COVID-19 home antibody testing research study

Information sheet for participants

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Frequently asked questions

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Privacy notice

Information you need to know

The University of Leicester’s Department of Health Sciences is leading the Extended cohort for E-health, Environment and DNA (EXCEED), a study of the causes of long term health conditions. The EXCEED study is of one of a number of studies taking part in the Longitudinal Health National Core Studies (NCS) programme led by Professor Nish Chaturvedi University College London (UCL) to understand the impact of Covid-19 on long term health. The National Core Studies is a UK Government funded initiative set-up in response to the coronavirus pandemic to allow for the investigation into high priority Covid-19 research questions.

This particular EXCEED Serology research study is focussing on identifying the presence of coronavirus antibodies in EXCEED study participants. The cost of the kits and tests is funded by the Department of Health and Social Care (DHSC).

The University of Leicester (the University) is the Data Controller for your information. Further information about the University can be found here: 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 using?

In this EXCEED Serology study we are collecting information from people who:

• Are in good health or have health problems; and
• Are aged 18 and over; and
• Have access to the internet.

We will only collect and use information from existing or new EXCEED study participants who have voluntarily agreed to participate in this study and have completed online participant consent forms in accordance with ethical requirements and to meet our legal obligations relating to confidentiality.

The information we will collect directly from participants includes:

• Your Name, home address and email address
• Special category health data relating to the collection of a blood sample to enable us to test for the presence of Coronavirus Antibodies

Why are we collecting your data for this Research Study?

This is an antibody research study. Antibodies are made by the immune system to fight infection. In this study, we will use the results of antibody tests that you do yourself at home to help us understand how many people in EXCEED may have already been infected with the virus which causes Covid-19.

This is part of a national initiative where other population based research studies in the UK are also asking their participants to complete the same antibody test. Analysing the information from EXCEED alongside these other studies will allow a greater understanding of the impact of Covid-19 on people’s health and other aspects of life.

How we will use this information?

We will add your antibody test results to the data we already hold to enable us to answer Covid-19 related research questions. Many of these questions are still being developed as we delve deeper into the impacts of Covid-19. As indicated above, anonymised results will be pooled with other studies and surplus blood samples will be reserved by for use by the EXCEED research team in future health research. In the longer term, EXCEED intends to deposit anonymised Covid-19 data in the National Core Studies research database – UK Longitudinal Linkage Collaboration (UK LLC).

In accordance with Government legislation, anonymised antibody test results will also be shared with Public Health England.

We and our partners 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) and store these securely in separate places.
• Your name and address will be sent to Thriva our partner to enable them to send out a home finger-prick blood test kit to you. Thriva will delete this contact information 7 days
• Your name and address will not appear on the sample you supply for testing nor on the return packaging. This will be replaced with your unique Study ID and Sample ID codes.
• You will send your blood sample by post for testing to a Lab used by Thriva. At this point your sample will be anonymised information since the Lab will not know that the sample relates to you and will not hold any other information enabling it to identify you.
• The test results will be returned to the University by the Lab and we will use the Sample ID and your Study ID codes to enable us to link the result to your participant data.
• We will make the results available to you using the contact information you provided.
• Any leftover blood from your sample will be returned to the University, stored under lab conditions and we will use this for further testing for EXCEED participants. Transport, storage and use of samples are governed and regulated by the Human Tissue Authority.

The University has technical and organisational measures in place to ensure that the participant data and test results used in this research is securely stored and only used for the purposes of this research. It also requires the 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 retain these tests results so we can continue this research over a long period so that this can be used to answer further research questions quickly to help improve clinical outcomes and the development of medicines in the long term.

Your antibody test results from this study may in future be shared with the UK LLC Database which is being stored in the Secure e-Research Platform (UKSeRP) managed by Swansea University. All the data being used in the establishment of this UK LLC database will be anonymised which means it will not be possible to identify you from the antibody test data we share with UK LLC (University of Bristol).

Although we share your antibody test results with you we will not be using your results to record, learn or decide something about you.

Due to the nature of the EXCEED study, there will be “profiling” of information including demographics, those who have medical conditions including Covid-19 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 Covid-19 on EXCEED participants, in terms of the purposes of this study.

This research study does not involve automated decision-making.

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 for the performance of a task in the public interest as set out in s8(c) of the Data Protection Act 2018 and UK 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 ‘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 information with others, who are we sharing it with?

This EXCEED study involves research and delivery partners, and other information processing operations. The following is a list 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:

• Other members of staff at the University outside the EXCEED research team on a need to know basis. For e,g. Staff who manage the Lab where blood samples will be stored.
• Thriva, our partner responsible for organising the test kits and the Testing of blood samples The lab used by Thriva will not receive any identifiable participant information.
• Royal Mail, who will only receive your name address, are being used by Thriva to send the test kits to participants and the samples to a Lab for testing.
• UK LLC SeRP databank managed by Swansea University (SAIL) with whom we will be sharing anonymous test results.
• We are required to share your anonymised antibody test results with Public Health England (PHE).
• Participant information may be required to be disclosed to other regulatory authorities and public health agencies.
• Only anonymised and summarised research information will be used in research analysis reports and in any scientific journals and other publications.

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 will we process your information for?

As EXCEED is a long term research study the information from this study will be used in our research until 2038.

For all information held by the University as out below, unless otherwise stated, all the personal/pseudonymised information held for this study will be deleted after 2038.

• Your consent to participate forms will be held until 2038.
• As you have given us permission, we will retain your contact information, otherwise we will delete it if you withdraw permission to use your samples in the research or 2038 whichever is the sooner.
• We will retain your leftover blood samples until they are used up or until 2038 whichever is the sooner.

Storage and future use of samples

• As you have given your permission we will keep any remaining samples (in their pseudonymised form) for the life of the EXCEED study for use in future ethically approved research.
• As you gave us permission to retain your samples for future research, it is necessary to retain your consent form until the samples have been depleted or destroyed, or if you withdraw your permission to use the samples. This may be up to six years after the study has concluded.
• The Human Tissue Authority is the regulatory authority responsible for the oversight and inspections of human tissue storage in the UK after a study has concluded. We require your consent form to comply with the Human Tissue Authority to ensure we have obtained your permission to retain the samples beyond the life of this project. Your consent form would be stored independently from your pseudonymised samples to ensure your samples remain anonymous to researchers that may use them in the future.

If your samples are used up within this period your consent form and personal information will be destroyed 6 years after the study ends.

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 EXCEED 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 the EXCEED scientific research study is long term and this study 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 only receive anonymised data or remove the identifiable personal information from the linked data sets or delete identifiable data within a very short period after processing it;
• 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 EXCEED Study website and the University’s main website.

We have concluded that the exercise of rights by participants would seriously impair the achievement of the Study objectives and the exemptions are necessary to enable us to fulfil our public health related 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. GDPR Articles 15,16,17,18 and 21 will not apply.

However if you withdraw permission to use the identifiable data we hold about you in this study at any stage, we will no longer use it. We are entitled to keep the anonymised information we have already obtained and which has already been processed in the research including the antibody test results which we are be obliged to share with PHE.

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

If you are concerned about our use of your information in this study please contact the University’s Data Protection Officer in the first instance by email: et177@leicester.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