concierge:

UCLH Information Governance (Research):