The safety and protection of the UK population’s personal information or data is enshrined in UK law. As such, the Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London is governed by all relevant UK legislation on keeping personal data safe. The CSPRG also adheres to all Imperial policies and best practice on information security and data protection, and implements additional group policies for the safe use and storage of all patient and public health data gathered for our cancer research studies.
Privacy and data protection information about the SIGGAR trials
The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London processed special category personal data for the SIGGAR trials.
SIGGAR involved two randomised controlled trials to compare the efficacy of Computed Tomographic Colonography (CTC) to two established examination techniques: colonoscopy and barium enema to examine patients with symptoms requiring a whole-colon examination.
Who did we receive data from?
Imperial College London was the recipient of data for the SIGGAR trials. The special category personal data for this study was received by the CSPRG from several sources, given below.
- NHS hospitals in England
The CSPRG received demographic information, symptom information, consent forms, trial-linked clinical notes and treatment data about patients in SIGGAR directly from the 21 hospitals in which the trials were conducted. The 21 participating hospitals were:
- Bradford Hospital, Bradford
- Frimley Park Hospital, Frimley
- Charing Cross Hospital, London
- Hammersmith Hospital, London
- St Mary’s Hospital, London
- Leighton Hospital, Cheshire
- University Hospital of North Tees, Stockton-on-Tees
- St Mark’s Hospital, London
- Nottingham City Hospital, Nottingham
- Nottingham Queens Medical Centre, Nottingham
- Oxford Radcliffe Hospital, Oxford
- Royal Oldham Hospital, Oldham
- Derriford Hospital, Plymouth
- Queen Alexandra Hospital, Portsmouth
- Royal Cornwall Hospital, Truro
- Royal United Hospital, Bath
- Withington Hospital, Manchester
- Wythenshawe Hospital, Manchester
- Queen Elizabeth Hospital, King’s Lynn
- Furness General Hospital, Burrow-in-Furness
- Royal Lancaster Infirmary, Lancaster
NHS England (formerly NHS Digital) collect and process data from across the health and social care system in England. NHS England provided cancer and deaths data about patients enrolled in SIGGAR to the CSPRG. NHS England received some of this data from the Office for National Statistics.
The Office for National Statistics process cancer and deaths data for patients in England. The Office for National Statistics provided this information to the CSPRG for the patients in SIGGAR. The data were passed to the CSPRG via NHS England.
The research team working on the SIGGAR study had access to the identifiable special category personal data for patients enrolled in the trials.
The SIGGAR study was performed in collaboration with researchers at University College London (UCL) and the University of Birmingham. The main analysis for the SIGGAR study was done in collaboration with researchers at UCL who received subsets of the data to answer specific research questions. Researchers at UCL also received a pseudonymised subset of the data to perform a Health Psychology Assessment. Researchers at the University of Birmingham received a pseudonymised subset of the data to perform a Health Economics Analysis. Both groups received only pseudonymised data and therefore could not link the data they received to identifiers such as names and NHS numbers.
What type of information do we hold for the SIGGAR study?
The CSPRG holds personal information (such as name, full date of birth, NHS number) for the 5,384 patients who were randomised on the SIGGAR trials and did not withdraw their consent.
We hold pseudonymised data for the 3,036 patients who were eligible but not randomised and 734 patients who were not eligible.
Additionally, we also hold:
- Clinical data including data on symptoms, endoscopy, pathology, radiology and blood tests.
- Cancer and mortality data from NHS England for patients in the SIGGAR trials.
Why do we need to hold identifiable data for this study?
The identifiable data was required during the study to collect the clinical information for consented patients. We have also used this information to collect the data required for the SOCCER study and to allow NHS England to identify the study participants and provide us with follow-up data on cancers/deaths.
What approvals has this study received?
This study was reviewed and approved by an independent ethics committee and other organisations with responsibilities for NHS patients and research involving the NHS as listed below:
- Northern and Yorkshire Multicentre Research Ethics Committee;
- Section 251 approval from Patient Information Advisory Group (PIAG) and the National Information Governance Board (NIGB), predecessors of the Confidentiality Advisory Group CAG);
- Research & Development approval from the NHS Trusts managing all hospitals involved in the study.
How long will we hold the data?
It is a requirement of Imperial College London, the organisation responsible for this study, that we hold data from all clinical trials for 10 years after the study end date. Data from SIGGAR was also used for the SOCCER study. SIGGAR and SOCCER were closed in February 2022, so we plan to hold the archived SIGGAR and SOCCER data until 2032.