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PATIENT INFORMATION SHEET (Virology) 2022/2023 GIVING SWAB SAMPLES FOR DISEASE SURVEILLANCE

What is disease surveillance?

Disease surveillance involves taking virology swabs from volunteer patients to help us to monitor the immunity of the population to infectious diseases; currently our focus is on COVID-19 and the spread of respiratory viruses.

NOSE and THROAT SWABS or VIROLOGY SURVEILLANCE

What is virology surveillance?

Virology surveillance is a programme to measure the effectiveness of the influenza/flu and COVID19 vaccinations using results from swabs taken by patients who are unwell. The swabs are used to monitor the spread of respiratory viruses, like flu and COVID-19, in different regions throughout the winter.

Why am I being swabbed?

You are being asked for a nose and throat swab. This is because your GP suspects that you may be suffering or have recently suffered from flu, COVID-19 or a similar respiratory illness.

Why are we conducting virology surveillance?

The anticipated burden of flu and COVID-19 during winter season on the National Health Service (NHS) is significant. By providing this swab, you are enabling public health bodies to make crucial public health decisions.

What happens now?

Your healthcare professional will ask you to give verbal consent. Written consent is not required as stipulated in The Health Service (Control of Patient Information) Regulations 2002 - Regulation 3. If you agree, they will take a nose and throat swab.

The samples which you have provided will be sent to the UK Health Security Agency (UKHSA) (formerly Public Health England) laboratory at Colindale to be tested for various respiratory viruses, including COVID-19, flu and respiratory syncytial virus (RSV).

Your NHS number will be assigned a unique identifier by UKHSA. The data from these tests will be linked confidentially to data regularly extracted from medical records, and stored at the secure server of the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) based at the University of Oxford. If you have requested a self-swabbing kit using the TakeATestUK.com website, this is through a UKHSA contract, and no data will be retained within the TakeATestUK.com system. For further details please visit: https://takeatestuk.com/phe-home/.

What will be done with my swab result?

Your swab result will be communicated to you, and it will be used (anonymously) to monitor the progress of flu and COVID-19, to give feedback to GPs regarding their diagnosis, to monitor antiviral resistance, to test how effective the flu and COVID-19 vaccine has been this season, and to provide the World Health Organization (WHO) with information help them to decide on next year’s flu vaccine. Your sample is very important.

Will my taking part in the study be kept confidential?

Virology swabs will be labelled with your details. However, to protect your privacy, the lab will not share your identity with the researchers. Your NHS number will be converted to a unique identifier. This surveillance will extract routinely collected data held in the surgery for all patients who have consented to take part by providing a nose and throat swab. This data will have the same unique identifier, and will be used to by researchers to link your sample to data such as your flu vaccination history.

What will happen to my data?

Data protection regulation requires that we state the legal basis for processing information about you. In the case of research, this is ‘a task in the public interest.’

UKHSA will act as joint Data Controllers with the Royal College of General Practitioners. The University of Oxford, as data processors, will collect data about you for this surveillance from your GP Practice. Both UKHSA and the Royal College of General Practitioners as joint data controllers are responsible for ensuring your data is managed securely.

We will be using information from NHS Digital in order to undertake this surveillance and will use the minimum personally-identifiable information possible.

Data protection regulation provides you with control over your personal data and how it is used. When you agree to your information being used in research, however, some of those rights may be limited in order for the research to be reliable and accurate. Further information about your rights with respect to your personal data is available at: https://compliance.web.ox.ac.uk/individual-rights.

Do I have to take part?

No. Your decision to take part is entirely voluntary. If you choose not to give a swab, it will not be collected. If you agreed to take part in the Enhanced Surveillance scheme, you may be contacted by one of the UKHSA clinical team.

Further Enquiries:

If you have any further enquiries regarding the Oxford RCGP Research and Surveillance Centre (RSC) and UKHSA virology surveillance scheme, please do not hesitate to contact your GP. Alternatively, if you require further details you can contact us by emailing practiceenquiries@phc.ox.ac.uk

 

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PATIENT INFORMATION SHEET (Serology) 2022/23 GIVING BLOOD SAMPLES FOR DISEASE SURVEILLANCE

What is disease surveillance?

Disease surveillance involves taking blood samples from volunteer patients to help us to monitor the immunity of the population to infectious diseases; currently our focus is on COVID-19 and the spread of respiratory viruses.

BLOOD SAMPLES or SEROLOGICAL SURVEILLANCE

Why have I been asked to take part in serological surveillance?

We invite patients who are attending routine blood sample appointments at their GP practices to give an extra sample of blood. You have been asked to take part because you have an appointment for a routine blood sample.

What happens now?

The health care professional taking the blood sample will ask you if you are willing to have an extra blood sample taken to be stored and used for disease surveillance purposes. You only need to give verbal consent. Written consent is not required as stipulated in The Health Service (Control of Patient Information) Regulations 2002 - Regulation 3.

The extra sample which you provide will be sent to the UK Health Security Agency (UKHSA) (formerly Public Health England) laboratory at Manchester to be tested as part of population-wide sampling. Blood samples are securely stored long term by UKHSA.

Your NHS number will be assigned a unique identifier or de-identified (pseudonymised) by UKHSA. The data from these tests will be linked confidentially to data regularly extracted from medical records, and stored at the secure servers of the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) based at the University of Oxford. It is not possible for researchers to know the identity of the sample giver.

What will be done with my blood sample?

Your blood sample will be tested with a number of assays to look at the levels of exposure to COVID19 infection in the community and responses to vaccination. This information has been very important to evaluate impact of COVID 19 vaccine programme and monitor vaccine responses in different patient groups. There is no result given to you or your GP.

From time to time samples may also be used for testing antibody levels for other communicable diseases which may be circulating in the community for the effectiveness of associated vaccines.

Will my taking part in the study be kept confidential?

Blood samples will be labelled with your details. However, to protect your privacy, the lab will not share your identity with the researchers and the sample bottle will be destroyed. Your NHS number will be converted to a unique identifier.

 What will happen to my data?

Data protection regulation requires that we state the legal basis for processing information about you. In the case of research, this is ‘a task in the public interest.’

UKHSA will act as joint Data Controllers with the Royal College of General Practitioners. The University of Oxford, as data processors, will collect data about you for this surveillance from your GP Practice. Both UKHSA and the Royal College of General Practitioners as joint data controllers are responsible for ensuring your data is managed securely.

We will be using information from NHS Digital in order to undertake this surveillance and will use the minimum personally-identifiable information possible.

Data protection regulation provides you with control over your personal data and how it is used. When you agree to your information being used in research. However, some of those rights may be limited in order for the research to be reliable and accurate. Further information about your rights with respect to your personal data is available at: https://compliance.web.ox.ac.uk/individual-rights.

Are there any possible disadvantages or risks from taking part?

We consider the procedure for the blood test to be low risk. Usually, this procedure causes some minor pain and might result in bruising. As you are already having a routine blood test, you will not require an additional needle to be inserted into a vein in the arm.

Do I have to take part?

No. Your decision to take part is entirely voluntary. If you choose not to give an additional blood sample, it will not be collected. Your health care professional will only collect the blood sample(s) for your prescheduled blood test(s).

Further Enquiries:

If you have any further enquiries regarding the Oxford-RCGP Research and Surveillance Centre (RSC) - UKHSA blood sampling for serological surveillance scheme, please do not hesitate to contact your GP. Alternatively, if you require further details you can contact us by emailing practiceenquiries@phc.ox.ac.uk

 

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