Royal Devon and Exeter NHS Foundation Trust

CQC Registered Health or/and Social Care provider

No

DARS-NIC-435152-C0H4N-v0.5

CLARITY IBD www.clarityibd.org (impaCt of bioLogic therApy on saRs-cov-2 Infection and immunity, https://doi.org/10.1186/ISRCTN45176516) is badged as a UK NIHR COVID-19 urgent public health study (1b) (https://www.nihr.ac.uk/covid-studies/). When referencing the evidence submitted, these objectives and processing information refer to Workflow 1 of the study (not Workflow 2). Patients with inflammatory bowel disease (IBD) are usually treated with immunosuppressive drugs. By inhibiting the immune system, these drugs increase the risk of serious infections and prevent vaccines fully working. Because COVID-19 is caused by a new virus, SARS-CoV-2, the researchers (Royal Devon and Exeter (RD&E) NHS Foundation Trust) don’t yet know if these drugs increase the risk of infection, life-threatening illness or reduce immunity that usually follows infection or vaccination. As a precaution the UK Government advised patients taking these medicines to follow strict social distancing measures, known as shielding, during lockdown periods. This study will investigate the impact of specific drugs and shielding on COVID-19 infection and subsequent immunity following infection or vaccination. The results of this study will help inform public health policy decisions for patients with IBD as well as millions of other UK patients treated with immunosuppressive drugs. 1. “What are the objectives of processing the data?” a. To conduct research: “The data is required to support the following research objectives: In patients with inflammatory bowel disease, on immunosuppressive medication, RD&E aim to define: - seroprevalence (number of persons in a population who test positive for a COVID-19 based on nasal/throat swab polymerase chain reaction, commonly performed to assess for acute infection) of SARS-CoV-2 through the early phase of the pandemic - seroconversion (time period during which SARS-CoV-2 antibodies develop and become detectable in the blood) in patients with confirmed infection by nasal/throat swab - the magnitude (extent) of SARS-Cov-2 antibodies in patients with confirmed infection - Demographic factors associated with COVID-19 disease, including gender, age, and deprivation 2. “What is your justification for each individual dataset?” To achieve these goals outlined in the CLARITY IBD research study, RD&E wish to collect the following data from the Demographics dataset: - NHS Numbers: For approx. 7,500 patients in whom RD&E have performed SARS-CoV-2 antibody testing on, RD&E require their NHS numbers in order to obtain further information from Public Health England on throat/nasal swab polymerase chain reaction results. RD&E have an agreement in place with Public Health England to supply them with nasal/throat swab polymerase chain reaction COVID-19 testing results. - Post code: For approx. 11,000 patients in whom RD&E have performed SARS-CoV-2 antibody testing on, RD&E require their residential post code. This will be to investigate the hypothesis that there are regional differences in COVID-19 infection across the UK, and that COVID-19 infection and severity differs across deprivation area. Please note that there is no biological reason for results not to be extrapolated to patients who are on anti-TNF medicine for non-IBD indications. It is hoped that results will directly be relevant, therefore, to any patent on anti-TNF/biologic therapy studied, including arthritis and psoriasis (the two most common non-IBD indications). 3. “Who are the data subjects?” The data subjects are a non-consented cohort of approx. 11,000 patients across the UK diagnosed with inflammatory bowel disease on immunosuppressive medication. This cohort was selected to provide a robust sample size to investigate variations impact of immunosuppressive therapy on SARS-CoV-2 infection and immunity, in line with our objectives, and therefore contains a mix of demographics (age, gender, ethnicity) in order to provide a suitably representative sample. Recruitment took place from 09-02-2020 to 30-10-2020 and is now complete so the cohort size will not increase. RD&E will test >15,000 serum samples from IBD patients for SARS-CoV2 antibodies. These include i) surplus serum samples from UK therapeutic drug monitoring laboratories retained since 09-02-2020 and ii) serum samples from patients recruited to the UK NIHR IBD Bioresource project. For each sample the supplier of the sample (the therapeutic drug monitoring laboratory or the UK NIHR IBD Bioresource) will provide the NHS number, date of birth, sex of the patient, postcode (if available), the date of the serum sample, the drug tested and the name of the referring hospital. These data will be provided for a COVID-19 purpose to the Royal Devon and Exeter NHS Foundation Trust. The study will use surplus serum samples from UK clinical laboratories saved following therapeutic drug monitoring tests. Additional serum samples will be obtained from the UK NIHR IBD Bioresource. 4. “How have you minimised your data request to what is absolutely necessary for your stated objectives?” “The following data minimisation options have been considered: RD&E are only requesting two variables (NHS number and Post Code)' 5. “Under what GDPR legal basis will you be processing this data?” “The Royal Devon and Exeter NHS Foundation Trust relies on GDPR Article 6(1)(e) – “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller”. Justification: The Royal Devon and Exeter NHS Foundation Trust is a NHS hospital, which is considered a public authority under the Data Protection Act 2018. It was legally established under a royal charter which states that one of its functions is to carry out research. This particular research is considered to be in the public interest because of the potential benefits to patient health, including to improve the quality of care for people living with inflammatory arthritis. The data requested is necessary to this research as the same outputs and benefits could not otherwise be achieved. The Royal Devon and Exeter NHS Foundation Trust relies on GDPR Article 9(2)(j) – “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject”. Justification: The data requested is necessary in order to meet the research objectives and has been minimised in a way that is proportionate to the intended purpose. RD&E has considered the interests of the data subjects including providing a transparent privacy notice that explains this use of data and the rights of data subjects, and data will be securely handled with role-based access controls to limit usage.” 6. “How are you addressing the common law duty of confidentiality?” The Royal Devon and Exeter NHS Foundation Trust relies on Regulation 3 (4) of the Health Service Control of Patient Information (COPI) Regulations 2002 to temporarily lift the Common Law Duty of Confidentiality. Patient consent for SARS-CoV-2 antibody testing was not sought and no prospective study visits are required. Justification: 'The COPI notice can be relied upon for the processing of confidential patient information for the purposes set out in Reg 3(1) of COPI in order to support the COVID-19 response. In direct relation to the study objectives, Regulation 3(1) confirms that confidential patient information may be processed for: • recognising trends in such diseases and risks; • controlling and preventing the spread of such diseases and risks; • monitoring and managing o the delivery, efficacy and safety of immunisation programmes The CLARITY study looks at risk of infection of COVID-19 amongst patients with inflammatory bowel disease treated with immunosuppressant medications. If a difference is found between patients on these treatments, this may have an impact and inform COVID-19 vaccine immunisation strategy/prioritisation for these patients. Where processing takes place under Reg3(1) COPI, the COPI notice states that confidential patient information must be processed solely for a COVID-19 purpose. In terms of Reg (3) - the processing of confidential patient information for the purposes specified in paragraph (1) may be undertaken by — (a)the Public Health Laboratory Service [Public Health England will use the NHS numbers and post codes of patients to link to COVID-19 nasal/throat swab polymerase chain reaction results]; (b)persons employed or engaged for the purposes of the health service [the processor of the data, is employed by the Royal Devon and Exeter Hospital, will use the data for Public Health England data linkage only]. The research project has received approval from the Surrey Borders Research Ethics Committee (20/HRA/3114) and Health Research Authority (IRAS: 283251, Protocol number: 2102102). The funders have no impact on the design or any inputs on the outputs of the study. They will have no access to any NHS Digital data.

This study addresses clinically relevant priority research questions relating to SARS-CoV-2 in a specific patient group. Obtaining estimates of the proportion of those patients already exposed to COVID-19 helps inform our knowledge and future planning. A greater understanding of the impact of immunosuppressive on SARS-CoV-2 acquisition, illness and immunity is needed to help define at risk patient groups and to determine the impact of preventative social distancing strategies. The data from this study may inform: 1. Alternative prescribing behaviour of immunosuppressive medication during the COVID pandemic if specific immunosuppressive therapies are associated with greater risks of severe COVID disease. 2. Alternative vaccination strategies if immunosuppressive drugs are associated immunosuppressive medication.

17/09/2021

De-Personalised

CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002

Statutory exemption to flow confidential data without consent

One-Off

TRE