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Coronavirus Disease (COVID-19) in the UK community

 Ethics Approval Reference R69035/RE005

Participant Information Sheet

1.           What is the purpose of the research?

This study is in response to the ongoing coronavirus disease (COVID-19) pandemic currently affecting the United Kingdom (UK).  There is an urgent need to determine the true prevalence of SARS-CoV-2, the virus which causes coronavirus disease (COVID-19), in the UK community to inform the public health response.

 This research is also being carried out to explore the use of nanopore technology, which sequences the whole genome of pathogens, as a diagnostic tool for this outbreak and to improve pandemic preparedness for future novel disease outbreaks.

 This study aims to:

 1. Determine the background infection prevalence of COVID-19 in the UK community

2. Validate a nanopore sequencing diagnostic approach for novel pathogen outbreaks

 Please note that test results will not be made available to you. Our tests are research-grade and will not be available within a clinically relevant timeframe.  Participating in our study does not change the public health advice to community members on when to seek healthcare advice, self-isolation and testing.

2.           Why have I been invited to take part?

You have been invited because you indicated on the online form on our website that you would like to participate in this study. You were randomly chosen based on your age, sex and location.

 The exclusion / inclusion criteria are:

 Inclusion:

 Exclusion:

 

3.           Do I have to take part?

No.  You can ask questions about the research before deciding whether or not to participate. If you do agree to participate, you may withdraw yourself from the study at any time prior to the samples being collected, de-identified and processed and results data pooled, without giving a reason, by advising the researchers of this decision.

 

4.       What will happen to me if I take part in the research?

If you are happy to take part in the research, you will be asked to read through the study procedures in your mail package and are invited to email covidstudy@zoo.ox.ac.uk or call Dr Simeon Innocent, 01865 (2) 86979, or Dr Cassidy Nelson, 01865 (6) 10997, if you have any questions at any stage.

 This should take approximately 30 minutes.

 After reading this information form, if you would still like to take part, you will then be asked to sign a consent form (enclosed sheet C).

 This testing kit contains two throat swabs and one finger-prick serology test. Enclosed are detailed instructions on how to self-collect (sheets D and E). Please refer to these sheets for further information.

 

You will then be asked to complete a questionnaire about your symptoms and risk factors online. You will also be asked to record your serology test result on this online questionnaire.

 

After collection, please put all samples in the return mail packaging as detailed on the instruction form (sheet F) for collection which has been arranged for you at the date and time provided to you.

 

5.           Are there any potential risks in taking part?

The following risks are involved in taking part:

 

The throat swab can be uncomfortable and in some participants can cause a gagging sensation or nausea. Rarely, vomiting can occur from stimulating the back of the throat.

 

For the finger-prick blood test, a sharp sensation is expected. After collection, sometimes excessive bleeding can occur. Firm pressure on the finger with a cotton bud or tissue can help stop the bleeding. Bruising or prolonged pain may rarely occur.

 

In order to reduce any potential risks, the researchers ask you follow the detailed instructions included in the pack. If you have any medical concerns, please contact us for advice using the contact details at the bottom of this form. Only in the case of any life-threatening emergency, please dial 999.

 

6.           Are there any benefits in taking part?

There will be no personal benefit to you from taking part in this research. Due to the research nature of this study, results will not be returned to study participants.

 

7.           Expenses and payments

There will be no payment for taking part in this study.

 

8.           What will happen to the samples I give?

The two throat swab samples will be stored at the University of Oxford in full compliance with all governance and regulation requirements. All samples will be de-identified with only the barcode unique identifier included to ensure anonymity. Only the named researchers of the study will have access to the individual results of the analysis. The samples you provide will be destroyed after processing.

 

One throat swab will be processed for PCR results at the University of Oxford. The other throat swab sample will be processed for nanopore sequencing in Vancouver, Canada. This sample will be shared with the British Columbia Center for Disease Control (BCCDC) and the University of British Columbia (UBC) and transferred to, and stored at, a destination outside of the UK and the European Economic Area. Result data will be securely transferred back to the University of Oxford. We will make sure that all identifiable data are removed and that sample transfer is done securely.

 

A de-identified summary report of the results will be shared with the National Health Service (NHS), the Behavioural Insights Team (BIT) and Public Health England (PHE) to help inform future public health responses to COVID-19 and other epidemics.

 

9.           What happens to the data provided?

 The information you provide during the study is the research data.  Any research data from which you can be identified (name, age, gender, contact details) are known as personal data.

 Personal / sensitive data will be destroyed within one week of all mail test kits being sent out to participants.

 Other research data (including consent forms) will be stored for at least 3 years after publication or public release of the work of the research. Consent forms will not contain your unique participant identifier number and will not be linked to the research data.

 The research team will have access to the research data.  Responsible members of the University of Oxford may be given access to data for monitoring and/or audit of the research.

 10.        Will the research be published?

The University of Oxford is committed to the dissemination of its research for the benefit of society and the economy and, in support of this commitment, has established an online archive of research materials. This archive includes digital copies of student theses successfully submitted as part of a University of Oxford postgraduate degree programme. Holding the archive online gives easy access for researchers to the full text of freely available theses, thereby increasing the likely impact and use of that research.

The research will be written up as a thesis. On successful submission of the thesis, it will be deposited both in print and online in the University archives, to facilitate its use in future research. The thesis will be openly accessible.  

 

11.        Who is organising and funding the research?

This research is being funded by Effective Giving UK and being organised by the Department of Zoology, University of Oxford.

 12.        Who has reviewed this study?

This study has been reviewed by, and received ethics clearance through, the University of Oxford Central University Research Ethics Committee (R69035/RE005).

13.        Who do I contact if I have a concern about the study or I wish to complain?

If you have a concern about any aspect of this study, please contact us at covidstudy@zoo.ox.ac.uk. You can also speak to Dr Simeon Innocent, 01865 (2) 86979, or Dr Cassidy Nelson, 01865 (6) 10997, cassidy.nelson@gtc.ox.ac.uk, and we will do our best to answer your query.  

 We will acknowledge your concern within 10 working days and give you an indication of how it will be dealt with.  

 If you remain unhappy or wish to make a formal complaint, please contact the Chair of the Research Ethics Committee at the University of Oxford who will seek to resolve the matter as soon as possible:

 Chair, Medical Sciences Inter-Divisional Research Ethics Committee; Email: ethics@medsci.ox.ac.uk; Address: Research Services, University of Oxford, Wellington Square, Oxford OX1 2JD

14.        Data Protection

The University of Oxford is the data controller with respect to your personal data and, as such, will determine how your personal data is used in the study.

 The University will process your personal data for the purpose of the research outlined above.  Research is a task that we perform in the public interest.

 Further information about your rights with respect to your personal data is available https://compliance.web.ox.ac.uk/individual-rights.

15.        Further Information and Contact Details

If you would like to discuss the research with someone beforehand (or if you have questions afterwards), please contact:

 Professor Michael Bonsall

Mathematical Ecology Research Group

Department of Zoology, University of Oxford

Zoology Research and Administration Building

11a Mansfield Road, Oxford, United Kingdom OX1 3SZ

University Phone: 01865 (2) 71234

University Email: michael.bonsall@zoo.ox.ac.uk

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