Ethics and Governance Framework

4. Structural and Governance Issues

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4.1. Public and participant involvement, engagement and communications

With 5 million adult recruits, Our Future Health will be interacting with more than 10 per cent of the adult population of the country. Keeping these people engaged and enthusiastic will require a dedication to regular, careful communication of the highest and most active standard, above anything that most scientific projects have attempted. The success of the Our Future Health cohort depends on building and maintaining public trust and confidence.

Participants and the public must be actively engaged from the beginning, and public involvement should be woven in at all levels of the cohort, rather than being siloed or seen as an ‘add-on’. This has a number of functions: first, to inform the development and design of the cohort to ensure the approach is acceptable to participants; secondly, to improve the quality and accessibility of specific material and information provided; and, thirdly, to continue to motivate participants to stay engaged. It is also an important way of demonstrating that the contribution participants make is recognised and reciprocated.

A public and participant involvement strategy must therefore be developed as an early priority.

This is likely to include a number of elements:

  • Establishing a public (and subsequently, participant) advisory panel to provide ongoing input into the design and development of Our Future Health.
  • Creating a much larger ‘user testing group’ (or groups) to trial consent materials and the digital platform to ensure they are fit-for-purpose.27
  • Public dialogue activities to explore specific issues in more detail, for example expectations relating to feedback or access to data.
  • Tailored engagement with ‘seldom-heard’ and ‘harder to reach’ groups to ensure Our Future Health is able to reach diverse communities in culturally appropriate ways.
  • In discussion with participants, thought should also be given as to how best to represent participants’ views on advisory groups, from Board-level down, to provide input into ongoing decision-making. Establishing a panel of members of the public initially, and participants subsequently, will be valuable to provide advice for the cohort long-term but, on its own, is not enough.
  • The digital platform is also likely to provide a route to consult participants quickly, efficiently and in new ways about proposed developments to the cohort.

Public engagement and involvement activities must be adequately resourced. Our Future Health should become an exemplar of best practice, making use of Our Future Health’s digital platform and trialling innovative approaches for engagement. A one-size-fits-all approach will not be suitable, because engagement and involvement activities and information will need to be tailored and appropriate for diverse populations.

Involvement and engagement activities should be monitored and evaluated during the life of the cohort, to examine their impact on decision-making and the development of Our Future Health, and to refine the Our Future Health approach. In addition, given that Our Future Health is intended to be a population health resource, there should also be a mechanism to ensure that discussions reflect the wider public interest.

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27 The HRA states the following: “the best way to make sure your consent documentation is fit for purpose is to test it with patient groups or other members of the public.”

4.2. Oversight and governance

4.2.1. Regulation and approval

The final Our Future Health protocol will need to be approved by the Health Research Authority (HRA). Its review will include the core scientific proposals, the operational procedures, detail of recruitment invitations, participant information and consent materials. The approval will cover consent for Phase 1, as set out in Section 3.2.2. If Our Future Health has Research Tissue Bank status28, projects using data or samples acquired and linked as part of Phase 1 would not need further Research Ethics Committee (REC) approval, provided they have gone through Our Future Health’s internal approval mechanism. Phase 1 consent will also include agreeing to receive invitations to join Phase 2 projects, but separate REC approval is likely to be needed for at least some of these new projects, which will have separate protocols, information and consent forms.

The cohort will also need to meet the requirements of the GDPR, the Human Tissue Act and other relevant research governance frameworks.

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4.2.2. Governance, advisory and control structure

Ensuring the right mechanisms for oversight and governance will be essential to ensure appropriate accountability for the programme, and to help build public trust and confidence. The governance mechanisms should be appropriately constituted, accountable, and open to scrutiny.

Our recommendations for the structure of Our Future Health are as follows:

  • Main Board: Our Future Health is a Charity, established as a company limited by guarantee. The Board establishes the ethos and broad operating principles of the Charity, which is perceived as a public-private partnership providing a resource for researchers to improve health, particularly by developing better early diagnostics and preventative interventions. This explicitly involves industrial partners. We believe this is the basis on which consent is being sought from the public. If this were to change, for example if it evolved over time to an industry-dominated programme with much more prominent commercial motives, we think it may jeopardise the consent which has been obtained. We do not anticipate this as a likely eventuality, but would urge that legal advice is sought on how the future status of the project can be protected from such a change.
  • Scientific Advisory Board/s: Our Future Health is a very large, ambitious and state-of-the-art concept. As a research platform, it has to collect and curate massive amounts of data in a way which will enable unpredictable numbers and types of future research projects. The design of protocols and of further research projects will require extensive scientific knowledge in many different fields. It would be expected that the CEO and Board of such an extensive programme would be supported by a very high-quality SAB. Disciplines which may be required include epidemiology, genetics and genomics, biostatistics, behavioural and other social sciences, public health, medicine, data management and handling. It may be necessary to divide the workload between more than one SAB. A separate International SAB is also recommended to ensure Our Future Health maintains work to the highest international standards. SABs usually are organised by, and report to, the CEO with provision for the Chair of the SAB to report directly to the Board as required.
  • Ethics Advisory Committee: EFAG is already well established. It has drawn up an ethical and governance framework for the project, with specific concentration on the issues arising from return of clinically relevant results to participants. An Ethics Advisory Committee (EAC) will be needed to monitor the development of the Our Future Health project, to react to new issues arising and to advise the CEO and the Board as the project progresses. EAC should be an advisory committee to the Executive and the Board. It sets its own agenda in consultation with the Board and the Executive. To ensure it can act as an independent voice, particularly in representing participants’ views, it must have the right to publish its recommendations and to speak publicly about its findings, although it would not expect to do this without prior notification to the Our Future Health Board. The Chair should have a place at a high level of the Project management structure, preferably on the project Board.
  • A participant advisory panel: As discussed in Section 4.1, there must be a mechanism for participants to provide ongoing input into the design and development of Our Future Health with a dedicated participant panel as part of the advisory structures of Our Future Health.
  • Access committee(s): As Our Future Health reaches maturity, it is hoped that it will facilitate research by many researchers from diverse backgrounds. The Access Committee must ensure that each researcher, and each project, is properly assessed before approval to access the resource. The mechanics of releasing appropriate data in a controlled fashion for approved projects is the responsibility of the Executive – the Access Committee sets policy, and then inspects and approves each application for use (although much of this can be delegated once a system is in place and running). It works closely with the Executive, and reports to the Board.
    The Access committee should develop clear policies on which to base its decisions, which should be as explicit as possible and should be publicly available e.g. on the Our Future Health website. It will monitor each application in order to ensure that both the applicant, and the proposed research, fit the access policies. The questions to be considered are discussed above in Section 3.5.1.
    The Access Committee/s will inform Our Future Health’s decision-making on the following issues:
    o requests for access to data and samples
    o requests to re-contact sub-groups of the cohort to take part in Phase2 studies
    o decisions about the provision of feedback
    o collection of data from new sources, such as wearables or social media.

    Although they raise some specific issues, these are all adjudicated by the access committee. In the case of Our Future Health, it may well be that the number of re-contact applications, and their potential complexity, will eventually necessitate more than one access committee.
    The Access Committee works in the best interests of the participants, and the charity. The skills needed on the committee are determined by the nature of its work. It must make assessments of science quality, probable health impact, and of likely participant views. People with broad experience across different fields will be particularly valuable as members.
  • Feedback Advisory Committee: The nature of Our Future Health makes issues relating to the provision of health-related information to participants a central issue, and one which has not previously been as intensively explored. As discussed in Section 3.4, it may be necessary to have a dedicated committee to provide advice on the detailed policy. There will also be an ongoing need to consider and monitor individual research programmes which may wish to return information to participants, either because it is part of the research design or because the selection of participants on basis of risk makes it likely that they will be made aware of their risk status. Exactly how work should be divided between Access and Feedback committees will have to be worked through once the groups are established, and kept under review as the project develops.
  • Special Advisory Committees: Our Future Health has established Advisory committees in relation to Industrial partners, and to the NHS. These are both critical areas of Our Future Health engagement, and this enables close contact with them.

The membership, responsibilities, operating principles, and records of decisions for all of these groups should be publicly available, for example through the project website. It will be important to have clear Terms of Reference for each group to ensure there are no gaps or unnecessary duplication. Some mechanism will also be needed to ensure that these various groups are kept informed about each other’s activities. This will make the whole process more efficient, and will create a better sense of a corporate enterprise. We assume there will also need to be special sub- committees relating to audit, remuneration, nominations and appointments etc, which should be set up to meet best practice requirements.

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4.2.3. Intellectual property, income generation and royalties

Our Future Health will need a clear statement to explain its approach to Intellectual Property, income generation and royalties. This should make clear who owns the data, and the approach that will be taken to any intellectual property generated from the data. The initial consent information should make clear that participants will not receive any financial gain from commercial exploitation. EFAG has not yet discussed these issues and should consider general principles and advice to Our Future Health in the near future.

4.3. External partnerships

The Our Future Health cohort will interact closely with a number of important external sectors: UK society (see Section 4.1), healthcare professionals and the NHS (see Section 4.4), government agencies, industry, and charities. Funding is expected to come from a consortium including government, charities and industry. It will be important to build close partnerships and to be transparent and open about these relationships.

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4.3.1. Government agencies

The Government has provided start-up funding for the project, through UK Research and Innovation (UKRI), and will provide continuing central support. UKRI may also fund independent researchers to use the resource, thus helping it to realise its full potential as a source of beneficial new information for society at large.

4.3.2. Charities

UK biomedical research charities will be approached to become founding partners of Our Future Health. Charities are likely to have a number of different roles, for example: provision of funding, identifying research priorities, supporting researchers seeking access to data for research studies, or funding research using sub-groups of the cohort in additional studies.

UK charities have excellent links to patient groups, strong brand recognition and are generally regarded as trustworthy by members of the public. Being associated with charities is therefore likely to enhance the standing and acceptability of the project and could help with recruitment. It will be crucial for Our Future Health to work to maintain this trust.

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4.3.3. Commercial partnerships

A range of commercial companies, including pharmaceutical, biotechnology, diagnostics and technology companies, are likely to be involved in the Our Future Health cohort. Commercial companies have expertise in discovering, developing and producing new diagnostics and methods for improving the early detection and treatment of chronic disease. Industry involvement is therefore essential if Our Future Health is to achieve its aims.

We know that the public are sometimes uncomfortable about commercial involvement in health data projects and, in a number of surveys, people have expressed concerns about companies using patient data29. It is important to address these concerns openly and proactively. Evidence suggests that there are two main causes. First, people worry about the risk to the individual or their family, with particular concern about data being used for marketing purposes. And secondly, there is unease about the impact for society, with concern that profit motives will override public benefits. There is particular resistance to the use of patient data by the insurance industry, for example. Evidence suggests that people are much more likely to accept commercial involvement if there is an explicit purpose and public benefit.

It will therefore be particularly important to set out fully the nature of any commercial participation in Our Future Health. Like the charitable and government sectors, it is anticipated that companies will have several different roles, including as:

  • Founding investors
  • Researchers, accessing cohort data to answer research questions
  • Funders of Phase 2 studies, inviting sub-groups of the cohort to take part in additional studies
  • Suppliers, including developing and maintaining the digital platform for the cohort.

These are different types of involvement which raise different issues and should be treated in distinct ways. A policy on commercial partnerships, including details about oversight and scrutiny, should be developed as a priority. This policy should explicitly include the set of ethical principles listed below. Given the importance of maintaining participant confidence, we recommend that it should be discussed with the Participant Advisory Panel as early as possible.

There are inevitable stresses between the public good benefits that will motivate most Our Future Health participants, and the needs of industry; but there are also many points on which these groups have common interests and goals. Project success requires that any significant conflicts of interest are openly acknowledged and appropriately managed. We set out some basic principles to help Our Future Health in guiding decisions about commercial partnerships.

  • Industry partners will play an important role in achieving Our Future Health’s goals and add value to the work. Commercial involvement should be welcomed, provided it is on terms which are consistent with the overall aims, objectives and values of Our Future Health.
  • Transparency is essential to build confidence. It will be important to clearly define different industry roles and Our Future Health must be explicit, both with participants and the wider public, about what partners receive in return for their investment. All contributors to and users of the project and its dataset should be publicly displayed on the website.
  • The involvement of industry partners must be clearly set out in the consent process. Many other cohorts allow industry access to the cohort for research, but Our Future Health industry partners are likely to be involved as co-funders from the beginning. It is also likely that many Phase 2 studies will be industry-led and funded. The nature and extent of industry involvement should be made clear to participants from the outset, with information about the likely role of commercial partners explained in an open and transparent way. Details of industry involvement should be kept up-to-date, with information available both on the website and as part of ongoing communication with participants. Participants must be able to see the reasons and benefits for industry involvement, and the measures put in place to protect their interests.
  • Participants should be given clear commitments that their privacy will be protected, including
    o No individual’s identifiable data will be disclosed to any partner, academic or industry, without the explicit consent of the individual concerned.
    o No individual’s identifiable data will be shared for marketing purposes.
    o All approaches for further contact will be made by Our Future Health itself, to explain what is required and to seek consent, before any data is disclosed. No individual approaches will be made to participants without their consent.
  • Industry involvement should be designed to further Our Future Health’s aims and to deliver public benefit, for example by speeding the discovery and development of diagnostics and treatments. Given that the interests of participants are served by making the resource as accessible as possible, no industry partner should be given exclusive access to the full resource. Where an industry partner provides intellectual effort or funding to develop new data using the cohort, there may need to be a limited element of exclusivity, allowing exclusive access to that specific newly developed data for a time-limited period. This should not be an automatic right for industry partners and must be justified on case-by-case basis. The same rules and bases for judgement should apply to academic or charity partners, although the needs and motivations may be different. For further discussion about arrangements for limited exclusivity, see Section 3.5.3.
  • Our Future Health is expected to have a small number of founding industry partners. These partners will have a key role in providing essential funding to set up the cohort, and without their support Our Future Health would not be feasible. There may, therefore, be good reason for them to have preferential terms of access for a time-limited period, but the details of any such arrangement will need careful thought. Terms that are seen to be not fair or appropriate could significantly undermine confidence in Our Future Health, and make recruitment more difficult. Care should be taken, for example, to ensure that academic, charity and SME- researchers are not excluded from accessing the full resource in any way. We recommend that the Participant Advisory Panel should discuss and scrutinize the conditions on which founding partners can join. Absolute transparency will be crucial. Founding partners should also commit to an agreed code of conduct, set out in the commercial partnerships policy.
  • When considering any partnership model, Our Future Health should take account of the Principles that the Department of Health and Social Care has developed to ensure appropriate benefit sharing when patient data is used by companies.30

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29 See for example, ‘The One-Way Mirror: Public attitudes to commercial access to health data’, Wellcome (2015) access-to-health-data-wellcome-mar16.pdf
30 health-data/creating-the-right-framework-to-realise-the-benefits-for-patients-and-the-nhs-where-data- underpins-innovation

4.4. Implications for healthcare professionals and the NHS

The Our Future Health cohort will be closely associated with the NHS throughout its existence. The proposed scale of the cohort means that there will be few GP practices that do not have participants on their patient lists. The implications for the NHS of recruitment strategies, the provision of feedback about health or risk status, and ongoing support for participants all need careful planning. Our Future Health will also be dependent on linking to NHS datasets to acquire ongoing updated medical information about participants.

As discussed in Section 1.3, Our Future Health is a research resource. However, primary care practices and other NHS related bodies may be involved in facilitating recruitment. There are likely to be occasions where a participant may need clinical assessment, screening, preventive measures or treatment as a result of information discovered through Our Future Health, and occasionally for ongoing support. They may also turn to the NHS for help and advice interpreting information they have received. The key issues for Our Future Health to consider are at what point the NHS can be expected to take on responsibility for this care and how this transition can be most effectively organised and managed. Our Future Health must be careful to ensure that healthcare professionals are properly prepared, well informed and not overburdened as a result of the programme.

Our Future Health cannot assume that clinical support for participants will simply materialise from the NHS without proper preparation. It is unrealistic to think that GPs will not notice the impact of 5 million people receiving information about their health or risk status. Indeed, the numbers could be higher because family members may also be affected and seek advice. The following guidance should therefore apply:

  • Ongoing engagement: It will be essential to ensure appropriate engagement with relevant NHS structures, both from the early stages of planning and throughout the lifetime of the cohort. This should be at high-level and also on the frontline, including both primary and secondary care and other healthcare professionals that may be affected (e.g. Blood Transfusion Service may be involved in recruitment; clinical geneticists in ongoing support and clinical management). If people in the NHS are not adequately prepared, Our Future Health risks rapidly losing the engagement of both GPs and participants. Unhappy doctors and unhappy participants could soon damage the credibility of Our Future Health and its ability to achieve its mission. These relationships must be meticulously prepared and cultivated before they can be relied on.
  • Early engagement with NHSX and NHS Digital will also be important to ensure the processes for data linkage can be streamlined as far as possible. (See Section 3.5)
  • Training and support: Because of the nature of the work that Our Future Health will facilitate, many GPs will find themselves unable to properly advise without help, on issues that arise from participation. Our Future Health will need to consider how to provide the tools and training to inform both participants and NHS staff. There may be existing models that could be built on, for example regional genomics centres, if appropriately engaged, may be able to help provide local expertise.
  • Ensuring appropriate resource: If Our Future Health is to be closely engaged in the NHS, there must be funding, resource and support to match. For example, there cannot be an expectation that overstretched NHS staff should be involved in recruitment activities in addition to their existing roles, without additional support and possibly resource. Any clinical duty of care required will also need to be appropriately resourced. One possibility might be to consider having trained ancillary staff, operating between the research programme and primary care, to help provide support to participants, either at recruitment or when feedback is provided.

As a first step, we recommend that Our Future Health should work with NHS to undertake a detailed analysis of how various aspects of the programme, including recruitment and the provision of feedback, will be implemented in practice. This should work through a number of examples to consider and evaluate the potential implications for healthcare professionals, to understand the potential challenges and barriers, and to assess what support may be required. It will be important to learn from previous examples, including the 100,000 Genomes Project, and to agree together what tangible support mechanisms may be required to deliver the programme effectively.

Implementation research will also be needed to explore how new innovations resulting from Our Future Health might be embedded into routine healthcare practice. This should consider if and how that innovation might be normalized within particular settings and will need to examine the different actors (including organizational infrastructure) that need to be involved in making the innovation work (or not work).

Our Future Health has the potential to provide evidence that informs the delivery of healthcare services in the future. For example, studies may reveal how information about risk could be provided to people most effectively, or how best to target screening programmes. While the research may take some time to mature, the outputs from Our Future Health should ultimately deliver benefit for the health of the whole population.

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