NHS England Data Sharing Remote Audit: Saving Faces - The Facial Surgery Research Foundation

Purpose

This report records the key findings of a remote data sharing audit of Saving Faces - The Facial Surgery Research Foundation (Saving Faces) between 27 February and 3 March 2023. It provides an evaluation of how Saving Faces conforms to the requirements of both:

• the data sharing framework contract (DSFC): CON-384008-T4W4W-v2.01
• the data sharing agreement (DSA): DARS-NIC-147858-KGYSS-v4.4

This DSA covers the provision of the following datasets:

The Controller is Saving Faces and the Processor is the Cancer Trials Centre (CTC) at University College London (UCL).

The SEND (selective neck dissection used electively) trial compares two standard surgical treatments for early oral cancer with no clinical evidence of lymph node metastases in the neck. The fundamental aim of the trial is to find better ways of treating patients with early mouth cancer. Saving Faces holds data previously disseminated and has requested new data for the SEND trial.

The trial has been closed to new patient recruitment since 2015. Findings published in 2019 showed patients with early mouth cancer who have resection of the cancer in the mouth and elective neck dissection at the same time have a survival benefit of 30% compared to patients who only have resection of the mouth cancer leaving the neck glands untouched. Based on these findings, Saving Faces believes there is reason to follow up patients for 10 years due to the risk of the cohort of patients getting new tumours.

This report also considers whether Saving Faces and its Processor 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 Data Sharing Remote Audit Guide version 1.

Audit type and scope

Data recipient’s acceptance statement

Saving Faces and the CTC have reviewed this report and confirmed that it is accurate. 

Data recipient’s action plan

Saving Faces and the CTC will establish a corrective action plan to address each finding shown in the findings table below. The Audit Team will validate this plan and the resultant actions at a post audit review with Saving Faces to confirm the findings have been satisfactorily addressed. The post audit review will also consider the outstanding evidence at which point the Audit Team may raise further findings.

The following tables identify the 4 agreement nonconformities, 1 organisation nonconformity, 3 opportunities for improvement and 1 point for follow-up raised as part of the audit. 

In addressing a finding, the data recipient must take account of any referenced supplementary notes.

Supplementary notes

The following note refers to the tables above and provides additional commentary on the linked finding.

Note 1.    Saving Faces declared that the CTC is no longer actively using the data as it is waiting for the next stage of the clinical trial when further data will be supplied, however the data is still being held by the CTC. Data was last supplied in 2018.

Use of data

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

Data location

Saving Faces and UCL confirmed that processing and storage locations, including disaster recovery and backups, of the dataset was limited to the locations 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:

• There were clear benefits from this clinical trial using the supplied data to health and social care. The following points were noted:
  • the SEND trial compared two standard treatments for early mouth cancer. Its findings showed that one method cures 30% more patients. This means that every five minutes, somewhere in the world, the life of one more person with mouth cancer is saved
  • the clinical trial enables surgeons for the first time to provide clear evidence regarding the benefits and impact of elective neck dissection for their patients thereby enabling patients to participate more effectively with decision-making regarding their treatment
  • patients therefore benefit by being offered more appropriate treatment based on their individual diagnosis, meaning they are less likely to need multiple surgeries.

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 England has prepared this audit report for its own purposes. As a result, NHS England 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 England 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.