Data Sharing Remote Audit: UK Biobank Limited

Purpose

This report records the key findings of a remote data sharing audit of UK Biobank Limited (UKB) between 19 and 23 July 2021.  It provides an evaluation of how UKB conforms to the requirements of both:

•    the data sharing framework contract (DSFC) CON-309882-D1H7D-v2.01
•    the data sharing agreement (DSA) DARS-NIC-08472-V9S6K-v12.2

This DSA covers the provision of the following datasets: 

The Controller is UKB and the Processor is the Nuffield Department of Population Health (NDPH) at the University of Oxford.

UKB was established as a medical research charity in 2003 and between 2006 and 2010 recruited 500,000 participants (then aged between 40 and 69) to take part in the project. The participants underwent measures, provided blood, urine and saliva samples for future analysis, supplied information about themselves and agreed to have their health followed via linkage to their health-related records. De-identified data are then made available to researchers who apply to use the resource to undertake health-related research that is in the public interest. 

This report also considers whether UKB and NDPH conform to their own policies, processes and procedures. 

The interviews during the audit were conducted through video conferencing. 

This is an exception report based on the criteria expressed in the NHS Digital Data Sharing Remote Audit Guide version 1.

Audit type and scope

As NDPH are responsible for the processing and storing of data, the audit focussed predominantly on technical controls at NDPH. Note, although researchers are increasingly being granted access to de-identified data through UK Biobank’s Research Analysis Platform, it was not considered during the audit as this location is excluded from the DSA.

Data recipient’s acceptance statement

UKB and NDPH have reviewed this report and confirmed that it is accurate.

Data recipient’s action plan

UKB will establish a corrective action plan to address each finding shown in the findings table below. NHS Digital will validate this plan and the resultant actions at a post audit review with UKB and NDPH to confirm the findings have been satisfactorily addressed. 

The following tables identify the 1 agreement nonconformity, 2 organisation nonconformities and 8 opportunities for improvement raised as part of the audit.

Supplementary notes

No notes.

Use of data

UKB and NDPH confirmed that the datasets were only being processed and used for the purposes defined in the DSA and and were only being linked with those datasets explicitly allowed in the DSA.

Data location

UKB confirmed that processing and storage locations, including disaster recovery and backups, of the dataset was limited to the location shown in the following table.  These locations conform with the territory of use defined in clause 2c of the DSA.

Backup retention

The duration for which data may be retained on backup media is:

Good practice

During the audit, the Audit Team noted the following area of good practice:

•    UKB and NDPH were able to clearly demonstrate the value the data supplied under this DSA has had towards researching cause, prevention and treatment of disease.
 

The audit was based upon a sample of the data recipient’s activities, as observed by the Audit Team. The findings detailed in this audit report may not include all possible nonconformities which may exist. In addition, as the audit interviews were conducted through a video conference platform certain controls, that would normally be assessed whilst onsite, could not be witnessed.

NHS Digital has prepared this audit report for its own purposes. As a result, NHS Digital does not assume any liability to any person or organisation for any loss or damage suffered or costs incurred by it arising out of, or in connection with, this report, however such loss or damage is caused. NHS Digital does not assume liability for any loss occasioned to any person or organisation acting or refraining from acting as a result of any information contained in this report.