Participant information sheet

Participant Information

We’d like to invite you to take part in EXCEED, a study which is investigating the causes of long term health conditions in Leicester and surrounding areas. We are asking people from Asian, Asian British, Black, Black British, Caribbean, African, Arab, mixed or multiple ethnic groups to join the study.

If you choose to take part, you will fill in a short questionnaire about your health. We will follow your health by studying information from your NHS health care records. We will use the “left over” sample when you have a blood test in the future as part of your care, to look at your DNA and other measures of your health.

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?

Your chance of developing any health condition is affected by many things in your life and your environment. These include what you eat, where you work, and the air you breathe. It is also affected by the genes (DNA) which you inherit from your parents.

We aim to understand how differences in our DNA affect whether we get diseases. This could help to develop new medicines and improve health outcomes for all people. At the moment our understanding comes from studies that mainly include volunteers from certain ethnic groups, which means we are missing important information for other groups. We hope this study will help doctors to fully understand how diseases affect different people and find treatments that work well for people from all ethnicities. To succeed, we need volunteers from all ethnic backgrounds to join the study.

We also aim to learn about things in the environment that cause disease. In the future, this could help people avoid things that harm their health, like air pollution.

As part of the study, we will look at your NHS health records. This means we can study a very large number of diseases, not just one or two. EXCEED has already been used in 60 research projects. These projects look at things like: heart disease, lung disease, blood pressure, liver disease, underactive thyroid and mental health.

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.

Who can take part?

We are inviting people who live in Leicester, Leicestershire and Rutland who are from Asian, Asian British British (including Indian, Pakistani, Bangladeshi and Chinese), Black, Black British, Caribbean, African, Arab, or mixed/multiple ethnic groups.

You can take part if you are aged 18 or over.

You can take part if you are in good health or have health problems.

You can take part if you have family members who join the study, or if your family members do not join the study.

You will need access to the internet to complete the consent and questionnaire. If you don’t have this, we will try to help you use another way to participate. We will try to provide information in other formats if you need this.

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
• Answer some questions about your lifestyle, height and weight

We ask for your permission to:

• Follow your health by accessing information from your past and future NHS health care records (including your NHS number).
• Use “left over” blood from samples that may be taken in future by your GP or the hospital as part of your normal care, once the tests required for your care have been carried out. This would be used for health-related research purposes, including DNA analysis. 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).
• Contact you in future to ask you some more questions about topics related to health.
• Invite you to take part in future studies, depending on your health status (for example, whether you have a particular long-term condition) or on information from your DNA. We will send you details of these studies and you will be free to decide whether or not to take part. Your decision will never affect your legal rights or medical care.

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 use via the EXCEED website: exceed.org.uk.

We will securely store your samples and your DNA will be analysed. This may include whole genome sequencing where we would study all the “letters” (bases) 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 improve health in the future, and could help reduce unfair differences in health if enough people from different backgrounds join the study.

There may be no direct benefit to you. If a new treatment or test were developed, there would be no financial benefit to you.

What are the possible disadvantages of taking part?

Completing the initial questionnaire will take about 15 minutes. Producing the saliva for the kit (if required at a later date) can also take some time.

Will I receive results of tests on my DNA?

Information relevant to your health or your family’s health might be discovered by the study of DNA. In rare situations, based on expert advice, we may contact a participant and advise them to seek medical advice, because the results from the research tests show that they have a specific genetic variant for which there may be medical treatment. For example, one which causes very high blood cholesterol which increases the risk of heart disease, but might be lowered by medication. On the consent form, we will ask you to choose whether you would wish to be contacted if we do find such a variation.

However, we will not routinely provide you with the results of all the genetic variants measured in the study.

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. The genetic measures done as part of the study are not of the same standard as genetic tests done by the NHS. It is important you understand that this study is not a substitute for medical screening, medical advice or medical 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 selected 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.

Will I be able to withdraw from the study?

Yes, you can withdraw from the study at any time, without giving a reason and without this having any impact on your medical care or legal rights.

The research will be most valuable if people do not withdraw from it, so we would encourage you to discuss any concerns you may have with the study team before agreeing to participate.

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 further contact and use of any samples and data collected from you up to that point. You will be able to opt for (a) no further contact, (b) no further access to your health records or (c) no further use of your samples or data. However, it will not be possible to remove your samples or data from any analysis or research already conducted using your samples and data before your withdrawal.

What are my choices about how my information is used?

We need to manage your records in specific ways for the research to be reliable. We will store, manage and use your personal data confidentially, securely and in accordance with our obligations under the UK General Data Protection Regulation (UK GDPR) and our Privacy Notice (see: exceed.org.uk/privacy).

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

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

• by reading our Privacy Notice at exceed.org.uk/privacy;
• 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 by 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 the study website, exceed.org.uk.

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