Participant information sheet

Participant Information

We’d like to invite you to take part in EXCEED, a study of the causes of long term health conditions. EXCEED is currently looking at the pandemic coronavirus disease, COVID-19. We aim to understand why some people develop more severe COVID-19 than others, and to understand its impact on long term health conditions.

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.

If you choose to take part, you will fill in short questionnaires about your health, including about symptoms of COVID-19. We will also ask about other the ways that the pandemic may have affected you. We will follow your health by studying information from your past and future NHS health care records. Later, to study DNA, we may send you a saliva sample collection kit by post or use a “left over” sample after you have had a blood test done at the hospital.

To help you decide if you would like to take part please read this leaflet carefully. If you have questions please contact us at exceed@leicester.ac.uk or on 0116 252 5997.

What is the aim of the study?

The chances of getting diseases are affected by your environment and genes. Environmental influences include smoking and air quality. Genetic influences are passed through the family and are written in your DNA.

Understanding the genetic causes of diseases is used to develop new medicines. Improved understanding of environmental causes of diseases can help us to improve the environment. As part of its mission, this study aims to improve understanding of COVID-19 and of long term health conditions, whether they occur on their own or in combination (called “multimorbidity”).

Who can take part?

You can take part if you:

• Are in good health or have health problems
• Are aged 18 and over
• Have access to the internet to complete the consent and questionnaire

You can’t take part if you:

• Are under age 18
• Can’t access the internet to complete the consent and questionnaire

If you’re not sure whether you can take part, please ask us.

What will I be asked to do?

If you’d like to take part we ask you to:

• Register your details and provide your consent online
• Complete a questionnaire asking about your lifestyle, height and weight
• Complete short questionnaires about symptoms of possible COVID-19 and other ways that the pandemic may have affected you

We ask for your permission to:

• Follow your health by extracting information from your past and future NHS health care records (including your NHS number), and from “COVID-19 symptom tracker” website or app if you use one
• Invite you to take part in future studies, depending on your health status or your DNA. Details of these studies will be sent out when the study is ready to recruit participants. You don’t have to take part – this will be your choice if and when contacted
• Use “left over” blood from samples that may be taken in future by your GP or the hospital as part of your care, once the tests required for your care have been carried out. This would be used for either DNA analysis or coronavirus antibody testing (if available). It will not affect the care you receive from your GP or the hospital
• Send you a kit to provide a saliva (spit) sample for DNA at a later date if required (for example, if you do not have any blood tests carried out, or if we cannot obtain sufficient DNA from “left over" blood)
• If it is feasible for you to have such a test as part of the study, we will send you a kit to test whether you have had COVID-19 and formed immunity. This information would be valuable in research to understand why some people with COVID-19 have few symptoms whilst others have severe disease. Because we don’t yet know what test will be available, the process for how we do this will be guided by a Scientific Committee. We will then send you details of the test when we are ready to undertake it

We will contact you by email, text message, phone, or post. If you wish, you can tell us which of these you would prefer to be used for future contact via the EXCEED website.

We will securely store your DNA sample and your DNA will be analysed. This may include whole genome sequencing where we would study all the letters of your DNA.

Before you join the study, please discuss any concerns with a member of the study team.

Is there any payment for taking part?

You will not be paid for taking part in the study.

What are the possible benefits of taking part?

This research could help NHS planning or improve health care in the future, 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.

What are the possible disadvantages of taking part?

Completing the initial questionnaire will take about 15 minutes, and the next COVID and health questionnaire about 20 minutes. Producing the saliva for the kit (if required) can also take some time.

Will I receive results of tests on my DNA?

Information relevant to you or your family might be discovered by the study of DNA. These measures are useful for research, but they are not the same as clinical genetic tests. Research genetic measures are not of a high enough standard for diagnosis. Therefore, we will not routinely provide you with the results of all the genetic variants measured in the study. In rare situations we may advise a participant to seek medical advice based on a research result for a specific genetic variant for which there may be medical treatment. For example, one which causes very high blood cholesterol which might be lowered by medication. A Scientific Committee based on expert advice will decide what is considered to be a genetic variant that can be medically treated. On the consent form, we will ask you to choose whether you would wish to be contacted if we do find such a variation. The Clinical Genetics Department at the Leicester Royal Infirmary have a dedicated genetic counselling clinic for patients where genetic variations have been identified in a research study. This will offer advice to patients on the significance of what has been discovered and the steps the patient can take to reduce the likelihood of this having an impact on health in the future.

However, it is important that you understand that we cannot identify all genetic variants for which there may be a medical treatment and our ability to continue the study and to contact participants will be subject to further funding. As a research study we do not have the resources that a screening programme has, and the research genetic measures are not of a comparable standard to genetic testing that is a part of a screening programme. It is important you understand that this study is not a substitute for medical screening, clinical advice or clinical care.

Who will be able to use my data and samples?

We may make available information and samples from the study, labelled only with unique codes (no names or addresses), to researchers approved by the EXCEED Data Access Committee, which is overseen by the EXCEED Independent Scientific Advisory Board. This could include researchers working overseas or in commercial companies, such as companies developing new drug treatments.

How will my samples and data be used?

We will need to use information from you and your medical records for this research project. This information will include your NHS number, 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.

We will keep all information about you safe and secure.

If some of your information is sent to approved researchers overseas, they 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.

The samples and data will be stored at the University of Leicester, University Hospitals of Leicester NHS Trust or at UK Biocentre using unique codes to identify each participant. To enable approved researchers to undertake research projects securely we may keep a copy of the data in a Trusted Research Environment (“Data Safe Haven”) such as SAIL Databank (Swansea). Any link between the unique codes and names will be stored separately and securely. Access to any identifiable data (e.g. name, address, NHS number) will be limited to select members of the research team and authorised individuals from the Trusted Research Environment, or from the Sponsor (University of Leicester), regulatory authorities or NHS (for example, for monitoring, audit or secure data linkage). We expect to store the samples and data for a period of 25 years, although this period will be reviewed by an expert Scientific Committee.

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 from the study, please contact a member of the study team who will ask you to sign a withdrawal form to confirm your wishes regarding the use of the sample and data collected to date, and regarding further contact.

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 EXCEED, we will invite you to take part in future studies, depending on your health status or your DNA. Details of these studies will be sent out when the study is ready to recruit participants. You don’t have to take part – this will be your choice if and when contacted.

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 exceed@leicester.ac.uk, or
• by ringing us on 0116 252 5997.

What if something goes wrong?

It is unlikely that you would be harmed taking part in this type of research study. There are no special arrangements for compensation. If you are harmed due to someone’s negligence, then you may have grounds for a legal action but you may have to pay for it. If you have a concern about any aspect of this study, you should speak to the researchers on 0116 252 5997. If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Please contact the Patient Information and Liaison Service (PILS) – Tel: 0808 1788337.

Will the findings of the research be published?

We will publish findings from the research in scientific journals. We will summarise published research on a study website TBA.

Who is organising and funding the research? How was it reviewed?

This research is led by Professor Martin Tobin and is organised through a partnership between researchers at the University of Leicester and University Hospitals of Leicester NHS Trust. The study has been supported by funding from the National Institute for Health Research, the Medical Research Council and the Wellcome Trust. This study has been reviewed and approved by an independent group of people called a Research Ethics Committee (East Midlands, Leicester) and by the University of Leicester as Sponsor.

Thank you for reading this information sheet.

Professor Martin Tobin, Principal Investigator

For further information, please contact the EXCEED study team:

Email: exceed@leicester.ac.uk

Phone: 0116 252 5997