PARTICIPANT INFORMATION SHEET – Isle of Wight Birth Cohort Study – Covid-19 Add-on

We would like to thank you for your involvement so far in the 1989/1990 birth cohort. The data we have been able to collect from you has been tremendously helpful in advancing understanding of asthma and other allergic diseases.
You are now being invited to take part in a small spin-off study to look at the symptoms and effect of Coronavirus on your immune system.

Before you decide to participate it is important for you to understand why the research is being done and what it will involve.

  • Part 1 tells you the purpose of this study and what will happen to you if you take part.
  • Part 2 gives you more detailed information about the conduct of the study.

Please read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

Part 1

What is the purpose of the study?

The world is struggling with a new threat that has impacted all our lives and caused huge suffering worldwide. Coronavirus infection is generally mild in children and young adults and they recover quickly. Indeed, many would have so mild an infection that they do not know about it or would have regarded the symptoms as due to a mild cold or flu. Nonetheless, the short- and long-term effects of this mild or asymptomatic infection in young adults are not yet known. We are planning to study these effects in the cohort participants. Therefore, we are asking you to let us know if you developed symptoms suggestive of Coronavirus, and the NHS helpline advised you to isolate yourself, or if you had a positive test for Coronavirus. We would like to gain a bit more information on the symptoms and duration of your illness and take a blood sample to look for the effect of Coronavirus on your immune system.

Why have I been chosen?

You have been chosen because you are part of the Isle of Wight Birth cohort. This is a birth cohort of nearly one-and-a-half-thousand young people all born on the Isle of Wight in 1989 and early 1990.

What will happen to me if I take part?

We would like you to visit the website below to complete a short questionnaire. If you do not have current symptoms or a very recent diagnosis of Covid-19 we will collect your current contact details and ask you to visit the website again if you do become unwell, or you are diagnosed with Covid-19.

If you have symptoms or a diagnosis of Covid-19, we will invite you to give a small sample of blood (30ml or about 1.5 table spoons). We can take the blood sample at St Mary’s or at your home, whichever is most convenient to you.

What do I have to do?

We would like you to visit the following website to complete a simple questionnaire:

www.isurvey.soton.ac.uk/38062

Once you have completed the questionnaire we will make contact with you to arrange an appointment for you provide a blood sample within 5 days after you have finished your period of isolation.

What are the possible disadvantages and risks of taking part?

The blood test may cause some slight, temporary discomfort.

In the highly unlikely event of any injury caused to you, medical care through the National Health Service will be available to you. St. Mary’s Hospital NHS Trust has indemnified this study.

What are the possible benefits of taking part?

Your participation will help us study the effect of coronavirus on your immune system immediately after you have recovered from Covid-19. We can use the information you provide in the short questionnaire to compare with information we have collected since 1989 and we may be able to determine if there are factors that could have an effect on whether and how severely the population in general are effected by Covid-19.

Do I have to take part?

It is up to you to decide whether or not to take part. If you do, you will be given a copy of this information sheet to keep and you be asked to complete an online consent form. If you would like a copy of your digitally signed consent, please let a member of the study team know. A decision to withdraw at any time, or a decision not to take part, will not affect the medical care you receive.

What if there is a problem?

If you have any questions or concerns, please contact Prof S. Hasan Arshad at The David Hide Asthma and Allergy Research Centre, St Mary’s Hospital, Newport, Isle of Wight. Telephone: 01983 530786. Email: iownt.Study.IOW@nhs.net

Will my taking part in the study be kept confidential?

Yes. All the information about your participation in this study will be kept confidential.

Contact for further information

Prof. S Hasan Arshad, The David Hide Asthma and Allergy Research Centre, St Mary’s Hospital, Newport, Isle of Wight. Telephone: 01983 530786. Email: iownt.Study.IOW@nhs.net

This completes Part 1 of the Information Sheet. Part 2 will give you more detailed information about the conduct of the study.

Part 2

What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak with the researchers who will do their best to answer your questions (Professor Arshad 01983 530786). If you still have questions or concerns, you can contact the Lead for Research and Development, St Mary’s Hospital, Newport, Isle of Wight, PO30 5TG; email iownt.research@nhs.net.

In the very unlikely event that something does go wrong and you are harmed during the research study there are no special compensation arrangements. If you are harmed and this is due to someone’s negligence then you may have grounds for a legal action for compensation against St Mary’s Hospital but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you.

How will we use information about you?

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

Some of your information will be sent to Europe and the United States of America. They must follow our rules about keeping your information safe.

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

You can find out more about how we use your information

Will my taking part in this study be kept confidential?

In this research study we will use information from your medical and GP records. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules.

The personal information collected will be kept confidential. The data we collect from you will not be labelled with your personal details and will be stored securely. Data collected during the study will be shared with our research collaborators in other universities in the UK, Europe and USA; however they will not know who the information belongs to as your name and address will not leave The David Hide Asthma and Allergy Research Centre. Only the study personnel will have access to your personal details. You will not be individually identified in any reports or publications resulting from the study. If you agree to take part in this study, you will have the option to take part in future research, approved by a Research Ethics Committee, using your data/samples saved from this study.

What will happen to any samples I give?

Blood: Our Clinical Scientist will process your blood sample on site at St Mary’s Hospital or in our partner Lab at Southampton General Hospital. The processed samples will then be sent to our collaborators at the La Jolla Institute of Immunology in San Diego, California, USA. The team at La Jolla will perform the immunological analyses on the samples.

Samples will be stored securely at St Mary’s or Southampton General Hospital until they are analysed. Only the researchers from the Allergy Centre will have access to them. Some of the blood samples will be analysed outside of St Mary’s Hospital (including in the USA). The samples will not be labelled with your name or address so that the researchers analysing them will not know that the sample belongs to you.

Will any genetic tests be done?

Genetic studies will be carried out to improve our understanding of how genes controlling our immune system influence how our immune system fights the Corona virus infection. Any genetic analyses conducted will be unlikely to produce results that have any relevance to you as an individual but will help us to develop fresh ideas that hopefully will improve our ability to develop new treatments for this or similar viral epidemics in the future. Thus, we would also like to store any samples collected for future research.

We will use this information for our study objectives and it will not be shared unless you agree to this during the consent process. In addition, if you agree, the data will be entered into external scientific databases so that it can be broadly shared with other researchers performing other genomic studies. For example, the National Institutes of Health (NIH, an agency of the US federal government) maintains a database called “dbGaP.” Databases like this serve as a repository of all kinds of genomic data from studies funded by the NIH and conducted in the US and around the world. The aim of collecting this information in a repository is to allow qualified researchers to look for genetic connections for a range of topics in the future. The information may be used to learn if certain genes are associated with certain traits, diseases and/or treatment effects. Making data broadly available in this way, means that your contribution and the data generated in this study could be helpful in advancing other areas of scientific research.

Traditionally used identifying information about you (such as name, phone number, address) will NOT be included in these databases or shared with others. De-identified genomic data generated in this study may be deposited in databases that will be publicly accessible via the Internet. Researchers with an approved study may access and utilise your de-identified genetic, genomic and/or health information deposited in the database (dbGAP) after approval by the regulatory authority (NIH). Strict safety measures are in place to protect the privacy of your information. However, because your genetic information is unique to you, there is a small chance that someone could trace it back to you or your family. The risk of this happening is very small, but may grow in the future. Researchers will always have a duty to protect your privacy and keep your information confidential.

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 choose to stop taking part in the study, we would like to continue collecting information about your health from central NHS medical records and from your GP. If you do not want this to happen, tell us and we will stop. We need to manage your records in specific ways for the research to be reliable. This means that we will not be able to let you see or change the data we hold about you.

You may withdraw consent for research use of genomic data or health information at any time. In this event, data will be withdrawn from any repository, if possible, but data already distributed for research use will not be retrieved.

The consent form for the study is split into two separate parts so if you want, you can consent to the genetic studies but not the genomic data sharing part of the study. If you decide to do this it will not affect your participation in the main part of the study.

What will happen to the results of the research study?

At the end of the study we will save some of the data in case we need to check it and/or use for future research. We aim to publish the results of the study in medical journals so that other doctors and researchers can make use of them. This is likely to be accompanied by an article in the local press on the Isle of Wight and sometimes in the national media. It will not be possible to identify any individual person involved in the study from these published results. We will make sure that no one can work out who you are from the reports we write.

Who is organising and funding the research?

The researchers at The David Hide Asthma and Allergy Research Centre are organising and carrying out this study. This study is being supported by Southampton Respiratory Biomedical Research Unit, which is funded by the National Institute of Health Research, UK. They are also being helped by a group of experts from the La Jolla Institute of Immunology, Michigan State University and University of Memphis in the United States of America, who will provide the expertise to analyse the blood samples and analyse the data collected.

Who has reviewed the study?

This study was given a favourable ethical opinion for conduct in the NHS by NRES Committee West Midlands – Edgbaston, reference number 15/WM/0071.

How long do I have to decide whether I should take part?

Your decision to participate in this study is entirely voluntary. You should take as much time as you need.

Thank you for taking time to read this information sheet.

 

IW Birth Cohort – Participant Information Sheet – COVID-19 Add-on | v1.1 – 08-Jun-2020 | REC Ref: 15/WM/0071