About the Winter Coronavirus (COVID-19) Infection Study

The coronavirus (COVID-19) endemic is still having an impact on the NHS and the lives of people across the UK.

The Winter Coronavirus (COVID-19) Infection Study (Winter CIS) aims to understand the impact of COVID-19, particularly over the winter period.

The data from this study are important in helping us understand:

• potential winter pressures to help support the NHS and other services to prepare for future stressors, and act as an early warning system for COVID-19

• improve public awareness of COVID-19 infection levels

• the impact of COVID-19 on the lives of individuals, the community and on health services and how they are changing

You have been contacted because you took part in the Coronavirus (COVID-19) Infection Survey (CIS) and agreed to be approached about other ethically approved research studies.

If you consent to take part, the Office for National Statistics (ONS) will send your contact details to the UK Health Security Agency (UKHSA). They will then send you 14 lateral flow tests for you to use within the study. These tests are free of charge for your use within the study.

Every four to five weeks you will be asked to take a lateral flow test and then answer a 10-to-15-minute questionnaire. You will have 7 days to do this; this is called a "testing window". This is the time period you have to take the test and complete the questionnaire.

The questionnaire will cover topics such as:

• your general health, including any recent coronavirus (COVID-19) symptoms

• recent vaccinations against COVID-19

• whether your usual activities or use of healthcare services have been affected

• whether your work and/or education has been affected

If you test positive, we will ask you to continue to test regularly and to complete a short two-to-three-minute follow-up questionnaire.

Only people who receive an invitation letter or email will be able to take part in the study. We are inviting some of the people who took part in the Coronavirus (COVID-19) Infection Survey (CIS) to take part.

We are only inviting people who agreed to be contacted about new research studies. That means we will not send an invitation to everybody in some households.

We need to collect data that represent different groups of people and provide the best use of public funds. After we have invited people to take part, we need their consent so we can use their data.

A parent or guardian must give consent for anybody aged under 16 years to take part in the study.

Once we have their consent, we can work out who to include to ensure that all groups are represented. This means that not everybody who gives their consent will be asked to take part. Anyone who is unable to complete their lateral flow test and fill-in their questionnaire can ask a trusted person to help them.

This is your chance to help us understand the impact of coronavirus (COVID-19), particularly over the winter period.   

While we are unable to offer any financial compensation or vouchers for taking part, your participation is highly appreciated and valued. You will help improve understanding of the impact of COVID-19 infections on: 

• your life 

• the community 

• health services 

This study will help the NHS prepare for potential winter pressures and could be part of an NHS early warning system for COVID-19.

Your participation is entirely voluntary, and you are free to leave the study at any time without providing a reason. Whether you take part will not affect the care you receive from the NHS. 

It is possible that not everyone in your household who took part in the Coronavirus (COVID-19) Infection Survey (CIS) has been invited to take part in this study. 

Anyone in your household who has been invited to take part in the study can make their individual choice as to whether they want to take part. Your participation will be important regardless of whether other household members take part or not.   

If you do not complete the consent questionnaire by the completion date, we will assume you do not want to take part in the Winter Coronavirus (COVID-19) Infection Study (Winter CIS).

Only those invited to the Winter Coronavirus (COVID-19) Infection Study (Winter CIS) can take part.

You will receive an email or letter from the Office for National Statistics (ONS) asking you to give your informed consent to take part in the study. You can give your consent using the link to the online form provided in your email or letter.

If you consent and are selected to take part, you will receive your 14 lateral flow tests to use as part of the study from the UK Health Security Agency (UKHSA) in the next few weeks.

We will ask you to take a lateral flow test, used at your own risk and complete an online questionnaire. This should take around 10 to 15 minutes. It will take longer to complete over the phone.

You will have 7 days to do this; this is called your "testing window". You will be asked to take part in a testing window approximately every four to five weeks until the study ends.

For those aged under 16 years, a parent or guardian can complete the questionnaire on their behalf. Anyone who is unable to complete their lateral flow test and fill-in their online questionnaire can ask a trusted person to help them.

Read more about taking part in the study on our How to take part page.

Within each testing window, we will ask you to:

1. Take your lateral flow test.

2. Complete and submit the questionnaire.

A link to the questionnaire and your 16-character access code will be in the email you receive each time you have a testing window. This is the time period you have to take the test and complete the questionnaire. You can also access the questionnaire on the Start the study page.

Completing the questionnaire

You will need your 16-character access code to enter the questionnaire. Your code is unique to each testing window. You will be sent a new access code for each questionnaire you complete. Any emails you receive will be from office.for.national.statistics.surveys@notifications.service.gov.uk.

If you cannot find your 16-character access code, you do not need to contact us. We will send you a reminder email with a new, replacement access code a few days before your testing window ends.

You can complete the questionnaire on a desktop, laptop, tablet, or smartphone. If you need to, you can stop and come back to the questionnaire later, within your testing window, using your 16-character access code.

Additional help

We are running this study online. If you are unable to complete the questionnaire online, you can ask a trusted person to help you.

You can also email Winter.Covid19.Infection.Study@ons.gov.uk if you need advice or help completing the questionnaire. The questionnaire will take longer to complete by telephone.

If your lateral flow test is positive for coronavirus (COVID-19), please follow the national guidelines at the time.

As part of your testing window, you need to record your lateral flow test result on the questionnaire in the section "Your test results".

If you test positive in your main testing window, you will need to take a lateral flow test every other day after your first positive test, until you get two negative test results in a row. This will help us to understand how long COVID-19 infections might last.

We will send you an email with a 16-character access code and a link to a short follow-up questionnaire. This questionnaire will ask you about the dates and results of your follow-up lateral flow tests and any symptoms you might have.

If you continue to test positive for 15 days after your follow-up questionnaire testing window has started, or you run out of lateral flow tests before you get two negative test results in a row, please complete and submit your follow-up questionnaire using the 16-character access code and the link from your follow-up email.

What do we mean by "every other day"?

Day 1 - positive test. Repeat lateral flow testing on day 3, day 5, day 7, day 9... Stop testing when you test negative two times in a row.

Any information you provide for this study will be legally protected and treated as confidential by the Office for National Statistics (ONS) and the UK Health Security Agency (UKHSA), in line with the Code of Practice for Statistics.

We will use the information we collect to produce statistics, inform coronavirus (COVID-19) surveillance efforts, and undertake research in the public good.

The ONS will consolidate your questionnaire responses with all other participants' responses into a single dataset. This will be used for analysis by both the ONS and the UKHSA. The ONS will share this consolidated dataset with UKHSA on, at least, a weekly basis and both organisations will use the data for their analysis.

De-identified data will be shared with third party service providers and approved researchers.

Any information you provide for this study will be legally protected and treated as confidential by the Office for National Statistics (ONS) and the UK Health Security Agency (UKHSA). For more information about what we do with your data, including your rights and contact details for our Data Protection Officers, the data protection information for Winter CIS, the ONS data protection pages and the UKHSA's privacy notice.

The Office for National Statistics (ONS) and the UK Health Security Agency (UKHSA, an Executive Agency of the Department of Health and Social Care (DHSC)) are the joint data controllers for the Winter Coronavirus (COVID-19) Infection Study (Winter CIS). This includes all data processed to support study set up, recruitment and data collection for the duration of the Winter CIS.

The UKHSA will not receive any of your personal data if you do not consent to take part in this study.

The UKHSA will receive a copy of the information gathered during the Winter CIS from the ONS and will, as necessary, share this with the national public health agencies in Wales, Scotland and Northern Ireland.

With your consent, the UKHSA will also receive information previously collected from you during the Coronavirus (COVID-19) Infection Survey (CIS). This will include personal data about you, such as your name and NHS number, as well as special category health data. The UKHSA will share this information, as necessary, with the national public health agencies in Wales, Scotland and Northern Ireland.

You can find more information about what will happen to your data in the data protection information for Winter CIS, the ONS data protection pages and the UKHSA's privacy notice.

Your participation is entirely voluntary. You are free to leave the study at any time without providing a reason by emailing Winter.Covid19.Infection.Study@ons.gov.uk.

It may take a few working days to process your request to leave the study. Any requests you receive to take a test and complete a questionnaire in the period between asking to leave the study and the processing of your withdrawal can be ignored.

If you have already completed one or more questionnaires when you decide to leave, we will still use the data collected up to the time you leave the study. This is because it provides vital information to help us understand the impact of coronavirus (COVID-19) infections.

If you do not consent to taking part, we will assume you do not want to take part in the study.

Parents or guardians of children aged under 16 years may also decide for their child to leave the study at any time without giving a reason.

The study is being conducted by the Office for National Statistics (ONS), and is commissioned and funded by the UK Health Security Agency (UKHSA). The UKHSA is an Executive Agency sponsored by the Department of Health and Social Care (DHSC).

The ONS is the government's largest independent producer of statistics. We collect information about the UK's society and economy. This provides evidence for policymakers and decision-makers so that they can direct resources to where they are needed most.

The ONS processes and sends all email and letter communications. All emails you receive will be from office.for.national.statistics.surveys@notifications.service.gov.uk. The UKHSA will send the lateral flow test kits to you.

At the Office for National Statistics (ONS) we are committed to making continued improvements to not only the data we collect, but also the way we collect it, and the burden that places on people who take part in our studies. You can indicate your interest to take part in user research by giving your consent to be contacted by one of our researchers.

You may then be invited to take part in a specific study about your experiences of taking part in the Winter Coronavirus (COVID-19) Infection Study (Winter CIS). This invitation will contain more detailed information about what is involved. If you then decide that you would like to take part, we will ask you again for your informed consent to take part in our user research survey.

If you have any further questions about the Winter Coronavirus (COVID-19) Infection Study or taking part, email Winter.Covid19.Infection.Study@ons.gov.uk.

If you cannot access the internet, you can call us on +44 8081 961270.