UK-REACH Participant Information

Registration for phase 1 of UK-REACH has closed however we are currently recruiting staff who have joined the healthcare workforce since 2021 to join the UK-REACH cohort and participate in the I-CARE study. Consented participants will be contacted when additional questionnaires are available for them to complete. The UK-REACH I-CARE study questionnaire 6 is open now.

We recently released a newsletter containing some of our interim results, it can be viewed on our Study News page. If you would like to see any publications which have been released, please visit our Publications page.

If you would like to find out more about each of the different parts of UK-REACH, you can find the participant information sheets and privacy notices for each part of UK-REACH below.

UK-REACH I-CARE Cohort Information

Participant Information Sheet

STUDY TITLE: United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers: Increasing retention of healthcare staff from ethnic minority groups (UK-REACH - I-CARE)

PARTICIPATION INFORMATION SHEET

Version 1.2, 16 September 24

Co - Principal Investigators: Professor Manish Pareek and Professor Katherine Woolf

Introduction

Thank you for taking the time to read this information.

We are inviting you to participate in a study seeking to understand why healthcare staff may wish to leave or change their jobs. In particular, we wish to focus on the experiences of healthcare staff from minoritised groups, especially in terms of ethnicity and migration status. We are calling this study I-CARE [Increasing retention of healthcare staff from ethnic minority groups]. It is a continuation of the UK-REACH cohort study [United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers].

Before you decide whether to take part, it is important that you understand why this research is being done and what it will involve. Please read the following information carefully and discuss it with others if you wish. If you have questions, please contact us at uk-reach@leicester.ac.uk or on 07425 611865.

What is the purpose of the study?

UK-REACH is a study of healthcare workers and people who work in healthcare settings. The I-CARE study builds on the UK-REACH cohort study.

The UK-REACH cohort was set up in 2020 to understand how personal factors (including ethnicity) and work-related factors related to the physical and mental health of healthcare workers during the COVID-19 pandemic.

The aim of the current I-CARE study is to improve our understanding of the personal and work-related factors that are related to healthcare workers’ intentions to change or leave their jobs, and sickness absence. In particular, we wish to understand how these factors might differ for staff from minoritised groups (focusing on ethnicity and migration status), and to explore potential reasons for this.

Why have I been invited to take part?

We are inviting you to take part in this study as you:

Previously consented to take part in the UK-REACH cohort study OR joined the register for your relevant healthcare profession since January 2021 OR started working in a healthcare setting since January 2021

AND;

Are aged 16 and over;
Live and work in the UK;
Are a healthcare worker OR working in a healthcare setting; OR registered with the General Medical Council, Nursing and Midwifery Council, General Dental Council, Health and Care Professions Council, General Optical Council, General Pharmaceutical Council or the Pharmaceutical Society of Northern Ireland (Note: You do not need to look after patients directly).

We welcome people from all communities to take part. Since the study is aiming to study the reasons that healthcare workers from minoritised communities may be thinking of changing or leaving their jobs, we encourage people from these communities to consider taking part.

We also welcome contributions from those who have left their jobs in healthcare as they may be able to provide valuable insights into what contributed to their decisions.

What will happen if I decide to take part?

If you are a new participant (not an existing member of the UK-REACH cohort), we will first ask you to:

Register for an account on the UK-REACH secure web page (you can find this link in your invitation email). You will then be guided through the steps that follow below.
Review the inclusion criteria (as above), to confirm that you are eligible to join the UK-REACH cohort and participate in the I-CARE study.
Fill in some personal and contact details on a profile page linked to your account.
Provide your consent to join the UK-REACH cohort, using our secure web page, if you are happy to do so, after you have had time to read and consider the information in this document.
- (Optional) You will be asked for your consent to have your questionnaire data periodically linked to your electronic health records (including any COVID-19 related records, and from COVID-19 research study symptom trackers and apps, if you use them) for as long as the study continues, which may be until 2045. Existing participants (recruited before 2024) have already provided their consent for this purpose, and all participants have the right to withdraw their consent for data linkage, if they wish. This linkage happens in the NHS independently of the research team and the health records are stored anonymously in an approved ‘Trusted Research Environment’, for the purposes of public interest research, by approved researchers. These linked data never leave the ‘Trusted Research Environment’, which has strict security like the NHS. The researchers who will analyse the data to answer research questions will not be able to identify you as all information that identifies you (such as your name, date of birth and postcode) will have been removed.
- (Optional) We will ask if we can re-contact you in the future to ask your permission to take part in additional studies. You don’t have to take part – this will be your choice, if/when contacted.

All participants (new participants and existing members of the UK-REACH cohort) will be asked to:

Provide their consent to participate in the I-CARE study, using our secure web page, if you are happy to do so, after you have had time to read and consider the information in this document. We will send reminders if you have part-completed the process. We will also ask for your permission to contact you if you are successful in the prize draw (see details below).
Complete the I-CARE questionnaire, which will take around 25 minutes. We will ask some basic information about you, your ethnicity, plus any thoughts or actions around changing or leaving your healthcare role, and also your attitude and experiences at work. If you have completed previous UK-REACH study questionnaires, then for some questions you will not be asked for details, if your circumstances have not changed.

Existing participants will be able to access the consent forms and questionnaire online, via their UK-REACH profile page. This link is included in your invitation email.

Do I have to take part?

You do not have to take part – it is up to you to decide whether or not you would like to take part. If you do decide to take part you are still free to withdraw at any time without giving a reason. Further information on withdrawing is provided under “What are my choices about how my information is used?”

If you decide to take part, you will be asked to complete a consent form once you have had the opportunity to read this leaflet and ask any questions you might have. You will be able to download an electronic copy of your consent form to keep for your own information.

What are the possible benefits of taking part?

This research is part of the UK-REACH cohort study and could help to improve understanding of why healthcare staff leave or stay in healthcare, particularly those from minoritised groups, and develop policy interventions to help healthcare organisations improve retention of these staff, but there may be no direct benefit to you.
You will have the option of giving your consent to be entered into a prize draw. Among those who consent to this and complete the questionnaire, 10 randomly selected respondents will win £250 in Amazon vouchers, 10 will win £50 in Amazon vouchers and 250 will win £5 in Amazon vouchers. Participants are free not to take part in the prize draw. If you do not want to take part in the prize draw you can indicate this on your consent form. The names of the winners will not be announced to protect their confidentiality. Winners will be notified via email and/or telephone/SMS within two weeks of the draw.
If a new treatment or test were developed, there would not be a financial benefit to you.

What are the possible disadvantages of taking part?

Who will be able to use my data?

The safety and security of participants’ data is of the utmost importance to the study team. There will be strict mechanisms in place for data storage and access, and you will not be identifiable by researchers. A small number of administrative staff will be able to see your personal details to enable us to support your UK-REACH account and link your data.

In discussion with the Co-Principal Investigators and UK-REACH/I-CARE Core Management Group, we may make information from the study, labelled only with unique codes, available to researchers approved by the UK-REACH/I-CARE Study Steering Committee. This information will not identify you and only be analysed in a secure research environment. Approved researchers will be required to adhere to strict data governance procedures detailed on the UK-REACH website. This could include researchers in other countries and in commercial companies.

How will my data be used?

Information including your name and contact details will be kept on record securely, these data will be kept separately from your research data and will only be used for two specific purposes:

Firstly, to allow secure linkage of the questionnaire data to your health records, if you agree.
Secondly, for future contact by the UK-REACH team. A very small number of study team members will have access to your name and contact details, so that we can re-contact you about other aspects of the study and the prize draw.

People who do not need to know who you are will not be able to see the data collected during the registration process (including name and contact details). Research Questionnaire data will be given a code number instead and will be stored separately from personally identifiable data.

We have already asked, or if you are new to UK-REACH we will ask, for your permission to periodically link your questionnaire responses to data from your medical records. Linkage to your health records is important as it will allow us to understand your health as a healthcare worker. These data may also be made available to other approved researchers for research that is in the public interest. The linkage process is highly secure and can be summarised as follows:

The personal information you provide to UK-REACH is used by the NHS to identify your NHS number;
Your NHS number is used by NHS organisations to link to your healthcare records;
Once your records have been located all identifiable information is removed (name, date of birth, address, NHS number);
De-identified healthcare records are attached to new, unique codes and are transferred securely to the UK Longitudinal Linkage Collaboration Trusted Research Environment (UK LLC TRE), hosted by Secure electronic Research Partnership UK (SeRP UK)) – for linkage to anonymised research data and storage in a ‘Trusted Research Environment’ (TRE) established for the specific purpose of securely linking and storing de-identified datasets;
Your questionnaire data – which has no personally identifiable information and is linked to your unique code is also transferred to the UK LLC TRE where it can be linked to your de-identified healthcare record. All analysis of health record linked data will take place within UK LLC TRE (hosted by SeRP UK, Swansea University).
The unique code linking to your health records will be generated by the NHS and shared only with the SeRP UK Gateway team for linkage and then storage in the TRE.

This process means that the researchers who will analyse the data to answer research questions will never be able to identify you and that healthcare records with your personal details attached never leave the NHS.

We will not share any information about your health, or any other information you have given us, with your employer or professional body.

Once we have finished the study, we will keep some of the data so we can check the results. We will use the information you provide in reports and publications, for example, in scientific journals. This will be anonymised, meaning that we will write our reports in a way that no-one can work out that you took part in the study.

Access to any identifiable data (e.g. name, address) will be limited to select members of the research team and authorised individuals from the NHS or from the Sponsor (University of Leicester) or regulatory authorities. We expect to store the data for a period of 25 years, although this period will be reviewed by an expert Scientific Committee.

Information from the study, labelled with only a unique identifier, may be made available to other approved researchers for research that is deemed in the public interest. This could include researchers in other countries and in commercial companies.

Please see our Privacy Notice for further information on how we process your data: //www.uk-reach.org/main/participants/

What are my choices about how my information is used?

You can stop being part of the cohort study at any time, without giving a reason. If you wish to withdraw from the study you can contact the study team by email or telephone (using the details provided below), who will confirm your wishes and ask you to complete a withdrawal form (this is optional). We would like to continue to access your health records for as long as the study continues, which maybe be until 2045, however, if you do not want this to happen then you can tell us on the withdrawal form or by contacting the study team by email or telephone (using the details provided below). If you are a new participant to this cohort, you can indicate your preferences regarding data linkage when filling in the consent form. If you do decide to withdraw then any data you have already provided will remain and be used in the study. No further data collection will be performed and we will not contact you again about this study.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

Where can I find out more about how my information is used?

You can find out more about how we use your information:

at www.hra.nhs.uk/information-about-patients/
By referring to our Privacy Notice https://www.uk-reach.org/main/participants/
by asking one of the research team
by sending and email to uk-reach@leicester.ac.uk or
by ringing or on 07425611865

What if something goes wrong?

If something does go wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for legal action for compensation against the University of Leicester but you may have to pay your legal costs. The normal NHS complaints service will still be available to you (if appropriate).

Will the findings of the research by published?

We will publish findings from the research in scientific journals. We will summarise published research on a study website: https://www.uk-reach.org.

Who is organising and funding the research?

This research is led by Professor Manish Pareek at the University of Leicester and Professor Katherine Woolf at University College London (UCL) and is organised through a partnership between academic institutions including University of Surrey, University of Oxford, University of Glasgow, and London North West University Healthcare NHS Trust. The I-CARE study has been supported by funding from the National Institute for Health Research (NIHR).

How was the study reviewed?

This study has been reviewed and approved by an independent group of people called a Research Ethics Committee (Brighton and Sussex) and by the University of Leicester as Sponsor. All research that involves NHS patients or staff, information from NHS medical records or uses NHS premises or facilities must be approved by an NHS Research Ethics Committee before it goes ahead. Approval does not guarantee that you will not come to any harm if you take part. However, approval means that the committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that you have been given sufficient information on which to make an informed decision.

Thank you for reading this information sheet.

For Further information, please contact the UK-REACH study team:

Email: uk-reach@leicester.ac.uk

Tel: 07425611865

Privacy Notice

UK-REACH/I-CARE Longitudinal Cohort Research Study Privacy Notice

Information you need to know:

The University of Leicester’s Department of Respiratory Sciences is leading the UK Research Study into Ethnicity and COVID-19 Outcomes in Healthcare Workers (UK-REACH) and the Increasing retention of healthcare staff from ethnic minority groups (I-CARE) sub study investigating in which contexts and why are staff from minoritised groups more likely to leave or stay within NHS workforce post-pandemic compared to white British groups. This research study is a partnership of leading researchers and clinicians with national organisations including the General Medical Council (GMC), Nursing and Midwifery Council, Royal Colleges and ethnic minority healthcare worker associations. The I-CARE sub-study is co-led by University College London.

The University of Leicester is the Data Controller for your information. Further information about the University can be found here: www.le.ac.uk/

The University's Data Protection Officer is: Parmjit Singh Gill, Data Protection Officer and Commercial Lawyer, University Of Leicester, University Road, Leicester, LE1 7RH. 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

What information are we collecting or using?

In UK-REACH I-CARE longitudnal cohort study we are collecting information from people who:

Previously consented to take part in the UK-REACH cohort study OR joined the register for your relevant healthcare profession since 1st January 2021 OR started working in a healthcare setting since 1st January 2021
AND; Are aged 16 and over and
Live and Work in the UK and
Are a healthcare worker or work in a healthcare setting; OR registered with the General Medical Council, Nursing and Midwifery Council, General Dental Council, Health and Care Professions Council, General Optical Council, General Pharmaceutical Council or the Pharmaceutical Society of Northern Ireland. (Note: You do not need to look after patients directly).

We will only collect and use your information if you have voluntarily agreed to participate in this study and have completed participant consent forms in accordance with ethical requirements and to meet legal obligations relating to confidentiality.

The information we will collect directly from you in the form of a questionnaire includes:

Your name, address and contact information including telephone/mobile numbers and email address.
age, sex, marital status and other background information including education
your work in healthcare, and your occupation and working life
special category information concerning your ethnicity, culture;
your home environment and living circumstances;
special category information concerning your physical and mental health;
your attitudes and values in life and at work;
information about your health;
your experience of events before and during the UK national lockdown

If you have consented for linkage to your health records we will also receive and use the following special category information provided by the NHS and other partners:

your routine NHS and GP records
any Covid-19 related records including positive tests and treatment, any test and trace records where you have signed up to these services

If you agree we will also :

Contact you about two further questionnaires over the next year in approximately 4 and 8 months' time.
Follow your health by extracting information from your past and future NHS health care records, any COVID-19 related records, and from COVID-19 symptom trackers and apps if you use them.
Contact you in the future to invite you to take part in additional studies.

Why are we collecting your data for this Research Study?

The main purpose of UK-REACH research study is to identify and understand if, how, and why, ethnicity affects clinical outcomes from COVID-19 in healthcare workers. In Work Package 2 we will specifically study healthcare workers and people who work in healthcare settings so that we can understand :

how social and work-related factors affect the risks of COVID-19 infection;
the impact on physical and mental health outcomes from COVID-19 among healthcare workers; and
how to help reduce differences in outcomes among healthcare workers from diverse ethnic groups.

The I-CARE study builds on the UK-REACH cohort study. The main purpose of the I-CARE study is to improve our understanding of the personal and work-related factors that are related to healthcare workers’ intentions to change or leave their jobs, and sickness absence. In particular, we wish to understand how these factors might differ for staff from minoritised groups (focusing on ethnicity and migration status), and to explore potential reasons for this.

Our purpose is also to carry out this research about healthcare workers over a long period so that this can be used to answer further research questions quickly to help improve clinical outcomes for healthcare workers in the long term. We will therefore continue to collect data about your health by extracting information from your past and future NHS routine health care records until 2045 if you have consented to this.

How we will use this data?

We will use your information to enable us to answer the main UK-REACH and I-CARE related research questions we have set out above.

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

Data managers from Leicester will separate out the personal identifiable information you supply (for e.g. name and contact information) from the questionnaire you completed and store these securely in separate places.
Your personally identifiable data will be sent to NHS Digital Health and Care Wales (DHSCW), who will pass it on to data owners in the NHS and request your NHS healthcare records. Personal identifiers will only be shared with the NHS in order to link your information to health records.
Your personally identifiable information will not leave the NHS but will be replaced with a code to ensure that all the information we need to collect about you can be linked to your questionnaire answers in a way that does not identify you. This is called pseudonymised information.
Pseudonymised information from your health records will be sent to our collaborator Swansea University who manage a secure trusted research information centre Secure eResearch Platform UK (SeRP UK). This will be done under our agreement with the UK Longitudinal Linkage Collaboration (UK-LLC) led by Bristol University. (The UK LLC is a collaboration of UK longitudinal studies, research universities, the NHS and UK statistical authorities operated by the University of Bristol.)
Your pseudonymised questionnaire data will separately be sent to SeRP UK where it will be encrypted with the DHSCW identifier.
Your pseudonymised health information will then be linked to your pseudonymised questionnaire information within SeRP UK’s secure data infrastructure. All other identifiable information such as geographic area and job title will be removed so that the information will become effectively anonymised for researchers, which means it is no longer possible to identify you from the information held. This information will be stored in the UK Longitudinal Linkage Collaboration (UK LLC)’s Trusted Research Environment (TRE) within SeRP UK.
All the data you have provided is fully de-identified before being deposited in the Trusted Research Environment – this does not contain participants name, any real world ID numbers (like NHS ID), address or full date of birth. The UK LLC does not include real world names of places people live or work, or the names or IDs of hospitals or other service providers.
UK-REACH and I-CARE Researchers from the University of Leicester and University College London (UCL) will only have access to this anonymised information and they will carry out their research within the UK LLC Trusted Research Environment within SeRP UK or, for questionnaire data not linked to medical records, within the secure research drives at the University.
Research analysis and outcome reports will be checked to ensure they are fully anonymised before they are allowed to leave the TRE.
Accredited researchers will be able to apply to access your de-identified linked-data within the UK LLC Trusted Research Environment.

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

Due to the nature of the study, there will be “profiling” of information including demographics, those who have medical conditions including Covid 19 outcomes and all participants who are in specific at-risk groups. This will allow us to be more precise in the way we study the impact of ethnicity and other demographic factors on the clinical and career outcomes in healthcare workers, in line with the purposes of the study.

The UK-REACH and I-CARE research study does not involve automated decision-making.

The UK LLC Privacy notice can be accessed here: Privacy Notice | UK Longitudinal Linkage Collaboration (ukllc.ac.uk)

What is the legal basis for processing the data?

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 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 legal basis for processing special category information are that:

processing is ‘necessary for reasons of public interest in the area of public health’, as set out in the Data Protection Act 2018 and GDPR Article 9.2(i); or
processing is necessary for ‘scientific research or statistical purposes’ in accordance with Article 89(1) 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?

This UK-REACH and I-CARE longitudinal cohort study involves research and delivery partners, such as other Universities, and other information processing 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:

University College London who are part of the Consortium carrying out this research.
NHS Digital Health and Care Wales (DHSCW) who will receive identifiable participant information from Leicester and share this with NHS dataa owners, your NHS healthcare records.
Swansea University/SeRP UK who will provide the main data centre facilities for the duration of the WP2 study and will link all the pseudonymised health and questionnaire data together.
Bona Fide researchers outside the UK-REACH and I-CARE study team who successfully apply to UK LLC and/or a separate UK-REACH Committee set up to consider such applications. (Anonymised data only.)
Participant information may be required to be disclosed to regulatory authorities such as MHRA and public health agencies.
Only anonymised and summarised research reports will be shared with our Stakeholder partners representing the Healthcare professions and healthcare workers.

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.

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 we will process your data for?

As UK-REACH is a longitudinal research study the information held by UK LLC SeRP UK Data centre will be retained for 25 years.

For other information held by Leicester as out below, unless otherwise stated, all the data held for this study will be deleted after 25 years.

Your consent to participate forms will be held for 25 years
The information you supplied in the questionnaires held by Leicester will be transferred to our Research File store and stored for 25 years.

What are your rights and how to enforce them?

Under Data Protection legislation, individuals normally 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 UK-REACH and I-CARE 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 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;
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 by use of third parties who will remove the identifiable personal information from the linked data sets;
We and our partners are under an obligation to maintain confidentiality in our handling of identifiable and pseudonymised 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.

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 research purposes.

How will this affect the rights of participants?

Whilst participants involved in this research may withdraw from the study at any time they 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. GDPR Articles 15,16,17,18 and 21 will not apply.

If you withdraw from the UK-REACH and I-CARE longitudinal cohort study at any stage, we will keep the information we have already obtained but, to safeguard your rights, we will use the minimum personally identifiable information possible.

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

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 DPO@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

Online questionnaire cohort information

Participant Information Sheet

Title of Project: UK-REACH Study: United Kingdom Research Study into Ethnicity and COVID-19 outcomes in Healthcare workers

Participant Information Sheet: UK-REACH (Work Package 2) v3.0 23/03/2021

Introduction

Thank you for taking the time to read this information.

We are inviting you to take part in a study to help us understand if, how, and why, ethnicity affects COVID-19 clinical outcomes in people from different ethnic backgrounds working in healthcare settings. This research is part of a larger project called “UK-REACH: United Kingdom Research Study into Ethnicity and COVID-19 outcomes in Healthcare workers”.

Before you decide whether to take part, it is important that you understand why the research is being done and what it will involve. Please read the following information carefully and discuss it with others if you wish. If you have questions please contact us at uk-reach@leicester.ac.uk or on 07425 611865.

What is the purpose of the study?

UK-REACH is a study of healthcare workers and people who work in healthcare settings and aims to better understand how social and work-related factors affect the risks of COVID-19 infection, the impact on physical and mental health outcomes from COVID-19 among healthcare workers, and how to help reduce differences in outcomes among healthcare workers from diverse ethnic groups.

Why have I been invited to take part?

We are inviting you to take part in this study as you:

Are aged 16 and over
Live and work in the UK
Are a healthcare worker or work in a healthcare setting
OR are registered with the General Medical Council, Nursing and Midwifery Council, General Dental Council, Health and Care Professions Council, General Optical Council, General Pharmaceutical Council or the Pharmaceutical Society of Northern Ireland? (Note: You do not need to look after patients directly.)

We welcome people from all communities to join the study. Minority ethnic and migrant communities have had higher rates of COVID-19 hospital admissions, and we encourage people from these communities to consider taking part.

You do not need to have had COVID-19 to join the study - It is important for us to include people who have and have not had this infection, and those who may not be sure.

You do not need to look after patients directly to join the study.

What will happen if I decide to take part?

We will ask you to:

Provide consent to participate in the study if you are happy to do so.
Register your details (including contact details and date of birth) and provide your consent online on our secure web page.
Complete a questionnaire, which will take around 30 minutes. We will ask some basic information about you, your ethnicity, plus whether or not you think you may have had COVID-19, and other aspects of your physical health, your mental health, occupation and working life, home environment and living circumstances. We will also ask about your attitudes and values in life and at work.
With your permission, we will periodically link to your electronic health records for up to 25 years. This will be done in the NHS and your information will remain anonymous to the research team.

If you have been invited by an email, text or letter there will be a link for you to access the registration, consent and questionnaire. If you have been invited by a member of the research team, they will help you or discuss with you how to access this.

We will ask for your permission to:

Contact you about two further questionnaires over the next year in approximately 4 and 8 months' time.
Send reminders if you have part-completed the process;
Periodically link to your electronic health records (including any COVID-19 related records, and from COVID-19 research study symptom trackers and apps, if you use them) for as long as the study continues, which may be up to 25 years. This linkage happens in the NHS independently of the research team and the health records are stored anonymously in an approved trusted research environment. The data never leave that environment which has strict security like the NHS. The researchers who will analyse the data to answer research questions will not be able to identify you as all information that identifies you (such as your name, date of birth and postcode) will have been removed.
Re-contact you in the future to ask your permission to take part in additional studies

Do I have to take part?

What are the possible benefits of taking part?

This research could help to increase understanding of the causes and consequences of COVID-19 infection, and to provide recommendations to the UK government on how to support healthcare workers in this and future pandemics, but there may be no direct benefit to you.
We will enter you into a prize draw in which 10 randomly selected respondents who complete each wave of the survey will win £250 Amazon voucher/cash, 10 will win £50 Amazon voucher/cash and 250 will win £5 Amazon voucher/cash. Participants are free not to take part in the prize draw. If you do not want to take part in the prize draw you can indicate this on your consent form. The names of the winners will not be announced to protect their confidentiality. The closing date for receipt of entry to the draw will be: Survey 1: 23:59 (UK time) 28th February 20201; Survey 2 - 17:00 (UK time) 26th June 2021; Survey 3 (TBC) 2021. Winners will be notified via email and/or telephone/SMS within two weeks of the closing date.
If a new treatment or test were developed, there would not be a financial benefit to you.

What are the possible disadvantages of taking part?

Completing the initial questionnaire will take about 30 minutes, and you will also have the option of completing additional questionnaires in future. In the questionnaire there are some questions about sensitive topics that some people may find upsetting – you can choose not to answer any question that you do not feel comfortable answering, and you may stop at any time. In addition we have provided links to resources and you can contact the study team by telephone or email.

Who will be able to use my data?

We may make available information and samples from the study, labelled only with unique codes (no names, NHS numbers or addresses), to researchers approved by the UK-REACH Study Steering Committee in discussion with the Chief Investigator and UK-REACH Core Management Group. This information will not identify you nor will it leave the trusted research environment.

How will my data be used?

Although information including name and contact details will be kept on record, these data will only be used for two specific purposes.

Firstly to allow linkage of the questionnaire data to your healthcare records
Secondly for future contact by the UK-REACH team. A very small number of study team members will have access to your name and contact details, so that we can recontact you about further questionnaires or other aspects of the study.

People who do not need to know who you are will not be able to see the data collected during the registration process (including name and contact details). Your data will have a code number instead and stored separately from the questionnaire data.

We will ask for your permission to periodically link your questionnaire responses to data from your medical records (including data on COVID-19), from COVID-19 research study symptom trackers and apps (if you use these) and from other research studies you may be participating in. Linkage to your health records is important as it will allow us to understand the long-term effects of the pandemic on your health.

The linkage process is highly secure and can be summarised as follows:

The personal information you provide to UK-REACH is used by the NHS to identify your NHS number
Your NHS number is used by NHS organisations to link to your healthcare records
Once your records have been located all identifiable information is removed (name, date of birth, address, NHS number)
De-identifed healthcare records attached to unique records are then transferred securely to the SAIL databank - a 'Trusted Research Environment' established for the specific purpose of securely link and storing de-identified datasets (more information here https://saildatabank.com).
Your Questionnaire data- which has no personally identifible information and is linked to your unique code is also transferred to the SAIL databank where it can be linked to your de-identified healthcare record. These linked data never leave SAIL and only approved researchers access the data by working virtually within SAIL by a secure link.
Any link between the unique codes and your personal details will be stored separately and securely at the University of Leicester.

This process means that the researchers who will analyse the data to answer research questions will never be able to identify you and that healthcare records with your personal details attached never leave the NHS.

We will not share any information about your health, or any other information you have given us, with your employer or professional body.

Information from the study, labelled with only a unique identifier, may be made available to other approved researchers. This could include researchers in other countries and in commerical companies.

What are my choices about how my information is used?

You can stop being part of the cohort study at any time, without giving a reason. If you wish to withdraw from the study we would like you to optionally complete a withdrawal form. This is so we are clear whether or not we can continue to access your electronic healthcare records. If you do not wish to complete a withdrawal form, you can contact the study team by telephone or email (using the details provided below). We would like to continue to access your health records for up to 25 years, however, if you do not want this to happen then you can tell us on the withdrawal form or by contacting the study team by email or telephone (using the details provided below). If you do decide to withdraw then any information already collected will remain and be used in the study. No further data collection will be performed and we will not contact you again about this study.

We need to mange your records in specific ways for the research to be reliable. This means that we won't be able to let you see or change the data we hold about you.

Where can I find out more about how my information is used?

You can find out more about how we use your information:

at www.hra.nhs.uk/information-about-patients/
by asking one of the research team
by sending and email to uk-reach@leicester.ac.uk or
by ringing or on 07425611865

What if something goes wrong?

Will the findings of the research by published?

We will publish findings from the research in scientific journals. We will summarise published research on a study website: https://www.uk-reach.org.

Information that you provide in the questionnaires, including quotes, may be used in publications although they will be anonymous.

Who is organising and funding the research?

This research is led by Dr Manish Pareek at the University of Leicester and is organised through a partnership between academic institutions including University College London, Swansea University SAIL Databank, Oxford University Hospitals NHS Trust and the University of Nottingham. The study has been supported by funding from the National Institute for Health Research and UK Research and Innovation.

How was the study reviewed?

This study has been reviewed and approved by an independent group of people called a Research Ethics Committee (Brighton and Sussex REC) and by the University of Leicester as Sponsor. All research that involves NHS patients or staff, information from NHS medical records or uses NHS premises or facilities must be approved by an NHS Research Ethics Committee before it goes ahead. Approval does not guarantee that you will not come to any harm if you take part. However, approval means that the committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that you have been given sufficient information on which to make an informed decision

Thank you for reading this information sheet.

For Further information, please contact the UK-REACH study team:

Email: uk-reach@leicester.ac.uk

Telephone: 07425611865

Privacy Notice

UK-REACH Research Study (Work Package 2) Privacy Notice

Information you need to know:

The University of Leicester’s Department of Respiratory Sciences is leading the UK Research Study into Ethnicity and COVID-19 Outcomes in Healthcare Workers(UK-REACH). This research study is a partnership of leading researchers and clinicians with national organisations including the General Medical Council (GMC), Nursing and Midwifery Council, Royal Colleges and ethnic minority healthcare worker associations.

The University of Leicester is the Data Controller for your information. Further information about the University can be found here: www.le.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.

What information are we collecting or using?

In UK-REACH study Work Programme 2 (WP2) we are collecting information from people who are:

Are aged 16 and over and
Live and Work in the UK and
Are a healthcare worker or work in a healthcare setting(even if they do not look after patients directly; or
Are registered with the General Medical Council, Nursing and Midwifery Council, General Dental Council, Health and Care Professions Council, General Optical Council, General Pharmaceutical Council or the Pharmaceutical Society of Northern Ireland.

The information we will collect directly from you in the form of questionnaires for WP2 includes:

Your name, and contact information including telephone/mobile numbers and email address.
age, sex, marital status and other background information including education
your work in healthcare, and your occupation and working life
special category information concerning your ethnicity, culture, religion, languages;
your home environment and living circumstances;
special category information concerning your physical and mental health;
your attitudes and values in life and at work;
your possible exposure to COVID-19;
your experience of events before and during the UK national lockdown

We will also receive and use the following special category information provided by the NHS and other partners:

your routine NHS and GP records
any Covid-19 related records including positive tests and treatment, any test and trace records where you have signed up to these services

If you agree we will also :

Contact you about two further questionnaires over the next year in approximately 4 and 8 months' time.
Follow your health by extracting information from your past and future NHS health care records, any COVID-19 related records, and from COVID-19 symptom trackers and apps if you use them.
Contact you in the future to invite you to take part in additional studies

Why are we collecting your data for this Research Study?

As COVID-19 is a new disease, the main purpose of this UK-REACH research study is to identify and to understand if, how, and why, ethnicity affects clinical outcomes from COVID-19 in healthcare workers. In Work Package 2 we will specifically study healthcare workers and people who work in healthcare settings so that we can understand :

how social and work-related factors affect the risks of COVID-19 infection;
the impact on physical and mental health outcomes from COVID-19 among healthcare workers; and
how to help reduce differences in outcomes among healthcare workers from diverse ethnic groups.

How we will use this data?

We will use your information to enable us to answer the main UK-REACH related research questions we have set out above.

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

Data managers from Leicester will separate out the personal identifiable information you supply (for e.g. name and contact information) from the questionnaire you completed and store these securely in separate places.
Your personally identifiable data will be sent to NHS Digital Health and Care Wales (DHSCW), who will pass it on to data owners in the NHS and request your NHS healthcare records. Personal identifiers will only be shared with the NHS in order to link your information to health records.
Your personally identifiable information will not leave the NHS but will be replaced with a code to ensure that all the information we need to collect about you can be linked to your questionnaire answers in a way that does not identify you. This is called pseudonymised information.
Pseudonymised information from your health records will be sent to our collaborator Swansea University who manage a secure trusted research information centre SeRP UK. This will be done under our agreement with the UK Longitudinal Linkage Collaboration (UK-LLC) led by Bristol University. (The UK LLC is a collaboration of UK longitudinal studies, research universities, the NHS and UK statistical authorities operated by the University of Bristol.)
Your pseudonymised questionnaire data will separately be sent to Secure eResearch Platform UK (SeRP UK) where it will be encrypted with the DHSCW identifier.
Your pseudonymised health information will then be linked to your pseudonymised questionnaire information within SeRP UK’s secure data infrastructure. All other identifiable information such as geographic area and job title will be removed so that the information will become effectively anonymised for researchers, which means it is no longer possible to identify you from the information held. This information will be stored in the UK Longitudinal Linkage Collaboration (UK LLC)’s Trusted Research Environment (TRE) within SeRP UK.
All the data you have provided is fully de-identified before being deposited in the Trusted Research Environment – this does not contain participants name, any real world ID numbers (like NHS ID), address or full date of birth. The UK LLC does not include real world names of places people live or work, or the names or IDs of hospitals or other service providers.
UK-REACH Researchers from the University and University College London (UCL) will only have access to this anonymised information and they will carry out their research within the UK LLC Trusted Research Environment within SeRP UK.
Research analysis and outcome reports will be checked to ensure they are fully anonymised before they are allowed to leave the TRE.
Accredited researchers will be able to apply to access your de-identified linked-data within the UK LLC Trusted Research Environment.

Due to the nature of the study, there will be “profiling” of information including demographics, those who have medical conditions including Covid 19 outcomes and all participants who are in specific at-risk groups. This will allow us to be more precise in the way we study the impact of ethnicity on the clinical outcomes of COVID-19 on healthcare workers, in terms of the purposes of the study.

WP2 of the UK-REACH research study does not involve automated decision-making.

The UK LLC Privacy notice can be accessed here: Privacy Notice | UK Longitudinal Linkage Collaboration (ukllc.ac.uk)

What is the legal basis for processing the data?

Our additional legal basis for processing special category information are that:

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 GDPR Article 9.2(i).
processing is necessary for ‘scientific research or statistical purposes’ in accordance with Article 89(1) 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?

This UK-REACH WP2 study involves research and delivery partners, such as other Universities, and other information processing 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:

University College London and Swansea University who are part of the Consortium carrying out this research analysis in WP2 study.
NHS Digital Health and Care Wales (DHSCW) who will receive identifiable participant information from Leicester and share this with NHS dataa owners, your NHS healthcare records.
Swansea University/SeRP UK who will provide the main data centre facilities for the duration of the WP2 study and will link all the pseudonymised health and questionnaire data together.
Bona Fide researchers outside the UK-REACH study team who successfully apply to UK LLC and/or a separate UK-REACH Committee set up to consider such applications
SAIL will provide the main data centre facilities for the duration of the study. They will receive information provided by DHCW, combine this with other administrative records and the information from the questionnaires, and create an anonymised data set for use by the research team.
Bona Fide researchers outside the UK-REACH study team who successfully apply to a separate Committee we will set up to consider such applications.
Participant information may be required to be disclosed to regulatory authorities and public health agencies.
Only anonymised and summarised research reports will be shared with our Stakeholder partners representing the Healthcare professions and healthcare workers.

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 we will process your data for?

As UK-REACH WP2 is a long COVID research study the information held by UK LLC SeRP UK Data centre will be retained for 25 years.

For other information held by Leicester as out below, unless otherwise stated, all the data held for this study will be deleted after 25 years.

Your consent to participate forms will be held for 25 years
The information you supplied in the questionnaires held by Leicester will be transferred to our Research File store after the third round of questionnaires have been completed and stored for 25 years.
If you have given us permission, we will retain your contact information, otherwise we will delete it if you withdraw from the research or after 25 years whichever is the sooner.

What are your rights and how to enforce them?

In this UK-REACH WP2 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 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 by use of third parties who will remove the identifiable personal information from the linked data sets;
We and our partners are under an obligation to maintain confidentiality in our handling of identifiable and pseudonymised 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.

How will this affect the rights of participants?

If you withdraw from the WP2 study at any stage, we will keep the information we have already obtained but, to safeguard your rights, we will use the minimum personally identifiable information possible.

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

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

Linkage to Health Records

When you joined UK-REACH we asked for your permission to link to your electronic health records. From this year, we are going to be working with the UK Longitudinal Linkage Collaboration (UK LLC) and the NHS to do this. It is important to know that researchers will never be able to identify you from your linked UK-REACH and health record data.

This letter explains how the linkage process will happen, how your data will be managed in a safe and secure way, and what this means for you. If you have further questions about please contact the UK-REACH Study Team on uk-reach@leicester.ac.uk

Who is UK-LLC?
UK LLC is a national collaboration of UK longitudinal cohort studies, universities, the NHS and UK statistical authorities. It is a unique resource that enables cross-sector research and supports research responses to immediate situations and future policy needs. UK-LLC receives funding from UK Research and Innovation (UKRI) through the Medical Research Council (MRC) and Economic and Social Research Council (ESRC).

Who will manage the linkage between my UK-REACH data and my NHS health record data? How is UK-LLC involved?
Linkage to your medical records will still be managed through the NHS (by NHS Digital Health and Care Wales). The NHS will work with the UK LLC to link your health record data to your UK-REACH questionnaire data, and make it available for research in a safe and secure way:

The NHS will remove identifying personal information (such as your name) from your health records
The NHS will transfer your pseudonymised health information to the UK Secure eResearch Platform, or SeRP. No identifiable information will leave the NHS.
Within the SeRP, your pseudonymised health information will be linked with your UK-REACH questionnaire data. Any information that could be used to identify you will be removed.
Your de-identified linked data from UK-REACH participants will be made available to approved researchers via the SeRP Trusted Research Environment (TRE).
Data in the TRE will not include the name, address, or date of birth, any real world ID numbers (like NHS ID), names of places where you live or work, or the names or IDs of hospitals or other service providers.
Researchers will never be able to identify you from your linked UK-REACH and health record data.

Who can apply to have access to my data?
Access to the anonymised linked data within UK-LLC is very strictly controlled. Only UK-based researchers who have been approved by the Office for National Statistics (ONS), the UK-LLC review panel and the UK-REACH study team will be permitted to access it to conduct research.
Researchers who wish to undertake any analysis on study data are required to go through a strict data access process and will need to be approved by the study team and data access committee. Only research in the public interest will be approved.

How will approved researchers access my data?
Research will access and analyse the linked data within the UK LLC Trusted Research Environment (TRE). No data on individuals will be able to leave the TRE: only aggregated data (such as graphs or tables) may be extracted.

How was the decision taken to manage my data in this way?
The inclusion of UK-REACH into UK-LLC has been approved by the UK-REACH Professional Expert Panel – a group of Health care workers representing the views of participants to ensure that the research stays relevant to the study population and activities are acceptable.
UK LLC’s activities are reviewed by a panel of data owners and data experts and a panel of public contributors. UK-LLC make a set of key commitments which they promise to abide by (https://ukllc.ac.uk/our-promises).

Can I refuse to have my data used in this way?
You have the right to withdraw your consent for data linkage, or to withdraw from the study altogether if you wish. To do so, contact the UK-REACH Study Team: uk-reach@leicester.ac.uk

I still have questions: what should I do?
If you have any questions please contact the UK-REACH Study Team on uk-reach@leicester.ac.uk

UK-REACH Work package 4 2020-22 Interviews and Focus Groups Study Information

Participant Information Sheet

Participant Information Sheet: UK-REACH (Work Package 4)

v2.1 27/10/2020

You are being invited to take part in qualitative research exploring your experiences during COVID-19, including your views, challenges you have experienced, or things you perceive have put you or others at risk. This research is part of a larger UKRI-DHSC/NIHR-funded project called “UK-REACH: United Kingdom Research Study into Ethnicity And COVID-19 outcomes in Healthcare workers”. Dr Laura Nellums, Assistant Professor in Global Health at the University of Nottingham (School of Medicine), is leading this qualitative research, which is part of Work Package 4 of the UK-REACH project. Researchers Dr Mayuri Gogoi and Fatimah Wobi are helping Dr Nellums with this Work Package 4. Before you decide to take part, it is important you understand why the research is being conducted and what it will involve. Please take time to read the following information carefully.

**UK-REACH: Investigator Details**
Principal Investigator	Dr Manish Pareek, University of Leicester
Co-Investigator	Professor Martin Tobin, University of Leicester
Co-Investigator	Professor Sue Carr, General Medical Council
Co-Investigator	Dr Katherine Woolf, University College London
Co-Investigator	Professor Chris McManus, University College London
Co-Investigator	Dr Laura Nellums, University of Nottingham
Co-Investigator	Dr Amit Gupta, Oxford University Hospitals/BAPIO
Co-Investigator	Professor David Ford, SAIL - University of Swansea
Co-Investigator	Professor Keith Abrams, University of Leicester
Co-Investigator	Dr Edward Dove, University of Edinburgh
Co-Investigator	Professor Ibrahim Abubakar, University College London

What is the purpose of the study?

The purpose of the UK-REACH project as a whole is to better understand if, how, and why, ethnicity affects COVID-19 clinical outcomes in health workers (including clinical and non-clinical staff). As part of this, the project is exploring aspects such as: linkage and analysis of anonymised GMC and NMC registration and NHS datasets, within a Trusted Research Environment (SAIL databank) to calculate the incidence of, and outcomes from, COVID-19 amongst health workers; and the establishment of a longitudinal cohort study of black, Asian and minority ethnic (BAME) health workers to understand changes in health outcomes, social circumstances and professional roles of BAME health workers (White ethnic group as comparator) over the course of forthcoming pandemic waves and beyond, facilitating understanding of absolute risk and generalisability of the findings.

This particular qualitative study (Work Package 4) has the aim of better understanding your experiences of COVID-19, especially things like your views of the pandemic, challenges you have faced, or things that you think have put you or others at risk. The primary aim of Work Package 4 is to better understand how social and work-related factors affect the risks of infection and poor health outcomes from COVID-19 among healthcare workers, and how to help reduce disparities in outcomes among healthcare workers from diverse ethnic groups.

Why have I been invited to take part?

You are invited to participate in this study because you are key stakeholder in health care in the UK. In particular, you are a staff member working in a healthcare setting, including possibly as a clinical or ancillary staff member working in either primary or secondary care settings, and hold unique insight into COVID-19 outcomes in health workers from diverse ethnic groups.

Do I have to take part?

No – it is entirely up to you. If you do decide to take part, please keep this Participant Information Sheet and complete the Informed Consent Form to show that you understand your rights in relation to the research, and that you are happy to participate. If you do decide to take part, you are still free to withdraw at any time and without giving a reason. Please note down your participant number (which is on the Consent Form) and provide this to the lead researcher if you seek to withdraw from the study at a later date. Deciding not to take part or withdrawing from the study will not affect your employment or rights in any way.

What will happen if I decide to take part?

You will first be asked to provide some basic demographic data (i.e. geographic location of work, age, country of birth, gender, and ethnicity). You will then be asked several open-ended questions regarding your personal views and experiences as a healthcare worker during COVID-19. Questions that this Work Package 4 seeks to explore include: What things have made it difficult for you to access information or help during COVID-19? What fears or concerns have you had, both in and outside of work? What factors do you think may have put you or others you know at increased risk of getting sick or having poor outcomes? Are there things that you think have been helpful that have been done in your workplace or community?

You will be invited to participate in either a focus group with other healthcare workers, or a one-to-one interview with a researcher. Your decision to participate will be confidential, and anything you say will also be confidential, and the information you give will be anonymised (so no personal data about you is shared). In the focus groups, you and other participants will be aware you are taking part, however, all participants will be required to keep information about those in the focus group and anything said confidential.

Interviews and focus groups will take place in a safe virtual environment (e.g. Zoom, Skype, Microsoft Teams, telephone) at a time that is convenient to you. Ideally, we would like to audio record your responses (and will require your consent for this) using an encrypted voice recorder or through the relevant platform software where possible (e.g. using the recording feature in Zoom or Teams), so the location should be in a fairly quiet area. To ensure you remain anonymous, you will be assigned a unique code at the beginning of the recording and we will use only this code if we have to address you during the discussion/interview and also while analysing your data. The focus groups will last approximately 1-1.5 hours, and the interviews around 45 minutes – 1 hour to complete. After the interview or focus group, you will be given given/voucher worth £20 in recognition of your contribution to the research.

What are the possible benefits of taking part?

By sharing your experiences with us, you will be helping Dr Laura Nellums and the UK-REACH project to better understand the experiences of healthcare workers like yourself in order to address important risk factors, better support healthcare workers, and ultimately reduce disparities in COVID-19 outcomes in healthcare workers across diverse ethnic groups.

Are there any risks associated with taking part?

We understand that these topics may be sensitive and it may be challenging to talk about some of your experiences or concerns, and we appreciate you sharing them with us. However, there are no other significant risks associated with participation. Personal or emotional risks involved are small – that is, they are equivalent to the possible stress faced by participants who discuss their professional experiences with friends, family or workplace colleagues. Should you feel uncomfortable sharing your opinion or experience at any time, you can refuse to answer any question at any time. Likewise, you may withdraw from the interview, focus group or the project at any time for any reason.

What if something goes wrong?

It is very unlikely that you would be harmed by taking part in this type of research study. However, if you wish to make a complaint about the project, please contact: uk-reach@leicester.ac.uk

What If I want to withdraw from the study?

Agreeing to participate in this project does not oblige you to remain in the study nor have any further obligation to this study. If, at any stage, you find the interview questions to be of a sensitive nature and are causing you emotional distress such that you wish to withdraw from the project, please inform the project administrator (Dr Laura Nellums, Laura.Nellums@Nottingham.ac.uk ), who will ensure your immediate withdrawal. You can withdraw from the interview, focus group, or the project for any reason at any time, and you do not need to specify a reason for your withdrawal. You should note that anonymised information you share in the research may be used in the production of formal research outputs (e.g. journal articles, conference papers, theses and reports) prior to your withdrawal and so you are advised to contact the research team at the earliest opportunity should you wish to withdraw from the study. On specific request we will destroy all your identifiable answers, but we will need to use the data collected and anonymised prior to your withdrawal, and to maintain our records of your consenting participation.

How will we use information about you?

We will use the information detailed as above for this research project. We will store your contact details if you have requested to receive a summary of findings. Your contact details will then be securely deleted.

People will use this information to do the research or to check your records to make sure that the research is being done properly. Specifically, Dr Laura Nellums, Dr Mayuri Gogoi and Fatimah Wobi will use this information as part of this Work Package 4, and if any checks will be done to make sure that the research is being done properly, they will be conducted by individuals from the University of Leicester (the project sponsor) and regulatory authorities in the UK, such as the Health Research Authority.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

The transcribing will be undertaken by a transcribing company that has a Confidentiality Agreement with the commissioning institution. The transcripts will be anonymised and no one will be able to identify you during this research. The recordings will be deleted once the transcription has successfully taken place. All electronic data will be stored on a password-protected computer file and any paper records will be stored in a locked filing cabinet. Your consent information wil be kept separately from your interview transcript in order to minimise risk of re-identification.

We will keep all information about you safe and secure.

Your anonymised data will be stored for up to 5 years and may be used in future ethically approved research. Any collaborators we share our data with must follow our rules about keeping your information safe.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

What are your choices about how your information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

If you agree to take part in this study, you will also have the option to consent to be re-contacted for future research.

Where can you find out more about how your information is used?

You can find out more about how we use your information:

at www.hra.nhs.uk/information-about-patients/
by asking one of the research team
or by contacting the Data Protection Officer of the University of Nottingham: Mr Simon Gill, dpo@Nottingham.ac.uk . Please note that you have the right at any time to lodge a complaint with the UK’s data protection supervisory authority, the Information Commissioner’s Office (ICO).

What will happen with the results of this study?

The results of this study will be summarised in published articles, reports and presentations. By consenting to participate in this study, you are agreeing to the use of your anonymised de-identified data collected in the interviews or focus groups in analysis and outputs. Quotes or key findings will always be made anonymous in any formal outputs unless we have your prior and explicit written permission to attribute them to you by name. Your anonymised data will be stored for a maximum of 5 years and may be used in future ethically approved research.

Who has reviewed this study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by the London - Brighton & Sussex Research Ethics Committee.

Who can I contact?

If you have any further questions about the UK-REACH, please contact the lead researcher (Principal Investigator), Dr Manish Pareek, NIHR Post-Doctoral Fellow, Associate Clinical Professor in Infectious Diseases, Department of Respiratory Sciences, University of Leicester: +44 (0)116 2585506; mp426@le.ac.uk.

For general information about how we use your data, please go to: https://www.nottingham.ac.uk/governance/records-and-information-management/data-protection/data-protection-policy.aspx

Privacy Notice

UK-REACH Research Study (Work Package 4) Privacy Notice

Information you need to know:

The University of Nottingham, working in collaboration with Leicester’s Department of Respiratory Sciences, are conducting a UK Research Study into Ethnicity and COVID-19 Outcomes in Healthcare Workers. This research study is a partnership of leading researchers and clinicians with national organisations including the General Medical Council (GMC), Nursing and Midwifery Council, Royal Colleges and ethnic minority healthcare worker associations.

The University of Leicester is the Data Controller for your information. Further information on the University can be found here: https://le.ac.uk/.

The University’s Data Protection Officer is: Elisabeth Taoudi, Data Protection Officer and Commercial Lawyer, University Of Leicester, University Road, Leicester, LE1 7RH. Tel: 0116 229 7640. Email: et177@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.

What information are we collecting or using?

In UK-REACH study Work Package 4 (WP4) we are collection information from people who are:

Aged 16 and over and
Live and work in the UK and are
a healthcare worker in any healthcare setting (even if you do not look after patients directly). For WP4 we are seeking to recruit participants from diverse ethnic backgrounds including Black and ethnic minority backgrounds, as well as white ethnic backgrounds.

We will only collect and use your information if you have voluntarily agreed to participate in this study and have completed participant consent forms in accordance with ethical requirements and to meet legal obligations relating to confidentiality.

The information we will collect directly from you in registration, consent forms and in the form of demographic data template questionnaires for WP4 includes:

Your name, and contact information including your email address
Age
Gender
Country of birth
Years in the UK
Ethnicity
Job Role and location

The information we may document from your views expressed during interviews includes the following:

background information including education, your work in healthcare, and your occupation and working life.
special category information concerning your ethnicity, culture, religion, languages.
your attitudes and values in life and at work.
Your experience working in this role during COVID-19.
risk factors you or other healthcare workers like yourself have experienced during the pandemic.
workplace support you have received during the pandemic.

If you agree, we will also retain your contact details so that we can invite you to take part in additional studies.

Why are we collecting your data for this Research Study?

As COVID-19 is a new disease, the main purpose of this UK-REACH research study is to identify and to understand if, how, and why, ethnicity affects clinical outcomes from COVID-19 in healthcare workers in order to understand how participant’s life experiences (within and outside of healthcare settings) may shape their perspectives on risk factors, challenges, fears, or helpful resources during the COVID-19 pandemic.

In Work Package 4 we will conduct interviews and focus groups to gather experiences during COVID-19, including your views, challenges you have experienced, or things you perceive have put you or others at risk.

The aim of the interviews is to understand:

If, how, and why, ethnicity affects COVID-19 clinical outcomes in health workers (including clinical and non-clinical staff).
To gather reflections on participants’ views and experiences as clinical and non-clinical healthcare workers during the COVID-19 pandemic;
To explore what factors healthcare staff feel have put them or other healthcare staff at risk;
To examine fears or concerns healthcare staff have experienced both in and outside of work;
To discuss challenges healthcare staff have experienced in accessing the information they need for protecting themselves.

Participation will be anonymous and confidential

How we will use this data?

We will use your information to enable us to answer the main UK-REACH related research questions for WP4 we have set out above.

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

Data will be collected from interviews and focus groups. These will only be recorded with participants’ permission.
Where we have your permission to record, the recordings will be anonymised upon transcription, and analysed. Original recordings will be deleted once they have been transcribed.
Interviews and focus groups may be conducted with interpreters using simultaneous translation where preferred by the participants.
Where data is collected using interpreters, only the English language data will be transcribed and analysed.

If preferred, participants may also write their responses to the questions in the topic guide, rather than provide them orally.

Both the Universities of Leicester and Nottingham have 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.

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.

WP4 of the UK-REACH research study does not involve automated decision-making or profiling we will

What is the legal basis for processing the data?

Our additional legal basis for processing special category information is that 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 GDPR Article 9.2.i ; and
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 sharing it with?

Access to original transcripts or any files containing identifiable and/or potentially sensitive information will be limited to members of the research team comprising staff from the Universities of Leicester and Nottingham.

We will be sharing information with:

A third party enabling them to be transcribe and anonymise information from the audio recording of interviews and focus groups. We have a contract with the third party for these services that includes terms relating to confidentiality to protect your privacy.
Bona Fide researchers outside the UK-REACH study team who successfully apply to our UK-REACH access committee will only have access to anonymised research data.
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 the University as sponsor, host institution, and the regulatory authorities to permit trial-related monitoring, audits and inspections.
Only anonymised and summarised research reports will be shared with our Stakeholder partners representing the Healthcare professions and healthcare workers.

We are also required to provide progress reports (including anonymised participant recruitment information) 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.

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 we will process your data for?

All the information being collected in WP4 will be processed and unless otherwise stated, the information will be held for and deleted after 5 years:

Your 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;
With permission, your identifiable personal information comprising your names and contact information will be retained by the University to enable us to invite you to participate in any future studies, otherwise we will delete it if you withdraw from the research or after 5 years whichever is the sooner.

What are your rights and how can you enforce them?

In this UK-REACH WP4 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 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 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 by use of pseudonymisation and anonymisation techniques in respect of the identifiable personal information from the questionnaires and transcripts of interviews and focus groups;
We, our partners and data processors are under an obligation to maintain confidentiality in our handling of identifiable and pseudonymised participants’ information;
We are making information about our research and use of information available to participants and the public through this privacy notice which is available on the UK REACH Study website and the University of Leicester main website.

How will this affect the rights of participants?

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 that has been pseudonymised or use of anonymised transcripts.

If you wish to ask questions about our research please contact Laura.Nellums@Nottingham.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 this data in this research or your rights, please first 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. In any communication, please provide the project title (“UK-REACH, Work Package 4”) 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 telephone: 0303 123 1113.

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

Legal and ethical issues related to data linkage and cohort study

Participant Information Sheet

Participant information sheet

UK-REACH (Work Package 3)

Legal and Ethical issues relating to data linkage and cohort study

V2.0 (12/10/2020)

You are being invited to take part in qualitative research on issues concerning data protection, confidentiality, ethnicity, COVID-19, and health as part of the UKRI-DHSC/NIHR-funded project “UK-REACH: United Kingdom Research Study into Ethnicity And COVID-19 outcomes in Healthcare workers”. UK-REACH is led by Dr Manish Pareek of the University of Leicester and involves five Work Packages. Dr Edward Dove, Lecturer in Health Law and Regulation at the University of Edinburgh (School of Law), is leading this ethico-legal qualitative research, which is part of Work Package 3 of the UK-REACH project. A research associate, Ms Ruby Reed-Berendt (University of Edinburgh), is helping Dr Dove with this Work Package 3. Before you decide to take part, it is important you understand why the research is being conducted and what it will involve. Please take time to read the following information carefully.

**UK-REACH: Investigator Details**
Principal Investigator	Dr Manish Pareek, University of Leicester
Co-Investigator	Professor Martin Tobin, University of Leicester
Co-Investigator	Professor Sue Carr, General Medical Council
Co-Investigator	Dr Katherine Woolf, University College London
Co-Investigator	Professor Chris McManus, University College London
Co-Investigator	Dr Laura Nellums, University of Nottingham
Co-Investigator	Dr Amit Gupta, Oxford University Hospitals/BAPIO
Co-Investigator	Professor David Ford, SAIL - University of Swansea
Co-Investigator	Professor Keith Abrams, University of Leicester
Co-Investigator	Dr Edward Dove, University of Edinburgh
Co-Investigator	Professor Ibrahim Abubakar, University College London

What is the Purpose of the Project?

The purpose of the UK-REACH project as a whole is to better understand if, how, and why, ethnicity affects COVID-19 clinical outcomes in health workers (including ancillary workers). As part of this, the project is exploring aspects such as: linkage and analysis of anonymised GMC and NMC registration and NHS datasets, within a Trusted Research Environment (SAIL databank) to calculate the incidence of, and outcomes from, COVID-19 amongst health workers; and the establishment of a longitudinal cohort study of black, Asian and minority ethnic (BAME) health workers to understand changes in health outcomes, social circumstances and professional roles of BAME health workers (White ethnic group as comparator) over the course of forthcoming pandemic waves and beyond, facilitating understanding of absolute risk and generalisability of the findings.

This particular Work Package 3 has the aim of better understanding and addressing the ethical and legal implications of large dataset analyses/cohort studies, especially issues concerning data protection, privacy and information governance associated with the linkage of professionals' registration data and healthcare data. It is clear that there are potential sensitivities of linking healthcare professionals' registration data to healthcare data (albeit anonymously and within the SAIL Trusted Research Environment). Questions that this Work Package 3 seeks to explore include: What are the ethical, legal and practical barriers (real or perceived) to participating in research projects such as this? What risks are created? The primary aim of this Work Package 3 is to consider how well and how far does anonymisation remain effective, if at all, in the context of research involving groups of health workers.

Why have I been invited to take part?

You are invited to participate in this Work Package 3 because you are key stakeholder in health care in the UK; in particular, you are a staff member working in a healthcare setting, including possibly as a clinical and ancillary staff member working in either primary and secondary care settings, and hold unique insight into matters concerning ethical and legal aspects of research on ethnicity and COVID-19 outcomes in health workers.

Do I have to take part?

No - it is entirely up to you. If you do decide to take part, please keep this Information Sheet and completed the Informed Consent Form to show that you understand your rights in relation to the research, and that you are happy to participate. If you do decide to take part, you are still free to withdraw at any time and without giving a reason. Please not down your participant number (which is on the Consent Form) and provide this to the lead researcher if you seek to withdraw from the project at a later date. Deciding not to take part of withdrawing from the project will not affect your employment or rights in any way.

What will happen if i decide to take part?

You will first be asked to provide several basic demographic data (i.e. geographic location of work, age range, country of birth, gender, ethnicity). You will then be asked several open-ended questions in an interview regarding your personal views on the legal, ethical and acceptability issues around data protection, privacy and information governance associated with the linkage of professionals' registration data and healthcare data. The interview questions will focus on: (1) Your experience as a key stakeholder or member in a healthcare organisation; (2) Your views on the barriers to and challenges associated with the linkage of professionals' registration data and healthcare data; and (3) Your views regarding information governance, including the role of consent, (public) trust, engagement, and anonymisation. The interview will take place in a safe virtual environment (e.g. Zoom, Skype, Microsoft Teams, telephone) at a time that is convenient to you.

Ideally, we would like to audio record your responses using an encrypted voice recorder (and will require your consent for this), so the location should be in a fairly quiet area. If you consent to audio recording, a participant number will be stated at the beginning of the recording so that you remain anonymous.

The interview should take around 30 to 45 minutes to complete. You may also be re-contacted if there is there is a follow-up element in the research (unless you choose to withdraw). You have the option to not wish to be re-contacted; if you select this option, you will only be asked to participate in the interview.

What are the possible benefits of taking part?

By sharing your experiences with us, you will be helping Dr Edward Dove and the UK-REACH project to better understand the legal, ethical and acceptability issues around data protection, privacy and information governance associated with the linkage of professionals' registration data and healthcare data.

Are there any risks associated with taking part?

There are no significant risks associated with participation. Personal or emtional risks invovled are small - that is, they are equivalent to the possible stress faced by participants who discuss their professional experiences with friends, family, or workplace colleagues. Should you feel uncomformtable sharing your opinion or experience at any time during the interview, you can refuse to answer any question at any time.

What if something goes wrong?

It is very unlikely that you would be harmed by taking part in this type of research study. However, if you wish to make a complaint about the project, please contact: Prof Niamh Nic Shuibhne, Director of Research, School of Law, University of Edinburgh: +44 (0)131 650 2049; niamh.nicshuibhne@ed.ac.uk In your communication, please provide the project title (“UK-REACH, Work Package 3”) and detail the nature of your complaint.

What if I want to withdraw from the project?

Agreeing to participate in this project does not oblige you to reamin in the project nor have any have any further obligation to this project. If, at any stage, you no longer want to be part of the project, please inform the project administrator (Dr Edward Dove, edward.dove@ed.ac.uk). You should note that your data may be used in the production of formal research outputs (e.g. journal articles, conference papers, theses and reports) prior to your withdrawal and so you are advised to contact the research team at the earliest opportunity should you wish to withdraw from the project. On specific request we will destroy all your identifiable answers, but we will need to use the data collected prior to your withdrawal, and to maintain our records of your consenting participation.

How will we use information about you?

We will use the information detailed as above for this research project. We will store your contact details if you have requested to receive a summary of findings and have agreed to be contacted for future research. Your contact details will then be deleted securely deleted.

People will use this information to do the research or to check your records to make sure that the research is being done properly. Specifically, Dr Edward Dove and Ms Ruby Reed-Berendt will use this information as part of this Work Package 3, and if any checks will be done to make sure that the research is being done properly, they will be conducted by individuals from the University of Leicester (the project sponsor) and regulatory authorities in the UK, such as the Health Research Authority.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

The transcribing will be undertaken by a transcribing company that has a Confidentiality Agreement with the University of Edinburgh. The transcripts will be anonymised and no one will be able to identify you during this research. The recordings will be deleted once the transcription has successfully taken place. All electronic data will be stored on a password-protected computer file and any paper records will be stored in a locked filing cabinet. Your consent information will be kept separately from your interview transcript so there is no risk of re-identification.

We will keep all information about you safe and secure.

Any collaborators we share our data with will follow our rules about keeping your information safe.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. Please note, however, that by participating in this interview, anonymous quotes and findings will be used in formal research outputs (such as articles and policy reports).

What are my choices about how my information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

Where can you find out more about how your information is used?

You can find out more about how we use your information:

At www.hra.nhs.uk/information-about-patients
By asking one of the research team
Or my contacting the Data Protection Officer at the University of Edinburgh: Dr Rena Gertz (Rena.Gertz@ed.ac.uk). Please note that you have the right at any time to lodge a complaint with the UK's data protection supervisory authority, the Information Commissioner's Office (ICO).

What will happen with the results of this project?

The results of this project may be summarised in published articles, reports and presentations. Quotes or key findings will always be made anonymous in any formal outputs unless we have your prior and explicity written permission to attribute them to you by name. Your anonymised data will be stored for a maximum of 5 years and may be used in future ethically approved research by Dr Edward Dove, or by other bona fide researchers who obtain permission from Dr Edward Dove to use the anonymised data for ethically approved research.

Who has reviewed this study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by London - Brighton & Sussex Research Ethics Committee (20/HRA/4718).

Who can I contact?

For general information about the University of Edinburgh's data protection policy for research projects, please go to: https://www.ed.ac.uk/records-management/privacy-notice-research

Privacy Notice

UK-REACH Research Study (Work Package 3) Privacy Notice

Information you need to know:

The University of Edinburgh, in conjunction with the University of Leicester’s Department of Respiratory Sciences are conducting a UK Research Study into Ethnicity and COVID-19 Outcomes in Healthcare Workers. This research study is a partnership of leading researchers and clinicians with national organisations including the General Medical Council (GMC), Nursing and Midwifery Council, Royal Colleges and ethnic minority healthcare worker associations.

The Universities of Edinburgh and Leicester are Joint Data Controllers for your information in Work package 3. Further information about Edinburgh can be found here: https://ed.ac.uk/ and about Leicester here: https://le.ac.uk/

Our Data Protection Officers are:

Edinburgh: Dr Rena Gertz. Email: Rena.Gertz@ed.ac.uk

Leicester: Elisabeth Taoudi, Data Protection Officer and Commercial Lawyer, University Of Leicester, University Road, Leicester, LE1 7RH. Tel: 0116 229 7640. Email: et177@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

What information are we collecting or using?

In UK-REACH study Work Programme 3 (WP3) we are collecting information from people who are:

Are aged 16 or over and
Live and Work in the UK and
Key staff opinion leaders in healthcare and/or health research

The information we will collect directly from you in the consent form and the demographic data template questionnaires for WP3 includes:

Your name, and contact information include telephone/mobile numbers and email address
Age
Gender
Nationality
Ethnicity
Job Role and location

The information we may document from your views expressed during interviews includes the following:

background information including education, your work in healthcare, and your occupation and working life.
special category information concerning your ethnicity, culture, religion, languages;
your attitudes and values in life and at work;

If you agree, we will retain your contact information to enable us to invite you to take part in additional studies.

What information are we collecting or using?

As COVID-19 is a new disease, the main purpose of this UK-REACH research study is to identify and to understand if, how, and why, ethnicity affects clinical outcomes from COVID-19 in healthcare workers in order to inform response strategies to reduce COVID-19 morbidity and mortality, and poor mental health outcomes in these individuals.

In Work Package 3 we will conduct interviews to investigate the ethical and legal implications of linking professionals' registration data to healthcare data through interviews with participants.

The aim of the interviews is to understand the perceptions of health care workers around key concerns, such as:

The ethical and legal implications of using health datasets for research,
Current safeguards in law, policy and regulation,
Research participants' rights and interests,
How race and ethnicity may influence risks and stigmatisation.

Our purpose is to gather views on protection measures that can or should be put in place by law or policy (e.g. privacy protections, human rights, equality rights) to adequately protect research participants (and the broader community, both BAME and otherwise).

Participation will be anonymous and confidential.

How will we use this data?

We will use your information to enable us to answer the main UK-REACH related research questions we have set out above.

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

Data collected from questionnaires will not identify you by name(your name will be replaced with a unique research code).
Interviews will be only be audio recorded with participants’ permission.
Before being transcribed the audio recording file a participant’s name will be replaced with a pseudonym.
Once the transcription it received, it will be anonymised and once this is done the original audio recording will be deleted.

Both the University of Leicester and the University of Edinburgh have 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.

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

WP3 of the UK-REACH research study does not involve automated decision-making or profiling.

What is the legal basis for processing the data?

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 GDPR Article 6.1(e). Research is a public task that the Universities of Leicester and Edinburgh perform in the public interest, and is part of their core functions as Universities.

Our additional legal basis for processing special category information is that 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 GDPR Article 9.2(i).

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

Only members of the UK research team for WP3 can access transcripts or any files containing identifiable and/or potentially sensitive information will not be authorised beyond the research team.

We will share information with:

Bona Fide researchers outside the UK-REACH study team who successfully apply to the access committee we will set up to consider such applications (which will include the Work Package 3 Co-Investigator for access requests specific to Work Package 3 data). Such access will only be provided to anonymised datasets.
Participant information may be required to be disclosed to regulatory authorities and public health agencies.
Direct access will be granted to authorised representatives from the University as sponsor, host institution, and the regulatory authorities to permit research related monitoring, audits and inspections.
Only anonymised and summarised research reports will be shared with our Stakeholder partners representing the Healthcare professions and healthcare workers.

We are also required to provide progress reports to our grant funders and the Department of Health and Social Care and because UK-REACH study is classed as Urgent Public Health Research this includes information about participant recruitment as well as summarised research information. However, this will not include any identifiable information about individual participants.

Anonymised information means that a person is cannot 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?

Information processed the Universities of Leicester and Edinburgh is set out below, and unless otherwise stated, the information will be held for, and deleted after 5 years:

Your consent to participate forms.
Your questionnaire responses
Anonymised transcripts of audio recordings.
With permission, your personal identifiable data comprising names and contact information will be stored so we can contact you about other future studies, otherwise we will delete it if you withdraw from the research or after 5 years whichever is the sooner.
Original audio recordings will be deleted as soon as they have been transcribed.

What are your rights and how to enforce them?

Under Data Protection legislation, in addition to the right to be informed, as a participant you have the following rights in relation to the personal identifiable information we have collected and hold about you as part of this research study:

the right to access the information we hold about you;
the right to rectification - this allows you to ask us to correct inaccurate factual information we hold about you;
the right to erasure - this right is only available if you have first objected to our processing of the identifiable information we hold about you and that objection has been upheld; and
The right to object to processing.

If you withdraw from the project, we will keep the information we have already obtained but, to safeguard your rights, we will use the minimum personally identifiable information possible.

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 personal information in this research study please first contact Prof Niamh Nic Shuibhne, Director of Research, School of Law, University of Edinburgh: +44 (0)131 650 2049; niamh.nicshuibhne@ed.ac.uk. In your communication, please provide the project title (“UK-REACH, Work Package 3”) and detail the nature of your concern or complaint.

Alternatively contact one of our Data Protection Officers using the details supplied above or by email to Rena.Gertz@ed.ac.uk or to Elisabeth Taoudi 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

Expedited linkage and analysis of healthcare care workers data (Privacy Notice Only)

UK-REACH Research Study (Work Package 1) Privacy Notice

Information you need to know:

The UK Research Study into Ethnicity and COVID-19 Outcomes in Healthcare Workers (UK-REACH) is a programme of research studies led by a consortium of leading researchers and clinicians working in partnership with UK organisations including the General Medical Council (GMC), Nursing and Midwifery Council, Royal Colleges and ethnic minority healthcare worker associations. Information about the UK-REACH programme can be found at https://uk-reach.org

The University of Leicester (Leicester) is the Sponsor for this research and its Department of Respiratory Sciences is leading the consortium involved in the UK-REACH research programme.

The UK REACH Programme is made up of six research studies (referred to as work packages). This privacy notice is for Work Package 1 which is a large data linkage study. A cohort of UK health care workers will be established through data sharing with health care regulators and NHS human resource databases. This cohort will then be linked to health care outcomes data so we can compare COVID outcomes by ethnicity in this group.

Leicester is the Data Controller for the UK-REACH programme including Work Package 1. Further information on the University can be found here: https://le.ac.uk/ .

Researchers from Leicester will be carrying out research in Work Package 1 . The information Leicester will use to carry out this research will be anonymised meaning it will not be possible for us to identify the individuals whose data we are analysing.

Swansea University (Swansea) is acting as Joint Data Controller on behalf of the Consortium for the purposes of Work Package 1 , including the pseudonymised personal information being received by the Swansea SAIL Databank.

Leicester’s Data Protection officer is: Elisabeth Taoudi, Data Protection Officer and in-house Commercial Lawyer, University Of Leicester, University Road, Leicester, LE1 7RH. Tel: 0116 229 7640. Email: et177@leicester.ac.uk .

haron Heys, Head of Legislation and Due Diligence, SAIL databank, University of Swansea, is the contact for data protection queries at Swansea for this project. Tel: 01792 205678. Email: s.m.heys@swansea.ac.uk

This privacy notice explains what information we are collecting, how we will use this information in Work Package 1 of this programme of research and what rights individuals have in relation to their information.

What information are you using?

This information in Work Package 1 relates to clinical and ancillary healthcare workers in the UK healthcare sector who are aged 16 or over and includes the following personal information:

Such as name, age, sex;
Healthcare professional registration information and NHS employment information including occupational roles and areas of practice.

We are also collecting the following special categories of data

Information relating to ethnicity
Routinely collected Health information from NHS trust and GP practices
Clinical information such as diagnoses and medical procedures including whether a person has tested positive and been treated for COVID 19 and their outcome (ITU admission, death).

We are not collecting personal information directly from any individual healthcare workers. Instead the identifiable personal data of approximately 1.5 million healthcare workers will be provided by the following Regulatory Bodies:

The General Medical Council, the Nursing and Midwifery Council, the General Dental Council, the General Optical Council, the General Pharmaceutical Council (E,W & S), the Pharmaceutical Society NI and the Health and Care Professions Council.

The NHS employee records service, ESR England and Wales and SWISS in Scotland, will also supply employment information about Healthcare workers.

All this information will be sent by them direct to either NHS Digital and /or NHS Wales Informatics Service (NWIS) for the purpose of linking this with healthcare records of healthcare workers held by the various NHS and other bodies listed below:

NHS Digital(England), NHS Scotland, HSC Northern Ireland, (NWIS), NHS Employee Records (England & Wales) and NHS Scotland Employee records
Intensive Care National Audit & Research Centre (ICNARC)

All identifiable personal information will remain within NHS Digital and NWIS. This means that before the combined information (datasets) is sent to Swansea SAIL databank, names and other identifiable data will be removed and replaced by a unique study code so it will not be possible to identify individual healthcare workers.

This de-identified information is known as pseudonymised information .

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

Personal information, special category personal information and pseudonymised information are all covered by the UK Data Protection Legislation.

What is our Research Purpose for using this personal information?

We are using this personal information to understand if, how, and why, ethnicity affects clinical outcomes from COVID-19 in healthcare workers.

How will we use this Information?

We will use the information to enable us to answer the Work Package 1 UK REACH Research question set out above.

Swansea SAIL databank will combine the pseudonymised datasets they receive with other pseudonymised administrative records relating to healthcare workers, They will then remove other information such as job title and geographical location that might make identification possible. They will create an anonymised dataset to be used for the research analysis. This anonymised dataset will not leave the SAIL databank.

Only approved members of the Leicester research team will be allowed access to the Work Package 1 anonymised dataset held in the SAIL databank and it will not be possible for our researchers to identify the individuals whose data we are analysing. Access will be through a virtual trusted research environment, so that data never leaves SAIL.

Leicester will use the data to create an accurate picture of the Healthcare sector and to understand just how many healthcare workers have been affected by COVID-19. This data will be used support policy makers, the healthcare sector and Professional regulators to respond to the impact of COVID and it will help us all to identify what further research work might be needed.

Due to the nature of this research study, there will be some “profiling” of information relating to healthcare workers where we compare the COVID outcomes of different subgroups defined, for example, by job role, age, sex, ethnicity and health. This may allow us to identify further research that would be of benefit to any specific at-risk groups.

Our research analysis does not involve any automated or other decision-making about individuals.

What is the legal basis for using this information?

The legal basis for the use of healthcare workers information in this research study is for the performance of a task in the public interest which is set the UK GDPR Article 6.1(e) and s8(c) of the Data Protection Act 2018. Research is a task that the Universities of Leicester and Swansea perform in the public interest, and is part of our core functions as Universities.

Our additional legal basis for processing special categories of personal information relating to health/healthcare and ethnicity is that it is necessary for reasons of public interest in the area of public health as set out in the Data Protection Act 2018 and UK GDPR Article 9.2 (i) and in relation to scientific research in the public interest Article 9.2 (j).

If we are sharing this information with others who are we sharing it with?

Personal Information received from the Regulatory bodies and employment records will only be shared with NHS Bodies and others as described above for the purpose of data linkage with healthcare records and the creation of the pseudonymised datasets to be sent to Swansea SAIL Databank.

No pseudonymised personal information received or held in the SAIL Databank relating to the UK-REACH study will be shared with anyone else. We and our data providers and partners may be required to allow access to personal data and pseudonymised data we hold or use for this Study by regulatory bodies, auditors and supervisory bodies including the Information Commissioner (ICO).

We are required to share anonymised summarised information with the Department of Health and Social Care.

Requests for access to the anonymised datasets held in the SAIL Databank by bona fide researchers from outside the UK-REACH research study team will be subject to an application and approval process managed by SAIL. All approved researchers will be required to sign a data access agreement with SAIL before they are allowed access to the anonymised information within SAIL.

We may share anonymised summary statistics with consortium members and collaborators from other Universities, our funders and stakeholders. Only anonymised summary information and statistics may be included in papers written in scientific journals, academic conferences or used in research grant applications. Neither you nor anyone else will be able to identify you from this summary information or statistics.

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

For how long will we retain and use this information ?

NHS Digital and NWIS will only hold and use the PII data they receive from the Regulators, ESR, ,SWISS and NHS bodies listed above whilst this is required for linkage of healthcare data and until it is replaced with the unique study code.

As UK-REACH is a long-term study the pseudonymised and anonymised information received and held in the SAIL databank for Work Programme 1 will be retained for 25 years to ensure this baseline information is available to support future research studies and questions as they emerge.

What are your rights and how to enforce them?

Under UK Data Protection Legislation individuals normally have rights in relation to their identifiable personal information, including pseudonymised information, we hold about them. For the purposes of this research study these rights are limited because the exercise of these rights would seriously impair the achievement of our research outcomes. These limitations are explained in more detail below:

The Right to be Informed Article 14 UK GDPR

As we are processing this information for public health and scientific research purposes and because it would be impossible for us to inform individuals since neither Leicester nor Swansea have direct access to the contact information of the 1.5 million healthcare workers, we are relying on the exception in Article14(5) of the UK GDPR. This means we are not required to notify individual data subjects about our use of their information for this research study.

Other Rights covered by Articles 15,16,17,18 and 21 UK GDPR.

Healthcare workers will not be able to exercise their rights to access their data, to request correction of inaccurate data or erasure of their data, to restrict processing of data or to object to our processing of their data.

We have concluded that the exercise of these rights by the healthcare workers (data subjects) would seriously impair the achievement of our scientific objectives and that restriction of their rights is necessary to enable us to fulfil our research purposes.

We are relying on the exemptions in Schedule 2 Part 6 paragraph 27 of the Data Protection Act 2018 as we are processing information for the purpose of scientific research Article 9(2) j in accordance with Article. 89(1) UK GDPR and Approved Medical Research covered by s19 Data Protection Act 2018.

In applying the exceptions and exemptions described above we have carried out a Data Protection Impact Assessment and taken into account:

That the results of our research will only be published or made available to collaborators outside the research team in an anonymised or summarised basis;
That attempting to obtain the contact details of the 1.5 million healthcare workers would involve disproportionate effort;
We and those who are receiving this data have taken appropriate measures to safeguard the personal and special category information provided and the pseudonymised information SAIL databank receive.
By carrying out our research using only anonymised information held in a virtual trusted research environment within the SAIL databank we are further protecting the rights and freedoms of the people whose information we will be using in our research;
We and all those who handle data on our behalf are under an obligation to maintain confidentiality in handling of personal identifiable or pseudonymised patient healthcare information relating to healthcare workers;
We are making information about our research and use of information relating to Healthcare workers available to the public through this privacy notice which will be available on the UK-REACH study website and the main websites of the both Leicester and Swansea.

If you wish to ask questions about our use of this information in our research please send an email to: uk-reach@leicester.ac.uk

If you are concerned about our use of information please contact Swansea’s Data Protection Officer in the first instance by email: dataprotection@swansea.ac.uk

How to complain to the Information Commissioner’s Office?

Any person has the right to raise concerns about the processing of personal information with the Information Commissioner (ICO).

The Information Commissioner can be contacted by:

Post: Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK95AF.
Telephone: 0303 123 1113.
Email contact can be made by accessing www.ico.org.uk

Challenging Vaccine hesitancy through Serious Games

Participant Information Sheet

STUDY TITLE: Co-production and evaluation of a brief low-cost online intervention to reduce SARS-CoV-2 vaccine hesitancy in UK healthcare workers from diverse ethnic groups

PARTICIPANT INFORMATION SHEET [usability testing]

Introduction

Thank you for taking the time to read this information.

We are inviting you to take part in a study to help us understand what healthcare workers from diverse backgrounds think of an online ‘serious’ game about Covid-19 vaccination. This research is part of a larger project called “UK-REACH: United Kingdom Research Study into Ethnicity and COVID-19 outcomes in Healthcare workers”. UK-REACH is a study of healthcare workers and people who work in healthcare settings and aims to better understand how social and work-related factors affect the risks of COVID-19 infection, the impact on physical and mental health outcomes from COVID-19 among healthcare workers, and how to help reduce differences in outcomes among healthcare workers from diverse ethnic groups.

We are inviting healthcare workers who are members of the stakeholder groups for the UK-REACH study to take part. This is because we are interested in the views of healthcare workers from diverse backgrounds and you have agreed to be contacted about the study. Before you decide whether to take part, it is important that you understand why the research is being done and what it will involve. Please read the following information carefully and discuss it with others if you wish. If you have questions, please contact us at uk-reach@leicester.ac.uk or on 07425 611865.

What is the purpose of the study?

This study aims to understand what healthcare workers from diverse backgrounds think about an online ‘serious’ game about Covid-19 vaccination. This is part of a larger study where the game will be updated and tested to see if it can help healthcare workers learn more about Covid-19 vaccination.

Why have I been invited to take part?

What will happen if I decide to take part?

We will ask you to:

Provide online consent to participate in the study if you are happy to do so.
Try the online ‘serious’ game and give us your views in two ways:
- A link to the prototype game will be sent to you a week before we meet
- You will also be asked to talk to a researcher whilst playing the game in a 30 minute ‘think aloud’ interview. This involves opening and playing the game whilst saying what you are thinking about the game. This conversation will be recorded, transcribed by the researcher and anonymised.
- A short questionnaire which will be emailed to you after you have tested the game. Questions will include how easy it to use the game, how long you spend playing it and how satisfied you are with it. This will take about 10 minutes to complete.
- Focus Games Ltd. Games are hosting the game. Whilst you are playing the game, data will be collected about your game activity (time taken to complete, overall score, answers to questions) but no personal data will be collected by the game. Activity information will be sent securely to the University of Leicester. Focus Games Ltd. Games will not store any data after it has been transferred. Focus Games Ltd. Games will not be able to identify you from your anonymised user ID.
- You may be contacted after your ‘think aloud’ interview so that we can check our findings are consistent with your views.
- Relevant sections of my data collected during the study, may be looked at by individuals from the University of Leicester and from regulatory authorities, where it is relevant to my taking part in this research.

You will be paid £20 per hour for your time for participating

Do I have to take part?

What are the possible benefits of taking part?

This research could help to improve understanding of whether an online game about Covid-19 vaccination can be easy to use by healthcare workers, and will help us do further research on whether the game can help healthcare workers learn about Covid-19 vaccination. There may be no direct benefit to you. If the game were to be used more widely the NHS, there would not be a financial benefit to you.

What are the possible disadvantages of taking part?

Completing the questionnaires and the think aloud interview will take about 1-2 hours of your time. You can choose not to answer any question that you do not feel comfortable answering, and you may stop at any time. You can contact the study team by telephone or email.

Will my participation be kept confidential?

Yes. We will follow ethical and legal practice in accordance with the Data Protection Act (2018). We will keep all information about you safe and secure.

Although information including name and contact details will be kept on record these will be held separately from your data collected during the research. A very small number of study team members will have access to your name and contact details. Your research data will have a code number so that you remain anonymous. Research data will be stored for 10 years.

People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details.

What are my choices about how my information is used?

You can stop being part of the study at any time, without giving a reason. If you wish to withdraw you can contact the study team by telephone or email (using the details provided below). If you do decide to withdraw then any information already collected will remain and be used in the study. No further data collection will be performed and we will not contact you again about this study.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

Where can I find out more about how my information is used?

You can find out more about how we use your information:

at www.hra.nhs.uk/information-about-patients
by asking one of the research team
by sending an email to uk-reach@leicester.ac.uk, or
by ringing us on 07425 611865.
by contacting the University’s Data Protection Officer, Parmjit Gill, University of Leicester, University Road, Leicester, LE1 7RH please email DPO@le.ac.uk.

What if something goes wrong?

It is unlikely that you will be harmed by taking part in this study. If you wish to complain about any aspect of the way in which you have been approached or treated during the course of this study, please contact UK-REACH project manager [insert name and contact details] who will acknowledge receipt of the complaint, investigate, and report back to you within a reasonable period of time. If you remain unhappy and wish to complain formally, you can do this by contacting the Pro Vice Chancellor for Research & Enterprise Professor Philip Baker (Philip.baker@leicester.ac.uk). Details can be obtained from the University of Leicester website: https://le.ac.uk/research/regi/ethics-and-integrity

Who is organising and funding the research?

This research is led by Dr Manish Pareek at the University of Leicester and is organised through a partnership between Focus Games Ltd. Games Ltd, and academic institutions including University College London and the University of Nottingham.

How was the study reviewed?

This study has been reviewed and approved by an independent group of people called a Research Ethics Committee and by the University of Leicester as Sponsor. All research that involves NHS patients or staff, information from NHS medical records or uses NHS premises or facilities must be approved by an NHS Research Ethics Committee before it goes ahead. Approval does not guarantee that you will not come to any harm if you take part. However, approval means that the committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that you have been given sufficient information on which to make an informed decision

Thank you for reading this information sheet.

For Further information, please contact the UK-REACH study team:

Email: uk-reach@leicester.ac.uk

Telephone: 07425611865

Privacy Notice

UK-REACH Research Study –FOCUS GAMES (Work Package 8)

Information you need to know

The University of Leicester’s Department of Respiratory Sciences is leading the UK Research Study into Ethnicity and COVID-19 Outcomes in Healthcare Workers (UK- REACH). This research study is a partnership of leading researchers and clinicians with national organisations including the General Medical Council (GMC), Nursing and Midwifery Council, Royal Colleges and ethnic minority healthcare worker associations. The University of Leicester (Leicester) is the Sponsor for this research.

In this sub-study (this Study) we are collaborating with the University of Nottingham (Nottingham), University College London (UCL) and a third party company Focus Games Ltd., to develop and pilot test an online game designed to reduce Covid vaccine hesitancy in health care workers.

Leicester is the Data Controller for your information. Further information on the University can be found here: https://le.ac.uk/ .

The University’s Data Protection Officer is: Parmjit Singh Gill, 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 in this Study, how we will use this information in this study and what rights participants have in relation to their information.

What information are we collecting or using?

In UK-REACH study Work Package 8 (WP8) we are collecting information at different phases of the study as follows :

Co-development of game:
We will collect contact details of existing members of our Professional Expert Panel.

For the User Testing stage we will be collecting data from people who are:

Are aged 16 and over and
Live and work in the UK and
Are a healthcare worker or work in a healthcare setting (even if they do not look after patients directly); or
Are registered with the General Medical Council, Nursing and Midwifery Council, General Dental Council, Health and Care Professions Council, General Optical Council, General Pharmaceutical Council or the Pharmaceutical Society of Northern Ireland and

For the Pilot Study we are collecting information from people who are:

Are aged 16 and over and
Live and work in the UK and
Are a healthcare worker or work in a healthcare setting (even if they do not look after patients directly); or
Are registered with the General Medical Council, Nursing and Midwifery Council, General Dental Council, Health and Care Professions Council, General Optical Council, General Pharmaceutical Council or the Pharmaceutical Society of Northern Ireland, and
Are participants in the UK REACH study who have agreed that we may contact them to invite them to participate in further studies.

In respect of User Testing we will collect the following information from you:

age, sex and other background information including education
occupation
special category information concerning your ethnicity
your vaccination status
We will also collect your name and contact information including telephone/mobile numbers and email address in order to contact you for the interview and to provide you with a shopping voucher in return for your time.

In respect of the pilot study we will collect the following information from you:

age, sex and other background information including education
occupation
special category information concerning your ethnicity
Your vaccination status.

If you participate in interviews or wish to receive a gift voucher in return for your time we will use your name and contact information including telephone/mobile numbers and email address.

Why are we collecting your data for this Research Study?

The aim of the study is to determine if a low-cost online ‘serious’ game about SARS-CoV-2 is perceived to be acceptable and usable among Health Care Workers (HCWs) from diverse ethnic groups in the UK, and if it changes knowledge, attitudes, and reduces SARS-CoV-2 vaccine hesitancy.

In particular we want to:

assess the game’s uptake (number of people who play the game);
assess the game’s acceptability and usability among diverse HCWs (views of diverse HCWs towards the game);
establish if the game changes HCW knowledge and attitudes about SARS-CoV-2 vaccines;
explore the relationship between playing the game and uptake of booster SARS-CoV-2 vaccines in winter 2022.
provide evidence to support a funding application for further evaluation and roll-out of the game within the NHS.

User testing will help us to ensure that the game works and is well designed ready for the Pilot study.

How we will use this data?

We will use your information to enable us to answer the UK-REACH Work Package 8 research questions set out above.

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

In respect of Co-design:
Collaborator contact details will be stored in the trial master file on the University’s secure drive.

In respect of the User Testing:

One researcher from UCL will collect your name and contact information when you are recruited in order to contact you to carry out an interview and provide you with a voucher in return for your time.
You will be invited to take part in the Game. The link to the game will be embedded within the UK-REACH website, with the game content hosted and controlled by Focus Games Ltd. The maker of the game, Focus Games Ltd, will hold only the the data from the game session. This means they will not be able to identify you or know that you took part in the User testing.
One researcher from UCL will carry out an interview with you. This will be audio recorded, and then transcribed. After transcription is completed your contact details and the recording will be deleted. Only the anonymised transcript will be shared with other researchers so they will not be able to identify you or know that you took part in this Study.

In respect of the Pilot Study:

The link to the game will be embedded within the UK-REACH website, with the game content hosted and controlled by Focus Games Ltd. An anonymised token will be attached to the website URL, which can be collected by the game, in order to enable linkage between data held by UoL and the data held by Focus Games. The maker of the Game, Focus Games Ltd, will collect only the anonymous token and the data from the game session. This means they will not be able to identify you or know that you took part.
Game data will be shared with the University of Leicester via a secure file drop.
Data managers from Leicester will use the token to link the game data to your UK REACH ID (pseudonym) and obtain your vaccination status.
Data managers from Leicester will link the game data, vaccination status and the answers to any questionnaires and interviews you undertake for Work Package 8. The data will then be fully anonymised and stored separately from the rest of the UK REACH Data set before being shared with researchers from Leicester, Nottingham and UCL.
If you agree to be interviewed and/or wish to receive a shopping voucher in return for your time we will collect your name and contact information in order to contact you. This will be deleted at the end of the study.
If you are interviewed, one researcher from UCL will carry out the interview with you. This will be audio recorded, and then transcribed and then the recording deleted. Only the anonymised transcript will be shared with other researchers so they will not be able to identify you or know that you took part in this Study.

Leicester has technical and organisational measures in place to ensure that your data used in this research is securely stored and only used by those involved in the research for the purposes of this research. It also requires the other Universities who are collaborating with us and will process your personal information to have their own technical and organisational measures in place to comply with UK Data Protection Legislation.

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

No automated decision-making or profiling of individual is involved in this research Study.

What is the legal basis for processing your information?

The legal basis for the processing of your participant information that we are collecting and using for the study is 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 performs in the public interest, and is part of its core functions as a University.

Our additional legal basis for processing your special category information relating to health and ethnicity is that 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 GDPR Article 9.2(i) and 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?

This UK-REACH WP8 study involves research and delivery partners, such as other Universities, and other information processing operations. The following is a list of the organisations we are sharing participant information with:

University College London who are carrying out recruitment for the User Testing stage, conducting interviews, and who are part of the Consortium carrying out this research analysis.
University of Nottingham who are part of the Consortium carrying out this research analysis.
Participant information may be required to be disclosed to regulatory authorities and public health agencies.

Only anonymised and summarised research reports will be shared with our Stakeholder partners representing the Healthcare professions and healthcare workers. 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.

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 we will process your data for?

Your information will be held for the duration of the Study, around 6 months. At the end of the study an anonymised research dataset will be transferred to the SAIL data centre for storage for ten years, then archived.

Audio recordings of interviews will be deleted after they have been transcribed. Interviewees’ contact details will be deleted once interviews have been transcribed and receipt of vouchers has been confirmed.

For other information held set out below, unless otherwise stated, the information will be held for and deleted after 25 years in line with the UK REACH main study:

Your consent to participate forms
Your withdrawal form should you wish to leave the study

What are your rights and how to enforce them?

In this UK-REACH WP8 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 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 for the study and taken into account:

That this public health and scientific research 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 and UK healthcare workers from minority ethnic backgrounds in particular;
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 participants whose information we will be using in our research;
We and our partners are under an obligation to maintain confidentiality in our handling of identifiable and pseudonymised 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 the UK REACH'S website uk-reach.org

How will this affect the rights of participants?

If you withdraw from the project, we will keep the information we have already obtained but, to safeguard your rights, we will use the minimum personally identifiable information possible.

If you have any queries about this research please contact the UK-REACH study team using these contact details: uk-reach@leicester.ac.uk or 07425611865.

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

If you wish to ask questions about our use of your 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 dpo@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

REACH-OUT: Caring for the healthcare workforce post-COVID-19

Participant Information Sheet

Title of Project: UK-REACH Study: United Kingdom Research Study into Ethnicity and COVID-19 outcomes in Healthcare workers

REACH-OUT: Caring for the healthcare workforce post-COVID-19

Participant Information Sheet: V1.0 20/05/2022

Principal Investigator: Professor Manish Pareek

Introduction

Thank you for taking the time to read this information.

We are inviting you to participate in the next part of the UK-REACH study with a focus on post-COVID-19 outcomes, including long-COVID and workforce recovery in healthcare workers from diverse ethnic backgrounds. We are calling this sub-study REACH-OUT (UK-REACH study of Post-COVID Outcomes).This study is a continuation of the UK REACH study. Before you decide whether to take part, it is important that you understand why this research is being done and what it will involve. Please read the following information carefully and discuss it with others if you wish. If you have questions, please contact us at uk-reach@leicester.ac.uk or on 07425 611865.

What is the purpose of the study?

UK-REACH is a study of healthcare workers and people who work in healthcare settings. The REACH-OUT study builds on the UK-REACH study, with overall aims to improve our understanding of:

the impact of medium-term and post-acute/long-COVID-19 illness on the physical, mental and occupational health outcomes among healthcare workers.
the prevalence of long-COVID among healthcare workers from diverse ethnic backgrounds.

Why have I been invited to take part?

We are inviting you to take part in this study as you:

Previously consented to take part in the UK-REACH cohort study
Are aged 16 and over
Live and work in the UK
Are a healthcare worker or work in a healthcare setting
OR are registered with the General Medical Council, Nursing and Midwifery Council, General Dental Council, Health and Care Professions Council, General Optical Council, General Pharmaceutical Council or the Pharmaceutical Society of Northern Ireland? (Note: You do not need to look after patients directly.)

You do not need to have had COVID-19 to join the study - It is important for us to include people who have and have not had this infection, and those who may not be sure.

You do not need to look after patients directly to join the study.

What will happen if I decide to take part?

We will ask you to:

Provide consent to participate in the study using our secure web page, if you are happy to do so.
Register your details (including contact details and date of birth) and provide your consent online on our secure web page.
Complete a questionnaire, which will take around 25 minutes. We will ask some basic information about you, your ethnicity, plus whether or not you think you may have had COVID-19, persistent symptoms of COVID-19 and other aspects of your physical health, your mental health, occupation and working life, home environment and living circumstances post-COVID-19. We will also ask about your attitudes, experiences and values in life and at work. Some of the questions are to find out what has changed, and if nothing has changed, you will not be asked for details.

In the invitation email there will be a link for you to access the consent form online. You can also access the consent form from your UK-REACH profile page.

We will ask for your permission to:

Contact you about completing different questionnaires over the next two years; Send reminders if you have part-completed the process; Contact you if you are successful in the prize draw.
Re-contact you in the future to ask your permission to take part in additional studies. You don’t have to take part – this will be your choice if and when contacted.

Do I have to take part?

You do not have to take part – it is up to you to decide whether or not you would like to take part. If you do decide to take part you are still free to withdraw at any time without giving a reason. Further information on withdrawing is provided under “What are my choices about how my information is used?”

What are the possible benefits of taking part?

This research is part of the UK REACH study and could help to improve understanding of the short- and medium- term impacts of long-COVID, and to provide recommendations to the UK government on how to support healthcare workers and the recovery of the health care system, but there may be no direct benefit to you.
If a new treatment or test were developed, there would not be a financial benefit to you.
We will enter you into a prize draw in which 10 randomly selected respondents who complete each wave of the survey will win £250 Amazon voucher/cash, 10 will win £50 Amazon voucher/cash and 250 will win £5 Amazon voucher/cash. Participants are free not to take part in the prize draw. If you do not want to take part in the prize draw you can indicate this on your consent form. The names of the winners will not be announced to protect their confidentiality. Winners will be notified via email and/or telephone/SMS within two weeks of the closing date.

What are the possible disadvantages of taking part?

Who will be able to use my data?

In discussion with the Chief Investigator and UK-REACH Core Management Group, we may make anonymous information from the study, labelled only with unique codes, available to researchers approved by the UK-REACH Study Steering Committee. This information will not identify you.

How will my data be used?

Information including name and contact details will be kept on record, these data will only be used for two specific purposes:

Firstly, to allow secure linkage of the questionnaire data to your health records.
Secondly, for future contact by the UK-REACH team. A very small number of study team members will have access to your name and contact details, so that we can re-contact you about other aspects of the study and the prize draw.

Information from the study, labelled with only a unique identifier, may be made available to other approved researchers. This could include researchers in other countries and in commercial companies.

Please see our Privacy Notice for further information on how we process your data: //www.uk-reach.org/main/participants/

What are my choices about how my information is used?

You can stop being part of the cohort study at any time, without giving a reason. If you wish to withdraw from the study we would like you to complete a withdrawal form, this is optional. If you do not wish to complete a withdrawal form, you can contact the study team by email or telephone (using the details provided below), who will confirm your wishes regarding data collected to date, and regarding further contact. We would like to continue to access your health records for up to 25 years, however, if you do not want this to happen then you can tell us on the withdrawal form or by contacting the study team by email or telephone (using the details provided below). If you do decide to withdraw then any information already collected will remain and be used in the study. No further data collection will be performed and we will not contact you again about this study.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

Where can I find out more about how my information is used?

You can find out more about how we use your information:

at www.hra.nhs.uk/information-about-patients/
By referring to our Privacy Notice https://www.uk-reach.org/main/participants/
by asking one of the research team
by sending and email to uk-reach@leicester.ac.uk or
by ringing or on 07425611865

What if something goes wrong?

Will the findings of the research by published?

We will publish findings from the research in scientific journals. We will summarise published research on a study website: https://www.uk-reach.org.

Who is organising and funding the research?

This research is led by Professor Manish Pareek at the University of Leicester and is organised through a partnership between academic institutions including University College London, Swansea University SAIL Databank, Oxford University Hospitals NHS Trust and the University of Nottingham. The REACH-OUT study has been supported by funding from the NHS Race and Health Observatory.

How was the study reviewed?

Thank you for reading this information sheet.

For Further information, please contact the UK-REACH study team:

Email: uk-reach@leicester.ac.uk

Telephone: 07425611865

Privacy Notice

REACH-OUT Qualitative Study Privacy Notice – Healthcare workers

Information you need to know:

The University of Leicester’s Department of Respiratory Sciences, are conducting this REACH OUT research study which is funded by the NHS Race and Health Observatory. REACH OUT is a sub-study of the UKRI-DHSC/NIHR-funded research project called “UK-REACH: United Kingdom Research Study into Ethnicity And COVID-19 outcomes in Healthcare workers”. The UK REACH research study is a partnership of leading researchers and clinicians with national organisations including the General Medical Council (GMC), Nursing and Midwifery Council, Royal Colleges and ethnic minority healthcare worker associations.

Leicester is the Data Controller for your information. Further information on the University can be found here: https://le.ac.uk/.

The University’s Data Protection Officer is: Parmjit Singh Gill, 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 REACH OUT Qualitative study and what rights participants have in relation to their information.

What information are we collecting or using?

In this REACH-OUT qualitative study, we are collecting information from existing UK REACH participants (WP2 and WP4) who consented to be contacted about future studies and who are:

Aged 16 or over and
Live and work in the UK and
A healthcare worker in any healthcare setting (even if you do not look after patients directly) who have had COVID-19 (with or without persistent symptoms) and
from diverse ethnic backgrounds including Black and ethnic minority backgrounds, as well as white ethnic backgrounds.

We will only collect and use your information if you have voluntarily agreed to participate in this REACH OUT qualitative study and have completed participant consent forms in accordance with ethical requirements and to meet legal obligations relating to confidentiality.

The information we will collect directly from you in registration, consent forms and in the form of demographic data template questionnaires for this qualitative study includes:

Your name and your contact information, including your email address and phone number
Age
Gender
Country of Birth
Years in the UK
Ethnicity
Job Role and Location
If you have or have had long COVID
If you have had any COVID-19 Vaccinations

The information we may document from your views expressed during interviews includes the following:

Background information including education, your work in healthcare, and your occupation and working life.
Experiences of acute COVID-19 infection/long COVID
Post-COVID-19/long COVID stigma
Your attitudes to, and impact of Covid 19 and long Covid on life and at work.
Your experience working in this role post- COVID-19.
Risk factors you or other healthcare workers like yourself have experienced post-COVID-19
Workplace support you have received post Covid 19.

We will retain your contact details so that we can invite you to take part in a second interview this year.

Why are we collecting your data for this Research Study?

As COVID-19 is a new disease, and there is so much we don’t know about long Covid the main purpose of this REACH-OUT research study is to estimate the prevalence of long COVID among healthcare workers, characterise the syndrome, and understand the impacts of medium-term and post-acute/long COVID illness on the mental, physical, and occupational health of diverse communities of HCWs in the UK, and their work and home lives.

In this particular qualitative study we will carry out one- to –one interviews to enable us to investigate the experiences of HCWs from diverse ethnic backgrounds who have had COVID-19, including long COVID, and the impact on their physical and mental health, work, and wider community and things they perceive have put them or others at risk.

The aim of this study is to understand:

HCWs’ experiences of acute infection (initial COVID-19 illness);
Whether participants have experienced any persistent symptoms/long COVID, and what these symptoms have been like over time;
The impact of acute and long COVID on mental and physical health, their work life, provision of care, and their home lives.
Their unmet needs, coping strategies, sources of support, healthcare seeking and experiences of healthcare, and response of their employer.

How will we use this data?

We will use your information to enable us to answer the main REACH-OUT related research questions for this study we have set out above.

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

Data will be collected from interviews. These will only be recorded with participants’ permission.
Where we have your permission to record, the recordings will be anonymised upon transcription, and before being analysed. Original recordings will be deleted once they have been transcribed and checked.
Interviews may be conducted with interpreters using simultaneous translation where preferred by the participants.
Where data is collected using interpreters, only the English language data will be transcribed and analysed.

The University of Leicester and our collaborators at University of Nottingham and University College London have 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.

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

This research study does not involve automated decision-making or profiling. we will

What is the legal basis for processing the data???

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

Our additional legal basis for processing special category information is that processing is necessary:

for reasons of public interest in the area of public health, specifically relating to the impact of COVID-19 and long Covid on Health Care workers, as set out in the Data Protection Act 2018 and GDPR Article 9.2.i ; and
for archiving in the public interest and 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?

A third party enabling them to be 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.
Our Research collaborators from the University of Nottingham and University College London
Bona Fide researchers outside the REACH OUT study team who successfully apply to our UK-REACH access committee will only have access to anonymised research data.
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 the University of Leicester as sponsor, host institution, and the regulatory authorities to permit audits and inspections.
Only anonymised and summarised research reports will be shared with our UK REACH Stakeholder partners representing the Healthcare professions and healthcare workers.

We are also required to provide progress reports (including anonymised participant recruitment information) and summarised research information to our grant funders but this will not include any information about individual participants.

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 we will process your data for?

As this sub -study is part of the 25 years Long term UK REACH study all the personally identifiable information being collected in this qualitative study will be processed and unless otherwise stated, the information will be held for and deleted after 25 years:

Your consent to participate forms;
Anonymised transcripts of audio recordings, held in our Research File store will be deleted after 5 years;
Encrypted original audio recordings will be deleted as soon as they have been transcribed and checked;

What are your rights and how can you enforce them?

Under Data Protection legislation, individuals normally have rights in relation to the personal information we hold about them including the right to access, to rectification, to erasure, to restrict or object to processing. However, in this REACH OUT qualitative research study these rights are limited in respect of this research in the following circumstances:

Because our research is being carried out as a public task in the public interest under Art 6.2.e and also for reasons of public interest in public health under Art 9.2.i the rights to erasure and to object to processing do not apply.
in respect of special category data because it is being processed for archiving in the public interest and scientific research under Art 9.2.j and we consider individual rights would seriously impair research outcomes, these rights are limited. We are relying on the exemptions in Schedule 2 Part 6 paragraph 27 of the Data Protection Act 2018 because we are processing this information in accordance with UK GDPR Art. 89(1) and Approved Medical Research covered by s19 Data Protection Act 2018.

Prior to applying the exception in 1) and the exemptions in 2) above, we have carried out a Data Protection Impact Assessment and taken into account:

That this public health related research sub-study is part of the long term UK REACH study and is of national significance because it relates to COVID -19, a new disease classed as a pandemic and also to long COVID;
That this research is of public interest because of the impact of COVID 19 and long Covid on the healthcare worker sector.
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 the UK REACH Study website and the University’s main website.

How will this affect the rights of participants?

Participants involved in this research will not be able to exercise their rights to access their personal information, to request correction of inaccurate information (where they cannot do this themselves) 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 withdraw from the REACH OUT sub-study, 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 that has been pseudonymised or use of anonymised transcripts.

If you wish to ask questions about our research, please contact the research team by email to uk-reach@leicester.ac.uk. In any communication, please provide the project title (“REACH-OUT, Qualitative study”).

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

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

REACH-OUT: Caring for the healthcare workforce post-COVID-19 Qualitative Substudy

Participant Information Sheet

Title of Project: UK-REACH Study: United Kingdom Research Study into Ethnicity and COVID-19 outcomes in Healthcare workers

REACH-OUT: Caring for the healthcare workforce post-COVID-19 (HEALTHCARE WORKERS)

Participant Information Sheet: V2.0 06/12/2022

You are being invited to take part in qualitative research exploring your experiences post COVID-19, and how that impacted your home and work lives, including your views, challenges you have experienced, or things you perceive have put you or others at risk. This research is funded by the NHS Race and Health Observatory and is a sub-study of a larger UKRI-DHSC/NIHR-funded project called "UK-REACH: United Kingdom Research Study into Ethnicity And COVID-19 outcomes in Healthcare workers". Amani Al-Oraibi, a PhD student at University of Leicester, is leading this qualitative research. Before you decide to take part, it is important you understand why the research is being conducted and what it will involve. Please take time to read the following information carefully.

REACH-OUT: Investigator details

Principal Investigator Professor Manish Pareek, University of Leicester
Co-Investigator Professor Katherine Woolf, University College London
Co-Investigator Dr Laura Nellums, University of Nottingham
Co-Investigator Professor Carolyn Tarrant, University of Leicester
Co-Investigator Amani Al-Oraibi, University of Leicester

What is the purpose of the study?

The purpose of the REACH-OUT study is to build on the UK-REACH study to estimate the prevalence of long COVID among healthcare workers, characterise the syndrome, and understand the impacts of medium-term and post-acute/long COVID illness on the mental, physical, and occupational health of diverse communities of HCWs in the UK, and their work and home lives.

This particular qualitative study has the aim of investigating the experiences of HCWs from diverse ethnic backgrounds who have had COVID-19, including long COVID, and the impact on their physical and mental health, work, and wider community.

Why have I been invited to take part?

You are invited to participate in this study because you are a worker in health care in the UK. In particular, you are a staff member working in a healthcare setting, including possibly as a clinical or ancillary staff member working in either primary or secondary care settings, and hold unique insight into post COVID-19 outcomes in health workers from diverse ethnic groups

Do I have to take part?

No - it is entirely up to you. If you do decide to take part, please keep this Participant Information Sheet and complete the Informed Consent Form to show that you understand your rights in relation to the research, and that you are happy to participate. If you do decide to take part, you are still free to withdraw at any time and without giving a reason. Please note down your participant number (which is on the Consent Form) and provide this to the lead researcher if you seek to withdraw from the study at a later date. Deciding not to take part or withdrawing from the study will not affect your employment or rights in any way.

What will happen if I decide to take part?

You will first be asked to provide some basic demographic data (i.e., geographic location of work, age, country of birth, gender, ethnicity, whether you experienced long COVID or not). You will then be asked several open-ended questions regarding your personal views and experiences as a healthcare worker post COVID-19. Questions that this qualitative study seeks to explore include: whether you experienced any persistent symptoms/long COVID and what these symptoms have been like over time, the impact of acute and long COVID on your mental and physical health and the things that have been helpful in your workplace or community to protect your health post-COVID-19 infection.

You will be invited to participate in a one-to-one interview with a researcher. Your decision to participate will be confidential, and anything you say will also be confidential, and the information you give will be anonymised (so no personal data about you is shared).

Interviews will take place in a safe virtual environment (e.g., Microsoft Teams, telephone) at a time that is convenient to you. Ideally, we would like to audio record your responses (and will require your consent for this) using an encrypted voice recorder or through the relevant platform software where possible (e.g., using the recording feature in Teams), so the location should be in a fairly quiet area. To ensure you remain anonymous, you will be assigned a unique code at the beginning of the recording, and we will use only this code if we have to address you during the discussion/interview and also while analysing your data. The interviews will take around 45 minutes - 1 hour to complete. After the interview, you will be given a voucher worth £20 in recognition of your contribution to the research

What are the possible benefits of taking part?

By sharing your experiences with us, you will be helping Amani Al-Oraibi and the REACH-OUT study to better understand the experiences of healthcare workers like yourself in order to address important risk factors, better support healthcare workers, and ultimately reduce disparities in post COVID-19 outcomes in healthcare workers across diverse ethnic groups.

Are there any risks associated with taking part?

We understand that these topics may be sensitive, and it may be challenging to talk about some of your experiences or concerns, and we appreciate you sharing them with us. However, there are no other significant risks associated with participation. Personal or emotional risks involved are small - that is, they are equivalent to the possible stress faced by participants who discuss their professional experiences with friends, family or workplace colleagues. Should you feel uncomfortable sharing your opinion or experience at any time, you can refuse to answer any question at any time. Likewise, you may withdraw from the interview, or the project at any time for any reason.

What happens if something goes wrong?

It is very unlikely that you would be harmed by taking part in this type of research study. However, if you wish to make a complaint about the study, please contact: uk-reach@leicester.ac.uk

What if I want to withdraw from the study?

Agreeing to participate in this project does not oblige you to remain in the study nor have any further obligation to this study. If, at any stage, you find the interview questions to be of a sensitive nature and are causing you emotional distress such that you wish to withdraw from the project, please inform the project administrator (uk-reach@leicester.ac.uk ), who will ensure your immediate withdrawal. You can withdraw from the interview, or the project for any reason at any time, and you do not need to specify a reason for your withdrawal. You should note that anonymised information you share in the research may be used in the production of formal research outputs (e.g., journal articles, conference papers, theses, and reports) prior to your withdrawal and so you are advised to contact the research team at the earliest opportunity should you wish to withdraw from the study. On specific request we will destroy all your identifiable answers, but we will need to use the data collected and anonymised prior to your withdrawal, and to maintain our records of your consenting participation.

How will we use information about you?

We will use the information detailed as above for this research study. We will store your contact details if you have requested to receive a summary of findings. Your contact details will then be securely deleted. People will use this information to do the research or to check your records to make sure that the research is being done properly. Specifically, Amani Al-Oraibi will use this information as part of this qualitative study, and if any checks will be done to make sure that the research is being done properly, they will be conducted by individuals from the University of Leicester (the project sponsor) and regulatory authorities in the UK, such as the Health Research Authority.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead

The transcribing will be undertaken by a transcribing company that has a Confidentiality Agreement with the commissioning institution. The transcripts will be anonymised, and no one will be able to identify you during this research. The recordings will be deleted once the transcription has successfully taken place. All electronic data will be stored on a password-protected computer file and any paper records will be stored in a locked filing cabinet. Your consent information will be kept separately from your interview transcript so there is no risk of re-identification. We will keep all information about you safe and secure

Your anonymised data will be stored for up to 5 years and may be used in future ethically approved research. Any collaborators we share our data with will follow our rules about keeping your information safe. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that ensures no-one can work out that you took part in the study

What are your choices about how your information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. We need to manage your records in specific ways for the research to be reliable. This means that we won't be able to let you see or change the data we hold about you. If you agree to take part in this study, you will also have the option to consent to be re-contacted for future research.

You can find out more about how we use your information:

at www.hra.nhs.uk/information-about-patients/
by asking one of the research team
or by contacting the Data Protection Officer of the University of Leicester. Please note that you have the right at any time to lodge a complaint with the UK's data protection supervisory authority, the Information Commissioner's Office (ICO).

What will happen with the results of this study?

The results of this study will be summarised in published articles, reports and presentations. By consenting to participate in this study, you are agreeing to the use of your anonymised de-identified data collected in the interviews in analysis and outputs. Quotes or key findings will always be made anonymous in any formal outputs unless we have your prior and explicit written permission to attribute them to you by name. Your anonymised data will be stored for a maximum of 5 years and may be used in future ethically approved research.

Who has reviewed this study?

Who can I contact?

If you have any further questions about UK-REACH or REACH-OUT, please contact the lead researcher (Principal Investigator), Prof Manish Pareek, NIHR Post-Doctoral Fellow, Clinical Professor in Infectious Diseases, Department of Respiratory Sciences, University of Leicester: +44 (0)116 2585506; mp426@le.ac.uk.

For general information about how we use your data, please go to: https://le.ac.uk/ias/data-protection

Privacy Notice

REACH-OUT Qualitative Study Privacy Notice – Healthcare workers

Information you need to know:

Leicester is the Data Controller for your information. Further information on the University can be found here: https://le.ac.uk/.

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

What information are we collecting or using?

In this REACH-OUT qualitative study, we are collecting information from existing UK REACH participants (WP2 and WP4) who consented to be contacted about future studies and who are:

Aged 16 or over and
Live and work in the UK and
A healthcare worker in any healthcare setting (even if you do not look after patients directly) who have had COVID-19 (with or without persistent symptoms) and
from diverse ethnic backgrounds including Black and ethnic minority backgrounds, as well as white ethnic backgrounds.

The information we will collect directly from you in registration, consent forms and in the form of demographic data template questionnaires for this qualitative study includes:

Your name and your contact information, including your email address and phone number
Age
Gender
Country of Birth
Years in the UK
Ethnicity
Job Role and Location
If you have or have had long COVID
If you have had any COVID-19 Vaccinations

The information we may document from your views expressed during interviews includes the following:

Background information including education, your work in healthcare, and your occupation and working life.
Experiences of acute COVID-19 infection/long COVID
Post-COVID-19/long COVID stigma
Your attitudes to, and impact of Covid 19 and long Covid on life and at work.
Your experience working in this role post- COVID-19.
Risk factors you or other healthcare workers like yourself have experienced post-COVID-19
Workplace support you have received post Covid 19.

We will retain your contact details so that we can invite you to take part in a second interview this year.

Why are we collecting your data for this Research Study?

The aim of this study is to understand:

HCWs’ experiences of acute infection (initial COVID-19 illness);
Whether participants have experienced any persistent symptoms/long COVID, and what these symptoms have been like over time;
The impact of acute and long COVID on mental and physical health, their work life, provision of care, and their home lives.
Their unmet needs, coping strategies, sources of support, healthcare seeking and experiences of healthcare, and response of their employer.

How will we use this data?

We will use your information to enable us to answer the main REACH-OUT related research questions for this study we have set out above.

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

Data will be collected from interviews. These will only be recorded with participants’ permission.
Where we have your permission to record, the recordings will be anonymised upon transcription, and before being analysed. Original recordings will be deleted once they have been transcribed and checked.
Interviews may be conducted with interpreters using simultaneous translation where preferred by the participants.
Where data is collected using interpreters, only the English language data will be transcribed and analysed.

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

This research study does not involve automated decision-making or profiling. we will

What is the legal basis for processing the data???

Our additional legal basis for processing special category information is that processing is necessary:

for reasons of public interest in the area of public health, specifically relating to the impact of COVID-19 and long Covid on Health Care workers, as set out in the Data Protection Act 2018 and GDPR Article 9.2.i ; and
for archiving in the public interest and 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?

A third party enabling them to be 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.
Our Research collaborators from the University of Nottingham and University College London
Bona Fide researchers outside the REACH OUT study team who successfully apply to our UK-REACH access committee will only have access to anonymised research data.
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 the University of Leicester as sponsor, host institution, and the regulatory authorities to permit audits and inspections.
Only anonymised and summarised research reports will be shared with our UK REACH Stakeholder partners representing the Healthcare professions and healthcare workers.

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 we will process your data for?

Your consent to participate forms;
Anonymised transcripts of audio recordings, held in our Research File store will be deleted after 5 years;
Encrypted original audio recordings will be deleted as soon as they have been transcribed and checked;

What are your rights and how can you enforce them?

Because our research is being carried out as a public task in the public interest under Art 6.2.e and also for reasons of public interest in public health under Art 9.2.i the rights to erasure and to object to processing do not apply.
in respect of special category data because it is being processed for archiving in the public interest and scientific research under Art 9.2.j and we consider individual rights would seriously impair research outcomes, these rights are limited. We are relying on the exemptions in Schedule 2 Part 6 paragraph 27 of the Data Protection Act 2018 because we are processing this information in accordance with UK GDPR Art. 89(1) and Approved Medical Research covered by s19 Data Protection Act 2018.

Prior to applying the exception in 1) and the exemptions in 2) above, we have carried out a Data Protection Impact Assessment and taken into account:

That this public health related research sub-study is part of the long term UK REACH study and is of national significance because it relates to COVID -19, a new disease classed as a pandemic and also to long COVID;
That this research is of public interest because of the impact of COVID 19 and long Covid on the healthcare worker sector.
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 the UK REACH Study website and the University’s main website.

How will this affect the rights of participants?

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

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

Linkage to Health Records

When you joined UK-REACH we asked for your permission to link to your Health records. From this year, we are going to be working with the UK Longitudinal Linkage Collaboration (UK LLC), to do this. UK LLC is a collaboration of UK longitudinal studies, universities, the NHS and UK statistical authorities, funded by UK Research and Innovation through the Medical Research Council and Economic and Social Research Council. Linkage to your medical records will still be managed through the NHS by NHS Digital Health and Care Wales. Your personal identifying information will be shared with the NHS only in order to link to your health records. No identifiable information will leave the NHS.

Your data will be pseudonymised by the NHS and then linked with UK-REACH study data within the UK Secure eResearch Platform (SeRP), hosted by the University of Swansea. It is then fully de-identified before being deposited in the SeRP Trusted Research Environment (TRE). (Data in the TRE will not include your name, address, or date of birth, any real world ID numbers (like NHS ID), names of places where you live or work, or the names or IDs of hospitals or other service providers.)

Access to only the anonymised linked data is very strictly controlled and only researchers approved by the Office for National Statistics, the UKLLC review panel and the UK-REACH study team will be permitted to access it. Analysis will take place within the UKLLC trusted research environment and only aggregated data (such as graphs) may be extracted. Researchers will never be able to identify you. The Trusted Research Environment meets the highest Information Security Standards ISO27001 and Digital Economy Act Accreditation.

UK based, ONS approved, researchers may apply for access to the de-identified linked data held in UK LLC in order to undertake additional research in the public interest. Individuals who wish to undertake any analysis on study data are required to go through a strict data access process and will need approval by the study team and data access committee.

UK LLC’s activities are reviewed by a panel of data owners and data experts and a panel of public contributors. UK LLC make a set of key commitments which they promise to abide by (https://ukllc.ac.uk/our-promises ). The inclusion of UK-REACH into UK LLC has been considered by the UK-REACH Professional Expert Panel – a group of Health care workers representing the views of participants to ensure that the research stays relevant to the study population and activities are acceptable. This change has was discussed at the meetings of 30th October 2023 and 23rd January 2024 and the written information for participants was reviewed and approved by PEP members in February 2024 prior to release.

You have the right to withdraw your consent for data linkage, or to withdraw from the study altogether if you wish. If you have any questions or would like to withdraw your consent, please contact the UK-REACH Study Team on uk-reach@leicester.ac.uk

UK-REACH I-CARE WP4&5 Cohort Information

Participant Information Sheet - Healthcare Workers

Participant Information Sheet (PIS) for HCW Interview (Work package 4)

STUDY TITLE: United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers: Increasing retention of healthcare staff from ethnic minority groups (UK-REACH - I-CARE)

Co - Principal Investigators: Professor Manish Pareek and Professor Katherine Woolf

Introduction

Thank you for taking the time to read this information.

We are inviting you to participate in a study seeking to understand why healthcare workers (HCWs) may wish to leave or change their jobs. In particular, we wish to focus on the experiences of healthcare staff from minoritised groups, especially in terms of ethnicity and migration status. We are calling this study I-CARE (Increasing retention of healthcare staff from ethnic minority groups) and it is a continuation of the UK-REACH study (United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers) which started during the pandemic in 2020.

What is the purpose of the study?

The aim of the I-CARE study is to improve our understanding of the personal and work-related factors that are related to healthcare workers’ intentions to change or leave their jobs. In particular, we wish to understand how these factors might differ for staff from minoritised groups (focusing on ethnicity and migration status), and to explore potential reasons for this. The I-CARE study builds on the UK-REACH study.

UK-REACH was set up to understand how personal (including ethnicity) and work-related factors related to the physical and mental health of healthcare workers and their experiences of working during the COVID-19 pandemic.

Why have I been invited to take part?

We are inviting you to take part in this study as you:

Are aged 18 and over;
Currently work or have recently worked in the NHS;
You are thinking of changing or leaving your job or have already left your NHS job.

We welcome people from all communities and all job roles (clinical and non-clinical) to take part. Since the study is aiming to analyse the reasons that healthcare workers from minoritised communities may be thinking of changing or leaving their jobs, we encourage people from these communities to consider taking part.

We also welcome contributions from those who have recently left their jobs in the NHS as they may be able to provide valuable insights into what contributed to their decision to leave.

What will happen if I decide to take part?

We will ask you to:

Register your details (including contact details) on our secure web page.
Confirm you have read this information sheet and provide consent to participate in the study using our secure web page, if you are happy to do so.
Complete a short demographic questionnaire which will take approximately 5 minutes. We will ask some basic information about you, including your age, ethnicity, job role and also if you plan to leave or have already left your job.
On the basis of the information you provide, we will screen your eligibility against our sampling criteria, and if you meet the criteria, you will be invited to take part in an interview.
Your decision to participate will be confidential, and anything you say will also be confidential, and the information you give will be anonymised (so no personal data about you is shared).
Interviews will be at a time that is convenient to you and most likely to take place in Microsoft Teams, which is a safe online platform approved by the University of Leicester. If there is preference for face-to-face/telephone interviews, this will be taken into consideration where feasible.
In the interview, you will be asked several open-ended questions regarding your perceptions about different aspects of your job, intention to leave, the impact this has/will have on your personal and professional life and finally your views about improving staff retention.
We will record your responses using the Teams feature or use an encrypted voice recorder if doing it face-to-face or telephonically (and will require your consent for this).
The interview will take around 45 minutes – 1 hour to complete.
The interviews will primarily be conducted in English however if you feel that language will be a significant barrier for you in expressing yourself during the interview, we might be able to arrange for an interpreter.
After the interview, we will offer you a £25 shopping voucher as a token of our appreciation, on signing a contributor disclaimer form which reiterates the voluntary nature of your participation.

In the invitation email there is a link for you to access the registration form, consent form and demographic questionnaire online.

In the consent form we will ask for your permission to:

Contact you again in the future to invite you take part in additional components of this study or other studies. You don’t have to take part – this will be your choice, if/when contacted.

Do I have to take part?

If you decide to take part, you will be asked to complete a consent form once you have had the opportunity to read this information sheet and ask any questions you might have. You will be able to download an electronic copy of your consent form to keep for your own information.

What are the possible benefits of taking part?

This research is part of the UK-REACH I-CARE study and could help to improve our understanding of why healthcare staff leave or stay in the NHS, particularly those from minoritised groups. The findings could inform policy interventions to help NHS organisations retain staff. However, there may be no direct benefit to you personally.

What are the possible disadvantages of taking part?

There are no known disadvantages or health risks associated with this research. However, there are some questions about sensitive topics that some people may find upsetting – you can choose not to answer any question that you do not feel comfortable answering, and you may stop at any time. The study team has experience of working on/hearing about difficult/sensitive topics and will follow a distress protocol if they identify any signs that you are becoming distressed during the interview and will support you. In addition, on the UK-REACH website, we provide contact details for organisations that provide support for mental health and wellbeing, including some particularly relevant to healthcare workers. You can also contact the study team by telephone or email. Contact details are provided at the start and end of this document.

Who will be able to use my data?

The safety and security of participants’ data is of the utmost importance to the study team. There will be strict mechanisms in place for data storage and access, and you will not be identifiable in research outputs. A small number of the research team will have access to your contact details to arrange, carry out and transcribe interview and make contact with you in the future if you have consented to this.

Your decision to participate will be confidential, and anything you say will also be confidential, and the information you give will be anonymised (so no personal data about you is shared). Your trust/employer will not be told that you have taken part in this research. In discussion with the Co-Principal Investigators and UK-REACH/I-CARE Core Management Group, we may make information from the study, labelled only with unique codes, available to researchers approved by the UK-REACH/I-CARE Core Management Group. This information will not identify you and identifiable information will be kept separate from the data. Approved researchers will be required to adhere to strict data governance procedures detailed on the UK-REACH website

How will we use information about you?

This information will include your name and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

The University of Leicester is the sponsor of this research, and is responsible for looking after your information. We will keep all information about you safe and secure by:

Keeping your name and contact details separately from your research data and will use these only for future contact by the UK-REACH I-CARE team. A very small number of study team members will have access to your name and contact details, so that we can re-contact you about other aspects of the study.
Demographic data will be given a code number instead and will be stored separately from personally identifiable data.
Recordings of interviews will be transcribed before analysis. The transcription will be undertaken by a transcribing company that has a Confidentiality Agreement with the research team. The recordings will be deleted once the transcription has successfully taken place.
The transcripts will be fully anonymised and no one will be able to identify you from the transcripts.
All electronic data will be stored on a password-protected computer file within a secure university file drive. Any paper records will be stored in a locked filing cabinet.
Your consent information will be kept separately from your interview transcript so there is no risk of re-identification.
Your anonymised data will be stored for up to 6 years from the end of the study and may be used in future ethically approved research. Any collaborators we share our data with will follow our rules about keeping your information safe.
We will write our reports in a way that ensures no-one can work out that you took part in the study.
Please see our Privacy Notice for further information on how we process your data

What are your choices about how your information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. If you wish to withdraw from the study, you can contact the study team by email or telephone (using the details provided), who will confirm and record your wishes to withdraw, and regarding further contact. If you do decide to withdraw, no further data will be collected about and from you. Any information that is already collected and analysed, will remain and be used in the study. You have the right to ask us to remove, change or delete data we hold about you for the purposes of the study. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.

No further data collection will be performed and we will not contact you again about this study.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you. You will be able to update your contact details in your UK-REACH account or via the study team.

Where can I find out more about how my information is used?

You can find out more about how we use your information:

at www.hra.nhs.uk/information-about-patients/
By referring to our Privacy Notice https://www.uk-reach.org/main/participants/
by asking one of the research team
by sending and email to uk-reach@leicester.ac.uk or
by ringing us on 07425611865
by contacting the University’s Data Protection Officer via email on dpo@le.ac.uk

What if something goes wrong?

Will the findings of the research by published?

We will publish findings from the research in scientific journals. We will summarise published research on a study website: https://www.uk-reach.org.

Who is organising and funding the research?

How was the study reviewed?

This study has been reviewed and approved by an independent group of people called a Research Ethics Committee (University of Leicester). All research that involves NHS patients or staff, information from NHS medical records or uses NHS premises or facilities must be approved by an NHS Research Ethics Committee before it goes ahead. Approval does not guarantee that you will not come to any harm if you take part. However, approval means that the committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that you have been given sufficient information on which to make an informed decision.

Thank you for reading this information sheet.

For Further information, please contact the UK-REACH I-CARE study team at:

Email: uk-reach@leicester.ac.uk

Tel: 07425 611865

UK-REACH I-CARE HCW PIS (WP4)_V1.2_26/03/2025

Participant Information Sheet - Healthcare Managers

Participant Information Sheet (PIS) for Managers Interview (Work package 4)

STUDY TITLE: United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers: Increasing retention of healthcare staff from ethnic minority groups (UK-REACH - I-CARE)

Co - Principal Investigators: Professor Manish Pareek and Professor Katherine Woolf

Introduction

Thank you for taking the time to read this information.

What is the purpose of the study?

Why have I been invited to take part?

We are inviting you to take part in this study as you:

Are aged 18 and over;
You work in a clinical or non-clinical role in a healthcare setting/the NHS and have managerial responsibility.

We also welcome contributions from those who have recently left their jobs in the NHS as they may be able to provide valuable insights into what contributed to their decision to leave.

What will happen if I decide to take part?

We will ask you to:

Register your details (including contact details) on our secure web page.
Confirm you have read this information sheet and provide consent to participate in the study using our secure web page, if you are happy to do so.
Complete a short demographic questionnaire which will take approximately 5 minutes. We will ask some basic information about you, including your age, ethnicity, job role and also if you plan to leave or have already left your job.
On the basis of the information you provide, we will screen your eligibility against our sampling criteria, and if you meet the criteria, you will be invited to take part in an interview.
Your decision to participate will be confidential, and anything you say will also be confidential, and the information you give will be anonymised (so no personal data about you is shared).
Interviews will be at a time that is convenient to you and most likely to take place in Microsoft Teams, which is a safe online platform approved by the University of Leicester. If there is preference for face-to-face/telephone interviews, this will be taken into consideration where feasible.
In the interview, you will be asked several open-ended questions about your perceptions regarding HCWs leaving their NHS jobs, the current attrition scenario, what institutions are doing to retain staff and also your recommendations to improve staff retention.
We will record your responses using the Teams feature or use an encrypted voice recorder if doing it face-to-face or telephonically (and will require your consent for this).
The interview will take around 45 minutes – 1 hour to complete.
After the interview, we will offer you a £25 shopping voucher as a token of our appreciation, on signing a contributor disclaimer form which reiterates the voluntary nature of your participation.

In the invitation email there is a link for you to access the registration form, consent form and demographic questionnaire online.

In the consent form we will ask for your permission to:

Contact you again in the future to invite you take part in additional components of this study or other studies. You don’t have to take part – this will be your choice, if/when contacted.

Do I have to take part?

What are the possible benefits of taking part?

What are the possible disadvantages of taking part?

Who will be able to use my data?

The safety and security of participants’ data is of the utmost importance to the study team. There will be strict mechanisms in place for data storage and access, and you will not be identifiable in research outputs. A small number of the research team will have access to your contact details to arrange, carry out and transcribe interview and make contact with you in the future if you have consented to this.

How will we use information about you?

This information will include your name and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

The University of Leicester is the sponsor of this research, and is responsible for looking after your information. We will keep all information about you safe and secure by:

Keeping your name and contact details separately from your research data and will use these only for future contact by the UK-REACH I-CARE team. A very small number of study team members will have access to your name and contact details, so that we can re-contact you about other aspects of the study.
Demographic data will be given a code number instead and will be stored separately from personally identifiable data.
Recordings of interviews will be transcribed before analysis. The transcription will be undertaken by a transcribing company that has a Confidentiality Agreement with the research team. The recordings will be deleted once the transcription has successfully taken place.
The transcripts will be fully anonymised and no one will be able to identify you from the transcripts.
All electronic data will be stored on a password-protected computer file within a secure university file drive. Any paper records will be stored in a locked filing cabinet.
Your consent information will be kept separately from your interview transcript so there is no risk of re-identification.
Your anonymised data will be stored for up to 6 years from the end of the study and may be used in future ethically approved research. Any collaborators we share our data with will follow our rules about keeping your information safe.
We will write our reports in a way that ensures no-one can work out that you took part in the study.
Please see our Privacy Notice for further information on how we process your data

What are your choices about how your information is used?

No further data collection will be performed and we will not contact you again about this study.

Where can I find out more about how my information is used?

You can find out more about how we use your information:

at www.hra.nhs.uk/information-about-patients/
By referring to our Privacy Notice https://www.uk-reach.org/main/participants/
by asking one of the research team
by sending and email to uk-reach@leicester.ac.uk or
by ringing us on 07425611865
by contacting the University’s Data Protection Officer via email on dpo@le.ac.uk

What if something goes wrong?

Will the findings of the research by published?

We will publish findings from the research in scientific journals. We will summarise published research on a study website: https://www.uk-reach.org.

Who is organising and funding the research?

How was the study reviewed?

Thank you for reading this information sheet.

For Further information, please contact the UK-REACH I-CARE study team at:

Email: uk-reach@leicester.ac.uk

Tel: 07425 611865

UK-REACH I-CARE Managers Interview PIS (WP4)_V1.2_26/03/2025

Privacy Notice

UK-REACH I-CARE Research Study (Work Packages 4&5) Privacy Notice

Information you need to know:

The University of Leicester’s Department of Respiratory Sciences are conducting a study to understand why healthcare workers (HCWs) may wish to leave or change their jobs. In particular, we wish to focus on the experiences of healthcare staff from minoritised groups, especially in terms of ethnicity and migration status. We are calling this study I-CARE (Increasing retention of healthcare staff from ethnic minority groups) and it is a continuation of the UK-REACH study (United Kingdom Research study into Ethnicity And COVID-19 outcomes in healthcare workers) which started during the pandemic in 2020.

In Work Packages 4 and 5 the University of Oxford and University College London (UCL) are our collaborators in undertaking research.

The University of Leicester is the Data Controller for your information. Further information on the University can be found here: https://le.ac.uk/.

The University’s Data Protection Officer is: Parmjit Singh Gill, Data Protection Officer, University Of Leicester, University Road, Leicester, LE1 7RH. 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

What information are we collecting or using?

We are collecting your personal information (name, email and phone number) as part of our registration process. This information will only be used for administrative purposes and not for research.

The information we will collect directly from you in the form of demographic questionnaire for WP4 includes:

Age
Gender
Ethnicity
Health Status
Job details
Nationality
Immigration Status
Working arrangements
Leaving intentions

The information we may document from your views expressed during interviews includes the following:

Your professional background, turnover intentions, turnover impact on your personal and professional life, and your views on staff retention. [For Healthcare Workers]
Your professional background, turnover intentions of staff, turnover impact on staff, patients and organisation, existing policies and actions on retention and your views on staff retention. [For Managers]

If you agree, we will also retain your contact details so that we can invite you to take part in additional studies.

Why are we collecting your data for this Research Study?

The aim of the I-CARE study is to improve our understanding of the personal and work-related factors that are related to healthcare workers’ intentions or actions to change or leave their jobs. In particular, we wish to understand how these factors might differ for staff from minoritised groups (focusing on ethnicity and migration status), and to explore potential reasons for this. The I-CARE study builds on the UK-REACH study. Our specific research questions are:

To improve our understanding of the personal and work-related factors that are related to healthcare workers’ intentions to change or leave their jobs, how these factors might differ for staff from minoritised groups, and to explore potential reasons for this.
To develop and refine a programme/system theory to improve understanding of how, why and in what contexts NHS policy interventions can improve the retention of NHS staff from minoritised groups post-pandemic.
To use the programme/system theory to co-design policy interventions to increase retention of NHS staff from minoritised groups, targeted at NHS trusts with low retention and average-to high proportions of staff from minoritised groups.

Participation will be anonymous and confidential

How we will use this data?

We will use your information to enable us to answer the main UK-REACH I-CARE related research questions for WP4&5 that we have set out above.

The safety and security of participants’ data is of the utmost importance to the study team. There will be strict mechanisms in place for data storage and access, and you will not be identifiable in research outputs. A small number of the research team will have access to your contact details to arrange, carry out and transcribe interview and make contact with you in the future if you have consented to this.

Your decision to participate will be confidential, and anything you say will also be confidential, and the information you give will be anonymised (so no personal data about you is shared). Your trust/employer will not be told that you have taken part in this research. In discussion with the Co-Principal Investigators and UK-REACH I-CARE Core Management Group, we may make information from the study, labelled only with unique codes, available to researchers approved by the UK-REACH I-CARE the Core Management Group. This information will not identify you and identifiable information will be kept separate from the data. Approved researchers will be required to adhere to strict data governance procedures detailed on the UK-REACH website www.uk-reach.org.

If you are taking part in the storytelling activity, you may be concerned that you could be identified from your audio story. It is not possible to completely eliminate this risk; however this risk will be very small. You can choose which parts of your story to tell, and which to leave out (you may wish to leave out anything you think could identify you). Your audio story resource will also be anonymised. This means that your name and any other identifying details about you will be changed (e.g. about your job, the place that you work or live, about your family, colleges and friends etc); and you can also choose to have your story voiced by a professional narrative practitioner if you wish. You will have the chance to work with the professional narrative practitioner to review your story and remove anything that you think might identify you. You will have the opportunity to approve the final story.

All the collaborating Universities have 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.

Data collected during the study may be looked at by individuals from regulatory authorities, 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.

WP4 and 5 of the UK-REACH I-CARE research study does not involve automated decision-making.

What is the legal basis for processing the data?

Our additional legal basis for processing special category information is that:

processing is ‘necessary for reasons of public interest in the area of public health’, as set out in the Data Protection Act 2018 and UK GDPR Article 9.2(i);

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

Access to transcripts or any files containing identifiable and/or potentially sensitive information will not be authorised beyond the research team comprising staff from the University and Leicester, UCL and University of Oxford.

We will be sharing the audio recording of interviews and focus groups with a third part for the purpose of enabling them to be transcribed. This will be covered by a contract including terms to protect your privacy.

Bona Fide researchers outside the UK-REACH and I-CARE study team who successfully apply to UK LLC and/or a separate UK-REACH Committee set up to consider such applications. (Anonymised data only.)
Participant information may be required to be disclosed to regulatory authorities such as MHRA and public health agencies.
Only anonymised and summarised research reports will be shared with our Stakeholder partners representing the Healthcare professions and healthcare workers.

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 we will process your data for?

All the information being collected in WP4 and 5 will be held by the University and unless otherwise stated, the information will be held for and deleted after 6 years:

Your consent to participate forms;
Anonymised transcripts of audio recordings, held in our Research File Store
Audio recordings will be deleted as soon as they have been transcribed;
With permission, your identifiable personal information comprising your names and contact information will be retained by the University to enable us to invite you to participate in any future studies, otherwise we will delete it if you withdraw from the research or after 6 years whichever is the sooner.

What are your rights and how can you enforce them?

In this UK-REACH I-CARE WP4&5 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 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 of national significance because it relates to NHS staff attrition which is crucial for effective service delivery and care of patients;
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 identifiable and pseudonymised 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.

How will this affect the rights of participants?

If you withdraw from the project, we will keep the information we have already obtained but, to safeguard your rights, we will use the minimum personally identifiable information possible.

If you wish to ask questions about our research please contact Laura.Nellums@Nottingham.ac.uk

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

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

If you are affected by any of the issues raised in your participation in UK-REACH or are looking for information about COVID-19 (Coronavirus) please visit:

Government Guidelines: www.gov.uk/coronvirus
NHS Advice: https://www.nhs.uk/conditions/coronavirus-covid-19/symptoms/
NHS - Where to get urgent help for mental health: https://www.nhs.uk/using-the-nhs/nhs-services/mental-health-services/where-to-get-urgent-help-for-mental-health/
Covid-19 Workforce Wellbeing: https://www.practitionerhealth.nhs.uk/covid-19-workforce-wellbeing
Victim Support - support for people affected by crime or traumatic events, including hate crime: https://www.victimsupport.org.uk/
Samaritans - Emotional Support for Everyday: www.samaritans.org
Mind - Advice and support for anyone with a mental health problem: www.mind.org.uk