Ethics and Governance Framework

1.Introduction

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1.1 Background and context  

Improvements in early detection and prevention of disease will enable better provision of care, improve outcomes and reduce costs to the health service.  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. A major role will be to enable the recruitment of targeted sub-populations for trials of diagnostics and therapeutics. The success of the Our Future Health cohort 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.  

The starting point for an ethical framework for Our Future Health is the three key principles underpinning most research involving human participants: respect for autonomy, beneficence and justice.1  Building on these principles, Our Future Health can learn from previous cohorts where appropriate, but some aspects need new deliberation. These include the practicalities of recruiting such a large and diverse cohort, and the proposal to provide individuals with information about their risk categorisation. Our Future Health must make the most of the opportunity to become an exemplar, using new digital technologies in a way that sets the bar high for care and sensitivity. 

Ethics and Feedback Advisory Group 

Very early in its development, Our Future Health established an independent Ethics and Feedback Advisory Group (EFAG) to provide strategic advice on the development of ethical guidelines and principles for the Our Future Health cohort, and to develop an Ethics and Governance Framework to guide its operations (see Annex A for a list of members of EFAG).  This Framework provides advice to the Our Future Health Board and Executive, and will be publicly available for funders, partners, researchers, participants and the general public.  EFAG, an independent group which reports to the Our Future Health Board, will continue as part of the long-term governance of the cohort and will be responsible for monitoring the implementation of the Framework, and for reviewing and updating it as appropriate.   

It will be important to ensure close interaction between EFAG and the emerging scientific strategy as the operating principles and discussions develop.  Extensive public involvement and significant piloting will be crucial to help answer some of the questions that have been raised and to provide evidence to inform the Framework and the Our Future Health programme.  

We envisage the Framework is a living document. It will initially need to be reviewed frequently, as experience accumulates from initial piloting and the impact of the COVID-19 pandemic on health services is clearer. After that, the Framework should be reviewed on a regular basis, at least every five years, to ensure that it remains relevant to current scientific and ethical standards.  

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1 The Declaration of Helsinki sets out the defining principles for research involving human participants. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research- involving-human-subjects/

1.2 What is new or different about Our Future Health? 

The Our Future Health cohort will learn from and build on best practice established by other cohorts, particularly UK Biobank. However, there are some aspects of Our Future Health which are new or different, and these need particular thought.  

  • The size of Our Future Health: Recruiting a cohort of 5 million people has never been attempted before. While the scale does not necessarily raise new ethical issues, it will be important to consider the practicalities of recruiting such a large and diverse cohort. Our Future Health will be interacting with more than 10% of the adult population of the UK, and it will be particularly important to consider how to ensure appropriate support is available for participants who need it (discussed further in Section 3.1 and 4.4).  
  • Digital platform: Our Future Health will make extensive use of a digital platform to keep in contact with participants and collect information.  It will be important to make sure the platform is used transparently and responsibly, with careful and sensitive communications.  Our Future Health must also work to ensure this approach does not exclude any groups, making alternative arrangements available if necessary.  
  • The proposal to frequently use the cohort to recruit participants for further trials: Our Future Health will have two elements – Phase 1 will include the recruitment and ongoing follow-up of 5 million people; Phase 2 will involve selected sub-sets of participants being invited to take part in additional studies. It will be important to be very clear about the different consent required for each phase. The need for initial broad consent, with further detailed supplementary consent for Phase 2 studies is discussed further in Section 3.2.2.   
  • Feedback: Our Future Health is still considering making certain health related information available to participants. The nature of some of the additional studies which can be envisaged will make it unavoidable to disclose some individual information of possible clinical relevance, to participants. Return of clinically relevant information could be of benefit to participants, if it is correct and leads to better health management or leaves them better informed about their health. But it can also be harmful, if it is confusing or misleading or leaves them with anxieties and concerns which are not properly managed. This means it will be particularly important for Our Future Health to take a careful and responsible approach to decisions about feedback, as discussed in Section 3.4.  

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1.3 Boundaries between research and clinical care 

Clinical care involving patients has the primary purpose of providing a direct benefit to the patient through diagnosis, prevention, care or treatment.  People are also sometimes asked to participate in projects which are purely research, with the primary purpose to test a hypothesis or to generate new generalisable knowledge. These two activities are often seen as separate, with different governance processes and expectations. However, the boundaries can be blurred. For example, a clinical trial of a new treatment involves both research and care; a genome analysed for diagnostic purposes might also provide evidence for research on the association of other genomic variations with particular diseases. Where research is undertaken in a clinical context with an individual patient it can be easily explained, but when it is scaled to involve large numbers of people, it becomes important to be clear what is involved. 

There is therefore a spectrum between care and research, and the scope of any related duty of care tracks that spectrum. The patient / clinician relationship creates a duty of care from the clinician to the patient which has been the subject of many years of legal precedent and covers many different facets of the interaction, from consultation to information, consent, treatment and follow up care.  At the other end of the spectrum, the participant / researcher duty of care is still a legal duty of care although its nature and scope are less well defined by legal precedent and more influenced by context, expectations and normal practice of biomedical research.   

The scope of the duty depends on, amongst other things: 

  • the nature of the research project; 
  • the basis on which participants are recruited (do they or should they expect any benefit from participating?); and  
  • what the participants should be and are told about the project.   

For example, a researcher owes the participant a duty of care which includes: 

  • the obligation to be clear, transparent and fair about the process; 
  • the obligation to make the process as safe as possible; 
  • the obligation to make the process relevant for effective research; 
  • the obligation to provide certain information back to participants. This is more nuanced and will depend on the nature of the information and how expectations have been set.  

For example, UK Biobank was established as a research project. The information provided to participants at the outset made it clear that participants should not expect any personal benefit, including clinical feedback, from taking part. The emphasis was on creating a research resource with the objective of generating discovery about disease in a generalisable manner. 

By contrast, the 100,000 Genomes Project was designed as a hybrid between research and clinical care. This is reflected in the information provided to participants, where there is an emphasis on the individual benefit that participants may receive as a result of taking part, including the potential of receiving an individual diagnosis, in addition to the research potential of the genome sequencing information. Participants were recruited as part of their NHS care, and any findings are provided by the clinical team, to ensure that appropriate clinical care and support is available.   

Our Future Health is different again. It is intended primarily as a research resource for generalisable discoveries, but participants may be invited to take part in additional trials, to test out diagnostics, treatments or behavioural interventions. This means that participants might receive different clinical care, or have more interaction with the health service, as a result of their involvement. From a participant’s perspective, Our Future Health is therefore further along the research-care spectrum than UK Biobank, but it is not as far along as 100,000 Genomes. 

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 project includes both research and clinical care, the legal situation and the scope of the duty inevitably becomes more complicated.  Our Future Health should ensure this is appropriately considered and any clinical duty of care required, (for example if an individual needs clinical assessment, screening, preventive measures or treatment as a result of information discovered through participation), will need to be appropriately resourced and supported.   

The implications are particularly relevant when considering consent (Section 3.2), feedback (Section 3.4) and ongoing support for participants (Section 4.4, Box 2). 

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2.0 Guiding Principles >