NHS Digital Data Release Register - reformatted

National Institute For Health Research projects

67 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

MR1393 - Join Dementia Research — DARS-NIC-366913-C2V5F

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, No - data flow is not identifiable, Identifiable, Anonymised - ICO Code Compliant, No, Yes (Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c), Informed Patient consent to permit the receipt, processing and release of data by NHS Digital, Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Research)

Sensitive: Non Sensitive, and Sensitive

When:DSA runs 2019-02-01 — 2022-01-31 2017.09 — 2024.02.

Access method: Ongoing, One-Off


Sublicensing allowed: No


  1. MRIS - List Cleaning Report
  2. Demographics


The ‘Join dementia research’ register is a national service funded by the Department of Health; it enables members of the public to register to be contacted about potential research studies. In registering they consent for their information to be available to the dementia research community

The link requested to HSCIC information will ensure people who are deceased are removed from the Department of Health (DOH) letter states that the ‘delegation will run up until September 2015’the ‘register’ of potential research volunteers to ensure that no harm or distress is caused by contacting people who have died.
The intention is to send HSCIC information on all volunteers from the register on a monthly or quarterly basis (depending on cost). The HSCIC will simply confirm if any of the volunteers have died by supplying fact of death. No updated demographics will be provided to University College London (UCL).

Yielded Benefits:

Using the NHS List Cleaning Product has yielded several benefits to several parties: • NIHR CRNCC has been able to remove several hundred deceased volunteers, enabling the Register to meet its required standards; • NIHR CRNCC is able to maintain the currency of the JDR Register; • NIHR CRNCC is able to prevent undue distress to JDR Registrants or their families by ensuring the research staff do not contact bereaved families; • NIHR CRNCC is able keep its promise to JDR Registrants and/or their families by ensuring the Registrant’s details are removed from the Register upon death; • The currency of the Register fosters trust between individuals and encourages participants to sign up; • Increased numbers signing up to the Register increases the likelihood of the JDR system being able to meet the PM challenge. The JDR Register ensures a steady supply of research participants to research studies for which they may have been matched. This increases the level of research into dementia, the potential for improving treatments for those with dementia and the likelihood of finding a cure for this terrible disease. • Nearly 40,000 volunteers have signed up to JDR to be contacted about Research opportunities, from these over 11,000 volunteers have been enrolled into research studies. JDR has been used on over 330 research studies in over 250 NHS, University and commercial sites. Data that has been supplied/will continue to be supplied from NHS Digital will not be used in support af a particular PhD or post graduate research study.

Expected Benefits:

The benefits are that ‘Join Dementia Research’ will be able to process data fairly without unintentionally breaching the undertaking given to volunteers that their identifiable information will be removed from the register after their deaths and a reduction in the risk of causing distress by attempting to contact members of the cohort that have deceased.
The following information provides background on ‘Join Dementia Research’:
The service has been running since July 2014, and was nationally launched in February 2015. The benefits described are already being recognized, but they will increase over the next 2-3 years and the register grows.
Benefits of the register -
‘Join dementia research’ has been funded by the Department of Health and is delivered in partnership with the National Institute for Health Research, Alzheimer Scotland, Alzheimer’s Research UK and the Alzheimer’s Society. Its development was prompted by the Prime Ministers Challenge on Dementia, and it’s purpose is to support the PM Challenge target to ensure 10% of all people with dementia are involved in dementia research.
The benefit of this being that:
a. The system enables everyone in the country aged over 18 has an opportunity to express an interest in being involved in research.
b. All dementia research studies taking place in the UK (funded by government, NIHR, charities and commercial organizations) with ethical approval can use the system. Providing a new and improved way of identifying and recruiting volunteers into vitally important dementia research studies.
c. The traditional way of recruiting dementia research volunteers, in through NHS memory clinics. This method takes time, as researchers wait for suitable subjects to come through clinic. Join dementia research removes this barrier, by having volunteers ready and waiting to join studies. All dementia research studies will recruit more quickly, saving time and money. Currently over 70% of research studies exceed recruitment target times, this system will speed up those times.
d. As a result of studies being concluded more quickly, we can ensure that the findings of those studies can be acted upon and implemented or considered for the benefit of patients and the public. The service will also help ensure that studies funded and delivered across the world could be attracted to take place in the UK.
e. The studies look at prevention, diagnosis, treatment, care and potentially cures for people living with dementia.
f. Over the next 12-18 months we expect the service to have attracted 100,000 volunteers and to become the main mechanism by which researchers find study volunteers.
g. The system is already supporting recruitment to 29 studies (over half of all studies on the NIHR CRN portfolio) and has recruited 219 (over 10%) of all participants into research studies which as the PROTECT study at Kings College, an important study which gathers data to support innovative research to improve our understanding of the ageing brain and why people develop dementia, and EXPEDITION 3 and Eli Lilly study which is testing a new medication for people with mild early dementia symptoms.
h. The service was nationally launched in February, it was announced in the media and here is a link to the press release with comments from Secretary of State for Health and Chief Medical Officer http://news.joindementiaresearch.nihr.ac.uk/press-pack-toolkit/
i. It will contribute to delivery of the Prime Minister Challenge on Dementia target of having 10% of all people with dementia involved in research.


The link to HSCIC will lead to the removal of records of deceased patients from the register which enables ‘Join Dementia Research’ to comply with the following undertaking from the consent forms used when recruiting patients:
“I understand that if I withdraw, or after my death, then all identifiable information will be removed from ‘Join dementia research’.”
The timely removal of deceased patients records will reduce the chances of contacting people who are deceased.
The register will be updated at least quarterly and possibly more frequently.


University College London Hospitals NHS Foundation Trust (UCLH) will periodically provide HSCIC with lists of identifying details of patients from the register. The lists will include name, date of birth, NHS number, postcode and gender Using its List Cleaning service, the HSCIC will confirm which patients are deceased. The information is then used to remove deceased patients from the register. Once the deceased patients have been removed from the register, the data supplied by the HSCIC will be permanently deleted. The data provided by HSCIC will not be shared, or processed by any third party and no third party can access records of patients deleted from the register to identify which were reported as deceased by the HSCIC.

Novavax — DARS-NIC-401171-F9Z8T

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 - s261(5)(c)

Purposes: Yes (Research)

Sensitive: Sensitive

When:DSA runs 2020-09-17 — 2021-01-31 2020.10 — 2020.12.

Access method: One-Off


Sublicensing allowed: No


  1. Permission to Contact


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, St Georges University Hospitals NHS Foundation Trust, by the data processor, NHS Digital, for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by the St Georges University Hospitals NHS Foundation Trust.

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. 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 Vaccine Study, will be sending the email to eligible participants.

The clinical trail that the service recruitment will support is a Phase 3 randomised observer-blind placebo controlled trial to evaluate the efficacy and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS CoV 2 rs) with matrix-M1™ Adjuvant in UK healthy adult participants ≥ 18 years of age.

This trial will enable the study to assess if people aged 18-84 years can be protected from COVID-19 with this new vaccine called (SARS-CoV 2 Recombinant(r) Spike (S) Protein Nanoparticle Vaccine (SARS CoV 2 rS) with Matrix-M adjuvant).

It will also give the study valuable information on safety aspects of the vaccine.

The trail aims to recruit up to 9000 volunteers, of which around 4500 will be vaccinated with the COVID-19 vaccine and 4500 will be vaccinated with a saline placebo.

As the purpose of processing is to support recruitment to a vaccine trial, Novavax has commercial licence to the vaccine and has therefore been involved in the development and manufacture of the vaccine and will be a stakeholder in the trial. The UK government has a contract with Novavax which has secured a supply of 60 million doses of the vaccine for HMG. The trial is solely funded by Novavax and delivered via the NIHR Clinical research network as an Urgent public health badged study, approved by the Department of Health and Social care. Novavax would potentially benefit from the future manufacture and sales of a vaccine beyond the period of the pandemic if proven successful as a result of this clinical trial. However, in this instance, the benefit to the UK public is proportionate to the commercial interests of Novavax.

Expected 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.


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.


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

Volunteers must be:
•Adult Males or Females ages 18 to 84 years (inclusive at Screening)

Volunteers must NOT have:
•Positive COVID tests
•Immune system disorders
•Pregnant women
•Cancer treatment
•Bleeding disorder
•Heart conditions

The exclusion criteria noted above is based on the information provided by cohort members on the permission to contact dataset, and is not collected from other NHS data sources. Additional exclusion criteria will be used by the site during the Screening phase.

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. In the event of the trial not achieving a suitable balance in recruited participants, such as an uneven ratio of males to females, subsequent mail outs may restrict the required criteria to a greater degree than previously, for example, only requesting details for male participants as opposed to both males and females. This could encompass any part of the criteria, such as age, gender, ethnicity or location and various others, depending on how the recruitment progresses.

NHS Digital will write to the individuals in the subset inviting them to participate within the trial using ethically approved text provided by St Georges University Hospitals NHS Foundation Trust. 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. The email will direct volunteers to Be Part of Research website to access study information and regional contact information.

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. Furthermore in order to ensure that NHS Digital are able to update the register with which participants are registered with an active trial, and therefore prevent them from being invited to any further trails the regional leads at each trial site will provide regular updates to NHS Digital of those registered participants who have consented. This sharing of information is built into the Permission to Contact signing up information and will also be added to the trial consent and participant information.

Individual trial recruitment sites and / or the lead site will supply NHS Digital with details of those who have signed up to take part in their trial so that NHS Digital can suitably capture this information within the Permission To Contact registry. All data that flows to NHS Digital in this context falls under the controllership of the lead site, regardless of whether they themselves are specifically involved in the processing of that data as it flows to NHS Digital. Depending on how the lead site / data controller manages the processing, there could be single flow directly to NHS Digital, or multiple flows from each individual site. However the data is flowed, once it is received at NHS Digital then NHS Digital become controller for that data in their existing role as controller of the Permission To Contact Registry.

Due to the nature of trial recruitment sites, they often only become confirmed as sites very close to recruitment, and so NHS Digital will leave the responsibility with the lead site / data controller to appointment data processors themselves under their own due diligence. This practice aligns with their obligations under GDPR as a data controller and the emphasis will be on the lead site / data controller to appoint appropriate data processors on their behalf. Ordinarily NHS Digital would carry out these checks, but attempting to do so for this service would cause unnecessary delay to the initial application, as well as potentially multiple and costly amendments thereafter. Therefore all recruitment sites / data processors and their processing activities will be covered under a suitable processing agreement between themselves and the lead site / data controller which does not require NHS Digital’s inclusion. Specific details of recruitments sites, such as key contact, location, will therefore not be made known to NHS Digital unless there is a specific reason to do so.

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

St Georges University Hospitals NHS Foundation Trust 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.