Our Future Health Recruitment Programme

Our Future Health intends to be the UK’s largest ever health research programme. It is designed to help people live healthier lives for longer through the discovery and testing of more effective approaches to prevention, earlier detection and treatment of diseases.

The overarching objective of Our Future Health is to help people live healthier lives for longer through better prevention, earlier detection and improved treatment of diseases. The Our Future Health research programme will aim to speed up the discovery of new methods of early disease detection, and the evaluation of new diagnostic tools, to help identify and treat diseases early when outcomes are usually better.

To achieve these objectives, Our Future Health aims to recruit up to 5 million adults from across the UK (from a variety of different recruitment routes including NHS England) to create a diverse and inclusive cohort of people who have consented to participate in the research.

• Specific Aim 1: Build a resource linking multiple sources of health and health-relevant information, including genetic data, on millions of people in the UK, to facilitate basic discovery research by academic and commercial researchers on early indicators of disease

• Specific Aim 2: Our Future Health analyse the participant health data* in the resource to estimate personal disease risk information for participants, based on genetic and non-genetic information, and offer this estimated personal health information to participants who wish to receive it

• Specific Aim 3: Re-contact sub-groups of participants generally for additional samples, non-routine data and secondary studies over time

• Specific Aim 4: Re-contact participants on a risk-stratified basis (i.e. recall-by-genotype/phenotype or sociodemographic characteristics) over time specifically to enable secondary studies by academic and commercial researchers that is greatly enhanced by being able to identify highly enriched sub-populations/sub-cohorts of participants.

*'Data' referenced in these specific aims above are not related to the data obtained under this specific Data Sharing Agreement (DSA). This DSA relates solely to providing NHS England Data to assist with the recruitment of participants into the Our Future Health programme.

Our Future Health has taken a steady approach to trialling and testing various recruitment routes, though pilots and often in partnership with other organisations. 2021 saw early pilots with NHS Blood and Transplant, and with National Institute for Health and Care Research (NIHR) which are being developed up into larger scale recruitment routes. 2022 saw pilots in Secondary Care, and a range of community based recruitment pilots in partnership with community based organisations. By summer of 2022, recruitment began at scale with NHS DigiTrials forming a key part of the strategy to achieve recruitment targets. An initial target of 100,000 consented participants by the end of 2022 was achieved and by October 2023, the milestone of 1 million consented participants had been achieved, making Our Future Health the fastest recruiting health research programme ever.

Any reference to "the programme team" in this DSA refers to members staff employed by Our Future Health directly working on the Our Future Health programme.

The programme is being conducted throughout the UK* and the aim is to recruit a total of 5 million participants, via a number of different recruitment routes. Our Future Health made the original application in April/May 2022, seeking to pilot a new approach to recruiting to a large and unprecedented research cohort, in partnership with the NHS.

*NHS England will be providing data for England and Wales only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.

The initial application sought to issue 3 million invitations, anticipating the recruitment of circa 150,000 participants, offering a potential recruitment rate of circa 5%. Alongside this pilot, Our Future Health was trialing a partnership with Boots UK PLC which enabled invited participants to book an appointment for physical measurements and a blood sample to be taken. Since that point, the pilot with NHS DigiTrials has demonstrated significant value and success as follows:

a) Current recruitment figures – of which between 77-79% are due to Digitrials letters. (Note this is likely to be an underestimate as not all who receive a Digitrials letter use the URL or QR code in the letter to access the website.)

b) Fastest recruiting programme ever - to date Our Future Health has recruited at three times the rate of UK Biobank and securing 1 million participants in the first year.

c) Enabled release into the Our Future Health TRE of 550,000 participant questionnaires for application/access by researchers now.

d) Includes never before collected data, at this scale, including information on vaping habits of half a million people.

e) The largest number of people recruited from underrepresented groups (under 40 years, lowest income quintile and non-white ethnicity) of any comparative study

The DigiTrials partnership has enabled testing of 38 unique letter templates, including 22 changes in invitation wording or presentation. This includes assessing letter performance by age, sex, and geographic factors including ethnicity, deprivation, and (in future) preferred language. This is enabling the creation of multivariable prediction models to automatically select the best letter for a given combination of demographics, in a given region.

Our Future Health aimed to recruit approximately 175,000 participants via NHS England recruitment for the first year , but the powerful success of the NHS DigiTrials Recruitment service, coupled with successful partnerships with Boots and Acacium to provide blood sampling clinics, meant that in the first full year of recruitment activity at scale, the programme issued 15 million invitations and recruited 1 million participants. Our Future Health know that between 77-79% of consented participants definitely joined as a result of an NHS DigiTrials invitation letter, which gives a minimum conversion rate across the year of between 5.13% and 5.3%. Our Future Health also know this is an underestimate of the recruitment impact of NHS DigiTrials, as recipients are encouraged to invite family and friends, and some recipients may log on via the Our Future Health on-line portal rather than using the QR access code in the invitation letter.

For the end of 2024, Our Future Health achieved 2 million consented participants.

INCLUSION CRITERIA:

• Reside within England and Wales

• 18 years or older:

NOTE: Our Future Health are not recruiting children under the age of 18 for the following reasons:

◦ In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised, and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

◦ The aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease).

◦ Our Future Health are using an opt-in model with explicit consent; this model would be considerably complicated by the inclusion of children particularly in the absence of adequate scientific or health rationale for their recruitment.

EXCLUSION CRITERIA:

The overall cohort of participant aims to be representative across UK geographical locations, age, gender and ethnicity. It is possible as part of the creation of each NHS England mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.

Our Future Health is not recruiting individuals under the age of 18 because the aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease). In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)

Involving the public in the design of Our Future Health is vitally important to its success. Our Future Health is building a governance structure that has public involvement and engagement embedded throughout, and has already demonstrated a clear commitment to involving and engaging the public in our development, build and operational activities.

In 2020, Our Future Health involved members of the public in the design and development of the public-facing materials as well as in other aspects of the project design. The design of the participant information sheet and consent form has included:

• 18 focus groups with 82 members of the public;

• 4 meetings with a co-design group comprised of 8 members of the public; and

• 21 user testing interviews with members of the public.

During 2021 Our Future Health worked with Claremont creative agency to conduct a programme of patient and public involvement work. Over 120 members of the public were involved during 2020-2021 including:

• 4 focus groups, 2 co-design meetings, 21 interviews with the public to develop the scientific protocol

• 12 interviews with a variety of stakeholders from charities and existing cohort studies

• 2 focus groups with 11 NHS primary care staff

• 18 focus groups, 10 co-design meetings, 21 interviews with the public to co-develop the participant information sheet, consent form & other public-facing videos & materials

• 21 interviews to understand the role of industry in health research

• 4 focus groups to explore insights around recruitment methods

• 3 focus groups to explore public motivators and feedback preferences

• 1 member of the public attended the Research Ethics Committee (REC) approval meeting with a member of Our Future Health

As it was qualitative research, not quantitative, the outputs of the work are summarised as follows:

• Co-designed and REC approved Patient Information Sheet (PIS) and Consent form

• 4 co-designed explainer videos for Our Future Health (YouTube)

• Public Engagement Strategy (Claremont 2021)

• Engaging Black Audiences Report (written by an external consultant)

30 members of the public were invited to join the Our Future Health Public Advisory Board, and 14 accepted. Six are affiliate members of the Secondary Care Working Group, Ethics Advisory Board and Technology Advisory Board (with two PPIE representatives on each). The Access Board will have equal representation of expert and public/participant members.

Outputs of these groups since 2021

• Agreed Terms of Reference, working principles, PPIE training pack and evaluation matrix

• 3 meetings held in 2021 and 1 ad-hoc consultation.

• Topics for consultation and input/approval have included the Founding Industry Member Policy, Trusted Research Environment (TRE), amendments to the PIS and consent form

In 2020-2022, Our Future Health involved over 3,600 members of the public in the design and development of the major public-facing materials, as well as in other aspects of the programme design. All projects involved members of the public and included representation from the following segments: early adopters (health), early adopters (civic minded), early majority, sceptics, lower income, South Asian ethnic background and Black ethnic background.

In addition, Our Future Health have successfully appointed and trained 22 members of the public to join their advisory boards and working groups (Public Advisory Board, Secondary Care Working Group, Primary Care Working Group, Ethics Advisory Board, Technology Advisory Board, and Access Board), with a further list of over 40 volunteers Our Future Health can consult for future user testing and PPIE activities. To support members of the public in taking on these roles Our Future Health have developed a PPIE training package for new public representatives. This work has been essential to ensuring that Our Future Health developed:

• a co-designed and REC approved PIS and consent form (one member of the public attended the REC meeting alongside a member of Our Future Health Staff),

• co-designed explainer videos for Our Future Health (YouTube), and

• a Public Engagement Strategy (Claremont 2021)

An example of the work undertaken on user experience was a survey to gauge public attitudes to Our Future Health. 2,767 people completed the survey which confirmed that the general public have a high interest in receiving personalised genetic information:

77% of participants wished to receive risk information of disease which is preventable or treatable,

65% wanted non-treatable risk information, and

77% would want ancestry information.

These insights are being used to support Our Future Health's developing feedback programme.

A full set of the participant-facing materials listed below:

- Baseline Questionnaire

- Consent form

- Frequently Asked Quesitons

- Invitation letters

- Newsletter

- Participant information sheet

- Pro-forma

- Refer a friend card

- Social postcard

- Thank you, postcard

- Volunteer voices stories

- Walk-in leaflet

With regards to the baseline questionnaire, all questions must have a response entered. The Our Future Health website forces an error response to any areas that are not complete. Participants have an option to select ‘prefer not to say’ or ‘other’ in some areas.

Our Future Health has continued to develop and test variations of the invitation letters, emails and Short Message/Messaging Service (SMS) messages to measure the impact on response rates overall and for sub-populations. To date, 38 letter variations have been tested. Our Future Health will also expand their range of case studies to include a broader range of stories from across section of sub-populations and highlighting a range of research opportunities within specific disease areas.

Our Future Health has updated the health measurement results proforma to include information about diabetes risk and a link to an online risk calculator (provided by Diabetes UK). This will allow participants to generate a letter to their GP based if they are found to be at high risk on their results. Our Future Health has also provided a link to the British Heart Foundation/NHS website where participants can calculate their ‘heart age’ using the information in the results proforma. In the event that participants are shown to a higher than normal cholesterol test, the pro forma directs them to on line information to support an informed decision on next steps and individual action to reduce cholesterol.

In 2022 PPIE - via the Our Future Health Public Attitudes tracker - accumulated 2676 respondents. This was repeated in 2023, with 1,339 respondents and the most recent data shows the following in relation to Industry Involvement:

74-92% of participants viewed data access as “Very” or “Fairly acceptable” for all types of researcher,

61-76% of the general public viewed data access as “Very” or “Fairly acceptable” for all types of researcher,

86% of participants viewed partnerships with industry as “Very acceptable” or “Fairly acceptable”,

66% of the general public viewed partnerships with industry as “Very acceptable” or “Fairly acceptable”

Our Future Health, as sole Controller, are using UK GDPR Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for Our Future Health legitimate interests which are described below.

The data to which access is requested are proportionate and necessary to achieve those interests. Our Future Health have completed a Legitimate Interests Assessment (LIA) and NHS England are satisfied that the interests of the data subjects do not override their legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subject's interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS England or after a defined period on completion of the project. Our Future Health considered the purpose, necessity and balance of the programme when completing their legitimate interest assessment.

It is acknowledged that Our Future Health has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation and visit the Our Future Health website. At that point, Our Future Health solicits the potential research participant’s explicit consent to join the programme for the purposes of making a contribution to research efforts to benefit the wider public's health. Participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.

Additionally (as health data is a special category of Personal Data), Our Future Health is using UK GDPR Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. Our Future Health’s ethically approved scientific research programme seeks to make advances in early disease detection and prevention to improve public health in the wider societal interest to help people live longer lives in better health. Without this research programme improvements in the early detection and possible prevention of disease are likely to either: (a) not take place; or (b) be negatively impacted. To improve the nation’s health Our Future Health aims to recruit research participants from as broad a spectrum of society as possible as overall health is a component of behavioural, social, environmental and genetic factors.

AGREEMENT VERSION HISTORY

The initial Health Regulatory Authority’s Confidentiality Advisory Group (CAG) approval to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002 (herein after called Section 251) provided support for approximately three million potential participants to be contacted. The amendment of this Data Sharing Agreement to version 1 saw an increase to the number of invitations from three million to 12 million.

Our Future Health had received Section 251 support for approximately 12 million patients to be contacted. This increased figure was due to the creation of pop-up clinics and mobile units to enable volunteers’ measurements and blood sample to be taken, which were not available to the applicant at the time of initial section 251 application. This means potential candidates could be invited at a higher rate, and greater scale to support achieving recruitment targets.

Since initial projections to April 2023, 350k volunteers have consented to participate in the programme, in the first 6 months of active recruitment. The programme aims to form a cohort of 5million volunteers, with particular focus on groups within the population who are traditionally under-represented in medical research.

In October 2022, scale up of the integrated processes enabled higher volumes of invitations to be issued per week. These processes included:

- planning new clinics

- Running media opt-out campaigns in planned areas

- Establishing clinics and training staff

- Identifying optimal cohort characteristics for the new batch of invitations

- Issue of invitations and release of appointments for booking by recipients

- Clinic opening in time to deliver booked appointments

Invitations issued to carefully selected groups have enabled this cohort growth to be carried out while developing a cohort make up that reflects the UK population. NHS DigiTrials has supported this specifically by enabling the targeting of specific age, sex and postcode characteristics, alongside careful placement of Our Future Health pop-up clinics in those targeted areas.

The increase in the recruitment rate has mean that limit of approximately 12 million invitation mail-outs would shortly be met by June 2023 and so Version 2 of this Data Sharing Agreement saw an increase of approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs. The Health Research Authority (HRA) Confidentiality Advisory Group (CAG) and Research Ethics Committee supported the increase from approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs.

Version 3 of this Data Sharing Agreement permitted a managed extension to this DSA to end of September 2023 to allow Our Future Health to address advice provided by the Advisory Group for Data and the HRA CAG. There was no change to the number of invitations being sent out from version 2 of this agreement.

In July 2023 under version 4 of this Data Sharing Agreement Our Future Health obtained support for a further increase in invitation mail-out numbers from the Health Research Authority (HRA) Confidentiality Advisory Group (CAG) CAG supported the increase in mail-outs from approximately 16 million invitation mail-outs to approximately 20 million invitation mail-outs. This was an incremental increase, with the first two million invitations provided at the commencement of version 4 of this agreement and the following two million invitations provided once NHS England were satisfied that Our Future Health had made substantive progress to address points raised through previous advice from NHS England. Our Future health provided sufficient evidence to NHS England on the progress made, and as a result the further two million invitation mail-outs were subsequently permitted.

In version 5 of the Data Sharing Agreement, Our Future Health seeks to obtain a further 5 million invitation mail-outs, taking the total number of invitations permitted to be released by NHS England to 25 million. This increase will be used to target individuals specifically in postcode areas within IMD deciles 1-3, areas with >15% non-white population or areas with higher levels of younger adults (under age 40 years).

The Confidentiality Advisory Group (CAG) support the increase in mail-outs from approximately 20 million invitation mail-outs to approximately 25 million invitation mail-outs.

Under version 7 of the Data Sharing Agreement, Our Future Health seeks to obtain an additional approximate 8 million patients to be contacted for consent, via DigiTrials, to make a total of approximately 33 million people. For this additional 8 million, the approach is to send the request file to NHS DigiTrials setting out the numbers of individuals by Age and Sex from each of a range of defined postcode areas.

As per the CAG approval letter, Our Future Health use the DigiTrials invitations specifically on postcode areas which either:

a) are designated in the bottom 2 Quintiles for deprivation:

b) Have a high( >15%) non-white ethnicity

c) Have a high proportion of people under 40.

CAG have agreed to allow Our Future Health to send personalised invitations to these 3 groups. This is because there is good evidence to suggest the response rate is much higher from these individuals with personalised invitations are used. This is important as recruitment from these 3 groups ensures the cohort is representative.

REQUESTING NOT TO TAKE PART IN THE PROGRAMME:

In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the Our Future Health Programme. Our Future Health will promote this information via the dedicated programme website (https://ourfuturehealth.org.uk/) and via local media for four weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS England will also promote this information via a dedicated page on its website (https://digital.nhs.uk/services/nhs-digitrials/how-we-identify-participants-for-the-our-future-health-programme). There will also be an option for people to register their request not to take part in Our Future Health by telephone. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection and as a result their details will not be on the list passed to APS Group for invitations to be sent.

ORGANISATION’S ROLES AND RESPONSIBILITIES:

Our Future Health is the Controller. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.

Our Future Health is responsible for:

1. Generating the invitation request(s) and sending to NHS England on a regular basis

2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)

3. Monitoring scope of the population booking appointments and entering the programme.

4. Adjusting the selection criteria for subsequent invitations to adjust for underrepresentation of target populations taking up the programme.

NHS England are acting as a Processor on behalf of Our Future Health and are responsible for:

1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees

2. Feeding back to Our Future Health the number of invitees actually fulfilled out of the total target population.

3. Removing objections or opt outs (where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)

4. Sending the list of invitees on to their third-party provider (Allied Publicity Services (APS) Group) for generating the invitation letters and mailing these out

5. Agreeing with Our Future Health key processing timelines, including

a. Time from submission to APS Group to mailout

b. Date of the mail outs

c. Daily cut-off times (i.e. after which processing will take place the next day)

d. Time to feedback to Our Future Health the numbers selected

6. Overseeing performance of APS Group and alerting performance issue to Our Future Health.

7. Feeding back to Our Future Health performance in relation to Key Performance Indicators (KPIs) of APS and NHS England

8. Where the number of invitees is less than the population available, invoking a system to choose invitees at random

9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations.

APS Group are acting as a Sub-Processor of NHS England. Their responsibility is to receive the lists of invitees from NHS England and mail out to them accordingly.

APS Group also manage the letters which are returned to the service. On the reverse of each envelope, APS’ address is provided as the return address. APS Group scan the 2d barcode displayed in the envelope window of each returned letter which is the unique identifier for the letter recipient. Based on what is written on the envelope, APS Group will assign a return reason code. The physical letters will be shredded once this is undertaken.

Our Future Health, as Controller, agrees to share this returns information with NHS England in its role as a Controller for the Personal Demographics Service (PDS). The APS group will return regular file extract to NHS England which contains the following data items:

• GUID – NHS England’s Unique ID

• Family Name

• Given Name

• Address Lines 1-5

• Postcode

• Letter Template

• Return Reason code

• APS Unique ID

NHS England will use this information in accordance with its statutory functions, including but not limited to:

• maintaining the quality of patient contact information in the Personal Demographics Service under the Spine Services (no.2) 2014 Directions

• maintaining GP patient lists under Schedule 3, Part 2, paras 17 and 28 of the National Health Service (General Medical Services Contracts) Regulations 2015 (as amended) (GMS Contract Regulations) and to meet its obligations under the Primary Care Registration Management Directions 2018 to perform its functions in connection with the provision of NHS services and in particular to comply with its duties under the GMS Contract Regulations

Our Future Health have a series of Programme oversight groups with PPIE representatives. Our Future Health has a robust governance structure with appropriate management and advisory boards to ensure thorough and informed oversight, management and decision making.

FUNDING

Our Future Health received initial funding via the UK Research and Innovation (UKRI) Life Sciences Industrial Strategy, with a commitment of £79m administered via the UKRI-Innovate . For more information on the role of Our Future Health’s industrial partners, please see the YouTube video <https://m.youtube.com/watch?v=OdQd9w-0bNk>. Our Future Health also has a programme of Founding Members, which includes charities and pharmaceutical and diagnostic companies, who have agreed, between them, to contribute a total of circa £150 million funding to the programme in return for becoming a Founding Member. The Founding Members will contribute a fixed sum each and have a seat on the Founders Board. None of the founding members will view or process NHS England Data. They do not make any decisions about the way Our Future Health is conducted or how the Data is used.

As well as contributing funding, the industry and charity members will bring considerable expertise in discovering and developing new methods of prevention, early detection and treatment of diseases and health conditions. These Founding Members will help Our Future Health co-design, co-deliver and co-fund the programme. By making Our Future Health resources available to researchers both from academia and industry, it is hoped to help accelerate the discovery and development of innovative diagnostics and treatments.

Our Future Health have agreed some specific terms with industry and charity members that recognise their investment in, and support to develop, Our Future Health from its early stages. These include:

• A seat on the Founders Board – one of the boards Our Future Health are setting up to help guide and shape Our Future Health. The Founders Board will:

o provide guidance on the scientific and technical aspects of Our Future Health;

o help Our Future Health to identify emerging challenges and opportunities; and

o help to make the programme valuable to as wide a range of researchers as possible.

The Founders Board will be able to nominate experts to sit on some other advisory boards established by Our Future Health to ensure that they can benefit from their expertise across the full breadth of the programme.

• During the early years of the programme, Our Future Health’s industry members will be the only large commercial organisations that are eligible to apply to use Our Future Health resources for research. This doesn’t affect access to Our Future Health for other

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS England will only be used to identify and invite potential participants. NHS England Record Level Identifiable Data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the Health Research Authority (HRA) and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets for 2024 are being agreed with funders for 2023 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign including key aggregate facts and figures about the recruitment progress has been running through out 2023 culminating in a significant campaign covering the achievement of 1 million participants consented by October 2023.

Whilst the outcomes of the recruitment mail-outs undertaken in this DSA do not directly benefit Health and Social Care, they are necessary to achieve secondary benefits through the eventual use of health data obtained from participants to Our Future Health as a result of these mailouts. At this current time (January 2024) approximately 18.3 million invitation letters have been sent out using the NHS DigiTrials Recruitment service and Our Future Health have recorded approximately 1.146 million individuals who have consented to participate in this project.

Our Future Health intends to be the UK’s largest ever health research programme. It is designed to help people live healthier lives for longer through the discovery and testing of more effective approaches to prevention, earlier detection and treatment of diseases.

The overarching objective of Our Future Health is to help people live healthier lives for longer through better prevention, earlier detection and improved treatment of diseases. The Our Future Health research programme will aim to speed up the discovery of new methods of early disease detection, and the evaluation of new diagnostic tools, to help identify and treat diseases early when outcomes are usually better.

To achieve these objectives, Our Future Health aims to recruit up to 5 million adults from across the UK (from a variety of different recruitment routes including NHS England) to create a diverse and inclusive cohort of people who have consented to participate in the research.

• Specific Aim 1: Build a resource linking multiple sources of health and health-relevant information, including genetic data, on millions of people in the UK, to facilitate basic discovery research by academic and commercial researchers on early indicators of disease

• Specific Aim 2: Our Future Health analyse the participant health data* in the resource to estimate personal disease risk information for participants, based on genetic and non-genetic information, and offer this estimated personal health information to participants who wish to receive it

• Specific Aim 3: Re-contact sub-groups of participants generally for additional samples, non-routine data and secondary studies over time

• Specific Aim 4: Re-contact participants on a risk-stratified basis (i.e. recall-by-genotype/phenotype or sociodemographic characteristics) over time specifically to enable secondary studies by academic and commercial researchers that is greatly enhanced by being able to identify highly enriched sub-populations/sub-cohorts of participants.

*'Data' referenced in these specific aims above are not related to the data obtained under this specific Data Sharing Agreement (DSA). This DSA relates solely to providing NHS England Data to assist with the recruitment of participants into the Our Future Health programme.

Our Future Health has taken a steady approach to trialling and testing various recruitment routes, though pilots and often in partnership with other organisations. 2021 saw early pilots with NHS Blood and Transplant, and with National Institute for Health and Care Research (NIHR) which are being developed up into larger scale recruitment routes. 2022 saw pilots in Secondary Care, and a range of community based recruitment pilots in partnership with community based organisations. By summer of 2022, recruitment began at scale with NHS DigiTrials forming a key part of the strategy to achieve recruitment targets. An initial target of 100,000 consented participants by the end of 2022 was achieved and by October 2023, the milestone of 1 million consented participants had been achieved, making Our Future Health the fastest recruiting health research programme ever.

Any reference to "the programme team" in this DSA refers to members staff employed by Our Future Health directly working on the Our Future Health programme.

The programme is being conducted throughout the UK* and the aim is to recruit a total of 5 million participants, via a number of different recruitment routes. Our Future Health made the original application in April/May 2022, seeking to pilot a new approach to recruiting to a large and unprecedented research cohort, in partnership with the NHS.

*NHS England will be providing data for England and Wales only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.

The initial application sought to issue 3 million invitations, anticipating the recruitment of circa 150,000 participants, offering a potential recruitment rate of circa 5%. Alongside this pilot, Our Future Health was trialing a partnership with Boots UK PLC which enabled invited participants to book an appointment for physical measurements and a blood sample to be taken. Since that point, the pilot with NHS DigiTrials has demonstrated significant value and success as follows:

a) Current recruitment figures – of which between 77-79% are due to Digitrials letters. (Note this is likely to be an underestimate as not all who receive a Digitrials letter use the URL or QR code in the letter to access the website.)

b) Fastest recruiting programme ever - to date Our Future Health has recruited at three times the rate of UK Biobank and securing 1 million participants in the first year.

c) Enabled release into the Our Future Health TRE of 550,000 participant questionnaires for application/access by researchers now.

d) Includes never before collected data, at this scale, including information on vaping habits of half a million people.

e) The largest number of people recruited from underrepresented groups (under 40 years, lowest income quintile and non-white ethnicity) of any comparative study

The DigiTrials partnership has enabled testing of 38 unique letter templates, including 22 changes in invitation wording or presentation. This includes assessing letter performance by age, sex, and geographic factors including ethnicity, deprivation, and (in future) preferred language. This is enabling the creation of multivariable prediction models to automatically select the best letter for a given combination of demographics, in a given region.

Our Future Health aimed to recruit approximately 175,000 participants via NHS England recruitment for the first year , but the powerful success of the NHS DigiTrials Recruitment service, coupled with successful partnerships with Boots and Acacium to provide blood sampling clinics, meant that in the first full year of recruitment activity at scale, the programme issued 15 million invitations and recruited 1 million participants. Our Future Health know that between 77-79% of consented participants definitely joined as a result of an NHS DigiTrials invitation letter, which gives a minimum conversion rate across the year of between 5.13% and 5.3%. Our Future Health also know this is an underestimate of the recruitment impact of NHS DigiTrials, as recipients are encouraged to invite family and friends, and some recipients may log on via the Our Future Health on-line portal rather than using the QR access code in the invitation letter.

For 2024, the target is to reach 2 million consented participants by end of December 2024.

INCLUSION CRITERIA:

• Reside within England and Wales

• 18 years or older:

NOTE: Our Future Health are not recruiting children under the age of 18 for the following reasons:

◦ In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised, and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

◦ The aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease).

◦ Our Future Health are using an opt-in model with explicit consent; this model would be considerably complicated by the inclusion of children particularly in the absence of adequate scientific or health rationale for their recruitment.

EXCLUSION CRITERIA:

The overall cohort of participant aims to be representative across UK geographical locations, age, gender and ethnicity. It is possible as part of the creation of each NHS England mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.

Our Future Health is not recruiting individuals under the age of 18 because the aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease). In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)

Involving the public in the design of Our Future Health is vitally important to its success. Our Future Health is building a governance structure that has public involvement and engagement embedded throughout, and has already demonstrated a clear commitment to involving and engaging the public in our development, build and operational activities.

In 2020, Our Future Health involved members of the public in the design and development of the public-facing materials as well as in other aspects of the project design. The design of the participant information sheet and consent form has included:

• 18 focus groups with 82 members of the public;

• 4 meetings with a co-design group comprised of 8 members of the public; and

• 21 user testing interviews with members of the public.

During 2021 Our Future Health worked with Claremont creative agency to conduct a programme of patient and public involvement work. Over 120 members of the public were involved during 2020-2021 including:

• 4 focus groups, 2 co-design meetings, 21 interviews with the public to develop the scientific protocol

• 12 interviews with a variety of stakeholders from charities and existing cohort studies

• 2 focus groups with 11 NHS primary care staff

• 18 focus groups, 10 co-design meetings, 21 interviews with the public to co-develop the participant information sheet, consent form & other public-facing videos & materials

• 21 interviews to understand the role of industry in health research

• 4 focus groups to explore insights around recruitment methods

• 3 focus groups to explore public motivators and feedback preferences

• 1 member of the public attended the Research Ethics Committee (REC) approval meeting with a member of Our Future Health

As it was qualitative research, not quantitative, the outputs of the work are summarised as follows:

• Co-designed and REC approved Patient Information Sheet (PIS) and Consent form

• 4 co-designed explainer videos for Our Future Health (YouTube)

• Public Engagement Strategy (Claremont 2021)

• Engaging Black Audiences Report (written by an external consultant)

30 members of the public were invited to join the Our Future Health Public Advisory Board, and 14 accepted. Six are affiliate members of the Secondary Care Working Group, Ethics Advisory Board and Technology Advisory Board (with two PPIE representatives on each). The Access Board will have equal representation of expert and public/participant members.

Outputs of these groups since 2021

• Agreed Terms of Reference, working principles, PPIE training pack and evaluation matrix

• 3 meetings held in 2021 and 1 ad-hoc consultation.

• Topics for consultation and input/approval have included the Founding Industry Member Policy, Trusted Research Environment (TRE), amendments to the PIS and consent form

In 2020-2022, Our Future Health involved over 3,600 members of the public in the design and development of the major public-facing materials, as well as in other aspects of the programme design. All projects involved members of the public and included representation from the following segments: early adopters (health), early adopters (civic minded), early majority, sceptics, lower income, South Asian ethnic background and Black ethnic background.

In addition, Our Future Health have successfully appointed and trained 22 members of the public to join their advisory boards and working groups (Public Advisory Board, Secondary Care Working Group, Primary Care Working Group, Ethics Advisory Board, Technology Advisory Board, and Access Board), with a further list of over 40 volunteers Our Future Health can consult for future user testing and PPIE activities. To support members of the public in taking on these roles Our Future Health have developed a PPIE training package for new public representatives. This work has been essential to ensuring that Our Future Health developed:

• a co-designed and REC approved PIS and consent form (one member of the public attended the REC meeting alongside a member of Our Future Health Staff),

• co-designed explainer videos for Our Future Health (YouTube), and

• a Public Engagement Strategy (Claremont 2021)

An example of the work undertaken on user experience was a survey to gauge public attitudes to Our Future Health. 2,767 people completed the survey which confirmed that the general public have a high interest in receiving personalised genetic information:

77% of participants wished to receive risk information of disease which is preventable or treatable,

65% wanted non-treatable risk information, and

77% would want ancestry information.

These insights are being used to support Our Future Health's developing feedback programme.

A full set of the participant-facing materials listed below:

- Baseline Questionnaire

- Consent form

- Frequently Asked Quesitons

- Invitation letters

- Newsletter

- Participant information sheet

- Pro-forma

- Refer a friend card

- Social postcard

- Thank you, postcard

- Volunteer voices stories

- Walk-in leaflet

With regards to the baseline questionnaire, all questions must have a response entered. The Our Future Health website forces an error response to any areas that are not complete. Participants have an option to select ‘prefer not to say’ or ‘other’ in some areas.

Our Future Health has continued to develop and test variations of the invitation letters, emails and Short Message/Messaging Service (SMS) messages to measure the impact on response rates overall and for sub-populations. To date, 38 letter variations have been tested. Our Future Health will also expand their range of case studies to include a broader range of stories from across section of sub-populations and highlighting a range of research opportunities within specific disease areas.

Our Future Health has updated the health measurement results proforma to include information about diabetes risk and a link to an online risk calculator (provided by Diabetes UK). This will allow participants to generate a letter to their GP based if they are found to be at high risk on their results. Our Future Health has also provided a link to the British Heart Foundation/NHS website where participants can calculate their ‘heart age’ using the information in the results proforma. In the event that participants are shown to a higher than normal cholesterol test, the pro forma directs them to on line information to support an informed decision on next steps and individual action to reduce cholesterol.

In 2022 PPIE - via the Our Future Health Public Attitudes tracker - accumulated 2676 respondents. This was repeated in 2023, with 1,339 respondents and the most recent data shows the following in relation to Industry Involvement:

74-92% of participants viewed data access as “Very” or “Fairly acceptable” for all types of researcher,

61-76% of the general public viewed data access as “Very” or “Fairly acceptable” for all types of researcher,

86% of participants viewed partnerships with industry as “Very acceptable” or “Fairly acceptable”,

66% of the general public viewed partnerships with industry as “Very acceptable” or “Fairly acceptable”

Our Future Health, as sole Controller, are using UK GDPR Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for Our Future Health legitimate interests which are described below.

The data to which access is requested are proportionate and necessary to achieve those interests. Our Future Health have completed a Legitimate Interests Assessment (LIA) and NHS England are satisfied that the interests of the data subjects do not override their legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subject's interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS England or after a defined period on completion of the project. Our Future Health considered the purpose, necessity and balance of the programme when completing their legitimate interest assessment.

It is acknowledged that Our Future Health has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation and visit the Our Future Health website. At that point, Our Future Health solicits the potential research participant’s explicit consent to join the programme for the purposes of making a contribution to research efforts to benefit the wider public's health. Participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.

Additionally (as health data is a special category of Personal Data), Our Future Health is using UK GDPR Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. Our Future Health’s ethically approved scientific research programme seeks to make advances in early disease detection and prevention to improve public health in the wider societal interest to help people live longer lives in better health. Without this research programme improvements in the early detection and possible prevention of disease are likely to either: (a) not take place; or (b) be negatively impacted. To improve the nation’s health Our Future Health aims to recruit research participants from as broad a spectrum of society as possible as overall health is a component of behavioural, social, environmental and genetic factors.

AGREEMENT VERSION HISTORY

The initial Health Regulatory Authority’s Confidentiality Advisory Group (CAG) approval to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002 (herein after called Section 251) provided support for approximately three million potential participants to be contacted. The amendment of this Data Sharing Agreement to version 1 saw an increase to the number of invitations from three million to 12 million.

Our Future Health had received Section 251 support for approximately 12 million patients to be contacted. This increased figure was due to the creation of pop-up clinics and mobile units to enable volunteers’ measurements and blood sample to be taken, which were not available to the applicant at the time of initial section 251 application. This means potential candidates could be invited at a higher rate, and greater scale to support achieving recruitment targets.

Since initial projections to April 2023, 350k volunteers have consented to participate in the programme, in the first 6 months of active recruitment. The programme aims to form a cohort of 5million volunteers, with particular focus on groups within the population who are traditionally under-represented in medical research.

In October 2022, scale up of the integrated processes enabled higher volumes of invitations to be issued per week. These processes included:

- planning new clinics

- Running media opt-out campaigns in planned areas

- Establishing clinics and training staff

- Identifying optimal cohort characteristics for the new batch of invitations

- Issue of invitations and release of appointments for booking by recipients

- Clinic opening in time to deliver booked appointments

Invitations issued to carefully selected groups have enabled this cohort growth to be carried out while developing a cohort make up that reflects the UK population. NHS DigiTrials has supported this specifically by enabling the targeting of specific age, sex and postcode characteristics, alongside careful placement of Our Future Health pop-up clinics in those targeted areas.

The increase in the recruitment rate has mean that limit of approximately 12 million invitation mail-outs would shortly be met by June 2023 and so Version 2 of this Data Sharing Agreement saw an increase of approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs. The Health Research Authority (HRA) Confidentiality Advisory Group (CAG) and Research Ethics Committee supported the increase from approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs.

Version 3 of this Data Sharing Agreement permitted a managed extension to this DSA to end of September 2023 to allow Our Future Health to address advice provided by the Advisory Group for Data and the HRA CAG. There was no change to the number of invitations being sent out from version 2 of this agreement.

In July 2023 under version 4 of this Data Sharing Agreement Our Future Health obtained support for a further increase in invitation mail-out numbers from the Health Research Authority (HRA) Confidentiality Advisory Group (CAG) CAG supported the increase in mail-outs from approximately 16 million invitation mail-outs to approximately 20 million invitation mail-outs. This was an incremental increase, with the first two million invitations provided at the commencement of version 4 of this agreement and the following two million invitations provided once NHS England were satisfied that Our Future Health had made substantive progress to address points raised through previous advice from NHS England. Our Future health provided sufficient evidence to NHS England on the progress made, and as a result the further two million invitation mail-outs were subsequently permitted.

In version 5 of the Data Sharing Agreement - this version - Our Future Health seeks to obtain a further 5 million invitation mail-outs, taking the total number of invitations permitted to be released by NHS England to 25 million. This increase will be used to target individuals specifically in postcode areas within IMD deciles 1-3, areas with >15% non-white population or areas with higher levels of younger adults (under age 40 years).

The Confidentiality Advisory Group (CAG) support the increase in mail-outs from approximately 20 million invitation mail-outs to approximately 25 million invitation mail-outs.

REQUESTING NOT TO TAKE PART IN THE PROGRAMME:

In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the Our Future Health Programme. Our Future Health will promote this information via the dedicated programme website (https://ourfuturehealth.org.uk/) and via local media for four weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS England will also promote this information via a dedicated page on its website (https://digital.nhs.uk/services/nhs-digitrials/how-we-identify-participants-for-the-our-future-health-programme). There will also be an option for people to register their request not to take part in Our Future Health by telephone. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection and as a result their details will not be on the list passed to APS Group for invitations to be sent.

ORGANISATION’S ROLES AND RESPONSIBILITIES:

Our Future Health is the Controller. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.

Our Future Health is responsible for:

1. Generating the invitation request(s) and sending to NHS England on a regular basis

2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)

3. Monitoring scope of the population booking appointments and entering the programme.

4. Adjusting the selection criteria for subsequent invitations to adjust for underrepresentation of target populations taking up the programme.

NHS England are acting as a Processor on behalf of Our Future Health and are responsible for:

1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees

2. Feeding back to Our Future Health the number of invitees actually fulfilled out of the total target population.

3. Removing objections or opt outs (where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)

4. Sending the list of invitees on to their third-party provider (Allied Publicity Services (APS) Group) for generating the invitation letters and mailing these out

5. Agreeing with Our Future Health key processing timelines, including

a. Time from submission to APS Group to mailout

b. Date of the mail outs

c. Daily cut-off times (i.e. after which processing will take place the next day)

d. Time to feedback to Our Future Health the numbers selected

6. Overseeing performance of APS Group and alerting performance issue to Our Future Health.

7. Feeding back to Our Future Health performance in relation to Key Performance Indicators (KPIs) of APS and NHS England

8. Where the number of invitees is less than the population available, invoking a system to choose invitees at random

9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations.

APS Group are acting as a Sub-Processor of NHS England. Their responsibility is to receive the lists of invitees from NHS England and mail out to them accordingly.

APS Group also manage the letters which are returned to the service. On the reverse of each envelope, APS’ address is provided as the return address. APS Group scan the 2d barcode displayed in the envelope window of each returned letter which is the unique identifier for the letter recipient. Based on what is written on the envelope, APS Group will assign a return reason code. The physical letters will be shredded once this is undertaken.

Our Future Health, as Controller, agrees to share this returns information with NHS England in its role as a Controller for the Personal Demographics Service (PDS). The APS group will return regular file extract to NHS England which contains the following data items:

• GUID – NHS England’s Unique ID

• Family Name

• Given Name

• Address Lines 1-5

• Postcode

• Letter Template

• Return Reason code

• APS Unique ID

NHS England will use this information in accordance with its statutory functions, including but not limited to:

• maintaining the quality of patient contact information in the Personal Demographics Service under the Spine Services (no.2) 2014 Directions

• maintaining GP patient lists under Schedule 3, Part 2, paras 17 and 28 of the National Health Service (General Medical Services Contracts) Regulations 2015 (as amended) (GMS Contract Regulations) and to meet its obligations under the Primary Care Registration Management Directions 2018 to perform its functions in connection with the provision of NHS services and in particular to comply with its duties under the GMS Contract Regulations

Our Future Health have a series of Programme oversight groups with PPIE representatives. Our Future Health has a robust governance structure with appropriate management and advisory boards to ensure thorough and informed oversight, management and decision making.

FUNDING

Our Future Health received initial funding via the UK Research and Innovation (UKRI) Life Sciences Industrial Strategy, with a commitment of £79m administered via the UKRI-Innovate . For more information on the role of Our Future Health’s industrial partners, please see the YouTube video <https://m.youtube.com/watch?v=OdQd9w-0bNk>. Our Future Health also has a programme of Founding Members, which includes charities and pharmaceutical and diagnostic companies, who have agreed, between them, to contribute a total of circa £150 million funding to the programme in return for becoming a Founding Member. The Founding Members will contribute a fixed sum each and have a seat on the Founders Board. None of the founding members will view or process NHS England Data. They do not make any decisions about the way Our Future Health is conducted or how the Data is used.

As well as contributing funding, the industry and charity members will bring considerable expertise in discovering and developing new methods of prevention, early detection and treatment of diseases and health conditions. These Founding Members will help Our Future Health co-design, co-deliver and co-fund the programme. By making Our Future Health resources available to researchers both from academia and industry, it is hoped to help accelerate the discovery and development of innovative diagnostics and treatments.

Our Future Health have agreed some specific terms with industry and charity members that recognise their investment in, and support to develop, Our Future Health from its early stages. These include:

• A seat on the Founders Board – one of the boards Our Future Health are setting up to help guide and shape Our Future Health. The Founders Board will:

o provide guidance on the scientific and technical aspects of Our Future Health;

o help Our Future Health to identify emerging challenges and opportunities; and

o help to make the programme valuable to as wide a range of researchers as possible.

The Founders Board will be able to nominate experts to sit on some other advisory boards established by Our Future Health to ensure that they can benefit from their expertise across the full breadth of the programme.

• During the early years of the programme, Our Future Health’s industry members will be the only large commercial organisations that are eligible to apply to use Our Future Health resources for research. This doesn’t affect access to Our Future Health for other researchers, such as those in smaller companies (SMEs) or non-commercial organisations like universities. Industry members will apply to Our Future Health’s Access Board for approval to conduct research in the same way as other researchers. All researchers, whether they are employed by universities, government, the NHS, charities or companies, will be held to the same standards.

• Founding members, as well as other researchers that use Our Future Health, will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers in future.

• Researchers may profit from discoveries they make using Our Future Health resources. Our industry members have agreed to make reasonable efforts to ensure that innovations developed using our resources are made available

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS England will only be used to identify and invite potential participants. NHS England Record Level Identifiable Data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the Health Research Authority (HRA) and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets for 2024 are being agreed with funders for 2023 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign including key aggregate facts and figures about the recruitment progress has been running through out 2023 culminating in a significant campaign covering the achievement of 1 million participants consented by October 2023.

Whilst the outcomes of the recruitment mail-outs undertaken in this DSA do not directly benefit Health and Social Care, they are necessary to achieve secondary benefits through the eventual use of health data obtained from participants to Our Future Health as a result of these mailouts. At this current time (January 2024) approximately 18.3 million invitation letters have been sent out using the NHS DigiTrials Recruitment service and Our Future Health have recorded approximately 1.146 million individuals who have consented to participate in this project.

Our Future Health intends to be the UK’s largest ever health research programme. It is designed to help people live healthier lives for longer through the discovery and testing of more effective approaches to prevention, earlier detection and treatment of diseases.

The overarching objective of Our Future Health is to help people live healthier lives for longer through better prevention, earlier detection and improved treatment of diseases. The Our Future Health research programme will aim to speed up the discovery of new methods of early disease detection, and the evaluation of new diagnostic tools, to help identify and treat diseases early when outcomes are usually better.

To achieve these objectives, Our Future Health aims to recruit up to 5 million adults from across the UK (from a variety of different recruitment routes including NHS England) to create a diverse and inclusive cohort of people who have consented to participate in the research.

• Specific Aim 1: Build a resource linking multiple sources of health and health-relevant information, including genetic data, on millions of people in the UK, to facilitate basic discovery research by academic and commercial researchers on early indicators of disease

• Specific Aim 2: Our Future Health analyse the participant health data* in the resource to estimate personal disease risk information for participants, based on genetic and non-genetic information, and offer this estimated personal health information to participants who wish to receive it

• Specific Aim 3: Re-contact sub-groups of participants generally for additional samples, non-routine data and secondary studies over time

• Specific Aim 4: Re-contact participants on a risk-stratified basis (i.e. recall-by-genotype/phenotype or sociodemographic characteristics) over time specifically to enable secondary studies by academic and commercial researchers that is greatly enhanced by being able to identify highly enriched sub-populations/sub-cohorts of participants.

*'Data' referenced in these specific aims above are not related to the data obtained under this specific Data Sharing Agreement (DSA). This DSA relates solely to providing NHS England Data to assist with the recruitment of participants into the Our Future Health programme.

Our Future Health has taken a steady approach to trialling and testing various recruitment routes, though pilots and often in partnership with other organisations. 2021 saw early pilots with NHS Blood and Transplant, and with National Institute for Health and Care Research (NIHR) which are being developed up into larger scale recruitment routes. 2022 saw pilots in Secondary Care, and a range of community based recruitment pilots in partnership with community based organisations. By summer of 2022, recruitment began at scale with NHS DigiTrials forming a key part of the strategy to achieve recruitment targets. An initial target of 100,000 consented participants by the end of 2022 was achieved and by October 2023, the milestone of 1 million consented participants had been achieved, making Our Future Health the fastest recruiting health research programme ever.

Any reference to "the programme team" in this DSA refers to members staff employed by Our Future Health directly working on the Our Future Health programme.

The programme is being conducted throughout the UK* and the aim is to recruit a total of 5 million participants, via a number of different recruitment routes. Our Future Health made the original application in April/May 2022, seeking to pilot a new approach to recruiting to a large and unprecedented research cohort, in partnership with the NHS.

*NHS England will be providing data for England and Wales only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.

The initial application sought to issue 3 million invitations, anticipating the recruitment of circa 150,000 participants, offering a potential recruitment rate of circa 5%. Alongside this pilot, Our Future Health was trialing a partnership with Boots UK PLC which enabled invited participants to book an appointment for physical measurements and a blood sample to be taken. Since that point, the pilot with NHS DigiTrials has demonstrated significant value and success as follows:

a) Current recruitment figures – of which between 77-79% are due to Digitrials letters. (Note this is likely to be an underestimate as not all who receive a Digitrials letter use the URL or QR code in the letter to access the website.)

b) Fastest recruiting programme ever - to date Our Future Health has recruited at three times the rate of UK Biobank and securing 1 million participants in the first year.

c) Enabled release into the Our Future Health TRE of 550,000 participant questionnaires for application/access by researchers now.

d) Includes never before collected data, at this scale, including information on vaping habits of half a million people.

e) The largest number of people recruited from underrepresented groups (under 40 years, lowest income quintile and non-white ethnicity) of any comparative study

The DigiTrials partnership has enabled testing of 38 unique letter templates, including 22 changes in invitation wording or presentation. This includes assessing letter performance by age, sex, and geographic factors including ethnicity, deprivation, and (in future) preferred language. This is enabling the creation of multivariable prediction models to automatically select the best letter for a given combination of demographics, in a given region.

Our Future Health aimed to recruit approximately 175,000 participants via NHS England recruitment for the first year , but the powerful success of the NHS DigiTrials Recruitment service, coupled with successful partnerships with Boots and Acacium to provide blood sampling clinics, meant that in the first full year of recruitment activity at scale, the programme issued 15 million invitations and recruited 1 million participants. Our Future Health know that between 77-79% of consented participants definitely joined as a result of an NHS DigiTrials invitation letter, which gives a minimum conversion rate across the year of between 5.13% and 5.3%. Our Future Health also know this is an underestimate of the recruitment impact of NHS DigiTrials, as recipients are encouraged to invite family and friends, and some recipients may log on via the Our Future Health on-line portal rather than using the QR access code in the invitation letter.

For 2024, the target is to reach 2 million consented participants by end of December 2024.

INCLUSION CRITERIA:

• Reside within England and Wales

• 18 years or older:

NOTE: Our Future Health are not recruiting children under the age of 18 for the following reasons:

◦ In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised, and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

◦ The aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease).

◦ Our Future Health are using an opt-in model with explicit consent; this model would be considerably complicated by the inclusion of children particularly in the absence of adequate scientific or health rationale for their recruitment.

EXCLUSION CRITERIA:

The overall cohort of participant aims to be representative across UK geographical locations, age, gender and ethnicity. It is possible as part of the creation of each NHS England mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.

Our Future Health is not recruiting individuals under the age of 18 because the aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease). In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)

Involving the public in the design of Our Future Health is vitally important to its success. Our Future Health is building a governance structure that has public involvement and engagement embedded throughout, and has already demonstrated a clear commitment to involving and engaging the public in our development, build and operational activities.

In 2020, Our Future Health involved members of the public in the design and development of the public-facing materials as well as in other aspects of the project design. The design of the participant information sheet and consent form has included:

• 18 focus groups with 82 members of the public;

• 4 meetings with a co-design group comprised of 8 members of the public; and

• 21 user testing interviews with members of the public.

During 2021 Our Future Health worked with Claremont creative agency to conduct a programme of patient and public involvement work. Over 120 members of the public were involved during 2020-2021 including:

• 4 focus groups, 2 co-design meetings, 21 interviews with the public to develop the scientific protocol

• 12 interviews with a variety of stakeholders from charities and existing cohort studies

• 2 focus groups with 11 NHS primary care staff

• 18 focus groups, 10 co-design meetings, 21 interviews with the public to co-develop the participant information sheet, consent form & other public-facing videos & materials

• 21 interviews to understand the role of industry in health research

• 4 focus groups to explore insights around recruitment methods

• 3 focus groups to explore public motivators and feedback preferences

• 1 member of the public attended the Research Ethics Committee (REC) approval meeting with a member of Our Future Health

As it was qualitative research, not quantitative, the outputs of the work are summarised as follows:

• Co-designed and REC approved Patient Information Sheet (PIS) and Consent form

• 4 co-designed explainer videos for Our Future Health (YouTube)

• Public Engagement Strategy (Claremont 2021)

• Engaging Black Audiences Report (written by an external consultant)

30 members of the public were invited to join the Our Future Health Public Advisory Board, and 14 accepted. Six are affiliate members of the Secondary Care Working Group, Ethics Advisory Board and Technology Advisory Board (with two PPIE representatives on each). The Access Board will have equal representation of expert and public/participant members.

Outputs of these groups since 2021

• Agreed Terms of Reference, working principles, PPIE training pack and evaluation matrix

• 3 meetings held in 2021 and 1 ad-hoc consultation.

• Topics for consultation and input/approval have included the Founding Industry Member Policy, Trusted Research Environment (TRE), amendments to the PIS and consent form

In 2020-2022, Our Future Health involved over 3,600 members of the public in the design and development of the major public-facing materials, as well as in other aspects of the programme design. All projects involved members of the public and included representation from the following segments: early adopters (health), early adopters (civic minded), early majority, sceptics, lower income, South Asian ethnic background and Black ethnic background.

In addition, Our Future Health have successfully appointed and trained 22 members of the public to join their advisory boards and working groups (Public Advisory Board, Secondary Care Working Group, Primary Care Working Group, Ethics Advisory Board, Technology Advisory Board, and Access Board), with a further list of over 40 volunteers Our Future Health can consult for future user testing and PPIE activities. To support members of the public in taking on these roles Our Future Health have developed a PPIE training package for new public representatives. This work has been essential to ensuring that Our Future Health developed:

• a co-designed and REC approved PIS and consent form (one member of the public attended the REC meeting alongside a member of Our Future Health Staff),

• co-designed explainer videos for Our Future Health (YouTube), and

• a Public Engagement Strategy (Claremont 2021)

An example of the work undertaken on user experience was a survey to gauge public attitudes to Our Future Health. 2,767 people completed the survey which confirmed that the general public have a high interest in receiving personalised genetic information:

77% of participants wished to receive risk information of disease which is preventable or treatable,

65% wanted non-treatable risk information, and

77% would want ancestry information.

These insights are being used to support Our Future Health's developing feedback programme.

A full set of the participant-facing materials listed below:

- Baseline Questionnaire

- Consent form

- Frequently Asked Quesitons

- Invitation letters

- Newsletter

- Participant information sheet

- Pro-forma

- Refer a friend card

- Social postcard

- Thank you, postcard

- Volunteer voices stories

- Walk-in leaflet

With regards to the baseline questionnaire, all questions must have a response entered. The Our Future Health website forces an error response to any areas that are not complete. Participants have an option to select ‘prefer not to say’ or ‘other’ in some areas.

Our Future Health has continued to develop and test variations of the invitation letters, emails and Short Message/Messaging Service (SMS) messages to measure the impact on response rates overall and for sub-populations. To date, 38 letter variations have been tested. Our Future Health will also expand their range of case studies to include a broader range of stories from across section of sub-populations and highlighting a range of research opportunities within specific disease areas.

Our Future Health has updated the health measurement results proforma to include information about diabetes risk and a link to an online risk calculator (provided by Diabetes UK). This will allow participants to generate a letter to their GP based if they are found to be at high risk on their results. Our Future Health has also provided a link to the British Heart Foundation/NHS website where participants can calculate their ‘heart age’ using the information in the results proforma. In the event that participants are shown to a higher than normal cholesterol test, the pro forma directs them to on line information to support an informed decision on next steps and individual action to reduce cholesterol.

In 2022 PPIE - via the Our Future Health Public Attitudes tracker - accumulated 2676 respondents. This was repeated in 2023, with 1,339 respondents and the most recent data shows the following in relation to Industry Involvement:

74-92% of participants viewed data access as “Very” or “Fairly acceptable” for all types of researcher,

61-76% of the general public viewed data access as “Very” or “Fairly acceptable” for all types of researcher,

86% of participants viewed partnerships with industry as “Very acceptable” or “Fairly acceptable”,

66% of the general public viewed partnerships with industry as “Very acceptable” or “Fairly acceptable”

Our Future Health, as sole Controller, are using UK GDPR Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for Our Future Health legitimate interests which are described below.

The data to which access is requested are proportionate and necessary to achieve those interests. Our Future Health have completed a Legitimate Interests Assessment (LIA) and NHS England are satisfied that the interests of the data subjects do not override their legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subject's interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS England or after a defined period on completion of the project. Our Future Health considered the purpose, necessity and balance of the programme when completing their legitimate interest assessment.

It is acknowledged that Our Future Health has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation and visit the Our Future Health website. At that point, Our Future Health solicits the potential research participant’s explicit consent to join the programme for the purposes of making a contribution to research efforts to benefit the wider public's health. Participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.

Additionally (as health data is a special category of Personal Data), Our Future Health is using UK GDPR Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. Our Future Health’s ethically approved scientific research programme seeks to make advances in early disease detection and prevention to improve public health in the wider societal interest to help people live longer lives in better health. Without this research programme improvements in the early detection and possible prevention of disease are likely to either: (a) not take place; or (b) be negatively impacted. To improve the nation’s health Our Future Health aims to recruit research participants from as broad a spectrum of society as possible as overall health is a component of behavioural, social, environmental and genetic factors.

AGREEMENT VERSION HISTORY

The initial Health Regulatory Authority’s Confidentiality Advisory Group (CAG) approval to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002 (herein after called Section 251) provided support for approximately three million potential participants to be contacted. The amendment of this Data Sharing Agreement to version 1 saw an increase to the number of invitations from three million to 12 million.

Our Future Health had received Section 251 support for approximately 12 million patients to be contacted. This increased figure was due to the creation of pop-up clinics and mobile units to enable volunteers’ measurements and blood sample to be taken, which were not available to the applicant at the time of initial section 251 application. This means potential candidates could be invited at a higher rate, and greater scale to support achieving recruitment targets.

Since initial projections to April 2023, 350k volunteers have consented to participate in the programme, in the first 6 months of active recruitment. The programme aims to form a cohort of 5million volunteers, with particular focus on groups within the population who are traditionally under-represented in medical research.

In October 2022, scale up of the integrated processes enabled higher volumes of invitations to be issued per week. These processes included:

- planning new clinics

- Running media opt-out campaigns in planned areas

- Establishing clinics and training staff

- Identifying optimal cohort characteristics for the new batch of invitations

- Issue of invitations and release of appointments for booking by recipients

- Clinic opening in time to deliver booked appointments

Invitations issued to carefully selected groups have enabled this cohort growth to be carried out while developing a cohort make up that reflects the UK population. NHS DigiTrials has supported this specifically by enabling the targeting of specific age, sex and postcode characteristics, alongside careful placement of Our Future Health pop-up clinics in those targeted areas.

The increase in the recruitment rate has mean that limit of approximately 12 million invitation mail-outs would shortly be met by June 2023 and so Version 2 of this Data Sharing Agreement saw an increase of approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs. The Health Research Authority (HRA) Confidentiality Advisory Group (CAG) and Research Ethics Committee supported the increase from approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs.

Version 3 of this Data Sharing Agreement permitted a managed extension to this DSA to end of September 2023 to allow Our Future Health to address advice provided by the Advisory Group for Data and the HRA CAG. There was no change to the number of invitations being sent out from version 2 of this agreement.

In July 2023 under version 4 of this Data Sharing Agreement Our Future Health obtained support for a further increase in invitation mail-out numbers from the Health Research Authority (HRA) Confidentiality Advisory Group (CAG) CAG supported the increase in mail-outs from approximately 16 million invitation mail-outs to approximately 20 million invitation mail-outs. This was an incremental increase, with the first two million invitations provided at the commencement of version 4 of this agreement and the following two million invitations provided once NHS England were satisfied that Our Future Health had made substantive progress to address points raised through previous advice from NHS England. Our Future health provided sufficient evidence to NHS England on the progress made, and as a result the further two million invitation mail-outs were subsequently permitted.

In version 5 of the Data Sharing Agreement - this version - Our Future Health seeks to obtain a further 5 million invitation mail-outs, taking the total number of invitations permitted to be released by NHS England to 25 million. This increase will be used to target individuals specifically in postcode areas within IMD deciles 1-3, areas with >15% non-white population or areas with higher levels of younger adults (under age 40 years).

The Confidentiality Advisory Group (CAG) support the increase in mail-outs from approximately 20 million invitation mail-outs to approximately 25 million invitation mail-outs.

REQUESTING NOT TO TAKE PART IN THE PROGRAMME:

In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the Our Future Health Programme. Our Future Health will promote this information via the dedicated programme website (https://ourfuturehealth.org.uk/) and via local media for four weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS England will also promote this information via a dedicated page on its website (https://digital.nhs.uk/services/nhs-digitrials/how-we-identify-participants-for-the-our-future-health-programme). There will also be an option for people to register their request not to take part in Our Future Health by telephone. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection and as a result their details will not be on the list passed to APS Group for invitations to be sent.

ORGANISATION’S ROLES AND RESPONSIBILITIES:

Our Future Health is the Controller. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.

Our Future Health is responsible for:

1. Generating the invitation request(s) and sending to NHS England on a regular basis

2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)

3. Monitoring scope of the population booking appointments and entering the programme.

4. Adjusting the selection criteria for subsequent invitations to adjust for underrepresentation of target populations taking up the programme.

NHS England are acting as a Processor on behalf of Our Future Health and are responsible for:

1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees

2. Feeding back to Our Future Health the number of invitees actually fulfilled out of the total target population.

3. Removing objections or opt outs (where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)

4. Sending the list of invitees on to their third-party provider (Allied Publicity Services (APS) Group) for generating the invitation letters and mailing these out

5. Agreeing with Our Future Health key processing timelines, including

a. Time from submission to APS Group to mailout

b. Date of the mail outs

c. Daily cut-off times (i.e. after which processing will take place the next day)

d. Time to feedback to Our Future Health the numbers selected

6. Overseeing performance of APS Group and alerting performance issue to Our Future Health.

7. Feeding back to Our Future Health performance in relation to Key Performance Indicators (KPIs) of APS and NHS England

8. Where the number of invitees is less than the population available, invoking a system to choose invitees at random

9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations.

APS Group are acting as a Sub-Processor of NHS England. Their responsibility is to receive the lists of invitees from NHS England and mail out to them accordingly.

A 'return to sender' address will be included on the letters. When letters are unable to be delivered to the participant address provided by NHS England - they will be returned to APS Group where they will be shredded. APS Group will provide NHS England with an aggregate report of number of returned letter.

Our Future Health have a series of Programme oversight groups with PPIE representatives. Our Future Health has a robust governance structure with appropriate management and advisory boards to ensure thorough and informed oversight, management and decision making.

FUNDING

Our Future Health received initial funding via the UK Research and Innovation (UKRI) Life Sciences Industrial Strategy, with a commitment of £79m administered via the UKRI-Innovate . For more information on the role of Our Future Health’s industrial partners, please see the YouTube video <https://m.youtube.com/watch?v=OdQd9w-0bNk>. Our Future Health also has a programme of Founding Members, which includes charities and pharmaceutical and diagnostic companies, who have agreed, between them, to contribute a total of circa £150 million funding to the programme in return for becoming a Founding Member. The Founding Members will contribute a fixed sum each and have a seat on the Founders Board. None of the founding members will view or process NHS England Data. They do not make any decisions about the way Our Future Health is conducted or how the Data is used.

As well as contributing funding, the industry and charity members will bring considerable expertise in discovering and developing new methods of prevention, early detection and treatment of diseases and health conditions. These Founding Members will help Our Future Health co-design, co-deliver and co-fund the programme. By making Our Future Health resources available to researchers both from academia and industry, it is hoped to help accelerate the discovery and development of innovative diagnostics and treatments.

Our Future Health have agreed some specific terms with industry and charity members that recognise their investment in, and support to develop, Our Future Health from its early stages. These include:

• A seat on the Founders Board – one of the boards Our Future Health are setting up to help guide and shape Our Future Health. The Founders Board will:

o provide guidance on the scientific and technical aspects of Our Future Health;

o help Our Future Health to identify emerging challenges and opportunities; and

o help to make the programme valuable to as wide a range of researchers as possible.

The Founders Board will be able to nominate experts to sit on some other advisory boards established by Our Future Health to ensure that they can benefit from their expertise across the full breadth of the programme.

• During the early years of the programme, Our Future Health’s industry members will be the only large commercial organisations that are eligible to apply to use Our Future Health resources for research. This doesn’t affect access to Our Future Health for other researchers, such as those in smaller companies (SMEs) or non-commercial organisations like universities. Industry members will apply to Our Future Health’s Access Board for approval to conduct research in the same way as other researchers. All researchers, whether they are employed by universities, government, the NHS, charities or companies, will be held to the same standards.

• Founding members, as well as other researchers that use Our Future Health, will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers in future.

• Researchers may profit from discoveries they make using Our Future Health resources. Our industry members have agreed to make reasonable efforts to ensure that innovations developed using our resources are made available in the UK to benefit NHS patients.

No NHS England Record Level Data covered by this DSA will be shared with any funders and final decision making on processing of the data rests with Our Future Health Executive Team and Board who are all substantive employees, therefore the funders are not Controllers or Processors in this DSA.

While Our Future Health are the Controller for this programme, they will have no access to the patient-level identifiable Data provided by NHS England to APS Group under this DSA.

COMMERCIAL PURPOSE

In the interests of full transparency, it is noted here that the programme is funded by commercial entities, who could ultimately benefit from the programme and the analyses produced.

There are several ways in which companies may become involved in Our Future Health:

>As a provider of products or services that the project will need.

>Providing part of the funding needed to set up and deliver the programme.

>Applying to analyse the de-identified data and samples to look for new ways to detect and treat diseases – there will be a fee charged for this.

>Running studies that involve re-contacting Our Future Health participants to ask if they want to take part in additional research designed to explore new

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS England will only be used to identify and invite potential participants. NHS England Record Level Identifiable Data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the Health Research Authority (HRA) and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets for 2024 are being agreed with funders for 2023 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign including key aggregate facts and figures about the recruitment progress has been running through out 2023 culminating in a significant campaign covering the achievement of 1 million participants consented by October 2023.

Whilst the outcomes of the recruitment mail-outs undertaken in this DSA do not directly benefit Health and Social Care, they are necessary to achieve secondary benefits through the eventual use of health data obtained from participants to Our Future Health as a result of these mailouts. At this current time (January 2024) approximately 18.3 million invitation letters have been sent out using the NHS DigiTrials Recruitment service and Our Future Health have recorded approximately 1.146 million individuals who have consented to participate in this project.

BACKGROUND

Our Future Health intends to be the UK’s largest ever health research programme. It is designed to help people live healthier lives for longer through the discovery and testing of more effective approaches to prevention, earlier detection and treatment of diseases.

Our Future Health's goal is to recruit up to five million adult volunteers from across the UK to create an incredibly detailed picture that truly reflects the whole of the population.

THE AIM OF THE PROGRAMME

The overarching objective of Our Future Health is to help people live healthier lives for longer through better prevention, earlier detection and improved treatment of diseases. The Our Future Health research programme will aim to speed up the discovery of new methods of early disease detection, and the evaluation of new diagnostic tools, to help identify and treat diseases early when outcomes are usually better.

To achieve these objectives, Our Future Health aims to recruit up to 5 million adults from across the UK (from a variety of different recruitment routes including NHS England) to create a diverse and inclusive cohort of people who have consented to participate in the research.

• Specific Aim 1: Build a resource linking multiple sources of health and health-relevant information, including genetic data, on millions of people in the UK, to facilitate basic discovery research by academic and commercial researchers on early indicators of disease

• Specific Aim 2: Our Future Health analyse the participant health data* in the resource to estimate personal disease risk information for participants, based on genetic and non-genetic information, and offer this estimated personal health information to participants who wish to receive it

• Specific Aim 3: Re-contact sub-groups of participants generally for additional samples, non-routine data and secondary studies over time

• Specific Aim 4: Re-contact participants on a risk-stratified basis (i.e. recall-by-genotype/phenotype or sociodemographic characteristics) over time specifically to enable secondary studies by academic and commercial researchers that is greatly enhanced by being able to identify highly enriched sub-populations/sub-cohorts of participants.

*'Data' referenced in these specific aims above are not related to the data obtained under this specific agreement. This agreement relates solely to providing data to assist with the recruitment of participants into the Our Future Health programme.

BACKGROUND TO RECRUITMENT

Our Future Health has taken a steady approach to trialling and testing various recruitment routes, though pilots and often in partnership with other organisations. 2021 saw early pilots with NHS Blood and Transplant, and with National Institute for Health and Care Research (NIHR) which are being developed up into larger scale recruitment routes. 2022 has seen pilots in Secondary Care, and a range of community based recruitment pilots in partnership with community based organisations. The NHS DigiTrials services will form a key part of the strategy to achieve recruitment targets in 2023.

PROGRAMME TEAM

Any reference to "the programme team" in this agreement refers to members staff employed by Our Future Health directly working on the Our Future Health programme.

PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)

Involving the public in the design of Our Future Health will be vitally important to its success. Our Future Health is building a governance structure that has public involvement and engagement embedded throughout, and has already demonstrated a clear commitment to involving and engaging the public in our development, build and operational activities.

In 2020, Our Future Health involved members of the public in the design and development of the public-facing materials as well as in other aspects of the project design. The design of the participant information sheet and consent form has included:

• 18 focus groups with 82 members of the public;

• 4 meetings with a co-design group comprised of 8 members of the public; and

• 21 user testing interviews with members of the public.

During 2021 Our Future Health worked with Claremont creative agency to conduct a programme of patient and public involvement work. Over 120 members of the public were involved during 2020-2021 including:

• 4 focus groups, 2 co-design meetings, 21 interviews with the public to develop the scientific protocol

• 12 interviews with a variety of stakeholders from charities and existing cohort studies

• 2 focus groups with 11 NHS primary care staff

• 18 focus groups, 10 co-design meetings, 21 interviews with the public to co-develop the participant information sheet, consent form & other public-facing videos & materials

• 21 interviews to understand the role of industry in health research

• 4 focus groups to explore insights around recruitment methods

• 3 focus groups to explore public motivators and feedback preferences

• 1 member of the public attended the REC approval meeting with a member of Our Future Health

As it was qualitative research, not quantitative, the outputs of the work are summarised as follows:

• Co-designed and REC approved PIS and Consent form

• 4 co-designed explainer videos for Our Future Health (YouTube)

• Public Engagement Strategy (Claremont 2021)

• Engaging Black Audiences Report (written by an external consultant)

30 members of the public were invited to join the Our Future Health Public Advisory Board, and 14 accepted. 6 are affiliate members of the Secondary Care Working Group, Ethics Advisory Board and Technology Advisory Board (with 2 PPIE representatives on each). The Access Board will have equal representation of expert and public/participant members.

Outputs of these groups since 2021

• Agreed Terms of Reference, working principles, PPIE training pack and evaluation matrix

• 3 meetings held in 2021 and 1 ad-hoc consultation.

• Topics for consultation and input/approval have included the Founding Industry Member Policy, TRE, amendments to the PIS and consent form

In 2020-2022, Our Future Health involved over 3,600 members of the public in the design and development of the major public-facing materials, as well as in other aspects of the programme design. All projects involved members of the public and included representation from the following segments: early adopters (health), early adopters (civic minded), early majority, sceptics, lower income, South Asian ethnic background and Black ethnic background.

In addition, Our Future Health have successfully appointed and trained 22 members of the public to join their advisory boards and working groups (Public Advisory Board, Secondary Care Working Group, Primary Care Working Group, Ethics Advisory Board, Technology Advisory Board, and Access Board), with a further list of over 40 volunteers Our Future Health can consult for future user testing and PPIE activities. To support members of the public in taking on these roles Our Future Health have developed a PPIE training package for new public representatives.

This work has been essential to ensuring that Our Future Health developed:

• a co-designed and REC approved PIS and consent form (one member of the public attended the REC meeting alongside a member of Our Future Health Staff),

• co-designed explainer videos for Our Future Health (YouTube), and

• a Public Engagement Strategy (Claremont 2021)

An example of the work undertaken on user experience was a survey to gauge public attitudes to Our Future Health. 2,767 people completed the survey which confirmed that the general public have a high interest in receiving personalised genetic information: 77% of participants wished to receive risk information of disease which is preventable or treatable, 65% wanted non-treatable risk information and 77% would want ancestry information.

These insights are being used to support Our Future Health's developing feedback programme.

A full set of the participant-facing materials listed below::

 Baseline Questionnaire

 Consent form

 FAQs

 Invitation letters

 Newsletter

 Participant information sheet

 Pro-forma

 Refer a friend card

 Social postcard

 Thank you, postcard

 Volunteer voices stories

 Walk-in leaflet

With regards to the baseline questionnaire, all questions must have a response entered. The website forces an error response to any areas that are not complete. Participants have an option to select ‘prefer not to say’ or ‘other’ in some areas.

Our Future Health will continue to develop and test variations of the invitation letters, emails and SMS messages to measure the impact on response rates overall and for sub-populations. Our Future Health will also expand their range of case studies to include a broader range of stories from across section of sub-populations and highlighting a range of research opportunities within specific disease areas.

Our Future Health are planning to update the health measurement results proforma to include information about diabetes risk and a link to an online risk calculator (provided by Diabetes UK). This will allow participants to generate a letter to their GP based if they are found to be at high risk on their results. Our Future Health will also be providing a link to the British Heart Foundation/NHS website where participants can calculate their ‘heart age’ using the information in the results proforma.

Ongoing PPIE via the Public Attitudes tracker, currently has 2676 respondents and the most recent data shows the following in relation to industry involvement and trust:

Industry Involvement:

 40.69% (485/1192) would feel comfortable with pharma, diagnostic and health tech companies having access to health information

 64.85% (773/1192) agree that partnerships with charities and industry will improve Our Future health

20.72% (247/1192) agree that partnerships with charities and industry would make them more likely to take part

14.26% (170/1192) agree that partnerships with charities and industry would make them less likely to take part

Measures of trust

 81.5% (971/1192) generally trust medical researchers in universities

 79.8% (951/1192) generally trust the NHS

 62.8% (746/1192) generally trust medical charities

 25.0% (498/1192) generally trust pharmaceutical companies

 22.6% (269/1192) generally trust the government

The most recent PPIE involved 15 members of the Public Advisory Group, the Ethics Advisory Group and the Equality, Diversity and Inclusion Group who were surveyed to establish views on increasing the volume of invitations sent via NHS DigiTrials.

Supporting information provided to the respondents described the legal framework of a CAG Section 251 approval, and the process of issuing invitations via NHS DigiTrials. It set out benefits and risks as follows, and all respondents were offered the opportunity to attend a Q&A session (either in a group session, or in smaller groups/one to one sessions where availability required it) to help them explore their views, ask questions and confirm their understanding prior to completing the survey.

The supporting information highlighted the following key risks and benefits:

1) Key benefits of using this approach include:

a) Ability to provide a personal invitation letter reaching every adult, especially those in traditionally under-represented groups. This will maximise Our Future Health's opportunity to create a health research database that includes more people from these groups than has previously been achieved

b) Ability to prioritise those who live in areas of high deprivation, and areas with higher levels of ethnic minorities to maximise the opportunity for people in these groups to join.

2) Key risks include:

a) Individuals might not feel comfortable being personally contacted by Our Future Health via their partnership with the NHS. This might cause some people to experience anxiety or anger.

b) The 3rd party mailing house responsible for printing and sending the invitations misuses the name and address information of the individuals we are contacting.

Summary results showed:

 in response to the question asking if the benefits of increasing the volume of invitations (to 45 million) outweighed the risks,

 66% (10) of respondents strongly, or somewhat agreed.

 19% (3) of respondents strongly or somewhat disagreed.

 13% (2) neither agreed nor disagreed.

UK GDPR LEGAL BASIS FOR PROCESSING OF PERSONAL DATA

Our Future Health, as sole Data Controller, are using Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for Our Future Health legitimate interests which are described below. The data to which access is requested are proportionate and necessary to achieve those interests. Our Future Health have completed a legitimate interests assessment (LIA) and NHS England are satisfied that the interests of the data subjects do not override their legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS England or after a defined period on completion of the project. Our Future Health considered the purpose, necessity and balance of the programme when completing their legitimate interest assessment.

It is acknowledged that Our Future Health has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation and visit the Our Future Health website. At that point, Our Future Health solicits the potential research participant’s explicit consent to join the programme for the purposes of making a contribution to research efforts to benefit the wider public's health. Participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.

Additionally (as health data is a special category of Personal Data), Our Future Health is using Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. Our Future Health’s ethically approved scientific research programme seeks to make advances in early disease detection and prevention to improve public health in the wider societal interest to help people live longer lives in better health. Without this research programme improvements in the early detection and possible prevention of disease are likely to either: (a) not take place; or (b) be negatively impacted. To improve the nation’s health Our Future Health aims to recruit research participants from as broad a spectrum of society as possible as overall health is a component of behavioural, social, environmental and genetic factors.

INCLUSION AND EXCLUSION CRITERIA

The programme will be conducted throughout the UK* and the aim is to recruit a total of 5 million participants, via a number of different recruitment routes. Our Future Health aim to recruit approximately 175,000 participants via NHS England recruitment for the first year.

*NHS England will be providing data for England and Wales only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.

Inclusion criteria:

• Reside within England and Wales

• 18 years or older:

NOTE: Our Future Health are not recruiting children under the age of 18 for the following reasons:

◦ In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised, and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

◦ The aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease).

◦ Our Future Health are using an opt-in model with explicit consent; this model would be considerably complicated by the inclusion of children particularly in the absence of adequate scientific or health rationale for their recruitment.

Exclusion criteria:

The overall cohort of participant aims to be representative across UK geographical locations, age, gender and ethnicity. It is possible as part of the creation of each NHS England mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.

Our Future Health is not recruiting individuals under the age of 18 because the aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease). In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

Recruitment began in Summer 2022 and will take place over several years. For the first year of recruitment, approximately 3 million patients will be identified and contacted. With an assumed response rate of 5%, approximately 175,000 patients should be recruited, however this recruitment target is an estimate and may be subject to change. The recruitment target and number of invites will be reviewed for future years.

AGREEMENT VERSION HISTORY

The initial Health Regulatory Authority’s Confidentiality Advisory Group (CAG) approval to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002 (herein after called Section 251) provided support for approximately three million potential participants to be contacted. The amendment of the agreement to version 1 saw an increase to the number of invitations from three million to 12 million.

Our Future Health had received Section 251 support for approximately 12 million patients to be contacted. This increased figure was due to the creation of pop-up clinics and mobile units to enable volunteers’ measurements and blood sample to be taken, which were not available to the applicant at the time of initial section 251 application. This means potential candidates could be invited at a higher rate, and greater scale to support achieving recruitment targets.

Since initial projections to April 2023, 350k volunteers have consented to participate in the programme, in the first 6 months of active recruitment. The programme aims to form a cohort of 5million volunteers, with particular focus on groups within the population who are traditionally under-represented in medical research.

In October 2022, scale up of the integrated processes enabled higher volumes of invitations to be issued per week. These processes included:

planning new clinics

Running media opt-out campaigns in planned areas

Establishing clinics and training staff

Identifying optimal cohort characteristics for the new batch of invitations

Issue of invitations and release of appointments for booking by recipients

Clinic opening in time to deliver booked appointments

Invitations issued to carefully selected groups have enabled this cohort growth to be carried out while developing a cohort make up that reflects the UK population. NHS DigiTrials has supported this specifically by enabling the targeting of specific age, sex and postcode characteristics, alongside careful placement of Our Future Health pop-up clinics in those targeted areas.

The increase in the recruitment rate has mean that limit of approximately 12 million invitation mail-outs would shortly be met by June 2023 and so Version 2 of the agreement saw an increase of approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs. The Health Research Authority (HRA) Confidentiality Advisory Group (CAG) and Research Ethics Committee supported the increase from approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs.

Version 3 of this agreement permitted a managed extension to this agreement to end of September 2023 to allow Our Future Health to address advice provided by the Advisory Board for Data and the HRA CAG. There was no change to the number of invitations being sent out from version 2 of this agreement.

**************** NEW FOR VERSION 4 OF THIS AGREEMENT ****************

Our Future Health sought a further increase in invitation numbers with the Health Research Authority (HRA) Confidentiality Advisory Group (CAG) in May 2023. CAG have supported the increase in mail-outs from approximately 16 million invitation mail-outs to approximately 20 million invitation mail-outs. This is an incremental increase, dependent on Our Future Health satisfying the relevant special conditions as set out by NHS England.

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REQUESTING NOT TO TAKE PART IN THE PROGRAMME:

In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the Our Future Health Programme. Our Future Health will promote this information via the dedicated programme website (https://ourfuturehealth.org.uk/) and via local media for four weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS England will also promote this information via a dedicated page on its website (https://digital.nhs.uk/services/nhs-digitrials/how-we-identify-participants-for-the-our-future-health-programme). There will also be an option for people to register their request not to take part in Our Future Health by telephone. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection and as a result their details will not be on the list passed to APS Group for invitations to be sent.

ORGANISATION’S ROLES AND RESPONSIBILITIES:

Our Future Health is the data controller. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.

Our Future Health is responsible for:

1. Generating the invitation request(s) and sending to NHS England on a regular basis

2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)

3. Monitoring scope of the population booking appointments and entering the programme.

4. Adjusting the selection criteria for subsequent invitations to adjust for underrepresentation of target populations taking up the programme.

NHS England are acting as a data processor on behalf of Our Future Health and are responsible for:

1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees

2. Feeding back to Our Future Health the number of invitees actually fulfilled out of the total target population.

3. Removing objections or opt outs (where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)

4. Sending the list of invitees on to their third-party provider (Allied Publicity Services (APS) Group) for generating the invitation letters and mailing these out

5. Agreeing with Our Future Health key processing timelines, including

a. Time from submission to APS Group to mailout

b. Date of the mail outs

c. Daily cut-off times (i.e. after which processing will take place the next day)

d. Time to feedback to Our Future Health the numbers selected

6. Overseeing performance of APS Group and alerting performance issue to Our Future Health.

7. Feeding back to Our Future Health performance in relation to Key Performance Indicators (KPIs) of APS and NHS England

8. Where the number of invitees is less than the population available, invoking a system to choose invitees at random

9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations.

APS Group are acting as a sub-processor of NHS England. Their responsibility is to receive the lists of invitees from NHS England and mail out to them accordingly.

A 'return to sender' address will be included on the letters. When letters are unable to be delivered to the participant address provided by NHS England - they will be returned to APS Group where they will be shredded. APS Group will provide NHS England with an aggregate report of number of returned letter.

Our Future Health have a series of Programme oversight groups with PPIE representatives. Our Future Health has a robust governance structure with appropriate management and advisory boards to ensure thorough and informed oversight, management and decision making.

FUNDING

Our Future Health received initial funding via the UK Research and Innovation (UKRI) Life Sciences Industrial Strategy, with a commitment of £79m administered via the UKRI-Innovate UK and £150 million funding from life sciences companies. For more information on the role of Our Future Health’s industrial partners, please see the YouTube video <https://m.youtube.com/watch?v=OdQd9w-0bNk>. Our Future Health also have a programme of Founding Members, which will include charities and pharmaceutical and diagnostic companies, who will contribute funding to the programme in return for becoming a Founding Member.

As well as contributing funding, the industry and charity members will bring considerable expertise in discovering and developing new methods of prevention, early detection and treatment of diseases and health conditions. These Founding Members will help Our Future Health co-design, co-deliver and co-fund the programme. By making Our Future Health resources available to researchers both from academia and industry, it is hoped to help accelerate the discovery and development of innovative diagnostics and treatments.

Our Future Health have agreed some specific terms with industry and charity members that recognise their investment in, and support to develop, Our Future Health from its early stages. These include:

• a seat on the Founders Board – one of the boards Our Future Health are setting up to help guide and shape Our Future Health. The Founders Board will:

o provide guidance on the scientific and technical aspects of Our Future Health;

o help Our Future Health to identify emerging challenges and opportunities; and

o help to make the programme valuable to as wide a range of researchers as possible.

The Founders Board will be able to nominate experts to sit on some other advisory boards established by Our Future Health to ensure that they can benefit from their expertise across the full breadth of the programme.

• During the early years of the programme, Our Future Health’s industry members will be the only large commercial organisations that are eligible to apply to use Our Future Health resources for research. This doesn’t affect access to Our Future Health for other researchers, such as those in smaller companies (SMEs) or non-commercial organisations like universities. Industry members will apply to Our Future Health’s Access Board for approval to conduct research in the same way as other researchers. All researchers, whether they are employed by universities, government, the NHS, charities or companies, will be held to the same standards.

• Founding members, as well as other researchers that use Our Future Health, will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers in future.

• Researchers may profit from discoveries they make using Our Future Health resources. Our industry members have agreed to make reasonable efforts to ensure that innovations developed using our resources are made available in the UK to benefit NHS patients.

No NHS England Record Level data covered by this Data Sharing Agreement will be shared with any funders and final decision making on processing of the data rests with Our Future Health Executive Team and Board who are all substantive employees, therefore the funders are not Data Controllers or Data Processors on this agreement.

COMMERCIAL PURPOSE

In the interests of full transparency, it is noted here that the programme is funded by commercial entities, who could ultimately benefit from the programme and the analyses produced.

It will take several years for discoveries to emerge from the research programme and any researchers, whether commercial or non-commercial, may profit from the discoveries they make from research using Our Future Health.

However, researchers who use Our Future Health will be required to disseminate the results of their research as rapidly and widely as possible, subject to ethics and confidentiality considerations. They will be encouraged to discuss their research findings with other scientists and the public, and to share relevant data and materials as openly as possible.

Researchers will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers and the public in future.

While Our Future Health are the data controller for this programme, they will have no access to the patient-level identifiable data provided by NHS England to APS Group under this agreement.

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS England will only be used to identify and invite potential participants. NHS England record Level Identifiable data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the HRA and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets have been set for 2023 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign may include key aggregate facts and figures about the recruitment progress.

Whilst the outcomes of the recruitment mail-outs undertaken in this agreement do not directly benefit Health and Social Care, they are necessary to achieve secondary benefits through the eventual use of health data obtained from participants to OFH as a result of these mailouts. At this current time (July 2023), approximately 13,680,000 invitation letters have been sent out using DigiTrials Recruitment service, and Our Future Health have recorded approximately 525,000 individuals who have consented to participate in this project.

BACKGROUND

Our Future Health intends to be the UK’s largest ever health research programme. It is designed to help people live healthier lives for longer through the discovery and testing of more effective approaches to prevention, earlier detection and treatment of diseases.

Our Future Health's goal is to recruit up to five million adult volunteers from across the UK to create an incredibly detailed picture that truly reflects the whole of the population.

THE AIM OF THE PROGRAMME

The overarching objective of Our Future Health is to help people live healthier lives for longer through better prevention, earlier detection and improved treatment of diseases. The Our Future Health research programme will aim to speed up the discovery of new methods of early disease detection, and the evaluation of new diagnostic tools, to help identify and treat diseases early when outcomes are usually better.

To achieve these objectives, Our Future Health aims to recruit up to 5 million adults from across the UK (from a variety of different recruitment routes including NHS England) to create a diverse and inclusive cohort of people who have consented to participate in the research.

• Specific Aim 1: Build a resource linking multiple sources of health and health-relevant information, including genetic data, on millions of people in the UK, to facilitate basic discovery research by academic and commercial researchers on early indicators of disease

• Specific Aim 2: Our Future Health analyse the participant health data* in the resource to estimate personal disease risk information for participants, based on genetic and non-genetic information, and offer this estimated personal health information to participants who wish to receive it

• Specific Aim 3: Re-contact sub-groups of participants generally for additional samples, non-routine data and secondary studies over time

• Specific Aim 4: Re-contact participants on a risk-stratified basis (i.e. recall-by-genotype/phenotype or sociodemographic characteristics) over time specifically to enable secondary studies by academic and commercial researchers that is greatly enhanced by being able to identify highly enriched sub-populations/sub-cohorts of participants.

*'Data' referenced in these specific aims above are not related to the data obtained under this specific agreement. This agreement relates solely to providing data to assist with the recruitment of participants into the Our Future Health programme.

BACKGROUND TO RECRUITMENT

Our Future Health has taken a steady approach to trialling and testing various recruitment routes, though pilots and often in partnership with other organisations. 2021 saw early pilots with NHS Blood and Transplant, and with National Institute for Health and Care Research (NIHR) which are being developed up into larger scale recruitment routes. 2022 has seen pilots in Secondary Care, and a range of community based recruitment pilots in partnership with community based organisations. The NHS DigiTrials services will form a key part of the strategy to achieve recruitment targets in 2023.

PROGRAMME TEAM

Any reference to "the programme team" in this agreement refers to members staff employed by Our Future Health directly working on the Our Future Health programme.

PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)

Involving the public in the design of Our Future Health will be vitally important to its success. Our Future Health is building a governance structure that has public involvement and engagement embedded throughout, and has already demonstrated a clear commitment to involving and engaging the public in our development, build and operational activities.

In 2020, Our Future Health involved members of the public in the design and development of the public-facing materials as well as in other aspects of the project design. The design of the participant information sheet and consent form has included:

• 18 focus groups with 82 members of the public;

• 4 meetings with a co-design group comprised of 8 members of the public; and

• 21 user testing interviews with members of the public.

During 2021 Our Future Health worked with Claremont creative agency to conduct a programme of patient and public involvement work. Over 120 members of the public were involved during 2020-2021 including:

• 4 focus groups, 2 co-design meetings, 21 interviews with the public to develop the scientific protocol

• 12 interviews with a variety of stakeholders from charities and existing cohort studies

• 2 focus groups with 11 NHS primary care staff

• 18 focus groups, 10 co-design meetings, 21 interviews with the public to co-develop the participant information sheet, consent form & other public-facing videos & materials

• 21 interviews to understand the role of industry in health research

• 4 focus groups to explore insights around recruitment methods

• 3 focus groups to explore public motivators and feedback preferences

• 1 member of the public attended the REC approval meeting with a member of Our Future Health

As it was qualitative research, not quantitative, the outputs of the work are summarised as follows:

• Co-designed and REC approved PIS and Consent form

• 4 co-designed explainer videos for Our Future Health (YouTube)

• Public Engagement Strategy (Claremont 2021)

• Engaging Black Audiences Report (written by an external consultant)

30 members of the public were invited to join the Our Future Health Public Advisory Board, and 14 accepted. 6 are affiliate members of the Secondary Care Working Group, Ethics Advisory Board and Technology Advisory Board (with 2 PPIE representatives on each). The Access Board will have equal representation of expert and public/participant members.

Outputs of these groups since 2021

• Agreed Terms of Reference, working principles, PPIE training pack and evaluation matrix

• 3 meetings held in 2021 and 1 ad-hoc consultation.

• Topics for consultation and input/approval have included the Founding Industry Member Policy, TRE, amendments to the PIS and consent form

In 2020-2022, Our Future Health involved over 3,600 members of the public in the design and development of the major public-facing materials, as well as in other aspects of the programme design. All projects involved members of the public and included representation from the following segments: early adopters (health), early adopters (civic minded), early majority, sceptics, lower income, South Asian ethnic background and Black ethnic background.

In addition, Our Future Health have successfully appointed and trained 22 members of the public to join their advisory boards and working groups (Public Advisory Board, Secondary Care Working Group, Primary Care Working Group, Ethics Advisory Board, Technology Advisory Board, and Access Board), with a further list of over 40 volunteers Our Future Health can consult for future user testing and PPIE activities. To support members of the public in taking on these roles Our Future Health have developed a PPIE training package for new public representatives.

This work has been essential to ensuring that Our Future Health developed:

• a co-designed and REC approved PIS and consent form (one member of the public attended the REC meeting alongside a member of Our Future Health Staff),

• co-designed explainer videos for Our Future Health (YouTube), and

• a Public Engagement Strategy (Claremont 2021)

An example of the work undertaken on user experience was a survey to gauge public attitudes to Our Future Health. 2,767 people completed the survey which confirmed that the general public have a high interest in receiving personalised genetic information: 77% of participants wished to receive risk information of disease which is preventable or treatable, 65% wanted non-treatable risk information and 77% would want ancestry information.

These insights are being used to support Our Future Health's developing feedback programme.

A full set of the participant-facing materials listed below::

 Baseline Questionnaire

 Consent form

 FAQs

 Invitation letters

 Newsletter

 Participant information sheet

 Pro-forma

 Refer a friend card

 Social postcard

 Thank you, postcard

 Volunteer voices stories

 Walk-in leaflet

With regards to the baseline questionnaire, all questions must have a response entered. The website forces an error response to any areas that are not complete. Participants have an option to select ‘prefer not to say’ or ‘other’ in some areas.

Our Future Health will continue to develop and test variations of the invitation letters, emails and SMS messages to measure the impact on response rates overall and for sub-populations. Our Future Health will also expand their range of case studies to include a broader range of stories from across section of sub-populations and highlighting a range of research opportunities within specific disease areas.

Our Future Health are planning to update the health measurement results proforma to include information about diabetes risk and a link to an online risk calculator (provided by Diabetes UK). This will allow participants to generate a letter to their GP based if they are found to be at high risk on their results. Our Future Health will also be providing a link to the British Heart Foundation/NHS website where participants can calculate their ‘heart age’ using the information in the results proforma.

Ongoing PPIE via the Public Attitudes tracker, currently has 2676 respondents and the most recent data shows the following in relation to industry involvement and trust:

Industry Involvement:

 40.69% (485/1192) would feel comfortable with pharma, diagnostic and health tech companies having access to health information

 64.85% (773/1192) agree that partnerships with charities and industry will improve Our Future health

20.72% (247/1192) agree that partnerships with charities and industry would make them more likely to take part

14.26% (170/1192) agree that partnerships with charities and industry would make them less likely to take part

Measures of trust

 81.5% (971/1192) generally trust medical researchers in universities

 79.8% (951/1192) generally trust the NHS

 62.8% (746/1192) generally trust medical charities

 25.0% (498/1192) generally trust pharmaceutical companies

 22.6% (269/1192) generally trust the government

The most recent PPIE involved 15 members of the Public Advisory Group, the Ethics Advisory Group and the Equality, Diversity and Inclusion Group who were surveyed to establish views on increasing the volume of invitations sent via NHS DigiTrials.

Supporting information provided to the respondents described the legal framework of a CAG Section 251 approval, and the process of issuing invitations via NHS DigiTrials. It set out benefits and risks as follows, and all respondents were offered the opportunity to attend a Q&A session (either in a group session, or in smaller groups/one to one sessions where availability required it) to help them explore their views, ask questions and confirm their understanding prior to completing the survey.

The supporting information highlighted the following key risks and benefits:

1) Key benefits of using this approach include:

a) Ability to provide a personal invitation letter reaching every adult, especially those in traditionally under-represented groups. This will maximise Our Future Health's opportunity to create a health research database that includes more people from these groups than has previously been achieved

b) Ability to prioritise those who live in areas of high deprivation, and areas with higher levels of ethnic minorities to maximise the opportunity for people in these groups to join.

2) Key risks include:

a) Individuals might not feel comfortable being personally contacted by Our Future Health via their partnership with the NHS. This might cause some people to experience anxiety or anger.

b) The 3rd party mailing house responsible for printing and sending the invitations misuses the name and address information of the individuals we are contacting.

Summary results showed:

 in response to the question asking if the benefits of increasing the volume of invitations (to 45 million) outweighed the risks,

 66% (10) of respondents strongly, or somewhat agreed.

 19% (3) of respondents strongly or somewhat disagreed.

 13% (2) neither agreed nor disagreed.

UK GDPR LEGAL BASIS FOR PROCESSING OF PERSONAL DATA

Our Future Health, as sole Data Controller, are using Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for Our Future Health legitimate interests which are described below. The data to which access is requested are proportionate and necessary to achieve those interests. Our Future Health have completed a legitimate interests assessment (LIA) and NHS England are satisfied that the interests of the data subjects do not override their legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS England or after a defined period on completion of the project. Our Future Health considered the purpose, necessity and balance of the programme when completing their legitimate interest assessment.

It is acknowledged that Our Future Health has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation and visit the Our Future Health website. At that point, Our Future Health solicits the potential research participant’s explicit consent to join the programme for the purposes of making a contribution to research efforts to benefit the wider public's health. Participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.

Additionally (as health data is a special category of Personal Data), Our Future Health is using Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. Our Future Health’s ethically approved scientific research programme seeks to make advances in early disease detection and prevention to improve public health in the wider societal interest to help people live longer lives in better health. Without this research programme improvements in the early detection and possible prevention of disease are likely to either: (a) not take place; or (b) be negatively impacted. To improve the nation’s health Our Future Health aims to recruit research participants from as broad a spectrum of society as possible as overall health is a component of behavioural, social, environmental and genetic factors.

INCLUSION AND EXCLUSION CRITERIA

The programme will be conducted throughout the UK* and the aim is to recruit a total of 5 million participants, via a number of different recruitment routes. Our Future Health aim to recruit approximately 175,000 participants via NHS England recruitment for the first year.

*NHS England will be providing data for England and Wales only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.

Inclusion criteria:

• Reside within England and Wales

• 18 years or older:

NOTE: Our Future Health are not recruiting children under the age of 18 for the following reasons:

◦ In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised, and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

◦ The aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease).

◦ Our Future Health are using an opt-in model with explicit consent; this model would be considerably complicated by the inclusion of children particularly in the absence of adequate scientific or health rationale for their recruitment.

Exclusion criteria:

The overall cohort of participant aims to be representative across UK geographical locations, age, gender and ethnicity. It is possible as part of the creation of each NHS England mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.

Our Future Health is not recruiting individuals under the age of 18 because the aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease). In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

Recruitment began in Summer 2022 and will take place over several years. For the first year of recruitment, approximately 3 million patients will be identified and contacted. With an assumed response rate of 5%, approximately 175,000 patients should be recruited, however this recruitment target is an estimate and may be subject to change. The recruitment target and number of invites will be reviewed for future years.

AGREEMENT VERSION HISTORY

The initial Health Regulatory Authority’s Confidentiality Advisory Group (CAG) approval to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002 (herein after called Section 251) provided support for approximately three million potential participants to be contacted. The amendment of the agreement to version 1 saw an increase to the number of invitations from three million to 12 million.

Our Future Health had received Section 251 support for approximately 12 million patients to be contacted. This increased figure was due to the creation of pop-up clinics and mobile units to enable volunteers’ measurements and blood sample to be taken, which were not available to the applicant at the time of initial section 251 application. This means potential candidates could be invited at a higher rate, and greater scale to support achieving recruitment targets.

Since initial projections to April 2023, 350k volunteers have consented to participate in the programme, in the first 6 months of active recruitment. The programme aims to form a cohort of 5million volunteers, with particular focus on groups within the population who are traditionally under-represented in medical research.

In October 2022, scale up of the integrated processes enabled higher volumes of invitations to be issued per week. These processes included:

planning new clinics

Running media opt-out campaigns in planned areas

Establishing clinics and training staff

Identifying optimal cohort characteristics for the new batch of invitations

Issue of invitations and release of appointments for booking by recipients

Clinic opening in time to deliver booked appointments

Invitations issued to carefully selected groups have enabled this cohort growth to be carried out while developing a cohort make up that reflects the UK population. NHS DigiTrials has supported this specifically by enabling the targeting of specific age, sex and postcode characteristics, alongside careful placement of Our Future Health pop-up clinics in those targeted areas.

The increase in the recruitment rate has mean that limit of approximately 12 million invitation mail-outs would shortly be met by June 2023 and so Version 2 of the agreement saw an increase of approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs. The Health Research Authority (HRA) Confidentiality Advisory Group (CAG) and Research Ethics Committee supported the increase from approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs.

*** NEW FOR VERSION 3 - THIS VERSION OF THE AGREEMENT ***

This version of the agreement permits a managed extension to this agreement to end of September 2023 to allow Our Future Health to address advice provided by the Advisory Board for Data and the HRA CAG. There is no change to the number of invitations being sent out from version 2 of this agreement.

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REQUESTING NOT TO TAKE PART IN THE PROGRAMME:

In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the Our Future Health Programme. Our Future Health will promote this information via the dedicated programme website (https://ourfuturehealth.org.uk/) and via local media for four weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS England will also promote this information via a dedicated page on its website (https://digital.nhs.uk/services/nhs-digitrials/how-we-identify-participants-for-the-our-future-health-programme). There will also be an option for people to register their request not to take part in Our Future Health by telephone. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection and as a result their details will not be on the list passed to APS Group for invitations to be sent.

ORGANISATION’S ROLES AND RESPONSIBILITIES:

Our Future Health is the data controller. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.

Our Future Health is responsible for:

1. Generating the invitation request(s) and sending to NHS England on a regular basis

2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)

3. Monitoring scope of the population booking appointments and entering the programme.

4. Adjusting the selection criteria for subsequent invitations to adjust for underrepresentation of target populations taking up the programme.

NHS England are acting as a data processor on behalf of Our Future Health and are responsible for:

1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees

2. Feeding back to Our Future Health the number of invitees actually fulfilled out of the total target population.

3. Removing objections or opt outs (where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)

4. Sending the list of invitees on to their third-party provider (Allied Publicity Services (APS) Group) for generating the invitation letters and mailing these out

5. Agreeing with Our Future Health key processing timelines, including

a. Time from submission to APS Group to mailout

b. Date of the mail outs

c. Daily cut-off times (i.e. after which processing will take place the next day)

d. Time to feedback to Our Future Health the numbers selected

6. Overseeing performance of APS Group and alerting performance issue to Our Future Health.

7. Feeding back to Our Future Health performance in relation to Key Performance Indicators (KPIs) of APS and NHS England

8. Where the number of invitees is less than the population available, invoking a system to choose invitees at random

9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations.

APS Group are acting as a sub-processor of NHS England. Their responsibility is to receive the lists of invitees from NHS England and mail out to them accordingly.

A 'return to sender' address will be included on the letters. When letters are unable to be delivered to the participant address provided by NHS England - they will be returned to APS Group where they will be shredded. APS Group will provide NHS England with an aggregate report of number of returned letter.

Our Future Health have a series of Programme oversight groups with PPIE representatives. Our Future Health has a robust governance structure with appropriate management and advisory boards to ensure thorough and informed oversight, management and decision making.

FUNDING

Our Future Health received initial funding via the UK Research and Innovation (UKRI) Life Sciences Industrial Strategy, with a commitment of £79m administered via the UKRI-Innovate UK and £150 million funding from life sciences companies. For more information on the role of Our Future Health’s industrial partners, please see the YouTube video <https://m.youtube.com/watch?v=OdQd9w-0bNk>. Our Future Health also have a programme of Founding Members, which will include charities and pharmaceutical and diagnostic companies, who will contribute funding to the programme in return for becoming a Founding Member.

As well as contributing funding, the industry and charity members will bring considerable expertise in discovering and developing new methods of prevention, early detection and treatment of diseases and health conditions. These Founding Members will help Our Future Health co-design, co-deliver and co-fund the programme. By making Our Future Health resources available to researchers both from academia and industry, it is hoped to help accelerate the discovery and development of innovative diagnostics and treatments.

Our Future Health have agreed some specific terms with industry and charity members that recognise their investment in, and support to develop, Our Future Health from its early stages. These include:

• a seat on the Founders Board – one of the boards Our Future Health are setting up to help guide and shape Our Future Health. The Founders Board will:

o provide guidance on the scientific and technical aspects of Our Future Health;

o help Our Future Health to identify emerging challenges and opportunities; and

o help to make the programme valuable to as wide a range of researchers as possible.

The Founders Board will be able to nominate experts to sit on some other advisory boards established by Our Future Health to ensure that they can benefit from their expertise across the full breadth of the programme.

• During the early years of the programme, Our Future Health’s industry members will be the only large commercial organisations that are eligible to apply to use Our Future Health resources for research. This doesn’t affect access to Our Future Health for other researchers, such as those in smaller companies (SMEs) or non-commercial organisations like universities. Industry members will apply to Our Future Health’s Access Board for approval to conduct research in the same way as other researchers. All researchers, whether they are employed by universities, government, the NHS, charities or companies, will be held to the same standards.

• Founding members, as well as other researchers that use Our Future Health, will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers in future.

• Researchers may profit from discoveries they make using Our Future Health resources. Our industry members have agreed to make reasonable efforts to ensure that innovations developed using our resources are made available in the UK to benefit NHS patients.

No NHS England Record Level data covered by this Data Sharing Agreement will be shared with any funders and final decision making on processing of the data rests with Our Future Health Executive Team and Board who are all substantive employees, therefore the funders are not Data Controllers or Data Processors on this agreement.

COMMERCIAL PURPOSE

In the interests of full transparency, it is noted here that the programme is funded by commercial entities, who could ultimately benefit from the programme and the analyses produced.

It will take several years for discoveries to emerge from the research programme and any researchers, whether commercial or non-commercial, may profit from the discoveries they make from research using Our Future Health.

However, researchers who use Our Future Health will be required to disseminate the results of their research as rapidly and widely as possible, subject to ethics and confidentiality considerations. They will be encouraged to discuss their research findings with other scientists and the public, and to share relevant data and materials as openly as possible.

Researchers will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers and the public in future.

While Our Future Health are the data controller for this programme, they will have no access to the patient-level identifiable data provided by NHS England to APS Group under this agreement.

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS England will only be used to identify and invite potential participants. NHS England record Level Identifiable data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the HRA and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets have been set for 2023 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign may include key aggregate facts and figures about the recruitment progress.

Whilst the outcomes of the recruitment mail-outs undertaken in this agreement do not directly benefit Health and Social Care, they are necessary to achieve secondary benefits through the eventual use of health data obtained from participants to OFH as a result of these mailouts. At this current time (July 2023), approximately 13,680,000 invitation letters have been sent out using DigiTrials Recruitment service, and Our Future Health have recorded approximately 525,000 individuals who have consented to participate in this project.

BACKGROUND

Our Future Health intends to be the UK’s largest ever health research programme. It is designed to help people live healthier lives for longer through the discovery and testing of more effective approaches to prevention, earlier detection and treatment of diseases.

Our Future Health's goal is to recruit up to five million adult volunteers from across the UK to create an incredibly detailed picture that truly reflects the whole of the population.

Our Future Health has received favourable ethical opinion on 29/03/2021, reviewed and issued by the NHS Health Research Authority (HRA) East of England – Cambridge East Research Ethics Committee.

THE AIM OF THE PROGRAMME

The overarching objective of Our Future Health is to help people live healthier lives for longer through better prevention, earlier detection and improved treatment of diseases. The Our Future Health research programme will aim to speed up the discovery of new methods of early disease detection, and the evaluation of new diagnostic tools, to help identify and treat diseases early when outcomes are usually better.

To achieve these objectives, Our Future Health aims to recruit up to 5 million adults from across the UK (from a variety of different recruitment routes including NHS England) to create a diverse and inclusive cohort of people who have consented to participate in the research.

• Specific Aim 1: Build a resource linking multiple sources of health and health-relevant information, including genetic data, on millions of people in the UK, to facilitate basic discovery research by academic and commercial researchers on early indicators of disease

• Specific Aim 2: Analyse the data in the resource to estimate personal disease risk information for participants, based on genetic and non-genetic information, and offer this estimated personal health information to participants who wish to receive it

• Specific Aim 3: Re-contact sub-groups of participants generally for additional samples, non-routine data and secondary studies over time

• Specific Aim 4: Re-contact participants on a risk-stratified basis (i.e. recall-by-genotype/phenotype or sociodemographic characteristics) over time specifically to enable secondary studies by academic and commercial researchers that is greatly enhanced by being able to identify highly enriched sub-populations/sub-cohorts of participants

BACKGROUND TO RECRUITMENT

Our Future Health has taken a steady approach to trialling and testing various recruitment routes, though pilots and often in partnership with other organisations. 2021 saw early pilots with NHS Blood and Transplant, and with National Institute for Health and Care Research (NIHR) which are being developed up into larger scale recruitment routes. 2022 has seen pilots in Secondary Care, and a range of community based recruitment pilots in partnership with community based organisations. The NHS DigiTrials services will form a key part of the strategy to achieve recruitment targets in 2023.

PROGRAMME TEAM

Any reference to "the programme team" in this agreement refers to members staff employed by Our Future Health directly working on the Our Future Health programme.

PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)

Involving the public in the design of Our Future Health will be vitally important to its success. Our Future Health is building a governance structure that has public involvement and engagement embedded throughout, and has already demonstrated a clear commitment to involving and engaging the public in our development, build and operational activities.

In 2020, Our Future Health involved members of the public in the design and development of the public-facing materials as well as in other aspects of the project design. The design of the participant information sheet and consent form has included:

• 18 focus groups with 82 members of the public;

• 4 meetings with a co-design group comprised of 8 members of the public; and

• 21 user testing interviews with members of the public.

During 2021 Our Future Health worked with Claremont creative agency to conduct a programme of patient and public involvement work. Over 120 members of the public were involved during 2020-2021 including:

• 4 focus groups, 2 co-design meetings, 21 interviews with the public to develop the scientific protocol

• 12 interviews with a variety of stakeholders from charities and existing cohort studies

• 2 focus groups with 11 NHS primary care staff

• 18 focus groups, 10 co-design meetings, 21 interviews with the public to co-develop the participant information sheet, consent form & other public-facing videos & materials

• 21 interviews to understand the role of industry in health research

• 4 focus groups to explore insights around recruitment methods

• 3 focus groups to explore public motivators and feedback preferences

• 1 member of the public attended the REC approval meeting with a member of Our Future Health

As it was qualitative research, not quantitative, the outputs of the work are summarised as follows:

• Co-designed and REC approved PIS and Consent form

• 4 co-designed explainer videos for Our Future Health (YouTube)

• Public Engagement Strategy (Claremont 2021)

• Engaging Black Audiences Report (written by an external consultant)

30 members of the public were invited to join the Our Future Health Public Advisory Board, and 14 accepted. 6 are affiliate members of the Secondary Care Working Group, Ethics Advisory Board and Technology Advisory Board (with 2 PPIE representatives on each). The Access Board will have equal representation of expert and public/participant members.

Outputs of these groups since 2021

• Agreed Terms of Reference, working principles, PPIE training pack and evaluation matrix

• 3 meetings held in 2021 and 1 ad-hoc consultation.

• Topics for consultation and input/approval have included the Founding Industry Member Policy, TRE, amendments to the PIS and consent form

**** PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE) UPDATE APRIL 2023 - VERSION 2 - THIS VERSION OF THE AGREEMENT ***

In 2020-2022, Our Future Health involved over 3,600 members of the public in the design and development of the major public-facing materials, as well as in other aspects of the programme design. All projects involved members of the public and included representation from the following segments: early adopters (health), early adopters (civic minded), early majority, sceptics, lower income, South Asian ethnic background and Black ethnic background.

In addition, Our Future Health have successfully appointed and trained 22 members of the public to join their advisory boards and working groups (Public Advisory Board, Secondary Care Working Group, Primary Care Working Group, Ethics Advisory Board, Technology Advisory Board, and Access Board), with a further list of over 40 volunteers Our Future Health can consult for future user testing and PPIE activities. To support members of the public in taking on these roles Our Future Health have developed a PPIE training package for new public representatives.

This work has been essential to ensuring that Our Future Health developed:

• a co-designed and REC approved PIS and consent form (one member of the public attended the REC meeting alongside a member of Our Future Health Staff),

• co-designed explainer videos for Our Future Health (YouTube), and

• a Public Engagement Strategy (Claremont 2021)

An example of the work undertaken on user experience was a survey to gauge public attitudes to Our Future Health. 2,767 people completed the survey which confirmed that the general public have a high interest in receiving personalised genetic information: 77% of participants wished to receive risk information of disease which is preventable or treatable, 65% wanted non-treatable risk information and 77% would want ancestry information.

These insights are being used to support Our Future Health's developing feedback programme.

A full set of the participant-facing materials listed below::

 Baseline Questionnaire

 Consent form

 FAQs

 Invitation letters

 Newsletter

 Participant information sheet

 Pro-forma

 Refer a friend card

 Social postcard

 Thank you, postcard

 Volunteer voices stories

 Walk-in leaflet

With regards to the baseline questionnaire, all questions must have a response entered. The website forces an error response to any areas that are not complete. Participants have an option to select ‘prefer not to say’ or ‘other’ in some areas.

Our Future Health will continue to develop and test variations of the invitation letters, emails and SMS messages to measure the impact on response rates overall and for sub-populations. Our Future Health will also expand their range of case studies to include a broader range of stories from across section of sub-populations and highlighting a range of research opportunities within specific disease areas.

Our Future Health are planning to update the health measurement results proforma to include information about diabetes risk and a link to an online risk calculator (provided by Diabetes UK). This will allow participants to generate a letter to their GP based if they are found to be at high risk on their results. Our Future Health will also be providing a link to the British Heart Foundation/NHS website where participants can calculate their ‘heart age’ using the information in the results proforma.

Ongoing PPIE via the Public Attitudes tracker, currently has 2676 respondents and the most recent data shows the following in relation to industry involvement and trust:

Industry Involvement:

 40.69% (485/1192) would feel comfortable with pharma, diagnostic and health tech companies having access to health information

 64.85% (773/1192) agree that partnerships with charities and industry will improve Our Future health

20.72% (247/1192) agree that partnerships with charities and industry would make them more likely to take part

14.26% (170/1192) agree that partnerships with charities and industry would make them less likely to take part

Measures of trust

 81.5% (971/1192) generally trust medical researchers in universities

 79.8% (951/1192) generally trust the NHS

 62.8% (746/1192) generally trust medical charities

 25.0% (498/1192) generally trust pharmaceutical companies

 22.6% (269/1192) generally trust the government

The most recent PPIE involved 15 members of the Public Advisory Group, the Ethics Advisory Group and the Equality, Diversity and Inclusion Group who were surveyed to establish views on increasing the volume of invitations sent via NHS DigiTrials.

Supporting information provided to the respondents described the legal framework of a CAG Section 251 approval, and the process of issuing invitations via NHS DigiTrials. It set out benefits and risks as follows, and all respondents were offered the opportunity to attend a Q&A session (either in a group session, or in smaller groups/one to one sessions where availability required it) to help them explore their views, ask questions and confirm their understanding prior to completing the survey.

The supporting information highlighted the following key risks and benefits:

1) Key benefits of using this approach include:

a) Ability to provide a personal invitation letter reaching every adult, especially those in traditionally under-represented groups. This will maximise Our Future Health's opportunity to create a health research database that includes more people from these groups than has previously been achieved

b) Ability to prioritise those who live in areas of high deprivation, and areas with higher levels of ethnic minorities to maximise the opportunity for people in these groups to join.

2) Key risks include:

a) Individuals might not feel comfortable being personally contacted by Our Future Health via their partnership with the NHS. This might cause some people to experience anxiety or anger.

b) The 3rd party mailing house responsible for printing and sending the invitations misuses the name and address information of the individuals we are contacting.

Summary results showed:

 in response to the question asking if the benefits of increasing the volume of invitations (to 45 million) outweighed the risks,

 66% (10) of respondents strongly, or somewhat agreed.

 19% (3) of respondents strongly or somewhat disagreed.

 13% (2) neither agreed nor disagreed.

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LEGAL BASIS FOR COMMON LAW

Our Future Health as data controller, are requesting to use NHS England data to support a research programme called ‘Our Future Health’. This agreement is specifically to support the recruitment of a cohort for this programme by writing out to individuals who meet the required eligibility criteria. The legal basis for the identifiable data from NHS England to flow to Allied Publicity Services (APS) Group for the purpose of Our Future Health inviting them to join the programme is Section 251 approval (NHS Act 2006).

UK GDPR LEGAL BASIS FOR PROCESSING OF PERSONAL DATA

Our Future Health, as sole Data Controller, are using Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for Our Future Health legitimate interests which are described below. The data to which access is requested are proportionate and necessary to achieve those interests. Our Future Health have completed a legitimate interests assessment (LIA) and NHS England are satisfied that the interests of the data subjects do not override their legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS England or after a defined period on completion of the project. Our Future Health considered the purpose, necessity and balance of the programme when completing their legitimate interest assessment.

It is acknowledged that Our Future Health has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation and visit the Our Future Health website. At that point, Our Future Health solicits the potential research participant’s explicit consent to join the programme for the purposes of making a contribution to research efforts to benefit the wider public's health. Participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.

Additionally (as health data is a special category of Personal Data), Our Future Health is using Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. Our Future Health’s ethically approved scientific research programme seeks to make advances in early disease detection and prevention to improve public health in the wider societal interest to help people live longer lives in better health. Without this research programme improvements in the early detection and possible prevention of disease are likely to either: (a) not take place; or (b) be negatively impacted. To improve the nation’s health Our Future Health aims to recruit research participants from as broad a spectrum of society as possible as overall health is a component of behavioural, social, environmental and genetic factors.

NHS ENGLAND'S POWERS OF DISSEMINATION UNDER SECTION 261 OF THE HEALTH AND SOCIAL CARE ACT

The Section 261 legal basis for NHS England to disseminate the data requested in this agreement is s261(5)(d) (common law remains met by a section 251):

“the disclosure is made to any person in circumstances where it is necessary or expedient for the person to have the information for the purpose of exercising functions of that person conferred under or by virtue of any provision of this or any other Act”

The Data Controller is a charity registered with the Charity Commission for England and Wales (charity number 1189681), and it is necessary for them to have the requested data for the purpose of exercising functions conferred under or by virtue of the Charities Acts.

INCLUSION AND EXCLUSION CRITERIA

The programme will be conducted throughout the UK* and the aim is to recruit a total of 5 million participants, via a number of different recruitment routes. Our Future Health aim to recruit approximately 175,000 participants via NHS England recruitment for the first year.

*NHS England will be providing data for England and Wales only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.

Inclusion criteria:

• Reside within England and Wales

• 18 years or older:

NOTE: Our Future Health are not recruiting children under the age of 18 for the following reasons:

◦ In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised, and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

◦ The aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease).

◦ Our Future Health are using an opt-in model with explicit consent; this model would be considerably complicated by the inclusion of children particularly in the absence of adequate scientific or health rationale for their recruitment.

Exclusion criteria:

The overall cohort of participant aims to be representative across UK geographical locations, age, gender and ethnicity. It is possible as part of the creation of each NHS England mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.

Our Future Health is not recruiting individuals under the age of 18 because the aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease). In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

Recruitment began in Summer 2022 and will take place over several years. For the first year of recruitment, approximately 3 million patients will be identified and contacted. With an assumed response rate of 5%, approximately 175,000 patients should be recruited, however this recruitment target is an estimate and may be subject to change. The recruitment target and number of invites will be reviewed for future years.

AGREEMENT VERSION HISTORY

VERSION 1 - The initial Section 251 approval provided support for approximately three million potential participants to be contacted. The amendment of the agreement to version 1 saw an increase to the number of invitations from three million to 12 million.

Our Future Health had received Section 251 support for approximately 12 million patients to be contacted. This increased figure was due to the creation of pop-up clinics and mobile units to enable volunteers’ measurements and blood sample to be taken, which were not available to the applicant at the time of initial section 251 application. This means potential candidates could be invited at a higher rate, and greater scale to support achieving recruitment targets.

*** UPDATE APRIL 2023 - VERSION 2 - THIS VERSION OF THE AGREEMENT ***

Since initial projections, to date, 350k volunteers have consented to participate in the programme, in the first 6 months of active recruitment. The programme aims to form a cohort of 5million volunteers, with particular focus on groups within the population who are traditionally under-represented in medical research.

In October 2022, scale up of the integrated processes enabled higher volumes of invitations to be issued per week. These processes included:

planning new clinics

Running media opt-out campaigns in planned areas

Establishing clinics and training staff

Identifying optimal cohort characteristics for the new batch of invitations

Issue of invitations and release of appointments for booking by recipients

Clinic opening in time to deliver booked appointments

Invitations issued to carefully selected groups have enabled this cohort growth to be carried out while developing a cohort make up that reflects the UK population. NHS Digitrials has supported this specifically by enabling the targeting of specific age, sex and postcode characteristics, alongside careful placement of Our Future Health pop-up clinics in those targeted areas.

The increase in the recruitment rate has mean that the current limit of approximately 12 million invitation mail-outs will shortly be met. This version of the agreement (V2) sees an increase of approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs. The Health Research Authority (HRA) Confidentiality Advisory Group (CAG) and Research Ethics Committee support the increase from approximately 12 million invitation mail-outs to approximately 16 million invitation mail-outs.

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REQUESTING NOT TO TAKE PART IN THE PROGRAMME:

In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the Our Future Health Programme. Our Future Health will promote this information via the dedicated programme website (https://ourfuturehealth.org.uk/) and via local media for four weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS England will also promote this information via a dedicated page on its website (https://digital.nhs.uk/services/nhs-digitrials/how-we-identify-participants-for-the-our-future-health-programme). There will also be an option for people to register their request not to take part in Our Future Health by telephone. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection and as a result their details will not be on the list passed to APS Group for invitations to be sent.

ORGANISATION’S ROLES AND RESPONSIBILITIES:

Our Future Health is the applicant and data controller. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.

Our Future Health is responsible for:

1. Generating the invitation request(s) and sending to NHS England on a regular basis

2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)

3. Monitoring scope of the population booking appointments and entering the programme.

4. Adjusting the selection criteria for subsequent invitations to adjust for underrepresentation of target populations taking up the programme.

NHS England are acting as a data processor on behalf of Our Future Health and are responsible for:

1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees

2. Feeding back to Our Future Health the number of invitees actually fulfilled out of the total target population.

3. Removing objections or opt outs (where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)

4. Sending the list of invitees on to their third-party provider (Allied Publicity Services (APS) Group) for generating the invitation letters and mailing these out

5. Agreeing with Our Future Health key processing timelines, including

a. Time from submission to APS Group to mailout

b. Date of the mail outs

c. Daily cut-off times (i.e. after which processing will take place the next day)

d. Time to feedback to Our Future Health the numbers selected

6. Overseeing performance of APS Group and alerting performance issue to Our Future Health.

7. Feeding back to Our Future Health performance in relation to Key Performance Indicators (KPIs) of APS and NHS England

8. Where the number of invitees is less than the population available, invoking a system to choose invitees at random

9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations.

APS Group are acting as a sub-processor of NHS England. Their responsibility is to receive the lists of invitees from NHS England and mail out to them accordingly.

A 'return to sender' address will need to be included on the letters. When letters are unable to be delivered to the participant address provided by NHS England - they will be returned to APS Group where they will be shredded. APS Group will provide NHS England with an aggregate report of number of returned letter.

Our Future Health have a series of Programme oversight groups with PPIE representatives. Our Future Health has a robust governance structure with appropriate management and advisory boards to ensure thorough and informed oversight, management and decision making.

FUNDING

Our Future Health received initial funding via the UK Research and Innovation (UKRI) Life Sciences Industrial Strategy, with a commitment of £79m administered via the UKRI-Innovate UK and £150 million funding from life sciences companies. For more information on the role of Our Future Health’s industrial partners, please see the YouTube video <https://m.youtube.com/watch?v=OdQd9w-0bNk>. Our Future Health also have a programme of Founding Members, which will include charities and pharmaceutical and diagnostic companies, who will contribute funding to the programme in return for becoming a Founding Member.

As well as contributing funding, the industry and charity members will bring considerable expertise in discovering and developing new methods of prevention, early detection and treatment of diseases and health conditions. These Founding Members will help Our Future Health co-design, co-deliver and co-fund the programme. By making Our Future Health resources available to researchers both from academia and industry, it is hoped to help accelerate the discovery and development of innovative diagnostics and treatments.

Our Future Health have agreed some specific terms with industry and charity members that recognise their investment in, and support to develop, Our Future Health from its early stages. These include:

• a seat on the Founders Board – one of the boards Our Future Health are setting up to help guide and shape Our Future Health. The Founders Board will:

o provide guidance on the scientific and technical aspects of Our Future Health;

o help Our Future Health to identify emerging challenges and opportunities; and

o help to make the programme valuable to as wide a range of researchers as possible.

The Founders Board will be able to nominate experts to sit on some other advisory boards established by Our Future Health to ensure that they can benefit from their expertise across the full breadth of the programme.

• During the early years of the programme, Our Future Health’s industry members will be the only large commercial organisations that are eligible to apply to use Our Future Health resources for research. This doesn’t affect access to Our Future Health for other researchers, such as those in smaller companies (SMEs) or non-commercial organisations like universities. Industry members will apply to Our Future Health’s Access Board for approval to conduct research in the same way as other researchers. All researchers, whether they are employed by universities, government, the NHS, charities or companies, will be held to the same standards.

• Founding members, as well as other researchers that use Our Future Health, will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers in future.

• Researchers may profit from discoveries they make using Our Future Health resources. Our industry members have agreed to make reasonable efforts to ensure that innovations developed using our resources are made available in the UK to benefit NHS patients.

No NHS England Record Level data covered by this Data Sharing Agreement will be shared with any funders and final decision making on processing of the data rests with Our Future Health Executive Team and Board who are all substantive employees, therefore the funders are not considered Data Controllers or Data Processors on this agreement.

COMMERCIAL PURPOSE

NHS England is content that the purpose of this programme is the recruitment into the Our Future Health Programme, which is aiming to be the largest ever health research programme, bringing people together to develop new ways to prevent, detect and treat diseases, thus clearly demonstrating that the study purpose is research into public health and therefore providing benefit to health and social care in the UK. However, in the interests of full transparency, it is noted here that the programme is funded by commercial entities, who could ultimately benefit from the programme and the analyses produced.

It will take several years for discoveries to emerge from the research programme and any researchers, whether commercial or non-commercial, may profit from the discoveries they make from research using Our Future Health.

However, researchers who use Our Future Health will be required to disseminate the results of their research as rapidly and widely as possible, subject to ethics and confidentiality considerations. They will be encouraged to discuss their research findings with other scientists and the public, and to share relevant data and materials as openly as possible.

Researchers will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers and the public in future.

While Our Future Health are the data controller for this programme, they will have no access to the patient-level identifiable data provided by NHS England to APS Group under this agreement.

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS England will only be used to identify and invite potential participants. NHS England record Level Identifiable data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the HRA and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets have been set for 2023 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign may include key aggregate facts and figures about the recruitment progress.

Yielded benefits have not been provided at this time as recruitment is ongoing.

BACKGROUND

Our Future Health intends to be the UK’s largest ever health research programme. It is designed to help people live healthier lives for longer through the discovery and testing of more effective approaches to prevention, earlier detection and treatment of diseases.

Our Future Health's goal is to recruit up to five million adult volunteers from across the UK to create an incredibly detailed picture that truly reflects the whole of the population.

Our Future Health has received favourable ethical opinion on 29/03/2021, reviewed and issued by the NHS Health Research Authority (HRA) East of England – Cambridge East Research Ethics Committee.

THE AIM OF THE PROGRAMME

The overarching objective of Our Future Health is to help people live healthier lives for longer through better prevention, earlier detection and improved treatment of diseases. The Our Future Health research programme will aim to speed up the discovery of new methods of early disease detection, and the evaluation of new diagnostic tools, to help identify and treat diseases early when outcomes are usually better.

To achieve these objectives, Our Future Health aims to recruit up to 5 million adults from across the UK (from a variety of different recruitment routes including NHS Digital) to create a diverse and inclusive cohort of people who have consented to participate in the research.

• Specific Aim 1: Build a resource linking multiple sources of health and health-relevant information, including genetic data, on millions of people in the UK, to facilitate basic discovery research by academic and commercial researchers on early indicators of disease

• Specific Aim 2: Analyse the data in the resource to estimate personal disease risk information for participants, based on genetic and non-genetic information, and offer this estimated personal health information to participants who wish to receive it

• Specific Aim 3: Re-contact sub-groups of participants generally for additional samples, non-routine data and secondary studies over time

• Specific Aim 4: Re-contact participants on a risk-stratified basis (i.e. recall-by-genotype/phenotype or sociodemographic characteristics) over time specifically to enable secondary studies by academic and commercial researchers that is greatly enhanced by being able to identify highly enriched sub-populations/sub-cohorts of participants

BACKGROUND TO RECRUITMENT

Our Future Health has taken a steady approach to trialling and testing various recruitment routes, though pilots and often in partnership with other organisations. 2021 saw early pilots with NHS Blood and Transplant, and with National Institute for Health and Care Research (NIHR) which are being developed up into larger scale recruitment routes. 2022 will see pilots in Secondary Care, and a range of community based recruitment pilots in partnership with community based organisations. The NHS DigiTrials services will form a key part of the strategy to achieve recruitment targets in 2022.

PROGRAMME TEAM

Any reference to "the programme team" in this agreement refers to members staff employed by Our Future Health directly working on the Our Future Health programme.

PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)

Involving the public in the design of Our Future Health will be vitally important to its success. Our Future Health is building a governance structure that has public involvement and engagement embedded throughout, and has already demonstrated a clear commitment to involving and engaging the public in our development, build and operational activities.

In 2020, Our Future Health involved members of the public in the design and development of the public-facing materials as well as in other aspects of the project design. The design of the participant information sheet and consent form has included:

• 18 focus groups with 82 members of the public;

• 4 meetings with a co-design group comprised of 8 members of the public; and

• 21 user testing interviews with members of the public.

During 2021 Our Future Health worked with Claremont creative agency to conduct a programme of patient and public involvement work. Over 120 members of the public were involved during 2020-2021 including:

• 4 focus groups, 2 co-design meetings, 21 interviews with the public to develop the scientific protocol

• 12 interviews with a variety of stakeholders from charities and existing cohort studies

• 2 focus groups with 11 NHS primary care staff

• 18 focus groups, 10 co-design meetings, 21 interviews with the public to co-develop the participant information sheet, consent form & other public-facing videos & materials

• 21 interviews to understand the role of industry in health research

• 4 focus groups to explore insights around recruitment methods

• 3 focus groups to explore public motivators and feedback preferences

• 1 member of the public attended the REC approval meeting with a member of Our Future Health

As it was qualitative research, not quantitative, the outputs of the work are summarised as follows:

• Co-designed and REC approved PIS and Consent form

• 4 co-designed explainer videos for Our Future Health (YouTube)

• Public Engagement Strategy (Claremont 2021)

• Engaging Black Audiences Report (written by an external consultant)

30 members of the public were invited to join the Our Future Health Public Advisory Board, and 14 accepted. 6 are affiliate members of the Secondary Care Working Group, Ethics Advisory Board and Technology Advisory Board (with 2 PPIE representatives on each). The Access Board will have equal representation of expert and public/participant members.

Outputs of these groups since 2021

• Agreed Terms of Reference, working principles, PPIE training pack and evaluation matrix

• 3 meetings held in 2021 and 1 ad-hoc consultation.

• Topics for consultation and input/approval have included the Founding Industry Member Policy, TRE, amendments to the PIS and consent form

LEGAL BASIS FOR COMMON LAW

Our Future Health as data controller, are requesting to use NHS Digital data to support a research programme called ‘Our Future Health’. This agreement is specifically to support the recruitment of a cohort for this programme by writing out to individuals who meet the required eligibility criteria. The legal basis for the identifiable data from NHS Digital to flow to Allied Publicity Services (APS) Group for the purpose of Our Future Health inviting them to join the programme is Section 251 approval (NHS Act 2006).

GDPR LEGAL BASIS FOR PROCESSING OF PERSONAL DATA

Our Future Health, as sole Data Controller, are using Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for Our Future Health legitimate interests which are described below. The data to which access is requested are proportionate and necessary to achieve those interests. Our Future Health have completed a legitimate interests assessment (LIA) and NHS Digital are satisfied that the interests of the data subjects do not override their legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project. Our Future Health considered the purpose, necessity and balance of the programme when completing their legitimate interest assessment.

It is acknowledged that Our Future Health has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation and visit the Our Future Health website. At that point, Our Future Health solicits the potential research participant’s explicit consent to join the programme for the purposes of making a contribution to research efforts to benefit the wider public's health. Participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.

Additionally (as health data is a special category of Personal Data), Our Future Health is using Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. Our Future Health’s ethically approved scientific research programme seeks to make advances in early disease detection and prevention to improve public health in the wider societal interest to help people live longer lives in better health. Without this research programme improvements in the early detection and possible prevention of disease are likely to either: (a) not take place; or (b) be negatively impacted. To improve the nation’s health Our Future Health aims to recruit research participants from as broad a spectrum of society as possible as overall health is a component of behavioural, social, environmental and genetic factors.

NHS DIGITAL'S POWERS OF DISSEMINATION UNDER SECTION 261 OF THE HEALTH AND SOCIAL CARE ACT

The Section 261 legal basis for NHS Digital to disseminate the data requested in this agreement is s261(5)(d) (common law remains met by a section 251):

“the disclosure is made to any person in circumstances where it is necessary or expedient for the person to have the information for the purpose of exercising functions of that person conferred under or by virtue of any provision of this or any other Act”

The Data Controller is a charity registered with the Charity Commission for England and Wales (charity number 1189681), and it is necessary for them to have the requested data for the purpose of exercising functions conferred under or by virtue of the Charities Acts.

INCLUSION AND EXCLUSION CRITERIA

The programme will be conducted throughout the UK* and the aim is to recruit a total of 5 million participants, via a number of different recruitment routes. Our Future Health aim to recruit approximately 175,000 participants via NHS Digital recruitment for the first year.

*NHS Digital will be providing data for England and Wales only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.

Inclusion criteria:

• Reside within England and Wales

• 18 years or older:

NOTE: Our Future Health are not recruiting children under the age of 18 for the following reasons:

◦ In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised, and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

◦ The aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease).

◦ Our Future Health are using an opt-in model with explicit consent; this model would be considerably complicated by the inclusion of children particularly in the absence of adequate scientific or health rationale for their recruitment.

Exclusion criteria:

The overall cohort of participant aims to be representative across UK geographical locations, age, gender and ethnicity. It is possible as part of the creation of each NHS Digital mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.

Our Future Health is not recruiting individuals under the age of 18 because the aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease). In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

Recruitment is expected to begin in Summer 2022 and take place over several years. For the first year of recruitment, approximately 3 million patients will be identified and contacted. With an assumed response rate of 5%, approximately 175,000 patients should be recruited, however this recruitment target is an estimate and may be subject to change. The recruitment target and number of invites will be reviewed for future years.

******NEW FOR VERSION 1 (DECEMBER 2022) ******

The initial Section 251 approval provided support for approximately three million potential participants to be contacted. The amendment of this version of the agreement (v1) is to increase the number of invitations from three million to twelve million.

Our Future Health have received Section 251 support for approximately 12 million patients to be contacted. This increased figure is due to the creation of pop-up clinics and mobile units to enable volunteers’ measurements and blood sample to be taken, which were not available to the applicant at the time of initial section 251 application. This means applicants can invite individuals at a higher rate, and greater scale to support achieving recruitment targets.

***************

REQUESTING NOT TO TAKE PART IN THE PROGRAMME:

In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the Our Future Health Programme. Our Future Health will promote this information via the dedicated programme website (https://ourfuturehealth.org.uk/) and via local media for four weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS Digital will also promote this information via a dedicated page on its website (https://digital.nhs.uk/services/nhs-digitrials/how-we-identify-participants-for-the-our-future-health-programme). There will also be an option for people to register their request not to take part in Our Future Health by telephone. NHS Digital will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection and as a result their details will not be on the list passed to APS Group for invitations to be sent.

ORGANISATION’S ROLES AND RESPONSIBILITIES:

Our Future Health is the applicant and data controller. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.

Our Future Health is responsible for:

1. Generating the invitation request(s) and sending to NHS Digital on a regular basis

2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)

3. Monitoring scope of the population booking appointments and entering the programme.

4. Adjusting the selection criteria for subsequent invitations to adjust for underrepresentation of target populations taking up the programme.

NHS Digital are acting as a data processor on behalf of Our Future Health and are responsible for:

1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees

2. Feeding back to Our Future Health the number of invitees actually fulfilled out of the total target population.

3. Removing objections or opt outs (where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)

4. Sending the list of invitees on to their third-party provider (Allied Publicity Services (APS) Group) for generating the invitation letters and mailing these out

5. Agreeing with Our Future Health key processing timelines, including

a. Time from submission to APS Group to mailout

b. Date of the mail outs

c. Daily cut-off times (i.e. after which processing will take place the next day)

d. Time to feedback to Our Future Health the numbers selected

6. Overseeing performance of APS Group and alerting performance issue to Our Future Health.

7. Feeding back to Our Future Health performance in relation to Key Performance Indicators (KPIs) of APS and NHS Digital

8. Where the number of invitees is less than the population available, invoking a system to choose invitees at random

9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations.

APS are acting as a sub-processor of NHS Digital. Their responsibility is to receive the lists of invitees from NHS Digital and mail out to them accordingly.

A 'return to sender' address will need to be included on the letters. When letters are unable to be delivered to the participant address provided by NHS Digital - they will be returned to APS where they will be shredded. APS will provide NHS Digital with an aggregate report of number of returned letter.

Our Future Health have a series of Programme oversight groups with PPIE representatives. Our Future Health has a robust governance structure with appropriate management and advisory boards to ensure thorough and informed oversight, management and decision making.

FUNDING

Our Future Health received initial funding via the UK Research and Innovation (UKRI) Life Sciences Industrial Strategy, with a commitment of £79m administered via the UKRI-Innovate UK and £150 million funding from life sciences companies. For more information on the role of Our Future Health’s industrial partners, please see the YouTube video <https://m.youtube.com/watch?v=OdQd9w-0bNk>. Our Future Health also have a programme of Founding Members, which will include charities and pharmaceutical and diagnostic companies, who will contribute funding to the programme in return for becoming a Founding Member.

As well as contributing funding, the industry and charity members will bring considerable expertise in discovering and developing new methods of prevention, early detection and treatment of diseases and health conditions. These Founding Members will help Our Future Health co-design, co-deliver and co-fund the programme. By making Our Future Health resources available to researchers both from academia and industry, it is hoped to help accelerate the discovery and development of innovative diagnostics and treatments.

Our Future Health have agreed some specific terms with industry and charity members that recognise their investment in, and support to develop, Our Future Health from its early stages. These include:

• a seat on the Founders Board – one of the boards Our Future Health are setting up to help guide and shape Our Future Health. The Founders Board will:

o provide guidance on the scientific and technical aspects of Our Future Health;

o help Our Future Health to identify emerging challenges and opportunities; and

o help to make the programme valuable to as wide a range of researchers as possible.

The Founders Board will be able to nominate experts to sit on some other advisory boards established by Our Future Health to ensure that they can benefit from their expertise across the full breadth of the programme.

• During the early years of the programme, Our Future Health’s industry members will be the only large commercial organisations that are eligible to apply to use Our Future Health resources for research. This doesn’t affect access to Our Future Health for other researchers, such as those in smaller companies (SMEs) or non-commercial organisations like universities. Industry members will apply to Our Future Health’s Access Board for approval to conduct research in the same way as other researchers. All researchers, whether they are employed by universities, government, the NHS, charities or companies, will be held to the same standards.

• Founding members, as well as other researchers that use Our Future Health, will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers in future.

• Researchers may profit from discoveries they make using Our Future Health resources. Our industry members have agreed to make reasonable efforts to ensure that innovations developed using our resources are made available in the UK to benefit NHS patients.

No NHS Digital Record Level data covered by this Data Sharing Agreement will be shared with any funders and final decision making on processing of the data rests with Our Future Health Executive Team and Board who are all substantive employees, therefore the funders are not considered Data Controllers or Data Processors on this agreement.

COMMERCIAL PURPOSE

NHS Digital is content that the purpose of this programme is the recruitment into the Our Future Health Programme, which is aiming to be the largest ever health research programme, bringing people together to develop new ways to prevent, detect and treat diseases, thus clearly demonstrating that the study purpose is research into public health and therefore providing benefit to health and social care in the UK. However, in the interests of full transparency, it is noted here that the programme is funded by commercial entities, who could ultimately benefit from the programme and the analyses produced.

It will take several years for discoveries to emerge from the research programme and any researchers, whether commercial or non-commercial, may profit from the discoveries they make from research using Our Future Health.

However, researchers who use Our Future Health will be required to disseminate the results of their research as rapidly and widely as possible, subject to ethics and confidentiality considerations. They will be encouraged to discuss their research findings with other scientists and the public, and to share relevant data and materials as openly as possible.

Researchers will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers and the public in future.

While Our Future Health are the data controller for this programme, they will have no access to the patient-level identifiable data provided by NHS Digital to APS Group under this agreement.

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS Digital will only be used to identify and invite potential participants. NHS Digital record Level Identifiable data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the HRA and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets have been set for 2022 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign may include key aggregate facts and figures about the recruitment progress.

Yielded benefits have not been provided at this time as recruitment is ongoing.

BACKGROUND

Our Future Health intends to be the UK’s largest ever health research programme. It is designed to help people live healthier lives for longer through the discovery and testing of more effective approaches to prevention, earlier detection and treatment of diseases.

Our Future Health's goal is to recruit up to five million adult volunteers from across the UK to create an incredibly detailed picture that truly reflects the whole of the population.

Our Future Health has received favourable ethical opinion on 29/03/2021, reviewed and issued by the NHS Health Research Authority (HRA) East of England – Cambridge East Research Ethics Committee.

THE AIM OF THE PROGRAMME

The overarching objective of Our Future Health is to help people live healthier lives for longer through better prevention, earlier detection and improved treatment of diseases. The Our Future Health research programme will aim to speed up the discovery of new methods of early disease detection, and the evaluation of new diagnostic tools, to help identify and treat diseases early when outcomes are usually better.

To achieve these objectives, Our Future Health aims to recruit up to 5 million adults from across the UK (from a variety of different recruitment routes including NHS Digital) to create a diverse and inclusive cohort of people who have consented to participate in the research.

• Specific Aim 1: Build a resource linking multiple sources of health and health-relevant information, including genetic data, on millions of people in the UK, to facilitate basic discovery research by academic and commercial researchers on early indicators of disease

• Specific Aim 2: Analyse the data in the resource to estimate personal disease risk information for participants, based on genetic and non-genetic information, and offer this estimated personal health information to participants who wish to receive it

• Specific Aim 3: Re-contact sub-groups of participants generally for additional samples, non-routine data and secondary studies over time

• Specific Aim 4: Re-contact participants on a risk-stratified basis (i.e. recall-by-genotype/phenotype or sociodemographic characteristics) over time specifically to enable secondary studies by academic and commercial researchers that is greatly enhanced by being able to identify highly enriched sub-populations/sub-cohorts of participants

BACKGROUND TO RECRUITMENT

Our Future Health has taken a steady approach to trialling and testing various recruitment routes, though pilots and often in partnership with other organisations. 2021 saw early pilots with NHS Blood and Transplant, and with National Institute for Health and Care Research (NIHR) which are being developed up into larger scale recruitment routes. 2022 will see pilots in Secondary Care, and a range of community based recruitment pilots in partnership with community based organisations. The NHS DigiTrials services will form a key part of the strategy to achieve recruitment targets in 2022.

PROGRAMME TEAM

Any reference to "the programme team" in this agreement refers to members staff employed by Our Future Health directly working on the Our Future Health programme.

PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)

Involving the public in the design of Our Future Health will be vitally important to its success. Our Future Health is building a governance structure that has public involvement and engagement embedded throughout, and has already demonstrated a clear commitment to involving and engaging the public in our development, build and operational activities.

In 2020, Our Future Health involved members of the public in the design and development of the public-facing materials as well as in other aspects of the project design. The design of the participant information sheet and consent form has included:

• 18 focus groups with 82 members of the public;

• 4 meetings with a co-design group comprised of 8 members of the public; and

• 21 user testing interviews with members of the public.

During 2021 Our Future Health worked with Claremont creative agency to conduct a programme of patient and public involvement work. Over 120 members of the public were involved during 2020-2021 including:

• 4 focus groups, 2 co-design meetings, 21 interviews with the public to develop the scientific protocol

• 12 interviews with a variety of stakeholders from charities and existing cohort studies

• 2 focus groups with 11 NHS primary care staff

• 18 focus groups, 10 co-design meetings, 21 interviews with the public to co-develop the participant information sheet, consent form & other public-facing videos & materials

• 21 interviews to understand the role of industry in health research

• 4 focus groups to explore insights around recruitment methods

• 3 focus groups to explore public motivators and feedback preferences

• 1 member of the public attended the REC approval meeting with a member of Our Future Health

As it was qualitative research, not quantitative, the outputs of the work are summarised as follows:

• Co-designed and REC approved PIS and Consent form

• 4 co-designed explainer videos for Our Future Health (YouTube)

• Public Engagement Strategy (Claremont 2021)

• Engaging Black Audiences Report (written by an external consultant)

30 members of the public were invited to join the Our Future Health Public Advisory Board, and 14 accepted. 6 are affiliate members of the Secondary Care Working Group, Ethics Advisory Board and Technology Advisory Board (with 2 PPIE representatives on each). The Access Board will have equal representation of expert and public/participant members.

Outputs of these groups since 2021

• Agreed Terms of Reference, working principles, PPIE training pack and evaluation matrix

• 3 meetings held in 2021 and 1 ad-hoc consultation.

• Topics for consultation and input/approval have included the Founding Industry Member Policy, TRE, amendments to the PIS and consent form

LEGAL BASIS FOR COMMON LAW

Our Future Health as data controller, are requesting to use NHS Digital data to support a research programme called ‘Our Future Health’. This agreement is specifically to support the recruitment of a cohort for this programme by writing out to individuals who meet the required eligibility criteria. The legal basis for the identifiable data from NHS Digital to flow to Allied Publicity Services (APS) Group for the purpose of Our Future Health inviting them to join the programme is Section 251 approval (NHS Act 2006).

GDPR LEGAL BASIS FOR PROCESSING OF PERSONAL DATA

Our Future Health, as sole Data Controller, are using Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for Our Future Health legitimate interests which are described below. The data to which access is requested are proportionate and necessary to achieve those interests. Our Future Health have completed a legitimate interests assessment (LIA) and NHS Digital are satisfied that the interests of the data subjects do not override their legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project. Our Future Health considered the purpose, necessity and balance of the programme when completing their legitimate interest assessment.

It is acknowledged that Our Future Health has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation and visit the Our Future Health website. At that point, Our Future Health solicits the potential research participant’s explicit consent to join the programme for the purposes of making a contribution to research efforts to benefit the wider public's health. Participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.

Additionally (as health data is a special category of Personal Data), Our Future Health is using Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. Our Future Health’s ethically approved scientific research programme seeks to make advances in early disease detection and prevention to improve public health in the wider societal interest to help people live longer lives in better health. Without this research programme improvements in the early detection and possible prevention of disease are likely to either: (a) not take place; or (b) be negatively impacted. To improve the nation’s health Our Future Health aims to recruit research participants from as broad a spectrum of society as possible as overall health is a component of behavioural, social, environmental and genetic factors.

INCLUSION AND EXCLUSION CRITERIA

The programme will be conducted throughout the UK* and the aim is to recruit a total of 5 million participants, via a number of different recruitment routes. Our Future Health aim to recruit approximately 175,000 participants via NHS Digital recruitment for the first year.

*NHS Digital will be providing data for England and Wales only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.

Inclusion criteria:

• Reside within England and Wales

• 18 years or older:

NOTE: Our Future Health are not recruiting children under the age of 18 for the following reasons:

◦ In order to facilitate research on common complex conditions such as heart disease and type 2 diabetes, it is necessary to have sufficient events or cases develop in the cohort during the first decades of its existence; including children would mean that there would be too few events for this vital discovery research to be enabled for many decades. This would mean that the benefits of the resource would not be realised, and would risk diminished value of the cohort to the scientific and health research community, and to wider society.

◦ The aetiology of childhood-onset conditions (such as childhood cancers and rare genetic disorders) differs to those of adult-onset conditions (such as breast cancer and Alzheimer's disease).

◦ Our Future Health are using an opt-in model with explicit consent; this model would be considerably complicated by the inclusion of children particularly in the absence of adequate scientific or health rationale for their recruitment.

Exclusion criteria:

The overall cohort of participant aims to be representative across UK geographical locations, age, gender and ethnicity. It is possible as part of the creation of each NHS Digital mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.

Recruitment is expected to begin in Summer 2022 and take place over several years. For the first year of recruitment, approximately 3 million patients will be identified and contacted. With an assumed response rate of 5%, approximately 150,000 patients should be recruited, however this recruitment target is an estimate and may be subject to change. The recruitment target and number of invites will be reviewed for future years.

REQUESTING NOT TO TAKE PART IN THE PROGRAMME:

In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the Our Future Health Programme. Our Future Health will promote this information via the dedicated programme website (https://ourfuturehealth.org.uk/) and via local media for four weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS Digital will also promote this information via a dedicated page on its website (https://digital.nhs.uk/services/nhs-digitrials/how-we-identify-participants-for-the-our-future-health-programme). There will also be an option for people to register their request not to take part in Our Future Health by telephone. NHS Digital will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection and as a result their details will not be on the list passed to APS Group for invitations to be sent.

ORGANISATION’S ROLES AND RESPONSIBILITIES:

Our Future Health is the applicant and data controller. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.

Our Future Health is responsible for:

1. Generating the invitation request(s) and sending to NHS Digital on a regular basis

2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)

3. Monitoring scope of the population booking appointments and entering the programme.

4. Adjusting the selection criteria for subsequent invitations to adjust for underrepresentation of target populations taking up the programme.

NHS Digital are acting as a data processor on behalf of Our Future Health and are responsible for:

1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees

2. Feeding back to Our Future Health the number of invitees actually fulfilled out of the total target population.

3. Removing objections or opt outs (where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)

4. Sending the list of invitees on to their third-party provider (Allied Publicity Services (APS) Group) for generating the invitation letters and mailing these out

5. Agreeing with Our Future Health key processing timelines, including

a. Time from submission to APS Group to mailout

b. Date of the mail outs

c. Daily cut-off times (i.e. after which processing will take place the next day)

d. Time to feedback to Our Future Health the numbers selected

6. Overseeing performance of APS Group and alerting performance issue to Our Future Health.

7. Feeding back to Our Future Health performance in relation to Key Performance Indicators (KPIs) of APS and NHS Digital

8. Where the number of invitees is less than the population available, invoking a system to choose invitees at random

9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations.

APS are acting as a sub-processor of NHS Digital. Their responsibility is to receive the lists of invitees from NHS Digital and mail out to them accordingly.

A 'return to sender' address will need to be included on the letters. When letters are unable to be delivered to the participant address provided by NHS Digital - they will be returned to APS where they will be shredded. APS will provide NHS Digital with an aggregate report of number of returned letter.

Our Future Health have a series of Programme oversight groups with PPIE representatives. Our Future Health has a robust governance structure with appropriate management and advisory boards to ensure thorough and informed oversight, management and decision making.

FUNDING

Our Future Health received initial funding via the UK Research and Innovation (UKRI) Life Sciences Industrial Strategy, with a commitment of £79m administered via the UKRI-Innovate UK. Our Future Health also have a programme of Founding Members, which will include charities and pharmaceutical and diagnostic companies, who will contribute funding to the programme in return for becoming a Founding Member.

As well as contributing funding, the industry and charity members will bring considerable expertise in discovering and developing new methods of prevention, early detection and treatment of diseases and health conditions. These Founding Members will help Our Future Health co-design, co-deliver and co-fund the programme. By making Our Future Health resources available to researchers both from academia and industry, it is hoped to help accelerate the discovery and development of innovative diagnostics and treatments.

Our Future Health have agreed some specific terms with industry and charity members that recognise their investment in, and support to develop, Our Future Health from its early stages. These include:

• a seat on the Founders Board – one of the boards Our Future Health are setting up to help guide and shape Our Future Health. The Founders Board will:

o provide guidance on the scientific and technical aspects of Our Future Health;

o help Our Future Health to identify emerging challenges and opportunities; and

o help to make the programme valuable to as wide a range of researchers as possible.

The Founders Board will be able to nominate experts to sit on some other advisory boards established by Our Future Health to ensure that they can benefit from their expertise across the full breadth of the programme.

• During the early years of the programme, Our Future Health’s industry members will be the only large commercial organisations that are eligible to apply to use Our Future Health resources for research. This doesn’t affect access to Our Future Health for other researchers, such as those in smaller companies (SMEs) or non-commercial organisations like universities. Industry members will apply to Our Future Health’s Access Board for approval to conduct research in the same way as other researchers. All researchers, whether they are employed by universities, government, the NHS, charities or companies, will be held to the same standards.

• Founding members, as well as other researchers that use Our Future Health, will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers in future.

• Researchers may profit from discoveries they make using Our Future Health resources. Our industry members have agreed to make reasonable efforts to ensure that innovations developed using our resources are made available in the UK to benefit NHS patients.

No NHS Digital Record Level data covered by this Data Sharing Agreement will be shared with any funders and final decision making on processing of the data rests with Our Future Health Executive Team and Board who are all substantive employees, therefore the funders are not considered Data Controllers or Data Processors on this agreement.

COMMERCIAL PURPOSE

NHS Digital is content that the purpose of this programme is the recruitment into the Our Future Health Programme, which is aiming to be the largest ever health research programme, bringing people together to develop new ways to prevent, detect and treat diseases, thus clearly demonstrating that the study purpose is research into public health and therefore providing benefit to health and social care in the UK. However, in the interests of full transparency, it is noted here that the programme is funded by commercial entities, who could ultimately benefit from the programme and the analyses produced.

It will take several years for discoveries to emerge from the research programme and any researchers, whether commercial or non-commercial, may profit from the discoveries they make from research using Our Future Health.

However, researchers who use Our Future Health will be required to disseminate the results of their research as rapidly and widely as possible, subject to ethics and confidentiality considerations. They will be encouraged to discuss their research findings with other scientists and the public, and to share relevant data and materials as openly as possible.

Researchers will be given time to analyse and interpret the findings of their research and assess their significance. The majority of researchers will then return a copy of their results to Our Future Health. This means that Our Future Health will constantly grow in breadth and depth, which will benefit other researchers and the public in future.

While Our Future Health are the data controller for this programme, they will have no access to the patient-level identifiable data provided by NHS Digital to APS Group under this agreement.

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS Digital will only be used to identify and invite potential participants. NHS Digital record Level Identifiable data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the HRA and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets have been set for 2022 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign may include key aggregate facts and figures about the recruitment progress.

Yielded Benefits is not a requirement for new applications.