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Investigating a vaccine against COVID-19

University of Oxford · Academic

Expired The latest version ended on 31 December 2020. The September 2026 register still lists the agreement, but its term has passed.

Reference
DARS-NIC-396423-H4Z6Z
Latest version
v2.3
Term of latest version
16 October 2020 to 31 December 2020
Start date
20 August 2020
Data controller
Sole Data Controller
Commercial purposes
Yes
Sublicensing
No
Files released to date
0

Why the data was released

Objective for processing

This Data Sharing Agreement authorises the use of information voluntarily provided to NHS Digital by individuals who have given permission to be contacted about potential participation in COVID-19 vaccine clinical trials. The data will be processed on behalf of the data controller, the University of Oxford, by the data processor, NHS Digital, for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by the University of Oxford.

The following provides background to the Permission to Contact (PtC) Service:

NHS Digital has agreed to work in partnership with the National Institute of Health Research (NIHR) to build and host a first of type online Permission to Contact (PtC) Service on nhs.uk where members of the public can register their details and give their permission to be contacted by researchers working on NIHR approved UK coronavirus vaccine trials about participating in those trials. As at 14th August 2020 there are two such trials. One is run by Oxford University and the other by Imperial College London. This PtC Service, which is called “Sign Up to be Contacted about Coronavirus Vaccine Studies” on the nhs.uk website was launched as a national service on 20th July 2020.

This Service enables participants to:

• Provide permission for NHS Digital to share an individual’s details provided through the Service with the researchers undertaking COVID-19 UK vaccine trials for the purposes of researchers contacting that individual about taking part in those trials.

• Provide their permission to be contacted by NHS Digital about progress and outcomes from CV19 vaccine studies and in relation to the development of the PtC Service, including to inform them of opportunities to participate in other types of health research.

The data collected from individuals who sign up includes sufficient information to achieve the following purposes:

• Matching potentially eligible participants to eligibility criteria provided by the vaccine trials for their specific studies. This data will comprise of age, sex, geographic locations, type of employment, and a number health question e.g. about whether they have long-term health conditions.

• Providing relevant details of potentially eligible participants which have been obtained through the Service to researchers. This will allow the researchers to contact the participants with a view to discussing their taking part in a trial and if so, to obtain their further permission to take part in the trial.

• NHS Digital will provide access to the information obtained from individuals through the Service via the existing Data Access Request Service (DARS) process available to researchers working on UK COVID-19 vaccine trials sponsored by the National Institute of Health Research. The Service will only provide researchers with the data collected directly from individuals themselves through the Service.

The contact details will be used to invite potentially eligible individuals to undertake an eligibility assessment and, if eligible, to give informed consent to participate in this trial. NHS Digital, as data processor acting on behalf of the Oxford Vaccine Study, will be sending the email to eligible participants.

The following provides information about the University of Oxford’s clinical trial:

A new virus causing respiratory disease emerged in Wuhan, China in December 2019 and has since rapidly spread to many other countries around the world, despite unprecedented containment efforts. The virus is part of the Coronavirus family which can cause respiratory infections ranging from the common cold to more severe diseases. This virus causes the disease known as COVID-19. Common symptoms of COVID-19 include fever, tiredness, and dry cough. Whilst about 80% of infected people have no or mild symptoms and will recover from the disease without needing special treatment, 1 in every 6 people who gets COVID-19 becomes seriously ill. Older people and those with underlying medical problems are more likely to develop serious illness. Thousands of deaths have been reported so far. The World health Organisation declared the COVID-19 epidemic a Public Health Emergency of International Concern on 30th January 2020.

There are no currently licensed vaccines and only a limited number of specific treatments for COVID-19.

The University of Oxford is undertaking a study to assess how well people of all ages can be protected from COVID-19 with a new vaccine called ChAdOx1 nCoV-19. This study will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.

The University of Oxford aims to enrol small numbers of older adults (aged 56-70 years, then 70+ years) before expanding to large numbers of adults across all ages (18+ years). After this, the University of Oxford will also assess the vaccine in a small cohort of children (5-12 years). In total the University of Oxford aims to enrol up to 12,330 volunteers.

The Permission to Contact (PtC) Service will be utilise to assist in recruitment of individuals aged 56+ who will be contacted and invited to participate in the vaccine trial.

Personal data can be lawfully processed under GDPR Articles 6(1)(e) and 9(2)(j) as this is a task in the public interest and classed as research.

Consent allows the data subjects’ confidential data to be used for this purpose satisfying the duty of confidence.

The organisations involved in the processing under this Agreement are the University of Oxford, the data controller, and NHS Digital which, as data processor, will extract a subset of individuals’ information from the PtC dataset and send these individuals emails inviting them to contact the University of Oxford to sign up to participate in the trial.

The University of Oxford will not directly access any of the data under this Agreement.

Organisations involved in the wider vaccine trial are:

• AstraZeneca UK Limited – who have licensed the vaccine and undertaken some of the vaccine manufacture and trial sample analysis

• Public Health England - research collaborator

• Numerous clinical trial sites (primarily NHS trusts)

• Various academic collaborators

None of these organisations have any involvement in the decisions taken by the University of Oxford in respect of the data under this Agreement.

The other organisation involved as the trial funder is the National Institute for Health Research (NIHR)/Department of Health and Social Care. The NIHR has supported the University of Oxford’s request to use the PtC service.

Processing activities

NHS Digital will extract a list of patients meeting the following criteria:

Volunteers must be:

• 56 years old or older and living in Sheffield, Northwick Park, Edinburgh or Liverpool, OR

• 70 years old or older and living in Birmingham or Hull (Castle Hill)

• 70 years old or older and living in London, Greater London, Paisley & Glasgow

• 70 years old or older and living in Newcastle, Sunderland and Gateshead area.

Volunteers must NOT:

• have had a positive COVID-19 swab/PCR/'antigen' test (antibody tests of any result are acceptable so if your database does not make a distinction between these, then ignore this item)

• be receiving current treatment for cancer

• have a bleeding disorder

• be pregnant, breastfeeding, or planning a pregnancy

NHS Digital will identify all individuals within the PtC dataset meeting the above criteria and will extract their names and email addresses.

It is not known in advance how many individuals meeting the above criteria will have records in the PtC dataset. The number may be amended and the process may be repeated depending on the level of response.

NHS Digital will write to the individuals in the subset inviting them to participate within the trial using ethically approved text provided by University of Oxford. The email will remind the individuals of the background of the permission to contact programme and give them the opportunity to state that they do not wish to be contacted again.

Individuals will not be contacted multiple times under this Agreement and NHS Digital will record the fact that the individuals have been contacted to ensure compliance with the maximum number of contacts outlined as part of consent.

No other processing of the data will take place and the data will not be linked with information from any other sources.

The University of Oxford will not hold or access the data directly and no data will be shared more widely. The data will only be accessed by NHS Digital employees.

Expected output

The information from NHS Digital will be used to facilitate contact with individuals who are potentially eligible and who have indicated willingness to potentially participate in studies/trials of COVID-19 vaccines.

This is expected to result in individuals entering the trials screening process with a view to them participating, with fully informed consent, in the Investigating a Vaccine Against COVID-19 study.

The main trial results of Investigating a Vaccine Against COVID-19 study are expected to inform development of a safe and effective vaccine against COVID 19.

Expected measurable benefits

The primary benefit of using the data will be to recruit participants for the clinical study/trial in a manner which:

• Enables individuals to volunteer in advance to participate in COVID-19 vaccine trials as an alternative to other potentially more intrusive mechanisms, e.g. sharing data with researchers about individuals under section 251 consents or COPI notices, which although lawful is initially less transparent.

• Allows researchers to identify a suitable cohort and recruit them quickly into the vaccine trials – thus reducing the overall time to recruit into the trials and to accelerate the delivery of an effective vaccine to treat individuals to manage the COVID-19 outbreak and to save lives.

• Reduces burden on research staff in identifying and contacting potential clinical trial participants.

• Supports the Vaccines Taskforce objectives to drive forward, expedite and coordinate efforts to research and then produce a coronavirus vaccine and make sure one is made available to the public as quickly as possible.

Benefits reported so far

Not stated in the register.

Datasets on the latest version

Legal basis for provision: Health and Social Care Act 2012 – s261(2)(c)

Datasets approved under DARS-NIC-396423-H4Z6Z-v2.3
DatasetType of dataSensitivity FrequencyConfidential data
Permission to Contact Identifiable Non-Sensitive One-Off Consent (Reasonable Expectation)

Files released

Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.

No files recorded as released under this agreement.

Version history

The register lists each renewal of this agreement as a separate row. This site has 3 versions.

DARS-NIC-396423-H4Z6Z-v2.3 16 October 2020 to 31 December 2020
Title
Investigating a vaccine against COVID-19
Commercial
Yes
Sublicensing
No
Datasets
1
Files released
0

Datasets: Permission to Contact

What changed from DARS-NIC-396423-H4Z6Z-v1.2

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-396423-H4Z6Z-v1.2
FieldWasBecame
Start date2020-09-092020-10-16

Processing activities

[5 paragraphs unchanged] • 70 years old or older and living in Newcastle, Sunderland and Gateshead area. [11 paragraphs unchanged]

Unchanged: Objective for processing, Expected output, Expected measurable benefits.

DARS-NIC-396423-H4Z6Z-v1.2 9 September 2020 to 31 December 2020
Title
Investigating a vaccine against COVID-19
Commercial
Yes
Sublicensing
No
Datasets
1
Files released
0

Datasets: Permission to Contact

What changed from DARS-NIC-396423-H4Z6Z-v0.2

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-396423-H4Z6Z-v0.2
FieldWasBecame
Start date2020-08-202020-09-09

Processing activities

[4 paragraphs unchanged] • 70 years old or older and living in London, Greater London, Paisley & Glasgow [11 paragraphs unchanged]

Benefits reported

Stated in the previous version and removed here.

Yielded Benefits is not a requirement for new applications.

Unchanged: Objective for processing, Expected output, Expected measurable benefits.

Objective for processing

This Data Sharing Agreement authorises the use of information voluntarily provided to NHS Digital by individuals who have given permission to be contacted about potential participation in COVID-19 vaccine clinical trials. The data will be processed on behalf of the data controller, the University of Oxford, by the data processor, NHS Digital, for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by the University of Oxford.

The following provides background to the Permission to Contact (PtC) Service:

NHS Digital has agreed to work in partnership with the National Institute of Health Research (NIHR) to build and host a first of type online Permission to Contact (PtC) Service on nhs.uk where members of the public can register their details and give their permission to be contacted by researchers working on NIHR approved UK coronavirus vaccine trials about participating in those trials. As at 14th August 2020 there are two such trials. One is run by Oxford University and the other by Imperial College London. This PtC Service, which is called “Sign Up to be Contacted about Coronavirus Vaccine Studies” on the nhs.uk website was launched as a national service on 20th July 2020.

This Service enables participants to:

• Provide permission for NHS Digital to share an individual’s details provided through the Service with the researchers undertaking COVID-19 UK vaccine trials for the purposes of researchers contacting that individual about taking part in those trials.

• Provide their permission to be contacted by NHS Digital about progress and outcomes from CV19 vaccine studies and in relation to the development of the PtC Service, including to inform them of opportunities to participate in other types of health research.

The data collected from individuals who sign up includes sufficient information to achieve the following purposes:

• Matching potentially eligible participants to eligibility criteria provided by the vaccine trials for their specific studies. This data will comprise of age, sex, geographic locations, type of employment, and a number health question e.g. about whether they have long-term health conditions.

• Providing relevant details of potentially eligible participants which have been obtained through the Service to researchers. This will allow the researchers to contact the participants with a view to discussing their taking part in a trial and if so, to obtain their further permission to take part in the trial.

• NHS Digital will provide access to the information obtained from individuals through the Service via the existing Data Access Request Service (DARS) process available to researchers working on UK COVID-19 vaccine trials sponsored by the National Institute of Health Research. The Service will only provide researchers with the data collected directly from individuals themselves through the Service.

The contact details will be used to invite potentially eligible individuals to undertake an eligibility assessment and, if eligible, to give informed consent to participate in this trial. NHS Digital, as data processor acting on behalf of the Oxford Vaccine Study, will be sending the email to eligible participants.

The following provides information about the University of Oxford’s clinical trial:

A new virus causing respiratory disease emerged in Wuhan, China in December 2019 and has since rapidly spread to many other countries around the world, despite unprecedented containment efforts. The virus is part of the Coronavirus family which can cause respiratory infections ranging from the common cold to more severe diseases. This virus causes the disease known as COVID-19. Common symptoms of COVID-19 include fever, tiredness, and dry cough. Whilst about 80% of infected people have no or mild symptoms and will recover from the disease without needing special treatment, 1 in every 6 people who gets COVID-19 becomes seriously ill. Older people and those with underlying medical problems are more likely to develop serious illness. Thousands of deaths have been reported so far. The World health Organisation declared the COVID-19 epidemic a Public Health Emergency of International Concern on 30th January 2020.

There are no currently licensed vaccines and only a limited number of specific treatments for COVID-19.

The University of Oxford is undertaking a study to assess how well people of all ages can be protected from COVID-19 with a new vaccine called ChAdOx1 nCoV-19. This study will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.

The University of Oxford aims to enrol small numbers of older adults (aged 56-70 years, then 70+ years) before expanding to large numbers of adults across all ages (18+ years). After this, the University of Oxford will also assess the vaccine in a small cohort of children (5-12 years). In total the University of Oxford aims to enrol up to 12,330 volunteers.

The Permission to Contact (PtC) Service will be utilise to assist in recruitment of individuals aged 56+ who will be contacted and invited to participate in the vaccine trial.

Personal data can be lawfully processed under GDPR Articles 6(1)(e) and 9(2)(j) as this is a task in the public interest and classed as research.

Consent allows the data subjects’ confidential data to be used for this purpose satisfying the duty of confidence.

The organisations involved in the processing under this Agreement are the University of Oxford, the data controller, and NHS Digital which, as data processor, will extract a subset of individuals’ information from the PtC dataset and send these individuals emails inviting them to contact the University of Oxford to sign up to participate in the trial.

The University of Oxford will not directly access any of the data under this Agreement.

Organisations involved in the wider vaccine trial are:

• AstraZeneca UK Limited – who have licensed the vaccine and undertaken some of the vaccine manufacture and trial sample analysis

• Public Health England - research collaborator

• Numerous clinical trial sites (primarily NHS trusts)

• Various academic collaborators

None of these organisations have any involvement in the decisions taken by the University of Oxford in respect of the data under this Agreement.

The other organisation involved as the trial funder is the National Institute for Health Research (NIHR)/Department of Health and Social Care. The NIHR has supported the University of Oxford’s request to use the PtC service.

Expected output

The information from NHS Digital will be used to facilitate contact with individuals who are potentially eligible and who have indicated willingness to potentially participate in studies/trials of COVID-19 vaccines.

This is expected to result in individuals entering the trials screening process with a view to them participating, with fully informed consent, in the Investigating a Vaccine Against COVID-19 study.

The main trial results of Investigating a Vaccine Against COVID-19 study are expected to inform development of a safe and effective vaccine against COVID 19.

DARS-NIC-396423-H4Z6Z-v0.2 20 August 2020 to 31 December 2020
Title
Investigating a vaccine against COVID-19
Commercial
Yes
Sublicensing
No
Datasets
1
Files released
0

Datasets: Permission to Contact

Objective for processing

This Data Sharing Agreement authorises the use of information voluntarily provided to NHS Digital by individuals who have given permission to be contacted about potential participation in COVID-19 vaccine clinical trials. The data will be processed on behalf of the data controller, the University of Oxford, by the data processor, NHS Digital, for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by the University of Oxford.

The following provides background to the Permission to Contact (PtC) Service:

NHS Digital has agreed to work in partnership with the National Institute of Health Research (NIHR) to build and host a first of type online Permission to Contact (PtC) Service on nhs.uk where members of the public can register their details and give their permission to be contacted by researchers working on NIHR approved UK coronavirus vaccine trials about participating in those trials. As at 14th August 2020 there are two such trials. One is run by Oxford University and the other by Imperial College London. This PtC Service, which is called “Sign Up to be Contacted about Coronavirus Vaccine Studies” on the nhs.uk website was launched as a national service on 20th July 2020.

This Service enables participants to:

• Provide permission for NHS Digital to share an individual’s details provided through the Service with the researchers undertaking COVID-19 UK vaccine trials for the purposes of researchers contacting that individual about taking part in those trials.

• Provide their permission to be contacted by NHS Digital about progress and outcomes from CV19 vaccine studies and in relation to the development of the PtC Service, including to inform them of opportunities to participate in other types of health research.

The data collected from individuals who sign up includes sufficient information to achieve the following purposes:

• Matching potentially eligible participants to eligibility criteria provided by the vaccine trials for their specific studies. This data will comprise of age, sex, geographic locations, type of employment, and a number health question e.g. about whether they have long-term health conditions.

• Providing relevant details of potentially eligible participants which have been obtained through the Service to researchers. This will allow the researchers to contact the participants with a view to discussing their taking part in a trial and if so, to obtain their further permission to take part in the trial.

• NHS Digital will provide access to the information obtained from individuals through the Service via the existing Data Access Request Service (DARS) process available to researchers working on UK COVID-19 vaccine trials sponsored by the National Institute of Health Research. The Service will only provide researchers with the data collected directly from individuals themselves through the Service.

The contact details will be used to invite potentially eligible individuals to undertake an eligibility assessment and, if eligible, to give informed consent to participate in this trial. NHS Digital, as data processor acting on behalf of the Oxford Vaccine Study, will be sending the email to eligible participants.

The following provides information about the University of Oxford’s clinical trial:

A new virus causing respiratory disease emerged in Wuhan, China in December 2019 and has since rapidly spread to many other countries around the world, despite unprecedented containment efforts. The virus is part of the Coronavirus family which can cause respiratory infections ranging from the common cold to more severe diseases. This virus causes the disease known as COVID-19. Common symptoms of COVID-19 include fever, tiredness, and dry cough. Whilst about 80% of infected people have no or mild symptoms and will recover from the disease without needing special treatment, 1 in every 6 people who gets COVID-19 becomes seriously ill. Older people and those with underlying medical problems are more likely to develop serious illness. Thousands of deaths have been reported so far. The World health Organisation declared the COVID-19 epidemic a Public Health Emergency of International Concern on 30th January 2020.

There are no currently licensed vaccines and only a limited number of specific treatments for COVID-19.

The University of Oxford is undertaking a study to assess how well people of all ages can be protected from COVID-19 with a new vaccine called ChAdOx1 nCoV-19. This study will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.

The University of Oxford aims to enrol small numbers of older adults (aged 56-70 years, then 70+ years) before expanding to large numbers of adults across all ages (18+ years). After this, the University of Oxford will also assess the vaccine in a small cohort of children (5-12 years). In total the University of Oxford aims to enrol up to 12,330 volunteers.

The Permission to Contact (PtC) Service will be utilise to assist in recruitment of individuals aged 56+ who will be contacted and invited to participate in the vaccine trial.

Personal data can be lawfully processed under GDPR Articles 6(1)(e) and 9(2)(j) as this is a task in the public interest and classed as research.

Consent allows the data subjects’ confidential data to be used for this purpose satisfying the duty of confidence.

The organisations involved in the processing under this Agreement are the University of Oxford, the data controller, and NHS Digital which, as data processor, will extract a subset of individuals’ information from the PtC dataset and send these individuals emails inviting them to contact the University of Oxford to sign up to participate in the trial.

The University of Oxford will not directly access any of the data under this Agreement.

Organisations involved in the wider vaccine trial are:

• AstraZeneca UK Limited – who have licensed the vaccine and undertaken some of the vaccine manufacture and trial sample analysis

• Public Health England - research collaborator

• Numerous clinical trial sites (primarily NHS trusts)

• Various academic collaborators

None of these organisations have any involvement in the decisions taken by the University of Oxford in respect of the data under this Agreement.

The other organisation involved as the trial funder is the National Institute for Health Research (NIHR)/Department of Health and Social Care. The NIHR has supported the University of Oxford’s request to use the PtC service.

Expected output

The information from NHS Digital will be used to facilitate contact with individuals who are potentially eligible and who have indicated willingness to potentially participate in studies/trials of COVID-19 vaccines.

This is expected to result in individuals entering the trials screening process with a view to them participating, with fully informed consent, in the Investigating a Vaccine Against COVID-19 study.

The main trial results of Investigating a Vaccine Against COVID-19 study are expected to inform development of a safe and effective vaccine against COVID 19.

Benefits reported

Yielded Benefits is not a requirement for new applications.

Register history

When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds, the earliest of which is July 2021.

Cite this page

NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-396423-H4Z6Z, “Investigating a vaccine against COVID-19”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-396423-h4z6z/ (accessed [date]).

This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.

Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-396423-H4Z6Z to see the original rows.