Join Dementia Research

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Objective for processing

The purpose of this agreement is to renew and extend the Data Sharing Agreement to continue receiving quarterly drops of data for list cleaning purposes. The Department of Health and Social Care requires access to NHS England data for the purpose of the following research project: The Join Dementia Research (JDR) register is a national service funded and owned by the Department of Health and Social Care; it enables members of the public from anywhere in the United Kingdom to register to be contacted about potential research studies. In registering they give consent for their information to be made available to the dementia research community. The data subjects are those that have registered to be part of JDR. This may include those who have dementia or carers, friends, relatives of those with dementia, as well as those without dementia. • Join Dementia Research If someone is not able to consent themselves, there are some circumstances where the applicant is able to take the consent of someone with power of attorney to make this decision on their behalf and give legal permission to hold their data. In England and Wales, this is called a Lasting Power of Attorney (LPA), and would need to be on health and welfare grounds. In Scotland, this is called a Welfare Power of Attorney. The person acting on behalf of a volunteer is called a consultee. The Join Dementia Research (JDR) register is a national service funded and owned by the Department of Health and Social Care; it enables members of the public from anywhere in the United Kingdom to register to be contacted about potential research studies. In registering, volunteers consent for their information to be made available to the dementia research community. The data subjects are those that have registered to be part of JDR. This may include those who have dementia or carers, friends, relatives of those with dementia, as well as those without dementia. Consultee advice falls under the Mental Capacity Act - Section 30-33 of MCA: JDR is a UK-wide service that allows people to register their interest in participating in dementia research and be matched to suitable studies via a website and database and is a key element of the Prime Minister’s Challenge on Dementia 2020. The Data collected under this Data Sharing Agreement (DSA) only relates to participants within England. This research is being carried out on behalf of the Secretary of State and the research is connected with the impairing condition, dementia. There are reasonable ground for believing that research of comparable effectiveness can't be carried out if the project has to be confined to, or relate only to, persons who have capacity to consent to taking part in it. The following is a summary of the aims of the wider JDR project provided by Department of Health and Social Care: The research has the potential to benefit the participant without imposing a burden disproportionate to the potential benefit. HRA have approved the project • Facilitate Participation in Research: Enable people with and without dementia, as well as carers and supporters, to register their interest in taking part in dementia research studies across the UK. When someone acts as a consultee, this doesn’t mean that they are giving consent for them to take part in healthcare research it only means they are giving consent for someone to enrol onto the registry; Each study has its own consent procedures and measures in place to ensure that the best interests of participants are protected. Each study has ethical approval in place and HRA have approved this process. • Connect Volunteers with Researchers: Match registered volunteers to suitable dementia research studies based on their profile and preferences. Someone may be able to consent to register on Join Dementia Research, but then as an illness like dementia progresses, may lack the capacity to consent in the future or manage their account. • Support Dementia Research Progress: Help researchers recruit participants more efficiently, thereby accelerating studies into the causes, diagnosis, treatment, and care of dementia. JDR will look to support people to express their wishes and make their own decisions about taking part in research for as long as they are able. • Raise Awareness: Increase public and professional awareness of the importance of dementia research and the role individuals can play in advancing it. JDR recognise that for some people, particularly those with dementia, there may come a time when being contacted may become a burden, or be unwelcome or confusing. In these cases, JDR look to make it as easy as possible or delete their account. • Ensure Accessibility: Provide multiple ways to register (online, by phone, or by post) to make the service accessible to a wide range of people, including those who may not be digitally connected. JDR are happy to hear not just from the volunteer, but also have processes where JDR can take a request from others including family, friends, healthcare professionals or researchers. • Empower Informed Choice: Allow volunteers to review study details and decide whether or not to participate, with no obligation after registration. Unless JDR hear from a volunteer or someone contacting us about their best interests, JDR will presume that there is ongoing consent to hold a volunteer’s data, even if they lose capacity. HRA have approved this process. • Maintain Ethical Standards: Ensure that participation is voluntary, informed, and that personal data is handled securely and respectfully. The JDR Registry does not make assessments about whether someone has ‘capacity’ to consent to take part in research or whether taking part in a particular study is in someone’s best interests. Each study team has their own agreed ethical protocol governing their study and consent process, and each study ensures the volunteers and representatives have understood the process and were able to ask any questions when they are matched to a study. NHS England provides updates on deceased registrants to keep the Join Dementia Research (JDR) registry current and to help prevent attempts to contact deceased individuals and potentially causing distress to families. Since December 2019, participants have the option to sign up to the JDR register via the following routes: The following NHS England Data will be accessed: 1) Online registration • Demographics – necessary because the JDR ascertain fact of death to remove registrants from Join Dementia Research Register. 2) Printed version of registration form (via post) The level of the Data will be 3) Registration can be done over the phone through the charity partners helplines • Identifiable – necessary because the Data needs to be linked to individual's records in the registry. The HRA approved the latest consent model in November 2019 and have fed back on the wording within some of the consent materials, which have since been incorporated into the documentation. The Data will be minimised as follows: JDR is a UK-wide service that allows people to register their interest in participating in dementia research and be matched to suitable studies via a website and database and is a key element of the Prime Minister’s Challenge on Dementia 2020. The data collected under this Agreement only relates to participants within England and Wales. • Limited to registrants who have joined the Join Dementia Research Register. The Data Controller has always been the Department of Health and Social Care, however contractual arrangements for the management of the service have changed over time. Under the previous contractual arrangement for the operational management of the service, the responsibility for data cleaning lay with University College London, who then acted as Data Processor. The Department of Health and Social Care is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. In March 2015 the Department of Health and the JDR Programme Board took the decision that the BAU elements of JDR delivery should be transferred from the Office of the NIHR National Director for Dementia Research to the NIHR Clinical Research Network Coordinating Centre (CRNCC). It was felt that the transfer of the JDR Service to the NIHR CRNCC would increase the opportunities for the best practice use of JDR in the recruitment of registrants into clinical trials as well as enabling greater coordination of the Local Clinical Research Networks (LRCN’s) resources required/time taken to identify and recruit people to NIHR Portfolio. Under the previous iteration of this Agreement The Data Processor was amended from University College London to the NIHR Clinical Research Network Coordinating Centre - which is made from a consortium agreement between part of the University of Leeds and Guy's and St Thomas' NHS Foundation Trust. UCL have ceased data processing responsibilities and transferred them to NIHR CRNCC. The former Director of the UCL office has confirmed that all data provided by DARS to UCL was destroyed. The lawful basis for processing personal data under the UK GDPR is: The delivery of the JDR Service is managed by the CRNCC through an Optional Services Work Order between the DHSC and the consortium of the University of Leeds and Guy’s and St Thomas’ NHS Foundation Trust. (GSTT) Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; DHSC is the sole Data Controller for the JDR Service. The Clinical Research Network Coordinating Centre (CRNCC) at the National Institute for Health Research (NIHR) administers the Service (along with Charity Partners) on behalf of the DHSC and thus University of Leeds and Guys's and St Thomas' NHS Foundation Trust are Data Processors. The charities that JDR work with are Alzheimer Scotland, Alzheimer’s Society and Alzheimer’s Research UK. They fulfil a helpdesk function on the service which includes adding new volunteers and updating existing accounts, as well as providing expert advice to the public about the service via telephone. They are not provided with access to the information JDR receive under this Agreement, that data is only handled and processed by the data processors listed within this Agreement. Funding is provided by the NIHR. No other funders / commissioners are involved. The lawful basis for processing special category data under the UK GDPR is: Under the current contractual arrangement, the operational management of the JDR Service is through the National Institute for Health and Care Research Clinical Research Network Coordinating Centre (NIHR CRNCC). The NIHR CRNCC is delivered under contract between DHSC and a consortium arrangement between the University of Leeds and Guy’s and St Thomas’ NHS Foundation Trust (GSTT). Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. Under this consortium most employees who work on the JDR Registry for the CRNCC are employed by University of Leeds (the majority) but one employee is substantively employed by GSTT with an honorary contract in place with University of Leeds. The data that this one member of staff (who works for CRNCC but is employed by GSTT) deals with is processed via the CRNCC systems and does not go into any systems operated/housed or held by GSTT. This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care. The DHSC remains the Data Controller whilst the NIHR CRNCC processes the data in accordance with the Optional Services Work Order between DHSC and the consortium of the University of Leeds and Guy's and St Thomas' NHS Foundation Trust. This means that University College London no longer play a role in the Service and are no longer listed as data processors. All data provided by NHS Digital to University College London was destroyed in accordance with the sharing agreement. The funding is provided by Department of Health and Social Care. The funding is specifically for the project described. Funding is ongoing. The funder will have no ability to suppress or otherwise limit the publication of findings. The Article 6 justification for processing the data is Article 6 (1)(e) of the GDPR - (processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller). The Department of Health is a public authority, performing it's public task to provide the services to deliver research into dementia. University of Leeds is a processor acting under the instructions of Department of Health and Social Care. The Article 9 justification for the processing of special categories of personal data is Article 9 ( 2)(j) of the GDPR - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject). Data must be processed in this way to allow the registry to be maintained correctly - so that research into dementia can continue. Schedule 1 Part 1 (4) of the Data Protection Act (DPA) 2018 also applies to this research. The operational management of the JDR Service is through the National Institute for Health and Care Research Research Delivery Network Coordinating Centre (NIHR RDNCC). The NIHR RDNCC is delivered under contract between DHSC and the University of Leeds. NIHR RDNCC information services are managed by PA Consulting via a direct contract with the DHSC. PA Consulting employees do not have any access to the data provided by NHS England, they do not act in a processing or controlling capacity. The purpose of this Agreement is to send NHS Digital information on all volunteers from the register on a quarterly basis. NHS Digital will simply confirm if any of the volunteers have died by supplying Informal date of death, Fact of death, Reason for removal, Reason for removal date and Study ID. The data being disseminated includes identifiers, however there are no other efficient means of obtaining this data. Alzheimer’s Society, Alzheimer’s Research UK, and Alzheimer Scotland – are not only delivery partners but contribute expertise and advocacy. They provide a dedicated helpdesk to support people registering for the service. Encourages people with dementia and their carers to participate in research. Offers guidance and reassurance to participants, ensuring ethical and informed involvement. The list cleaning product included latest deaths data. The list cleaning product requested from NHS Digital ensured people who were deceased were removed from the Department of Health and Social Care (DHSC) Join Dementia Research System. In 2020 the list clean report service ceased and NHS Digital started providing quarterly drops of the Demographics dataset from their Cohort Management System (CMS). This continues to ensure people who were deceased are removed from the Department of Health and Social Care (DHSC) Join Dementia Research System. By removing deceased volunteers it will ensure potential research volunteers are not harmed or distressed by attempting to contact people who have died. Without this product, it would be far more difficult for the Join Dementia Research System to be kept up to date. There is no wider collaboration or use of the data intended other than what is stated in this Agreement. All dementia research studies taking place in the UK (funded by government, NIHR, charities and commercial organisations) with ethical approval can use the system. Please note that although commercial organisations may apply to access the data within the JDR, no NHS Digital data is ever added to the JDR. NHS Digital will not disseminate data that will be used directly in Dementia Research Studies. Moreover, NHS Digital provide the CRNCC with updated lists of registrants to the JDR platform, to let them know who is deceased, and therefore who can continue to be contacted by the JDR about future potential studies that they potentially could be involved in. This cleaning of the data is essential to ensure that no stress is caused to family members of deceased, and that only living people are approached, to make the JDR registry as robust and accurate as possible. It should be remembered that the service managed by CRNCC is a JDR Register i.e. the staff are not involved directly in contacting individuals about research studies. That is done by qualified research professionals and research studies are managed by health professionals; registrants have a choice about whether or not to be involved in any research study.

Processing activities

NHS Digital reminds all organisations party to this agreement of the need to comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). University of Leeds will transfer data to NHS England. The data will consist of identifying details: Name, Date of birth, NHS number, Address, Postcode, Gender & unique person ID for the cohort to be linked with NHS England data. Historically, the National Institute of Health Research (NIHR) Clinical Research Network Coordinating Centre (NIHR CRNCC) periodically (on an ad-hoc basis - every four months) provided NHS Digital with lists of registrants. The list included: NHS England will provide the relevant records from the Demographic datasets to University of Leeds. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient. • Name, The Data will not be transferred to any other location. • Date of birth, The Data will be stored on servers at University of Leeds. • NHS number (if available), The Data will be accessed by authorised personnel via remote access. • Address, The Controller must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. • Postcode For remote access: • Gender. - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; Using it's List Cleaning report service, every four months NHS Digital confirmed back to NIHR CRNCC which registrants were deceased, providing the following data items: - Access controls granting users the minimum level of access required are in place; - Supplied identifiers - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; - Date of Latest Posting - Multifactor authentication (MFA) is required for remote access; - Latest Posting - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; From 2020, when the list clean report service ceased, NHS Digital started providing quarterly drops of the Demographics dataset from the Cohort Management System (CMS). At that time it was agreed between the Department of Health and Social Care and NHS Digital that only the following data items required to be sent to NHS Digital: - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. • Study ID The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). • NHS Number The Data will not leave England/Wales, at any time. • Date Of Birth Access is restricted to employees or agents of the (NIHR RDNCC) at University of Leeds who have authorisation from the Principal Investigator. • Surname All personnel accessing the Data have been appropriately trained in data protection and confidentiality. • Forename The Data will not be linked with any other data. • Gender The identifying details will be stored in a separate database. NHS England will not disseminate data that will be used directly in Dementia Research Studies. Moreover, NHS England provide the NIHR RDNCC with updated lists of registrants to the JDR platform, to let them know who is deceased, and therefore who can continue to be contacted by the JDR about future potential studies that they potentially could be involved in. • Postcode Analysts from the (NIHR RDNCC) at University of Leeds will process/analyse the Data for the purposes described above. • Middle Names/Initials Since 2020, NHS Digital have sent, and will continue to send, the following data items back to the NIHR CRNCC on a quarterly basis: - Informal date of death - Fact of death - Reason for removal - Reason for removal date - Study ID The data provided by NHS Digital is then used to remove deceased registrants from the secure JDR platform. JDR requires all of these identifiers in order verify that the correct participant is being removed from the JDR. Only staff with appropriate permissions are able to access the JDR platform to perform edits. The JDR platform is hosted in a cloud environment. NIHR CRNCC information services are managed by PA Consulting via a direct contract with the DHSC. PA Consulting employees do not have any access to the data provided by NHS Digital, they do not act in a processing or controlling capacity. Once the deceased registrants have been removed from the Register, the data supplied by NHS Digital is permanently deleted. The data provided by NHS Digital will not be shared, or processed by any third party and no third party can access records of registrants deleted from the register to identify which were reported as deceased by NHS Digital. NHS Digital data will not be linked with any other data except in the way already described in section 5A. These data processing activities are only carried out by substantive employees of the data processors, or those with an honorary contract, who are aware of data protection and confidentiality requirements and are trained in their responsibilities for this. The registry allows anyone in the United Kingdom to sign up; however, NHS Digital only receive and disseminate data for participants registered in England and Wales, which is the data that is being requested under this agreement.

Expected output

NHS Digital will utilise the identifiers provided by NIHR CRNCC, to produce a report for the CRNCC which will clearly show which of the JDR registrants have deceased. The report will include up-to-date details for JDR registrants at that point in time and will further be marked up to identify those who have deceased. There will be no other information provided from NHS Digital than fact of death and informal date of death. RDNCC JDR staff will use the Data to edit the JDR Registry. CRNCC JDR staff will then use this report to edit the JDR Registry. The records of deceased registrants will be removed from the register which enables Join Dementia Research͛ to comply with the following undertaking from the consent forms used when recruiting volunteers: “I agree to my information being held on Join Dementia Research, until I, or my representative, request withdrawal. Basic details of volunteers will be shared with other NHS organisations to identify if they have died, and I agree to this. If I withdraw, or if Join Dementia Research is notified of my death, then all my personal identifiable information will be removed from Join Dementia Research”. [1 paragraph unchanged] This is the extent of the activity associated with this report. Once deceased registrants have been removed from the JDR Register, the information provided by NHS Digital England is then permanently deleted. The information provided by NHS Digital England is used for a very specific objective i.e. data cleansing, in order to maintain the currency of the JDR Registry and to ensure NIHR CRNCC RDNCC fulfils it’s its promise to registrants that upon death, their identifiable information will be removed. [16 words unchanged] There will be no supplementary reports, journal articles, webinars or workshops created. There will be no creation/development of algorithms or testing of new tools and new technologies intended to be made using the data that NHS Digital England will provide.

Expected measurable benefits

The report provided by NHS Digital England is used to cleanse the JDR Register of deceased registrants, thereby ensuring [17 words unchanged] made. Maintaining an up-to-date Register is a benefit to both the NIHR CRNCC, RDNCC, DHSC and the Office of the National Director for Dementia Research. The [9 words unchanged] all of the above agencies but particularly to families of the deceased. The report from NHS Digital England benefits the provision of health care by enabling NIHR CRNCC RDNCC via Join Dementia Research to be able to process data fairly without [8 words unchanged] their identifiable information will be removed from the register after their deaths. In terms of benefits to the promotion of health, Join Dementia Research has been running since July 2014, and was nationally launched in February 2015. As at the end of December 2021, 2024, the total number of volunteers registered on Join Dementia Research was 50,580. 82,169. JDR has been used on 587 775 studies in over 284 324 sites. Studies include both healthcare studies and social care research studies, with [37 words unchanged] in dementia research. The benefits of the JDR system include the following: [1 paragraph unchanged] • All dementia research studies taking place in the UK (funded by [18 words unchanged] organisations may apply to access the data within the JDR, no NHS Digital England data is ever added to the JDR. JDR database. • JDR provides a new and improved way of identifying and recruiting [22 words unchanged] that takes time, as researchers wait for suitable subjects to come through clinic. Join dementia research clinics. JDR removes this barrier, by having volunteers ready and waiting to join studies. [4 paragraphs unchanged] • Over the next 2 years NIHR CRNCC RDNCC expect the service to have attracted over 100,000 volunteers and to become the main mechanism by which researchers find study volunteers. [1 paragraph unchanged] Without this data dissemination, there is a danger that the JDR Register would not be up to date. It would also not allow the NIHR CRNCC RDNCC to fulfil its promise to registrants, this being: [1 paragraph unchanged]

Benefits reported

Using the NHS List Cleaning Product service and subsequent data updates has yielded several benefits to several parties: • NIHR CRNCC has been able to remove several hundred deceased volunteers, enabling the Register to meet it's its required standards. NIHR CRNCC RDNCC has a duty to comply with the data protection principles of accuracy and storage limitation. By being able to cleanse the JDR Register on a regular basis, NIHR CRNCC RDNCC is ensuring that the data it holds on Registrants is accurate. Cleansing of deceased registrants also means that NIHR CRNCC RDNCC are able to ensure that information is not stored for longer than [54 words unchanged] JDR. The number of Registrants on the Register has now increased to 50,580. over 85,000. • NIHR CRNCC RDNCC is able to maintain the currency of the JDR Register. NIHR CRNCC RDNCC has a duty to both the registered volunteers and researchers to be [7 words unchanged] date (also see above reference to compliance with data protection principles. NIHR CRNCC RDNCC is able to prevent undue distress to JDR Registrants and/or their families [20 words unchanged] to studies thereby aiding the efficiency and effectiveness of study recruitment processes. • NIHR CRNCC RDNCC is able to keep it's its promise to JDR Registrants and/or their families by ensuring the Registrant’s details are removed from the Register upon death. NIHR CRNCC notes, RDNCC notes in the Volunteer Registrant Registration Form that if a Registrant withdraws or after their death, all of [5 words unchanged] their representative’s if appropriate) will be removed from the JDR Register. NIHR CRNCC RDNCC believe that because NIHR CRNCC RDNCC are able to demonstrate and uphold this promise, that this builds trust in the Register and its operation. This, NIHR CRNCC RDNCC believes, has encouraged and increased sign up of registrants to the Register. • The currency of the Register fosters trust between individuals and encourages participants to sign up. • 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. As of the end of December 2024, the total number of volunteers registered on Join Dementia Research was 82,169,and total enrolments into studies exceeded 89,000. So it is clear that JDR is being well utilised in terms of dementia research. 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. • Increased numbers signing up to the Register increases the likelihood of the JDR system being able to meet the Prime Minister's challenge. One of the key aspirations included in this was “Increased numbers of people with dementia participating in research, with 25 per cent of people diagnosed with dementia registered on Join Dementia Research and 10 per cent participating in research, up from the current baseline of 4.5 per cent”. It is estimated that around 850,000 people in the UK have dementia. NIHR CRNCC is working towards achieving the 10 percent target year on year. • 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. In terms of percentage of those with dementia or caring for someone with dementia being involved in research, the total number of volunteers registered on Join Dementia Research as of December 2021 was 50,580. So it is clear that JDR is being well utilised in terms of dementia research. 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.

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Objective for processing

The Join Dementia Research register is a national service funded and owned by the Department of Health and Social Care; 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 data subjects are those that have registered to be part of JDR. This may be those who have dementia or carers, friends, relatives of those with dementia. The purpose of this agreement is to renew and extend the Data Sharing Agreement to continue receiving quarterly drops of data for list cleaning purposes. JDR is a UK-wide service that allows people to register their interest in participating in dementia research and be matched to suitable studies via website and database and is a key element of the Prime Minister’s Challenge on Dementia 2020. The Join Dementia Research (JDR) register is a national service funded and owned by the Department of Health and Social Care; it enables members of the public from anywhere in the United Kingdom to register to be contacted about potential research studies. In registering they give consent for their information to be made available to the dementia research community. The data subjects are those that have registered to be part of JDR. This may include those who have dementia or carers, friends, relatives of those with dementia, as well as those without dementia. The Data Controller has always been the Department of Health and Social Care, however contract arrangements for the management of the service have changed over time. Under the previous contractual arrangement for the operational management of the service, the responsibility for data cleaning lay with University College London, who then acted as Data Processor. If someone is not able to consent themselves, there are some circumstances where the applicant is able to take the consent of someone with power of attorney to make this decision on their behalf and give legal permission to hold their data. In England and Wales, this is called a Lasting Power of Attorney (LPA), and would need to be on health and welfare grounds. In Scotland, this is called a Welfare Power of Attorney. The person acting on behalf of a volunteer is called a consultee. Under the current contractual arrangement, the operational management of the JDR Service is through the NIHR Clinical Research Network Coordinating Centre (NIHR CRNCC). The NIHR CRNCC is delivered under contract between DHSC and a consortium arrangement between the University of Leeds and Guy’s and St Thomas’ NHS Foundation Trust. Consultee advice falls under the Mental Capacity Act - Section 30-33 of MCA: This research is being carried out on behalf of the Secretary of State and the research is connected with the impairing condition, dementia. There are reasonable ground for believing that research of comparable effectiveness can't be carried out if the project has to be confined to, or relate only to, persons who have capacity to consent to taking part in it. The research has the potential to benefit the participant without imposing a burden disproportionate to the potential benefit. HRA have approved the project When someone acts as a consultee, this doesn’t mean that they are giving consent for them to take part in healthcare research it only means they are giving consent for someone to enrol onto the registry; Each study has its own consent procedures and measures in place to ensure that the best interests of participants are protected. Each study has ethical approval in place and HRA have approved this process. Someone may be able to consent to register on Join Dementia Research, but then as an illness like dementia progresses, may lack the capacity to consent in the future or manage their account. JDR will look to support people to express their wishes and make their own decisions about taking part in research for as long as they are able. JDR recognise that for some people, particularly those with dementia, there may come a time when being contacted may become a burden, or be unwelcome or confusing. In these cases, JDR look to make it as easy as possible or delete their account. JDR are happy to hear not just from the volunteer, but also have processes where JDR can take a request from others including family, friends, healthcare professionals or researchers. Unless JDR hear from a volunteer or someone contacting us about their best interests, JDR will presume that there is ongoing consent to hold a volunteer’s data, even if they lose capacity. HRA have approved this process. The JDR Registry does not make assessments about whether someone has ‘capacity’ to consent to take part in research or whether taking part in a particular study is in someone’s best interests. Each study team has their own agreed ethical protocol governing their study and consent process, and each study ensures the volunteers and representatives have understood the process and were able to ask any questions when they are matched to a study. Since December 2019, participants have the option to sign up to the JDR register via the following routes: 1) Online registration 2) Printed version of registration form (via post) 3) Registration can be done over the phone through the charity partners helplines The HRA approved the latest consent model in November 2019 and have fed back on the wording within some of the consent materials, which have since been incorporated into the documentation. JDR is a UK-wide service that allows people to register their interest in participating in dementia research and be matched to suitable studies via a website and database and is a key element of the Prime Minister’s Challenge on Dementia 2020. The data collected under this Agreement only relates to participants within England and Wales. The Data Controller has always been the Department of Health and Social Care, however contractual arrangements for the management of the service have changed over time. Under the previous contractual arrangement for the operational management of the service, the responsibility for data cleaning lay with University College London, who then acted as Data Processor. In March 2015 the Department of Health and the JDR Programme Board took the decision that the BAU elements of JDR delivery should be transferred from the Office of the NIHR National Director for Dementia Research to the NIHR Clinical Research Network Coordinating Centre (CRNCC). It was felt that the transfer of the JDR Service to the NIHR CRNCC would increase the opportunities for the best practice use of JDR in the recruitment of registrants into clinical trials as well as enabling greater coordination of the Local Clinical Research Networks (LRCN’s) resources required/time taken to identify and recruit people to NIHR Portfolio. Under the previous iteration of this Agreement The Data Processor was amended from University College London to the NIHR Clinical Research Network Coordinating Centre - which is made from a consortium agreement between part of the University of Leeds and Guy's and St Thomas' NHS Foundation Trust. UCL have ceased data processing responsibilities and transferred them to NIHR CRNCC. The former Director of the UCL office has confirmed that all data provided by DARS to UCL was destroyed. [1 paragraph unchanged] The way the contract of the consoritum is structured means that most employees who work on the JDR Registry for the CRNCC are employed by University of Leeds (the majority) but one employee is substantively employed by GSTT. The data that this one member of staff (who works for CRNCC but is employed by GSTT) deals with is processed via the CRNCC systems and does not go into any systems operated/housed or held by GSTT. DHSC is the sole Data Controller for the JDR Service. The Clinical Research Network Coordinating Centre (CRNCC) at the National Institute for Health Research (NIHR) administers the Service (along with Charity Partners) on behalf of the DHSC and thus University of Leeds and Guys's and St Thomas' NHS Foundation Trust are Data Processors. The charities that JDR work with are Alzheimer Scotland, Alzheimer’s Society and Alzheimer’s Research UK. They fulfil a helpdesk function on the service which includes adding new volunteers and updating existing accounts, as well as providing expert advice to the public about the service via telephone. They are not provided with access to the information JDR receive under this Agreement, that data is only handled and processed by the data processors listed within this Agreement. Funding is provided by the NIHR. No other funders / commissioners are involved. DHSC is Under the Data Controller for current contractual arrangement, the operational management of the JDR Service. Service is through the National Institute for Health and Care Research Clinical Research Network Coordinating Centre (NIHR CRNCC). The NIHR CRNCC administers the Service (along with Charity Partners) on behalf of the is delivered under contract between DHSC and thus a consortium arrangement between the University of Leeds and Guys's Guy’s and St Thomas' Thomas’ NHS Foundation Trust are Data Processors. Primary funding comes from the NIHR. No other funders / commissioners are involved. (GSTT). The DHSC remains the Data Controller whilst the NIHR CRNCC processes the data in accordance with the Optional Services Work Order between DHSC and the consortium of the University of Leeds and Guy's and St Thomas' NHS Foundation Trust. This means that University College London no longer play a role in the Service and are no longer listed as data processors. Under this consortium most employees who work on the JDR Registry for the CRNCC are employed by University of Leeds (the majority) but one employee is substantively employed by GSTT with an honorary contract in place with University of Leeds. The data that this one member of staff (who works for CRNCC but is employed by GSTT) deals with is processed via the CRNCC systems and does not go into any systems operated/housed or held by GSTT. The DHSC remains the Data Controller whilst the NIHR CRNCC processes the data in accordance with the Optional Services Work Order between DHSC and the consortium of the University of Leeds and Guy's and St Thomas' NHS Foundation Trust. This means that University College London no longer play a role in the Service and are no longer listed as data processors. All data provided by NHS Digital to University College London was destroyed in accordance with the sharing agreement. [1 paragraph unchanged] The Article 9 justification for the processing of special categories of personal [87 words unchanged] to be maintained correctly - so that research into dementia can continue. Schedule 1 Part 1 (4) of the Data Protection Act (DPA) 2018 also applies to this research. The list cleaning product requested from NHS Digital will ensure people who are deceased are removed from the Department of Health and Social Care (DHSC) Join Dementia Research System. By removing deceased volunteers it will ensure potential research volunteers are not harmed or distressed by attempting to contact people who have died. Without this product, it would be far more difficult for the Join Dementia Research System to be kept up to date. The purpose of this Agreement is to send NHS Digital information on all volunteers from the register on a quarterly basis. NHS Digital will simply confirm if any of the volunteers have died by supplying Informal date of death, Fact of death, Reason for removal, Reason for removal date and Study ID. The data being disseminated includes identifiers, however there are no other efficient means of obtaining this data. The purpose of this agreement is to send NHS Digital information on all volunteers from the register on an ad-hoc basis (every four months). NHS Digital will simply confirm if any of the volunteers have died by supplying fact of death. No other updated demographics will be provided to the NIHR CRNCC at the University of Leeds. There are no other efficient means of obtaining this data. There is no wider collaboration or use of the data intended other than what is stated in this agreement. The list cleaning product included latest deaths data. The list cleaning product requested from NHS Digital ensured people who were deceased were removed from the Department of Health and Social Care (DHSC) Join Dementia Research System. In 2020 the list clean report service ceased and NHS Digital started providing quarterly drops of the Demographics dataset from their Cohort Management System (CMS). This continues to ensure people who were deceased are removed from the Department of Health and Social Care (DHSC) Join Dementia Research System. By removing deceased volunteers it will ensure potential research volunteers are not harmed or distressed by attempting to contact people who have died. Without this product, it would be far more difficult for the Join Dementia Research System to be kept up to date. The data requested is not intended nor will it be used for any PhD studies or projects. There is no wider collaboration or use of the data intended other than what is stated in this Agreement. NHS Digital will not disseminate data that will be used directly in Dementia Research Studies. Moreover, NHS Digital provide the CRNCC with updated lists of registrants to the JDR platform, to let them know who is deceased, and therefore who can continue to be contacted by the JDR about future potential studies. that they potentially could be involved in. This cleaning of the data is essential to ensure that no stress is caused to family members of deceased, and that only suitable candidates are approached to make research as robust and accurate as possible. It should be remembered that the service managed by CRNCC is a JDR Register i.e. the staff are not involved directly in contacting individuals about research studies. That is done by qualified research professionals and research studies are managed by health professionals; registrants have a choice about whether or not to be involved in any research study. All dementia research studies taking place in the UK (funded by government, NIHR, charities and commercial organisations) with ethical approval can use the system. Please note that although commercial organisations may apply to access the data within the JDR, no NHS Digital data is ever added to the JDR. NHS Digital will not disseminate data that will be used directly in Dementia Research Studies. Moreover, NHS Digital provide the CRNCC with updated lists of registrants to the JDR platform, to let them know who is deceased, and therefore who can continue to be contacted by the JDR about future potential studies that they potentially could be involved in. This cleaning of the data is essential to ensure that no stress is caused to family members of deceased, and that only living people are approached, to make the JDR registry as robust and accurate as possible. It should be remembered that the service managed by CRNCC is a JDR Register i.e. the staff are not involved directly in contacting individuals about research studies. That is done by qualified research professionals and research studies are managed by health professionals; registrants have a choice about whether or not to be involved in any research study.

Processing activities

[1 paragraph unchanged] The Historically, the National Institute of Health Research (NIHR) Clinical Research Network Coordinating Centre (NIHR CRNCC) will periodically (on an ad-hoc basis - every four months) provide provided NHS Digital with lists of registrants. The lists will include list included: [6 paragraphs unchanged] Using its List Cleaning product, NHS Digital will confirm back to NIHR CRNCC which registrants are deceased. NHS Digital will send back a Member Number (Study ID), supplied identifiers (minus NHS Number) and the fact of death (if applicable) back to the University of Leeds. This will happen each quarter. The data provided by NHS Digital is then used to remove deceased registrants from the secure JDR platform. Only staff with appropriate permissions are able to access the JDR platform to perform edits. The JDR platform is hosted in a cloud environment. NIHR CRNCC information services are managed by PA Consulting via a direct contract with the DHSC. PA Consulting employees do not have any access to the data provided by NHS Digital, they do not act in a processing or controlling capacity. Once the deceased registrants have been removed from the Register, the data supplied by NHS Digital is permanently deleted. The data provided by NHS Digital will not be shared, or processed by any third party and no third party can access records of registrants deleted from the register to identify which were reported as deceased by NHS Digital. Using it's List Cleaning report service, every four months NHS Digital confirmed back to NIHR CRNCC which registrants were deceased, providing the following data items: These data processing activities are only carried out by substantive employees of the data processors who are aware of data protection and confidentiality requirements and are trained in their responsibilities for this. - Supplied identifiers - Date of Latest Posting - Latest Posting From 2020, when the list clean report service ceased, NHS Digital started providing quarterly drops of the Demographics dataset from the Cohort Management System (CMS). At that time it was agreed between the Department of Health and Social Care and NHS Digital that only the following data items required to be sent to NHS Digital: • Study ID • NHS Number • Date Of Birth • Surname • Forename • Gender • Postcode • Middle Names/Initials Since 2020, NHS Digital have sent, and will continue to send, the following data items back to the NIHR CRNCC on a quarterly basis: - Informal date of death - Fact of death - Reason for removal - Reason for removal date - Study ID The data provided by NHS Digital is then used to remove deceased registrants from the secure JDR platform. JDR requires all of these identifiers in order verify that the correct participant is being removed from the JDR. Only staff with appropriate permissions are able to access the JDR platform to perform edits. The JDR platform is hosted in a cloud environment. NIHR CRNCC information services are managed by PA Consulting via a direct contract with the DHSC. PA Consulting employees do not have any access to the data provided by NHS Digital, they do not act in a processing or controlling capacity. Once the deceased registrants have been removed from the Register, the data supplied by NHS Digital is permanently deleted. The data provided by NHS Digital will not be shared, or processed by any third party and no third party can access records of registrants deleted from the register to identify which were reported as deceased by NHS Digital. NHS Digital data will not be linked with any other data except in the way already described in section 5A. These data processing activities are only carried out by substantive employees of the data processors, or those with an honorary contract, who are aware of data protection and confidentiality requirements and are trained in their responsibilities for this. The registry allows anyone in the United Kingdom to sign up; however, NHS Digital only receive and disseminate data for participants registered in England and Wales, which is the data that is being requested under this agreement.

Expected output

NHS Digital will utilise the list identifiers provided by NIHR CRNCC CRNCC, to produce a report for the CRNCC which will clearly show which of the JDR registrants have deceased. The report will include name, date of birth, NHS number, address, postcode and gender up-to-date details for JDR registrants at that point in time and will further be [10 words unchanged] be no other information provided from NHS Digital than fact of death - no details and informal date of cause, date or locaiton of death (if available) will be given. death. [1 paragraph unchanged] “I understand that if I withdraw, or after my death, then all identifiable information will be removed from Join dementia research”. “I agree to my information being held on Join Dementia Research, until I, or my representative, request withdrawal. Basic details of volunteers will be shared with other NHS organisations to identify if they have died, and I agree to this. If I withdraw, or if Join Dementia Research is notified of my death, then all my personal identifiable information will be removed from Join Dementia Research”. The timely removal of deceased registrant records will reduce the chances of attempting to contacting contact people who are deceased / family members of deceased volunteers thereby preventing added distress. The JDR Register will be updated each time the report is sent. [1 paragraph unchanged] The information provided by NHS Digital is used for a very specific objective i.e.data i.e. data cleansing, in order to maintain the currency of the JDR Registry and [34 words unchanged] There will be no supplementary reports, journal articles, webinars or workshops created. [1 paragraph unchanged]

Expected measurable benefits

The report provided by NHS Digital is used to cleanse the JDR [57 words unchanged] all of the above agencies but particularly to families of the deceased. It furthers trust between the NIHR CRNCC, and registrants as it ensures CRNCC is able to fulfil its obligations to registrants in a timely manner. [1 paragraph unchanged] In terms of benefits to the promotion of health, Join Dementia Research has been running since July 2014, and was nationally launched in February 2015. By February 2019 As at December 2021, the Register had over 39,500 total number of volunteers and had supported more than 11,000 instances of recruitment to dementia research registered on Join Dementia Research was 50,580. JDR has been used on 587 studies in the UK. over 284 sites. Studies include both healthcare studies and social care research studies, with studies covering both volunteers with dementia as well as those who care for people with dementia. Join Dementia Research aims to support the PM Prime Minister's Challenge target to ensure 10% of all people with dementia are involved in dementia research. The benefits of the JDR system include the following: [1 paragraph unchanged] • All dementia research studies taking place in the UK (funded by government, NIHR, charities and commercial organisations) with ethical approval can use the system. Please note that although commercial organisations may apply to access the data within the JDR, no NHS Digital data is ever added to the JDR. [8 paragraphs unchanged] ““I understand that if “If I withdraw, or after if Join Dementia Research is notified of my death, then all my personal identifiable information will be removed from Join Dementia Research”.

Benefits reported

[1 paragraph unchanged] • NIHR CRNCC has been able to remove several hundred deceased volunteers, enabling the Register to meet its required standards; • NIHR CRNCC has been able to remove several hundred deceased volunteers, enabling the Register to meet it's required standards. NIHR CRNCC has a duty to comply with the data protection principles of accuracy and storage limitation. By being able to cleanse the JDR Register on a regular basis, NIHR CRNCC is ensuring that the data it holds on Registrants is accurate. Cleansing of deceased registrants also means that NIHR CRNCC are able to ensure that information is not stored for longer than is necessary. Researchers using the Register benefit by knowing that data on the Register is subject to regular cleansing and is thus likely to be up to date. This aids the efficiency and effectiveness of study recruitment processes. Holding a current Register has fostered trust between individuals and encourages participants to sign up to JDR. The number of Registrants on the Register has now increased to 50,580. • NIHR CRNCC is able to maintain the currency of the JDR Register; • NIHR CRNCC is able to maintain the currency of the JDR Register. NIHR CRNCC has a duty to both the registered volunteers and researchers to be able to keep the Register up to date (also see above reference to compliance with data protection principles. NIHR CRNCC is able to prevent undue distress to JDR Registrants and/or their families by ensuring the research staff do not contact bereaved families. Researchers are assured that they are only inviting current registrants to studies thereby aiding the efficiency and effectiveness of study recruitment processes. • 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 it's promise to JDR Registrants and/or their families by ensuring the Registrant’s details are removed from the Register upon death. NIHR CRNCC notes, in the Volunteer Registrant Form that if a Registrant withdraws or after their death, all of their personal identifiable data (and their representative’s if appropriate) will be removed from the JDR Register. NIHR CRNCC believe that because NIHR CRNCC are able to demonstrate and uphold this promise, that this builds trust in the Register and its operation. This, NIHR CRNCC believes, has encouraged and increased sign up of registrants to the Register. • 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. • 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 Prime Minister's challenge. One of the key aspirations included in this was “Increased numbers of people with dementia participating in research, with 25 per cent of people diagnosed with dementia registered on Join Dementia Research and 10 per cent participating in research, up from the current baseline of 4.5 per cent”. It is estimated that around 850,000 people in the UK have dementia. NIHR CRNCC is working towards achieving the 10 percent target year on year. • 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. In terms of percentage of those with dementia or caring for someone with dementia being involved in research, the total number of volunteers registered on Join Dementia Research as of December 2021 was 50,580. So it is clear that JDR is being well utilised in terms of dementia research. 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. 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.

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

Datasets: + Demographics

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.