Privacy Notices

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Information you need to know

The Post-Hospitalisation COVID -19 Research Study (PHOSP-COVID) is a consortium of leading researchers and clinicians from across the UK working together to understand and improve long-term health outcomes for patients who have been in hospital with confirmed or suspected COVID-19. Information about the PHOSP-COVID Research Study can be found at https://phosp.org

The research study is being organised and funded by the NIHR Leicester Biomedical Research Centre and supported by a grant to the University of Leicester from MRC-UK Research and Innovation and the National Institute for Health Research(NIHR). The Study has received ethical approval from the Yorkshire and Humber - Leeds West Research Ethics Committee and approval from the Health Research Authority.

The University of Leicester is Leading the Consortium of 26 UK Universities and approximately 44 NHS Trusts who are involved in this national research study.

The University of Leicester is the Data Controller for the participant personal information we will process as part of this research study. Further information on the University can be found here: https://le.ac.uk/

The Data Protection Officer is: Parmjit Singh Gill, Information Assurance Services Manager and Data Protection Officer, University of Leicester, University Road, Leicester, LE1 7RH. Tel: 0116 229 7946. Email: dpo@leicester.ac.uk.

This privacy notice explains what information we are collecting, how we will use this information in this study and what rights participants have in relation to their information.

Version 2: 26.04.2022/IAS

Your questions answered

NHS Trust Hospitals and NHS Digital and other partners who are supporting this study will be providing personal information obtained directly from or about adult patients who have been admitted to Hospital with confirmed or suspected COVID 19 symptoms and subsequently been discharged from hospital.

We will only collect and use information about those patients who have voluntarily agreed to participate in this study and have completed patient consent forms in accordance with ethical requirements and to meet legal obligations relating to confidentiality.

The information collected from or about participants includes:

  • Their personal information such as full name, address, telephone/mobile numbers and email address. Street and postcode information will be used to access environmental data (for example, air pollution) that is required for the research.
  • Demographic information including age, sex and special category personal information concerning ethnicity and health.

Personal information and Special category information relating to health will be collected from or about participants who have agreed to participate at one or more of three research stages (called Tiers) as follows:

Tier 1 –We will collect routine healthcare records and samples including:

  • signs and symptoms, current medications, results from blood tests, questionnaires, laboratory results or imaging ordered by their doctors;
  • all clinical records and case notes relating to their Covid-19 hospitalisation, as well as GP, health and social care records from before and after their Covid-19 hospitalisation;
  • Leftover Blood samples from tests ordered by doctors which may be used to measure DNA; and
  • Saliva samples, which may be used to measure DNA where there are no blood samples.

We will only be collecting information that is required for this research but, since this is a long term Public Health study, it is our intention to continue to collect information from participant’s electronic patient records held by NHS Digital for 25 years.

Tier 2 – We will continue to collect updated participant Tier 1 health information but we will also collect additional information for this research study from some participants including:

  • where these have not already been requested as part of their clinical care, further blood tests for clinical testing for example a blood count, kidney and liver function, a hormone from the heart, a test for diabetes, tests similar to cholesterol, vitamin D levels;
  • additional research samples including blood, oral and urine samples;
  • carrying out additional tests such as ‘activity monitoring’; and
  • information gathered in the form of questionnaires (for example, Quality of Life questionnaires).

As part of this study, we will use the samples obtained in both Tier 1 and Tier 2 to look at how the body is affected by COVID-19. We will use samples to analyse DNA (genetic variation), RNA (how genes work) and other molecules.

Tier 3 – We will seek participants’ agreement to keep their personal details so we can contact them about participating in additional research studies.

Personal information is information that relates to and enables a living individual to be identified from that information.

Special Category Information: Health and demographic information such as ethnicity relating to participants is classed as a special category of personal information and we are required by law to take additional care to protect it.

The University has technical and organisational measures in place to ensure that the data used in this research is securely stored and only used for the purposes of this research. It also requires the other Universities who are collaborating with us in this study, the NHS Trust hospitals, NHS Digital and other partners who will provide, or process participant information to have their own technical and organisational measures in place to comply with Data Protection Legislation.

As COVID-19 is a new disease, the main purpose for processing participant information in this research study is to identify whether there are longer-term health problems of COVID-19 for those adults admitted to hospital.

We want to understand:

  • why some people experience more severe COVID-19 than others
  • why some people recover more quickly than others
  • why some patients develop other health problems later on
  • which treatments or interventions patients received in hospital or afterwards were helpful
  • how we can improve the care of patients after they have been discharged from hospital.

Our additional Public Health purpose is to develop a resource of data and samples that other researchers can use to answer their questions quickly to help improve outcomes in future. This will provide the best use of the time, information and samples patients participating in this study provide.

We will use patient information to:

  • enable us to study the progress of the recovery of COVID-19 patients and to understand the full impact this virus has on them in terms of health and well-being;
  • identify whether there are longer-term health problems of COVID-19 for those who were admitted to hospital.
  • look at how the human body is affected by COVID-19 by using samples obtained in both Tier 1 and Tier 2 to analyse DNA (genetic variation), RNA (how genes work) and other molecules.
  • create a national database of COVID-19 patient information. This will involve linking the patient information we collect directly from patients with other information held by other organisations for e.g. NHS digital;
  • help our researchers to identify priority areas for further research in the Tier 3 stage and beyond.

We will not be using the data to record, learn or decide something about the individual patients whose information we are using.

Due to the nature of the study, there will be “profiling” of patient information relating to demographics, patients who have multiple medical conditions at the same time and all patients who are in specific at-risk groups. This will allow us to be more precise in the way we study the impact of COVID-19 on, and to improve our understanding of different patient groups in term of the purposes of the study.

The Research study does not involve automated decision-making.

The legal basis for the processing of participant information that we are collecting and using for the study is Public Task as set out in the Data Protection Act 2018 and UK GDPR Article 6.1(e). Research is a public task that the University of Leicester performs in the public interest, and is part of its core functions as a University.

Our additional conditions for processing special category information are:

  1. processing is necessary for reasons of public interest in the area of public health, specifically relating to COVID-19, as set out in the Data Protection Act 2018 and UK GDPR Article 9.2(i); and
  2. that it is necessary for ‘scientific research or statistical purposes’ as set out in the Data Protection Act 2018 and UK GDPR Article 9.2(j).

This is a complex study and involves many research and delivery partners, such as Universities, Hospitals. Laboratories, information processing and logistics operations. The following is a list of some of the organisations we are sharing participant information with, but is not an exhaustive list of all those who we may need to involve over the life of the study:

  • 26 Universities who are part of the Consortium carrying out this study for analysis of the participant data provided by their local NHS Trust Hospitals.
  • The University of Edinburgh who will provide the main data centre facilities for the duration of the study. They will carry out data linkage services whereby participant data collected by the NHS Trust hospitals will be combined with participant information held by others partners such as NHS Digital, NCIMIS (CT scans and X-rays) and other Studies such as ISARIC (Oxford and Edinburgh Universities).
  • Royal Mail services contracted by the University of Leicester to deliver sample DNA saliva test kits to eligible participants.
  • The Wellcome Trust Clinical Research Facility, University of Edinburgh, who will receive the research samples being collected from participants by the University of Leicester and carry out the DNA analysis for the study. This will also be covered by a Materials Transfer Agreement between the University of Edinburgh and the University of Leicester.
  • The Liverpool Good Clinical Practice lab who will manage the research samples being collected and analysed for the study.
  • Oxford University who will provide us with True Colours Quality of Life Questionnaire services for all participants.
  • Leicester Diabetes Research Centre who will provide Tier 2 Activity monitoring services.
  • We will act on any test results including questionnaires that require follow-up, most commonly this will be by informing the participant and their GP of a particular result. Other than this, we will not be sharing information with participants or their GP about any test results or assessments.
  • Bona Fide researchers outside the PHOSP-COVID study team who successfully apply to our Executive Board and Steering Committee and whose application for access to the research data will be overseen by the External Scientific Advisory Board (this body comprises senior, independent people who will not be involved in the collection or analysis of the PHOSP-COVID samples or participant information).
  • In the long term, the Health Data Research UK Digital Innovation Hub and The Health Data Research Hub for Respiratory Health (BREATHE) based in Swansea, or a similar trusted research data storage facility, will hold a copy of the PHOSP-COVID database with access governed by a data access committee. This is to ensure that this important database is available for future research projects in the public interest.
  • Participant information and samples may be disclosed to regulatory authorities and public health agencies.

We are also required to provide progress reports and summarised research information to our grant funders and the Department of Health and Social Care but this will not include any information about individual participants.

We will only share with all these parties the minimum information that is necessary for them to undertake the task they are performing. We will not share information that identifies participants such as their name and contact information with people who do not need to know this. In such cases, we will replace name and contact details with a code number – this is called pseudonymised information.

In contrast, Anonymised information means that a person cannot be identified from the information and it is not personal information for the purposes of Data Protection Legislation.

The PHOSP-COVID research is a long-term study this means we will be processing participant data for 25 years after the initial 18 months of the study. The national database of participant information we are creating will be transferred to a trusted long term data facility and will be kept for a further 25 years to enable it to be used for any future research which has appropriate approvals.

Under Data Protection legislation, individuals have rights in relation to the personal information we hold about them. For the purposes of research, where such individual rights would seriously impair research outcomes, such rights are limited.

In this research study, we need to limit participant’s rights and are relying on the exemptions in Schedule 2 Part 6 paragraph 27 of the Data Protection Act 2018 because we are processing this information for scientific research in accordance with UK GDPR Art. 89(1) and Approved Medical Research covered by s19 Data Protection Act 2018.

Prior to applying these exemptions, we have carried out a Data Protection Impact Assessment and taken into account:

  • That this public health and scientific research is long term and is of national significance because it relates to COVID -19, a new disease classed as a pandemic because it has affected people in many countries;
  • That the results of our research will only be published in an anonymised or summarised basis;
  • We have taken appropriate measures to safeguard participant information we collect or receive and to protect the rights and freedoms of the patients whose information we will be using in our research;
  • We and our partners are under an obligation to maintain confidentiality in our handling of participants’ information;
  • We are making information about our research and use of their information available to participants and the public through this privacy notice which is available on this Study website and the University’s main website

We have concluded that the exercise of rights by participants would seriously impair the achievement of the Study objectives and the exemptions are necessary to enable us to fulfil our public health and scientific research purposes.

Participants involved in this research will not be able to exercise their rights to access their personal information, to request correction of inaccurate information or erasure of their information, to restrict processing of information or to object to our processing of their information even if they leave the study. UK GDPR Articles 15,16,17,18 and 21 will not apply.

If you wish to ask questions about our use of this data or your rights, you may contact Information Assurance Services by email at ias@leicester.ac.uk or the University’s Data Protection Officer by email at et177@leicester.ac.uk.

Anyone can raise concerns about how their information has been processed with the Information Commissioner’s Office (ICO). The ICO may be contacted:

  • By Post addressed to: Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF.
  • By Telephone: 0303 123 1113.
  • By Email: contact can be made by accessing www.ico.org.uk

Privacy Notice

PHOSP COVID 19 sub-study - UK evaluation of NHS support post-hospitalisation for COVID19 to inform service development and achieve holistic, integrated, equitable and cost-effective services

Information you need to know

The University of Leicester (Leicester) and The London School of Hygiene and Tropical Medicine (LSHTM) are jointly conducting research to Understand NHS care pathways for survivors of a Covid 19 hospital admission (the Study).

This Study is part of the national Post-hospitalisation COVID-19 Research Study (PHOSP COVID 19) which aims to identify whether there are longer-term health problems of COVID-19 for those who were admitted to hospital. Leicester is the sponsor for the PHOSP-COVID 19 Research.

Leicester and LSHTM are Joint Data Controllers for your information for the purposes of the Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR). Leicester and LSHTM undertake to treat all your personal data in accordance with these data privacy laws.

Further information about Leicester can be found here: https://le.ac.uk/ , and information about LSHTM can be found here https://www.lshtm.ac.uk.

Personal data and privacy enquiries relating to this Study should be directed to Leicester’s Data Protection Officer Parmjit Singh Gill Information Assurance Services Manager who can be contacted by post addressed to the Data Protection Officer, The University of Leicester, University Road, Leicester, LE1 7RH or by email: dpo@leicester.ac.uk.

This privacy notice is supplemental to the main PHOSP-COVID 19 privacy notice and explains what information we are collecting, how we will use your personal information in this Study and what rights you have in relation to your information.

What information are we collecting or using?

This Study comprises 4 work packages as follows:

Work package 1 lead by Leicester: An online survey of clinicians about their organisations’ post-hospitalisation pathway services

Work package 2 lead by Leicester: a) Interviews with clinicians and healthcare managers about designing and delivering post-hospitalisation care pathways and b) Interviews with patients about their experiences of post-discharge care.

Work package 3 by LSHTM: Focusing on remote analysis of the PHOSP-COVID data set held within a trusted research environment at Public Health Scotland in Edinburgh with respect to quality of life, health care resource use and productivity losses for subjects in the 12-months after hospital discharge.

Work package 4 lead by LSHTM: Bringing together the previous three work packages in order to project the quality adjusted life year and health care burden over the long term, separately estimated by different levels of post-hospitalisation pathway services.

In Work packages 1 and 2 we will be collecting information from existing PHOSP COVID 19 participants and other people aged 16 and over and who are either:

  • Clinicians working in healthcare settings providing healthcare pathways or
  • Healthcare staff responsible for developing and implementing post hospitalisation healthcare pathways for Covid 19 patients in their organisations or
  • Covid 19 patients who have experienced these healthcare pathways.

We will only collect and use your information in this research if you have voluntarily agreed to participate in this Study and have given verbal consent in accordance with ethical requirements and to meet legal obligations relating to confidentiality.

The personal information we will collect directly from you in agreeing to participate and in consent forms includes:

For Clinicians and Healthcare staff:

  • First and last name and contact information including email address

For Patients

  • First and last name and contact information including your email address
  • Health/healthcare information you share in the interviews

For Clinicians only , your responses to the Online Survey (JISC) about your organisation’s post-hospitalisation pathway services.

For all participants invited to an interview with one of our researchers, the information we may document from your views expressed during interviews includes the following:

  • For clinicians, healthcare professionals and managers’ your experiences of designing and delivering post-hospitalisation pathway services; or
  • For patients, your experiences of post discharge care following a hospital stay with COVID-19.

In Work packages 3 and 4, we will be accessing and using research datasets from the national PHOSP COVID 19 Study and the outputs from work packages 1 and 2 of this Study. LSHTM will not have access to your personal contact or other identifiable information held by Leicester. In addition none of these datasets will contain personal identifiable information so it will not be possible for LSHTMM researchers to tell that you took part in this Study.

Why are we collecting your data for this Study?

As COVID-19 is a new disease, the main purpose of this Study is to explore healthcare staff and managers’ experiences of designing and delivering post-hospitalisation services and patients’ experiences of post discharge care following a hospital stay with COVID-19. The data will be used to inform the National Institute for Health Research funded evaluation of support in post-hospitalisation for COVID19. The data will also inform service development to help achieve holistic, integrated, equitable and cost effective services.

The aim of research is to understand:

  • The range of care pathways implemented for COVID-19 patients after discharge from hospital.
  • The experiences of healthcare professionals and managers of implementing such pathways, including barriers and facilitators and lessons learned.
  • The experiences patients have of care pathways post hospitalisation with COVID-19, including how such care pathways are integrated with other healthcare they may be receiving.

How we will use this data?

We will use your information to enable us to answer the research questions for this Study we have set out above.

In Work packages 1 and 2 we will do this in a way that protects your identity as follows:

  • Data collected from interviews these will only be recorded with participants’ permission.
  • Where we have your permission to record, the recordings will be professionally transcribed by a third party with whom we have a contract and any information from which you could be identified will be removed upon transcription. Original recordings will be deleted once they have been transcribed.
  • Any views or opinions used in our research findings or publications will be anonymised so it will not be possible to identify you from those comments.

Leicester has technical and organisational measures in place to ensure that your information used in this Study is securely stored and only used for the purposes of this study, as described in this notice. LSHTM also has technical and organisational measures in place to protect the data it uses for this Study.

Individuals from regulatory authorities may look at data collected during the study; these bodies have their own technical and organisational measures in place to comply with Data Protection Legislation.

We will not be using the data to record, learn or decide something about you.

This Study does not involve automated decision-making or profiling.

What is the legal basis for processing the data?

The legal basis for processing your information that we are collecting and using for this Study is for the performance of a task in the public interest (Public Task) as set out in the Data Protection Act 2018 and UK GDPR Article 6.1(e). Research is a public task that the Leicester and LSHTM perform in the public interest, and is part of their core functions.

Our additional legal basis for processing special category health information you provide in interviews is that processing is necessary for scientific research as set out in the Data Protection Act 2018 and GDPR Article 9.2.j.

If we are sharing your data with others, who are we sharing it with?

Access to original transcripts or any files containing identifiable special category health and/or potentially sensitive information will be limited to members of the research team at Leicester.

We will be sharing information with:

  • Our third party provider who will transcribe and anonymise information from the audio recording of interviews. We have a contract with the third party for these services that includes terms relating to confidentiality to protect your privacy.
  • Online Surveys (JISC) who are our third party processor contracted to administer the surveys to be carried out with participating Clinicians.
  • The University of Edinburgh who are providing the main data centre services for PHOSP COVID 19 studies and are a Joint Data Controller (with Leicester) for the data held in the data centre.
  • Other third party providers of technology we use to support recruitment, communications and virtual interviews for e.g. Microsoft Teams and related back-up systems.
  • Bona Fide researchers outside the Study team who successfully apply to our PHOSP COVID 19 access committee. They will only have access to research data that does not identify individuals.
  • Participant information may be required to be disclosed to regulatory authorities and public health agencies though most will only require anonymised information.
  • Direct access will be granted to authorised representatives from Leicester and LSHTM as sponsor, host institution, and the regulatory authorities to permit monitoring, audits and inspections.

We are also required to provide progress reports and summarised, anonymised research information to our grant funders the National Institute for Health Research UK for their related research purpose as described in this notice but this will not include any information about individual participants.

We will only share with all these parties the minimum information that is necessary for them to undertake the task they are performing. We will not share information that identifies participants such as their name and contact information with people who do not need to know this.

Anonymised information means that a person can no longer be identified from the information and it is not personal information for the purposes of Data Protection Legislation.

How long will we process your data for?

All the identifiable information being collected from you in this Study will be processed and unless otherwise stated, the information will be held for and deleted after 5 years:

  • Your verbal consent to participate forms;
  • Anonymised transcripts of audio recordings, held in our Research File store;
  • Encrypted original audio recordings which will be deleted as soon as they have been transcribed;

Anonymised and summarised research data, analysis, outcomes and reports will be kept indefinitely and are not considered to be personal data so they are not covered by the Data Protection legislation.

What are your rights and how can you enforce them?

Under UK Data Protection legislation, you normally have rights in relation to the personal information we hold about you. For the purposes of research, where such individual rights would seriously impair research outcomes, your rights are limited.

In this Study, and specifically in respect of patient health and healthcare information we need to limit your rights and are relying on the exemptions in Schedule 2 Part 6 paragraph 27 of the Data Protection Act 2018 because we are processing this information for scientific research in accordance with UK GDPR Art. 89(1) and Approved Medical Research covered by s19 Data Protection Act 2018.

Prior to applying these exemptions, we have carried out a Data Protection Impact Assessment and taken into account:

  • That this scientific research is of public interest and national significance because it relates to COVID-19, a new disease classed as a pandemic because it has affected people in many countries;
  • That the results of our research will only be published in an anonymised or summarised basis;
  • We have taken appropriate measures to safeguard participant information we collect or receive and to protect the rights and freedoms of all participants including patients whose information we will be using in our research by use of anonymisation techniques in respect of the identifiable personal or pseudonymised information from the survey questionnaires and transcripts of interviews;
  • We, our partners and data processors are under an obligation to maintain confidentiality in our handling of your identifiable and pseudonymised information;
  • We are making information about our research and use of information available to you and the public through this privacy notice which is available on the PHOSP COVID 19 website phosp.org, Leicester’s and LSHTM’s main websites.
  • We have concluded that the exercise of rights by participants would seriously impair the achievement of the Study objectives and the exemptions are necessary to enable us to fulfil our scientific research purposes.

How will this affect your rights as a participant?

Whilst you and other participants involved in this research may withdraw from the study at any time you will not be able to exercise your rights to access your personal information, to request correction of inaccurate information or erasure of your information, to restrict processing of information or to object to our processing of your information even if you leave the study. These rights, which are set out in the UK GDPR (Articles 15,16,17,18 and 21) will not apply.

If you withdraw from the project, we will keep the information we have already obtained but we will protect your rights in our research analysis since this will only involve processing information and the use of transcripts which do not identify you.

If you wish to ask questions about our research please contact Dr Charlotte Overton, one of the researchers at Leicester, by email charlotte.overton@leicester.ac.uk

What right do you have to complain to the Information Commissioner's office?

If you have concerns or wish to complain about our use of your data in this Study or your rights, please contact Information Assurance Services by email at ias@leicester.ac.uk or Leicester’s Data Protection Officer by email at dpo@leicester.ac.uk. In any communication, please provide the project title (“NHS Care Pathways COVID -19 Study”) and detail the nature of your concern or complaint.

Anyone can raise concerns about how their information has been processed with the Information Commissioner’s Office (ICO).

The ICO may be contacted:

By Post addressed to: Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF.

By Email: contact can be made by accessing www.ico.org.uk

Version: Final Approved v1 IAS/23.11.2021

Privacy Notice

PHOSP COVID 19 sub-study – Post-COVID cognitive impairment: characterisation and intervention (CFOG)

Information you need to know

The Department of Psychology at the University of Oxford(Oxford) is conducting research to understand Post-Covid Cognitive Impairment (the Study) and in particular how cognitive impairment or “brain fog” affects participants recovering following hospitalisation with COVID -19.

This tier 3 research is a sub-study of the national Post-hospitalisation COVID-19 Research Study (PHOSP COVID 19) which aims to identify whether there are longer-term health problems of COVID-19 for those who were admitted to hospital. The University of Leicester (Leicester) is the sponsor for the PHOSP-COVID 19 Research and Oxford is a member of the Consortium. Funding for this project is provided by The National Institute for Health Research UK Research and Innovation.

Leicester and Oxford are Joint Data Controllers of the information used in this Study for the purposes of the Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR). Leicester and Oxford undertake to treat all your personal data in accordance with these data privacy laws. This Study is being funded by MQ Transforming Mental health and The Wolfson Foundation.

Further information about Leicester can be found here: https://le.ac.uk/, and information about Oxford can be found here www.psych.ox.ac.uk.

Personal data and privacy enquiries relating to this Study should be directed to Oxford’s Data Protection Officer who can be contacted by email: information.compliance@admin.ox.ac.uk

This privacy notice is supplemental to the main PHOSP-COVID 19 privacy notice and explains what information we are collecting, how we will use your personal information in this Study and what rights you have in relation to your information.

What information are we collecting or using?

As a participant in the main PHOSP-COVID 19 research, you have already agreed we may use your name and contact information including your email address to invite you to participate in this Study. In addition Oxford will generate a unique Study ID (CFOG ID) for you to use if you want to take part.

If you voluntarily agree to participate in this Study and give electronic consent to participate to comply with ethical requirements and to meet legal obligations relating to confidentiality we will collect the following additional information from you:

  • Health/healthcare and lifestyle information you share when you complete the online questionnaire
  • Health information comprising your responses to the online cognitive tests you undertake using the Cognitron system.
  • Using both your unique PHOSP COVID 19 and CFOG ID’s the new data collected in this study will be linked with data already collected from your participation in the main PHOSP-COVID study (e.g., results of blood tests and other observations at the time of your COVID-19 infection), and the C-MORE study (brain MRI) if you were also part of this.
  • The linkage of data will be carried out in a Data Safe Haven/Trusted Research Environment (TRE) run by Public Health Scotland (PHS) which we are already using to manage data collected in the Main PHOSP COVID 19 study.

The linked data set will then be de-identified and combined to produce an anonymised research dataset which will not leave the PHS TRE. This means that the Research team at Oxford will only access the anonymised research dataset through a virtual desktop access process managed by the PHS TRE. The researchers will not be able to identify you from this dataset or even know you took part in the research.

Why are we collecting your data for this Study?

As COVID-19 is a new disease, there is so much that we don’t yet know about the long term impacts on people who were hospitalised with this virus. This sub-study is about cognitive problems following COVID-19 (also known as ‘brain fog’). Brain fog is a term used to describe a range of significant difficulties in thinking, memory, attention and word finding reported by people after COVID-19. We know very little about what ‘brain fog’ is, beyond how often it is likely to occur.

We would like to understand:

  • The nature of post-COVID ‘brain fog’, and what aspects of cognition (e.g., memory or attention) are most affected.
  • If we can identify sub-groups of patients based on the kind of ‘brain fog’ they have.
  • Whether any symptoms of brain fog are related to biological markers of COVID-19 such as the results of blood tests.
With this knowledge, we hope to be able to find potential treatments to improve ‘brain fog’.

How will we use your data?

We will use your information to enable us to answer the research questions for this Study we have set out above.

We will do this in a way that protects your identity as follows:

  • The only identifiable information Oxford hold about you will be an electronic list linking your name and contact details to the unique codes (CFOG ID and PHOSP ID numbers) you have been allocated.
  • Leicester has technical and organisational measures in place to ensure that your contact information used in this Study is securely transferred to Oxford and only used for the purposes of this study, as described in this notice.
  • Oxford also has technical and organisational measures in place to protect the data it receives and processes for this Study. Only 2 researchers from Oxford will have access to a research dataset.

Individuals from regulatory authorities may look at data collected during the study; these bodies have their own technical and organisational measures in place to comply with Data Protection Legislation.

We will not be using the data to record, learn or decide something about you.

This Study does not involve automated decision-making but does involve some profiling to help us identify sub-groups of participants according to the kind of brain fog they have.

What is the legal basis for processing the data?

The legal basis for processing your information that we are collecting and using for this Study is for the performance of a task in the public interest (Public Task) as set out in the Data Protection Act 2018 and UK GDPR Article 6.1(e). Research is a public task that Leicester and Oxford perform in the public interest, and is part of their core functions as Universities.

Our additional legal basis for processing special category personal information relating to health and/or ethnicity you provide is that processing of this information is necessary for scientific research as set out in the Data Protection Act 2018 and GDPR Article 9.2.j.

If we are sharing your data with others, who are we sharing it with?

We will be sharing information with:

  • H2Cognitive Designs Ltd (H2CD) our third party processor who provide the online questionnaire and cognitive tests and provide the results. We have a contract with HSCD for these services that includes terms relating to confidentiality to protect your privacy. We are not sharing your name and contact information with them so they will not be able to identify you.
  • The Usher Institute at the University of Edinburgh (Edinburgh) who manage the PHOSP COVID 19 Database and for which they are joint Data Controller with Leicester. They will receive the tests and questionnaire results from Cognitron and will securely transfer that data to the PHS.
  • Public Health Scotland (PHS) Data Safe Haven/TRE who will receive the tests and questionnaire results and carry data linkage, with your other health information, de-identification and secure storage of the research dataset. They will also manage access to the Study dataset they hold.
  • Bona Fide researchers outside the Study team who must first successfully apply to our PHOSP COVID 19 access committee and then to the PHS TRE. They will only have access to anonymous research data that does not identify individuals.
  • Participant information may be required to be disclosed to regulatory authorities and public health agencies though most will only require anonymised information.
  • Access will be granted to authorised representatives from Leicester as sponsor and Oxford as lead research institution, and the regulatory authorities to permit monitoring, audits and inspections.

Oxford are also required to provide progress reports and summarised, anonymised research information to grant funders but this will not include any information about individual participants.

We will only share with all these parties the minimum information that is necessary for them to undertake the task they are performing. We will not share information that identifies participants such as their name and contact information with people who do not need to know this.

Anonymised information means that a person can no longer be identified from the information and it is not personal information for the purposes of Data Protection Legislation.

How long will we process your data for?

This study is expected to last for approximately 12 months from when we start to recruit participants but may be extended subject to funder approval. All the identifiable information being collected from you in this Study will be processed as stated below:

  • Your online consent to participate will be retained to confirm that you agreed to take part in the study;
  • Oxford will delete the personal contact information it holds about you once it has sent the first email inviting you to participate. Similarly it will delete your personal contact information, if this was used, after sending a second reminder email inviting you to participate.
  • The anonymised data relating to the questionnaires and tests you completed, will be stored on the H2CD Cognitron secure server until 6 months after the Study has been completed after which it will be deleted.

The information collected in the questionnaire and tests you completed for this study will be combined with the information we hold about you in the main PHOSP COVID database. As this is part of a long-term study this will be held for 25 years after which it will be transferred to a data safe haven storage facility for a further 25 years. For further information see the main study privacy notice at phosp.org.

Anonymised, aggregated or summarised research data, analysis, outcomes and reports will be kept indefinitely and are not considered to be personal data covered by the Data Protection legislation.

Your contact information and email address will be retained by Leicester as part of the main PHOSP COVID 19 study if we have your consent to do, so that we may contact you to invite you to participate in future research studies.

What are your rights and how can you enforce them?

Under UK Data Protection legislation, you normally have rights in relation to the personal information we hold about you. For the purposes of this research study, where such individual rights would seriously impair research outcomes, your rights are limited.

In this Study, and specifically in respect of patient health and healthcare information we need to limit your rights and are relying on the exemptions in Schedule 2 Part 6 paragraph 27 of the Data Protection Act 2018 because we are processing this information for scientific research in accordance with UK GDPR Art. 89(1) and Approved Medical Research covered by s19 Data Protection Act 2018.

Prior to applying these exemptions, we have carried out a Data Protection Impact Assessment and taken into account:

  • That this scientific research is of public interest and national significance because it relates to COVID -19, a new disease classed as a pandemic because it has affected people in many countries;
  • This particular study is concerned with improving our understanding of the long term impacts of the disease in the area of cognitive ability on those who were hospitalised but recovered and the identification of possible treatments for those affected.
  • That the results of our research will only be published in an anonymised or summarised basis;
  • We have taken appropriate measures to safeguard participant information we collect or receive and to protect the rights and freedoms of all participants including patients whose information we will be using in our research by use of anonymisation techniques in respect of the identifiable personal or pseudonymised information from the survey questionnaires and cognitive tests
  • We, our partners and data processors are under an obligation to maintain confidentiality in our handling of your identifiable, pseudonymised and anonymised information;
  • We are making information about our research and use of information available to you and the public through this privacy notice which is available on the PHOSP COVID 19 website phosp.org.
  • We have concluded that the exercise of rights by participants would seriously impair the achievement of the Study objectives and the exemptions are necessary to enable us to fulfil our scientific research purposes.

How will this affect your rights as a participant?

Whilst you and other participants involved in this research may withdraw from this study at any time you will not be able to exercise your rights to access your personal information, to request correction of inaccurate information or erasure of your information, to restrict processing of information or to object to our processing of your information even if you leave this study. These rights, which are set out in the UK GDPR (Articles 15,16,17,18 and 21) will not apply.

If you withdraw from this study, we will keep the information we have already obtained but we will protect your rights by placing the information from the questionnaire and Cognitron tests you complete in the PHS Data Safe Haven to which we do not have direct access. Oxford’s research analysis will only be carried out using an anonymised version of this linked dataset held in the PHS TRE and their research analysis findings and publications will not identify you.

If you wish to ask questions about this research study please contact Dr Maxime Taquet -, the researcher at Oxford, by email maxime.taquet@medsci.ox.ac.uk

What right do you have to complain to the Information Commissioner’s Office?

If you have concerns or wish to complain about our use of your data in this Study or your rights, please first contact Oxford’s Data Protection Officer by email at information.compliance@admin.ox.ac.uk. In any communication, please provide the study title (“PHOSP-COVID CFOG Oxford Study”) and detail the nature of your query, concern or complaint.

Anyone can raise concerns about how their information has been processed with the Information Commissioner’s Office (ICO).

The ICO may be contacted:

By Post addressed to: Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF.

By Email: contact can be made by accessing www.ico.org.uk

Version: 1 IAS/01.11.2022