Ethics and Governance Framework

Executive Summary

Improvements in early detection and prevention of disease will enable better provision of care, reduce costs and improve health outcomes.  The Our Future Health (Our Future Health) programme aims to enrol up to five million people to a research cohort to help address this need.  The success of Our Future Health depends on building and maintaining public trust and confidence. This will require the programme to demonstrate high ethical and governance standards across all its activities. Our Future Health established an Ethics and Feedback Advisory Group (EFAG) to develop an Ethics and Governance Framework to guide its operations.

Our Future Health can learn from best practice established by other large cohorts, for example UK Biobank. However, there are some novel aspects of Our Future Health which need particular thought, such as:  

  • the size of Our Future Health and the practicalities of recruiting such a large and diverse cohort, including the need to communicate with participants largely through a digital platform, with very little opportunity for personal contact;  
  • the intention to regularly use the cohort to recruit participants for further studies to test diagnostics, treatments or behavioural interventions;  
  • the proposal to provide participants with individual health-related information, for example their disease risk categorisation. 

We set out some key principles that should guide decision making and offer some high-level guidance on the major operational areas of the programme. 

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The balance between research and care 

In order to ensure clarity in its relationship with participants, we recommend that Our Future Health should be approved and regulated as a research programme. Participants should not expect to receive individual clinical care as a result of taking part. However, Our Future Health should recognise that its relationship with some participants may go beyond that of pure research.  Where a participant needs clinical assessment, screening, support or treatment as a result of information discovered through Our Future Health, this must be appropriately resourced and supported.   

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Public and participant involvement 

The success of the Our Future Health cohort critically depends on building and maintaining public trust and confidence. A public and participant involvement strategy must be developed as a priority. Extensive public involvement and significant piloting from the very beginning will be crucial to help answer some of the questions that have been raised and to provide evidence to inform this Framework and the Our Future Health programme.  

Involving participants in a meaningful way over the lifetime of the cohort will help strengthen the programme, ensure it meets the expectations of those who contribute their time, data, samples and information, and help motivate participants to stay engaged. Public engagement and involvement activities must be woven in at all levels of the cohort, and adequately resourced.

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Recruitment 

Recruiting a cohort of 5 million people has never been attempted before. Our Future Health will need to interact with more than 10 per cent of the adult population of the UK, and responsible use of a digital platform will be essential to help achieve this. 

Our Future Health must endeavour to recruit a broad mix of people that reflects the diversity of the UK population, including (but not limited to) a range of ethnic and socioeconomic backgrounds. This will be crucial to ensure discoveries from Our Future Health can be of value across society and to understand differences between different sections of the population. Recruitment methods should be carefully designed in consultation with people from underrepresented and seldom heard groups, to reduce barriers to participation.  Specific effort should be made to facilitate both the recruitment and continued involvement of people with limited capacity to consent. (See Section 3.1) 

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Consent 

We recommend that Our Future Health should operate with 2 stages of consent.  

  • Phase 1: Every participant should be recruited with a single broad consent. This should set out clearly what participation will involve; and give permission for initial assessment, sample collection and analysis, and long-term follow-up through linkage to health and health-related data. Participants should also agree to be re-contacted with requests for further information and samples, or to be invited to take part in additional studies. 
  • Phase 2: Additional studies will each need supplementary consent, which will provide more detailed information about the details of the individual study. There is no obligation on participants to agree to take part in any phase 2 study – each will be the subject of a separate and independent consent. 

Phase 1 consent will need to be broad, to define the types of research that might be facilitated, and how access will be governed. It should be made clear that the decisions participants may face later could be complex and have significant implications for their lives. 

Our Future Health should follow best practice to ensure appropriate standards for valid consent. The way in which information is conveyed is as important as the information itself and Our Future Health should make sure that information resources are available in a range of accessible formats, and try to assess whether participants have understood the information.  

Participants have a right to withdraw from the Our Future Health cohort at any time, without having to give a reason. This should be explained as part of the consent process. (See Section 3.2) 

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Recontact 

Participants might be re-contacted for additional studies that require new sampling or clinical assessment, additional data linkage, enrolment in a trial or a new follow-up programme. The Phase 1 consent process should set expectations for why and how participants might be re-contacted over the lifetime of the cohort. 

Initial recontact should always be by the Our Future Health team. Participants should be given the choice whether or not they are willing to provide additional samples or information. A governance mechanism will be needed to assess and approve additional studies, taking care to monitor and avoid recontact fatigue leading to cohort attrition. (See Section 3.3)  

Some studies may require that participants are made aware of individual health information, for example if they are being recruited because of their risk of a particular disease, the reason for their selection will need to be explained. However, this could disclose information about their risk profile before they have given consent.  Strategies which do not involve selection before consent should be used where possible. 

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Provision of individual health-related information (“Feedback”) 

There is significant debate about whether and how participants should be provided with individual health-related information. Providing clinically significant information to participants can be of benefit, if it is valid and leads to better health management but it can also be harmful, if it is misleading, causes distress or results in unnecessary medical procedures.  

Our Future Health must take a responsible and cautious approach, based on the following principles: 

  • Participants must be given a choice about receiving individual feedback. 
  • Our Future Health must have a transparent mechanism to assess potential benefits and harms before any feedback is provided. 
  • There must be a robust, long-term clinical support system in place for participants who receive individual information in this way.  

We distinguish between two types of feedback, which should be treated differently: 

  1. Clinically significant information, which is already used in routine practice to guide clinical management.  This type of information may be provided on initial examination when admitted to the study, or on an ongoing basis during the course of the cohort, provided the principles described above are met and the practicalities can be appropriately addressed. However, in practice this is far from straightforward, and we discuss the many problems surrounding the return of clinically relevant information to participants (Section 3.4.4). 
  1. Information of unproven clinical validity or utility. This type of information should only be provided if participants give additional, specific consent as part of a separate research protocol. 

Our Future Health must actively engage with the public and participants to understand people’s expectations about feedback.  The approach to providing feedback must be clearly explained during the consent process. This should take into account uncertainties, recognising that feedback policies may need to be updated in light of emerging evidence and decisions may change over time.  

Our Future Health may consider offering participants information about their risk status for certain diseases. Some risk stratification will be clinically validated (e.g. a QRisk score for cardiovascular risk, or a high cholesterol level) but some will be of unproven clinical validity or utility. Polygenic risk scores (PRS), for example, have not yet been widely used in clinical careInformation that is not of proven clinical utility or validity (including, currently, most PRS) should only be provided with separate, specific consent which carefully explains the uncertainties. When providing any information about risk profiling, it is crucial that the inherent complexities and uncertainties are communicated. 

Our Future Health should not provide complex information to participants without ensuring ongoing support is available to help them manage and interpret that information.  This could have considerable resource implications which must be appropriately addressed from the outset. We would caution strongly against providing a feedback programme, however well intended, without ensuring that a high-quality long-term support system is in place. (See Section 3.4) 

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Data stewardship 

Our Future Health will collect a vast amount of data over the lifetime of the cohort.  In order to build and retain participants’ trust, Our Future Health must demonstrate a robust approach to data security and have rigorous processes to control access and use.  The initial consent process should set out information about what data is collected, how data will be kept safe, and how data access will be managed.  The importance of transparency cannot be overstated. Our Future Health’s approach should be grounded in the National Data Guardian’s advice that there should be ‘no surprises’.  

Initially Our Future Health will collect information from NHS records and other health and social care datasets, but there is potential for linkage with other types of dataset over the lifetime of the cohort, including information collected from wearables or social media.  There must be a transparent mechanism for making decisions about additional data linkage, with a clear scientific rationale for extending data collection. We anticipate that data linkage beyond health and care datasets will need additional consent.  

Our Future Health must develop a robust and transparent policy that sets out detailed information about how data and samples may be accessed and used. There must be an explicit mechanism to ensure appropriate research access to the accumulated cohort data, in order to maximise the value of the resource in the public interest. An appropriately constituted data and sample access committee(s) (DAC), reporting to the Our Future Health Board, should be responsible for access policy and overseeing decisions about access to data and samples.   

The resource should be available to all bona fide researchers for all types of health-related research that is in the public interest, in accordance with the participants’ consent. The same criteria should be applied to all researchers, whether academic, charitable or commercial companies, and whether from the UK or abroad.  No party should be given exclusive access to the resource. Short term exclusivity for newly generated data may be granted to researchers who generate the data, to allow them to exploit their own research findings before they become widely available, but this should not be an automatic right. The need for, and duration of, data exclusivity must be agreed by the Data Access Committee on a case-by-case basis. (See Section 3.5) 

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Support for participants   

Participants must be given appropriate support throughout the programme, and this must be adequately resourced. Communications must be clear and accessible to ensure participants understand the implications of participation and have help when interpreting feedback. It will be essential to also provide a level of personal support for those who need it, whether by telephone, online or face-to-face. 

Governance, advisory and control structures 

Our Future Health must be governed well and in the public interest. The governance mechanisms should be appropriately constituted, accountable and open to scrutiny. The mechanisms should include a main Board, Scientific Advisory Board(s), an Ethics Advisory Committee and a Participant Advisory Panel.  Special advisory committees will also be required, including dedicated Access and Feedback Committees. (See Section 4.2) 

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External partnerships  

The Our Future Health cohort depends on close partnerships between participants, researchers, healthcare professionals, industry, charities, government and international research efforts. The roles of different partners must be transparent, and clearly defined.  

Commercial partners: Industry partners will play an important role in achieving Our Future Health’s goals and add value to the work, but the public and participants can be uncomfortable about commercial involvement. It is important to address these concerns proactively and openly. A policy on commercial partnerships, including details about oversight and scrutiny, should be developed as a priority, and the involvement of industry partners must be carefully explained in the consent process.  We recommend that the Participant Advisory Panel should be involved in the development of this policy, and should also discuss and scrutinize the conditions on which Founding Partners can join.  Industry involvement must be on terms which are consistent with the overall aims, objectives and values of Our Future Health, and should be designed to deliver public benefit.  (See Section 4.3)   

Implications for the NHS: The Our Future Health cohort will be closely associated with the NHS and there must be funding, resource and support to match. Our Future Health must ensure that healthcare professionals are properly prepared, well informed and not overburdened as a result of the programme. It will be essential to ensure appropriate engagement within relevant NHS professionals and structures throughout the lifetime of the cohort.  We recommend that Our Future Health should work with NHS bodies and personnel to undertake a detailed analysis of the resource implications of implementation for the NHS. (See Section 4.4) 

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