Ethics and Governance Framework

3. Guidance for Major Operational Themes  

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In this section, we offer high level guidance on the major operational areas of the programme: recruitment, consent, re-contact, feedback of individual findings, and stewardship of data.  

3.1. Recruitment  

The ethical principle of justice requires that there be fair procedures in the selection of research participants, with different groups of society offered the opportunity to participate.2 The following guidance should apply for recruitment to Our Future Health: 

  • Inclusivity: To ensure that discoveries can be of value across society, efforts must be made 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, and those with underlying physical and mental health conditions. This will help to ensure that, when there is targeted recruitment to further studies, large enough numbers are available from minority populations. Our Future Health should use innovative outreach approaches to engage with, involve, and ensure it is accessible to, diverse populationsRecruitment methods should be carefully considered, in consultation with people from underrepresented and seldom heard groups, to reduce barriers to participation.  While we appreciate that it may be difficult to have an entirely representative cohort, the aim should be to have a more balanced representation in order for findings to be generalisable3, and any major gaps should be transparently explained.  Recruiting, retaining and involving a diverse sample of the population will require considerable focus and effort, and it is critical that adequate resource is allocated for this part of the programme.4 It will also be valuable to hear from people who choose not to join or who drop out, to understand their concerns. 
  • Mental capacity: It is a matter of social justice that the recruitment and consent processes, as well as other aspects of the Our Future Health programme, account for the fact that some individuals in society have limited capacity to provide consent, and that some participants will lose (and possibly regain) mental capacity while part of the Our Future Health programme. Although there are obvious hurdles to overcome, we recommend that specific effort should be made to facilitate both the recruitment and continued involvement of such participants. Our Future Health should state explicitly the approach that will be taken if a participant loses capacity during the lifetime of the cohort. 
  • Digital platform: Since the main route for recruitment, consent and ongoing engagement will of necessity be via a digital platform, it will be important to ensure that this does not unnecessarily exclude any groups from participation in Our Future Health. 
  • Reimbursement: Participants should not have to meet any costs of taking part in the cohort and so recompense for expenses should be made available. In situations which make unusual demands on participants’ time, compensation for time spent can be considered. 
  • Association with the NHS: It is possible that recruitment will take place within an NHS setting, for example close to Health Check clinics.5 This could be a useful way to help recruit a diverse population at a moment where they are already thinking about their health.6 However it will be important to manage expectations to avoid confusion between recruitment for a research programme and the delivery of healthcare. It must be made clear that participants should not expect to receive individual clinical care as a result of taking part in Our Future Health.  The approach should also ensure that those who do not want to participate in research are not deflected from receiving clinical care.  The significant resource implications for the NHS are addressed in Section 4.4. 

2 The Belmont Report, page 9 (Part D: Applications – Selection of Subjects)
3 For example, a cohort of two thirds women and one third men would not be representative but would still be generalisable if the numbers in both groups are large enough to support robust comparisons between the two groups. It may be necessary to have over-representation of some minority groups in order to have sufficient numbers for valuable and robust research.
4 In addition to standard materials, some tailored materials for some groups will be needed, e.g. easy-to-read documents for people with learning difficulties, translation into the five most dominant languages in the UK, videos are all but essential for certain groups of people with certain forms of impairment.
5 There is an opportunity to embed social and behavioural science research that examines experiences around recruitment in a medical setting as part of the Our Future Health cohort. This could be particularly relevant given the very different contexts of the NHS Health Check and blood donation, where one begins with an expectation of receiving health information while the other is solely altruistic.
6 We note that the current shift to remote consultation as a result of COVID-19 may lead to some practical difficulties.

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The ethical principle of respect for autonomy requires that people should be given the opportunity to choose what will or will not happen to them, which means that adequate standards of valid consent must be met during all recruitment processes.7 We recommend that Our Future Health should seek initial broad consent for all participants at recruitment  (Phase 1 consent), with further detailed supplementary consent as required for additional studies (Phase 2) (see Section 3.2.2 for further discussion).   

Valid consent comprises three components: (a) information, (b) comprehension and (c) voluntariness. 

a) Information:  At the time of recruitment into Our Future Health, potential participants must be given sufficient detail about the programme which they are being invited to join to make an informed decision.  

  • Information about the implications of taking part. Individuals should be adequately informed about the nature and purpose of the cohort, what is involved, what will be required at entry, and what type of information will be collected on an ongoing basis. Potential participants must be given a sense of what is reasonable for them to expect from participation.  A list of information that should be provided, based on Health Research Authority (HRA) guidance, is given in Box 1.   
  • Broad consent. The consent requested at Phase 1 should be broad (described as generic by the HRA) because it will not be possible to anticipate all future research at the time of consent. Consent should enable research into human health and disease and factors that may influence them, and strategies for improving health care.  
  • Setting expectations about research-care boundaries. People should be asked to consent to Our Future Health on the understanding that this is a research project, rather than raising expectations that participants will receive individual clinical care.  Although there may also be clinical or behavioural interventions that arise from their participation, the personal clinical benefit of participation should not be overstated. Providing, or raising the expectation of personally useful clinical information can lead to therapeutic misconception – the individual believes that they are taking part in the project because of the personal clinical information it will provide them, rather than for the purpose of furthering knowledge of disease and treatment for everyone.  
  • Ongoing engagement. Beyond the information provided during consent, Our Future Health should continue to communicate regularly with participants, to remind them about the nature of the cohort study as a whole, what is involved and what they might expect, and to update them on progress of the work. 

b) Comprehension: the way in which information is conveyed is as important as the information itself. 

  • Scalability. The Our Future Health programme will need to provide information in a way that is scalable, i.e. leveraging online approaches rather than one-to-one in-person methods; however, the information must still be presented in a way that supports adequate comprehension and meets all the usual standards of informed consent.  
  • Proportionality. The amount and nature of information and support provided to potential participants should be proportionate to the scale and complexity of the Our Future Health programme. It will be important to strike a balance between providing adequate information while avoiding ‘information overload’. 
  • Adequate time. Participants should not face the decision about participation in Our Future Health ‘out of the blue’, but should be given adequate time to think about their decision; this should include time to discuss participation with others who may be affected by their involvement (e.g. family members).  
  • Multiple formats. Information should be offered to potential participants in multiple formats (e.g. videos, animations, audio, interactive website) in order to make it as accessible as possible. The information provided must be consistent across formats.  
  • Plain accessible language. All information provided should be clear, concise and avoid jargon. Written information should be readable to people with a wide range of literacy levels, consistent with HRA guidance8 and the Plain English Campaign “Crystal Mark”.9  Information will need to be available in a range of languages to reach diverse groups. 
  • Opportunity to ask questions. Potential participants must have the opportunity to ask questions and have these answered both initially and over time by an appropriately trained individual; this does not need to be done in-person, but can be done via telephone, email, online etc.  
  • Ascertaining comprehension. Our Future Health should endeavour to assess whether participants have understood the information.  We do not recommend the use of a quiz or test as a formal requirement during the consent process, because it is challenging to define quantitatively whether an individual has ‘adequate’ knowledge, and such tests may present unnecessary barriers to participation in the Our Future Health programme.  However, it will be important to explore all available ways to ensure participants understand the information and innovative alternatives, such as the use of decision aids10, should be explored instead.

c) Voluntariness: consent is valid only if voluntarily given. 

  • Ensuring consent is valid. Ensuring consent is valid involves making all reasonable efforts to assess whether appropriate information is given so that participants understand what they are signing up for, in addition to ensuring they are doing so free of coercion and undue influence. In the Our Future Health programme, ensuring valid consent will require a range of activities, including making sure that information resources are available in a range of accessible formats for different cultures (e.g. different languages, versions for visually impaired individuals).  
  • Well-recorded documentation of consent. It is vital that there is a well-documented electronic record of an individual’s consent, including clarity about which secondary (phase 2) studies they have consented to and which they have refused, in order to ensure that subsequent users of data know that participants did give consent, and what constraints there are on the uses of data. Appropriate mechanisms will be needed to ensure that consent is given by the participant themselves when it is given via a digital platform (in line with the HRA guidance on e-consent).11 
  • Values as well as comprehension. Potential participants will want to be comfortable that they are taking part in something which accords with their values. The consent process should reflect that an informed decision is one that is not only informed by adequate knowledge but also an understanding of whether the programme is consistent with the individual’s personal values. Some research studies have used web-based tools that include ‘values clarification exercises’ as part of helping individuals make decisions about participation.12  

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7 UK Policy Framework for Health and Social Care Research, Health Research Authority (2017).
10 Decision aids for people facing health treatment or screening decisions: Cochrane Review 2017.
11 HRA statement on eConsent (2018) publish-joint-statement-seeking-and-documenting-consent-using-electronic-methods-econsent/

  • The purpose of the cohort and why the research is taking place: this needs to be very clear about what type of research is acceptable and / or if anything is excluded.
  • What participation will involve, including the initial collection of samples and long-term follow-up of participations throughout the lifetime of the cohort (see Section 3.2.3).
  • The use of data: The information provided should set out what data about individuals will be collected or linked, and from what types of sources, who will have access to it and for what purposes, how decisions will be made, and how confidentiality and anonymity will be protected. This should include clear red lines, setting out what Our Future Health will never do with data (see Section 3.5).
  • Re-contact: The initial consent process should set expectations for how participants might be re-contacted, including that some participants may be invited to take part in additional studies over the lifetime of the cohort, which would need further consent (see Section 3.3).
  • Feedback: Potential participants must be informed about how communication of individual findings will be handled, both at initial examination and subsequently. This should explain the types of information that may be provided, the process and likely timeframe, and the choices that participants will have. It should also include explanation about the uncertainty around the interpretation of some information and how decisions about feedback will be made (see Section 3.4).
  • Withdrawal: The approach that will be taken if participants choose to withdraw at any stage, should be set out in the initial consent (see Section 3.2.3).
  • The funding and governance of the project, including the role of commercial partners, and the expectation that commercial companies will be able to access the data for research purposes, or apply to Our Future Health to invite participants to take part in phase 2 studies (see Section 4.3). This should also include clarification that participants will not receive financial gain from any commercial exploitation.
  • Implications for insurance: HRA guidance states that potential participants should be told if participation might affect any insurance cover that they may have. Since Our Future Health is a research project, and much of the work done on the cohort will be governed by separate embedded research projects, those participating will not need to declare any findings to their insurers. However, this is less clear if Our Future Health provides individual findings (e.g. Polygenic Risk Scores for specific diseases) to participants, outside of any research protocol. This is discussed further in Box 5.
  • The fact that participation is voluntary
  • The implications for a participant’s individual care.

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3.2.2 Initial and supplementary consent 

Our Future Health will have two elements: Phase 1 will involve the recruitment, enrolment and long-term follow-up of 5 million people, and then sub-sets of participants could be invited to take part in additional studies during Phase 2. Our Future Health should use initial broad consent for Phase 1, with further detailed supplementary consent as required for additional studies in Phase 2. 

a) Initial (Phase 1) consent  
This should allow: 

  1. Initial assessment at recruitment, including clinical examination, sample collection and survey completion;  
  1. Analyses including DNA studies, from collected samples; 
  1. Long-term follow-up, through ongoing access and linkage to health and care records (and other specified relevant datasets); 
  1. Long-term storage of samples and health-related data (in compliance with GDPR);  
  1. Use of stored samples and data for studies by external researchers, if approved through Our Future Health governance structures;  
  1. Re-contact by Our Future Health to ask for further information or samples, with no obligation to accept;  
  1. Re-contact by Our Future Health to invite participation in additional studies, which may be undertaken by external researchers or Our Future Health, with no obligation to accept (see Section 3.3); 
  1. Feedback of individual ‘clinically significant findings’, if participants have opted to receive feedback (as discussed further in Section 3.4).  

This consent will need to be broad, define the types of research that might be facilitated, and how access will be governed. It should set expectations about what participation will involve, as set out in Box 1, and about why, how and when participants could be invited to give consent for additional studies.   

b) Supplementary (Phase 2) consent  
This will need to be sought for additional studies that require new sampling or clinical assessment, additional data linkage, enrolment in a trial or a new follow-up programme. Additional studies must be approved by Our Future Health and relevant research governance structures. Initial recontact should always be by the Our Future Health team (see Section 3.3). The additional consent will need to explain the new study, set out what is involved, and provide details about feedback where relevant. The process should be kept as efficient as possible, so as to minimise burden on participants while at the same time allowing them to understand the new study and make an informed decision about participation. Where further consent is for a clinical trial, the consent processes and information required are likely to be more detailed, following specific HRA guidance. 

A key point is that although initial consent will be broad and general, the decisions that participants may face later could be complex and have significant implications for their lives. The initial consent process, while high level, will therefore need to set expectations clearly while supplementary consent will be essential to ensure participants are appropriately informed to make more specific choices.  Issues arising in these subsequent (Phase 2) studies might be sufficiently complex that more traditional face-to-face consenting is deemed necessary, but the numbers of people recruited to individual sub-studies is likely to be far smaller than the whole cohort. 

Our Future Health should avoid having a menu of different options within the initial consent. In dealing with so many participants, many of whom will be recruited to a variety of separate specific sub-studies, it will be critically important that the Our Future Health consent records show clearly what each participant has agreed to. 

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3.2.3 Right to Withdraw

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. The approach that will be taken if participants choose to stop taking part should be clearly set out, with information about what will happen to their data and samples.

Three options for withdrawal should be offered13:

  • ‘No further contact’: Our Future Health would no longer contact the participant, but would have their permission to retain and use information and samples collected previously, and to continue to obtain and use further information from health records.
  • ‘No further access’: Our Future Health would no longer contact the participant or obtain further information from their health records, but would still have their permission to retain and use information and samples collected previously.
  • ‘No further use’: Our Future Health would no longer contact the participant or obtain further information, and any information and samples collected previously would no longer be available to researchers. Our Future Health would destroy samples (although it may not be possible to trace all distributed sample remnants) and would only hold information for archival audit purposes.

It should be made clear that, with any of these options, it would not be possible to remove data from research that had already taken place. Our Future Health may need to retain minimal personal data for archival audit purposes, and to assess any impact on research findings, but this administrative record should not be part of the main database that is available to researchers.

Some participants will die while still part of the cohort. In line with the Human Tissue Act 2004 (in England, Wales and Northern Ireland) and HTA Code of Practice on Consent (2017) the participant’s consent to join Our Future Health would remain valid even after their death and data would continue to be retained. This provision maximises the potential for increased medical knowledge from information about the participant. Although the participant’s consent extends beyond their death, the participant’s relatives may sometimes have a different opinion after the participant has died. This view should be handled sensitively by the Our Future Health team, with relatives being encouraged to respect their deceased relative’s wishes.

13 These options are modelled on the approach taken by UK Biobank and Genomics England

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3.3. Re-Contact

Ongoing communication with participants will be a key feature of Our Future Health. The initial consent process at the time of recruitment should set expectations for why, how and when participants might be re-contacted over the lifetime of the cohort. These include:

  • To provide general updates about the cohort, recent news and developments, for example through newsletters and bulletins.
  • To provide feedback of individual health-related findings to participants (see Section 3.4 below).
  • To ask for additional samples or further information as part of the cohort follow-up, for example to complete a new survey or to collect data from a wearable.
  • To invite participants to take part in further research, which may be conducted by third parties (although contact should initially come from Our Future Health); this may require the provision of feedback, for example of individual risk categorisation.

Participants should always be contacted first by the Our Future Health team; this is likely to be through the digital platform (except for those participants who do not use the digital platform). Participants should be given the choice whether or not they are willing to provide additional samples or information, or whether they want to receive feedback. Participants have a clear right to refuse. Detailed records of consent or refusal must be kept accessible to guide decisions on data usage.

Participation in Our Future Health is a long-term endeavour. It should be made clear to participants that, although they will be kept regularly updated about the cohort’s progress, they should not necessarily expect to be re-contacted, either with information about individual findings or an invitation to an additional study, within the first few years. Such re-contact may not come until many years after the study began. Some sub-groups of participants found to have particular risk status may be more likely to be re-contacted sooner, but the information gathered about all participants as part of initial Phase 1 consent alone will be of considerable value to medical research.

Where re-contact is to invite participants to take part in a further study, the following guidance should apply:

  • Mechanism for assessing studies. Our Future Health will need a formal mechanism to assess and approve additional studies, for example a dedicated committee (see Section 4.2.2). The decision process will need to consider the science and ethics, but also issues such as burden on participants, the costs and resource required, and the depletion of limited samples. The tolerance of many participants to frequent re-contact should not be taken for granted, particularly for groups with uncommon but “interesting risk profiles”. This committee will need to establish criteria for selecting acceptable studies, and whether there should be a limit on the number of times a participant can be approached to take part in additional studies. The safety of the proposed research, and issues such as whether they will involve disclosure of personal predictive health information and how that will be managed, will be very important. Our Future Health is likely to be exploring new territory in this area. Care will need to be taken to monitor and avoid recontact fatigue leading to cohort attrition. Participants views will be important in helping to inform these decisions, particularly when assessing whether the level of burden on participants is appropriate.
  • Supplementary consent for additional (Phase 2) studies. The participant will be re-contacted, and the nature of the new study and the implications of taking part will be explained. Participants must be given the choice whether to participate and have a clear right to refuse. This process should be kept as efficient and concise as possible, so as to minimize burden on participants while at the same time allowing them to fully understand the role they are being asked to play in the research programme. It should be made clear that, once participants agree to take part in a specific additional study, they may then be contacted directly by the study organisers.
  • Risk stratification. If selected participants are invited to take part in additional studies on the basis of their risk of particular disorders, the basis of their selection will need to be explained to them and this will disclose information about their risk profile. The decision-making mechanism will therefore also need to take into account whether providing such information is appropriate (see Section 3.4 below), and how to manage the disclosure process. Participants must be given a choice as to whether they would like to learn this information. This leads to a dilemma: if only at-risk groups are approached, there is a risk that information would be divulged before consent is obtained. The mechanism for recontact will therefore need careful thought on a case-by-case basis. This is likely to be a particular issue when dealing with chronic conditions for which no validated clinical action is available. Strategies which do not involve selection before consent should be developed wherever practicable.

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Providing general feedback on the progress of a project, including aggregate findings, to all participants is recognised as good practice. This should be given to all participants in lay language and accessible formats, for example through a regular newsletter. Our Future Health should explore ways to make the most of the digital platform to maintain engagement with participants, while not being overly intrusive.

There is significantly more debate about whether and how participants should be provided with individual health-related feedback. In theory, where findings relating to an individual participant are of known clinical validity and utility, it is possible to make the case that information should be given, because they might benefit from knowing the information clinically; and for reasons of reciprocity, respect and transparency. However, providing access to complex information without appropriate support may be of limited benefit or even harmful, e.g. if it results in unnecessary medical procedures or causes distress.

It will be crucial to understand more about what participants might want in the way of feedback, and particularly to explore the implications of feedback as a motivation for people to take part in Our Future Health. Initial small focus groups suggested that the promise of providing feedback may encourage some people to participate and foster long-term engagement with the cohort, but this needs more testing and evaluation in practice and at scale. Not everyone will be motivated by receiving individual feedback. Participants are being asked to be altruistic, and for some people being provided with thanks, encouragement and information about the progress of their collective endeavour will be enough. For others, the possibility of receiving feedback might even deter them from taking part. Our Future Health must actively engage with the public and participants to understand people’s expectations about feedback, with a programme of deliberative work to develop the most appropriate approach. This will need to address views about providing feedback both during Phase 1 and as part of Phase 2 studies, and whether people might be interested in receiving comparative information about the cohort as a whole. These discussions must be structured to enable participants to see and come to a judgement about both the benefits and the hazards as well of receiving individual information. Without appropriate understanding, feedback may simply be seen as a risk-free benefit. The protocols will need to be carefully piloted and revisited and refined over the course of the cohort.

3.4.1 Principles for the provision of feedback

Deciding whether individual health-related information should be given to participants is a balance between its value and the undoubted potential for harm. The approach must be responsible and cautious. We set out some basic principles to help Our Future Health in guiding decisions about feedback of information of proven clinical significance.

  • Participants must have a choice: Participants should be able to choose (both during the initial consent process, and for subsequent Phase 2 studies) whether or not to receive feedback about their individual findings.14 We recognise that if participants do not want to receive feedback at any stage of the study, it may limit their ability to be invited to take part in Phase 2 studies, but we see choice as essential.15
  • Assessment of benefits and harms: Communication of clinically significant information to participants can be of benefit to them, if it is correct, robust and leads to better health management or leaves them better informed about their health. It can also be harmful, if it is confusing or misleading or leaves them with anxieties and concerns which are not properly managed. An assessment of potential good versus harm must precede any attempt to provide such information to participants. (see Section 3.4.4)
  • There must be an explicit purpose for providing feedback which can be clearly explained to participants: There are different responsibilities depending on whether feedback is being provided to inform clinical care, or as part of research, including recruiting participants to an additional research study. We recommend that an explicit decision is taken in each case, as to whether the feedback proposed is predominantly “clinical” or “research”, as this will guide the way it is managed and the responsibilities which Our Future Health takes on itself in providing the information.
  • Careful communication: Findings must be communicated clearly, responsibly and with care, especially given the potential complexity of the information. (see Section 3.4.3)
  • There must be adequate long-term clinical support for those receiving individual feedback: Our Future Health should not provide complex information to participants without ensuring ongoing support is available to help them manage and interpret that information. We would caution strongly against providing a feedback programme, however well intended, without ensuring that a high-quality, tailored and long-term support system is in place. It should not be assumed that the NHS will simply be able to provide this ongoing support without prior agreement. Failure to ensure specific and properly resourced support risks causing harm to some participants and bringing the entire programme into disrepute. The provision of proper support may have significant resource implications. (see Section 3.4.4)

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14 Knoppers et al (2013). The NASEM report also concluded that when individual research results are offered, participants have the right to decide whether to receive their results.
15 We note that there may be legal implications if a participant chooses not to receive information about clinically relevant information that might need to be explored in more detail.

3.4.2 Types of feedback

a) Providing feedback about clinically significant information

‘Clinically significant’ information is information that is already accepted and used in routine clinical practice to guide clinical management. Such a finding, whether physical, imaging or laboratory results (e.g. selected DNA mutations or biochemical abnormalities) would, if discovered during a normal clinical interaction, require discussion, further investigation or treatment. To be clinically significant, a finding must meet two criteria:

  1.  Be clinically valid: this refers to how well the variant being analysed is related to the presence, absence, or risk of a specific disease.16 The findings must have been accepted as clinically valid on the basis of satisfactory evidence by relevant health authorities and health professionals.
  2. Have clinical utility: this refers to whether the finding can provide information about diagnosis, treatment, management or prevention of a disease that will be helpful to a participant.17 The finding must be accepted by informed clinicians as being actionable or appropriate to guide clinical decision-making.

Where feedback is clinically significant, of both proven clinical validity and utility, it could be justifiable to provide the information to participants, provided all the principles described above (Section 3.4.1) are met. In particular, there must be careful assessment of the benefits and harms, consent must be given (see Section 3.4.3), and there must be a robust support system in place (see Section 3.4.4).

There are two different situations in which Our Future Health might consider providing such feedback:

  • On initial examination when admitted to the study. We consider it good practice that there should be immediate feedback of key results of measurements on recruitment, for example, BMI or blood pressure. Usually only abnormal measurements would be reported, but this may need to be reconsidered if some recruitment is via the NHS Health Check (or something similar), where the expectation is that all results will be provided.
  • On an ongoing basis during the course of the cohort. The concept of providing clinically significant feedback on an ongoing basis to participants may initially be attractive, but the practicalities should not be underestimated. While in principle it might be possible to define a list of clinically significant findings that could be provided during the lifetime of the cohort, experience has shown that this is not easy in practice, particularly in rapidly evolving areas such as genetics/genomics.18 Thought also needs to be given as to how often the list would be revised, and whether feedback for any one individual would be provided as a one-off activity or on an ongoing basis as new knowledge accrues. The criteria that should be taken into consideration are discussed further in Section 3.4.4 and Box 3. We believe such feedback could sometimes be justified but, because of the complexity of these issues, we do not at this stage recommend it without detailed further consideration.

b) Providing feedback about information of unproven clinical validity or utility

Information about an individual which may potentially be significant to the individual’s health, but which has not been validated to the extent of being generally recognised or accepted for clinical use, must be treated with extreme caution. It would not usually be appropriate to give participants individual information of unproven clinical validity or utility, because the information may be misleading and could lead to unnecessary harm or distress. However, there are two reasons why Our Future Health may want to consider giving such feedback:

  • For the purposes of research: Our Future Health could have the opportunity to assess the impact of providing feedback about risk information, to understand more about whether or how patients manage their risks, and to explore how to provide information about risk appropriately and sensitively.
  • For transparency: If a sub-group is invited to an additional trial on the basis of risk categorisation (using a method that is not yet fully clinically validated), the researchers inviting participants to these studies will know they are considered to be at increased risk. In order to ensure the enrolment process for those studies is transparent, and consent is valid, individual participants will also need to know why they are considered eligible.

Our Future Health must exercise caution before providing such information. We recommend it should only be provided if participants give additional, specific consent as part of a separate research protocol. This separate consent (usually when sub-groups of participants are invited to join additional Phase 2 studies) should include more detailed information about the nature of the proposed study, the information which will be fed back and the uncertainties relating to it, and allow participants to decide specifically whether or not to receive the information. The principles set out above (Section 3.4.1) must also apply, including a thorough assessment of benefits and harms, and the provision of robust long-term support for participants (discussed further in Section 3.4.4 below).

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16 A Thorogood (2019) Return of individual genomic research results: are laws and policies keeping step? European Journal of Human Genetics 27, 535–546 (2019)
18 it can be extremely difficult to clearly define what is clinically significant, particularly in rapidly evolving areas such as genetics/genomics, where it is difficult to prove both the clinical validity and utility on an individual basis. This difficulty may be exacerbated where the findings are detected as part of a population screen rather than through clinical presentation.

Box 2: Why should Our Future Health not routinely provide all genomic information to participants?

It could be argued that people have an absolute right to their own personal information. It is possible for people to access direct-to-consumer genetic tests and receive information about their genome and possible disease susceptibilities from a number of commercial organisations, although these tests are not without problems. *

We do not recommend Our Future Health should take a similar approach, for a number of reasons. Participants are agreeing to take part in a research project, and being offered what could be perceived as diagnostic information risks confusing some people about the purpose of the cohort. The clinical validity and utility of much of the information from such tests is not yet fully established, and it risks undermining trust in Our Future Health if such information is given without due care and responsibility. This is particularly so since Our Future Health is a large national programme, with considerable support from public funds, and closely associated with the NHS which has a strong reputation for evidence-based health care. Although some people may be attracted by the idea of receiving such information and appreciate its limitations, others may become confused or anxious, may turn to their clinical carers for support, and a few such cases could lead to a damaging public impression of the Our Future Health programme.

There would be significant resource implications for the NHS, if 5 million participants visit their GPs to seek advice and help with interpretation of the information they have received. Healthcare professionals will be particularly cautious about participants receiving information where there is not sufficient evidence for implementation in clinical practice, or clear, agreed clinical management guidelines. Many of them may feel unable to give proper advice.

We are extremely cautious about whether it would be appropriate to provide participants with access to all raw data about themselves (either on request, or routinely). Providing access to vast amounts of uninterpreted information creates a risk that erroneous medical implications will be deduced, and leave participants overwhelmed and vulnerable. Such information should only be safely divulged if there are adequate support facilities to help interpret and utilise the information appropriately.

In either case, this should only be considered if Our Future Health provided the resource for a long term robust clinical genetic support for participants.

*See for example the position statement on Direct-to-Consumer genetic testing by the Royal College of GPs and the British Society for Genetic medicine

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3.4.3 Setting and managing expectations about feedback

Information during initial consent: The approach to providing feedback must be explained during the consent process.19 This should include information about the types of feedback that might be provided, the process, a realistic timeframe, and the choices that participants will be given. Care must be taken to ensure the study is not viewed as a likely source of diagnostic information for individual participants, to explain the potential uncertainties and to set expectations appropriately. It should be made very clear what types of information will be provided initially. For example, if participants are invited to undertake a memory test as part of recruitment, should they expect to be given the results?

Recognising uncertainties: The nature of the science conducted with the Our Future Health cohort will evolve, and findings that are not initially of proven validity or utility might be viewed differently as evidence accumulates. Our Future Health should recognise that feedback policies may well need to be updated and decisions may change over time. This approach should be communicated to participants during initial consent.

19 Knoppers BM, Deschênes M, Zawati MH, et al. Population studies: return of research results and incidental findings Policy Statement. Eur J Hum Genet 2013;21:245–7. doi:10.1038/ejhg.2012.152)

3.4.4 Delivering feedback

Addressing the practical implications of providing feedback is an essential part of ensuring any feedback is responsible. Our Future Health’s approach to providing feedback must take into account the following points:

  • Making decisions about the provision of feedback: There will need to be a formal, transparent and accountable mechanism to provide ongoing advice to the Board on different feedback situations. One option would be a standing expert advisory committee. This group would need to agree overarching policies, keep them under review as evidence evolves, and make decisions about specific instances of feedback and recontact. An indicative list of questions that the committee would need to consider in each case is set out in Box 3. This includes assessment of the utility and validity of the information being provided, the implications for individuals and the practicalities of providing the information. The committee should be appropriately constituted with expertise to consider the scientific and clinical evidence, ethical issues, the resource implications, participant views and communication strategies. The decisions of this committee, and the reasonings, should be publicly accessible.
  • Providing support and advice: When people receive results from direct-to-consumer testing, they frequently turn to their GP for advice and support in interpreting this information. The same is likely to apply for Our Future Health participants given information about their health, and care must be taken not to become a burden on the NHS. Participants will need expert advice about what to do with health information they receive. Our Future Health will need to consider how to ensure appropriate support is available, and the role of the GP. Feedback should only proceed if long-term arrangements are in place to manage any issues which may arise for the participants who receive such information, whether they relate to accessing further medical care and treatment or to the resolution of uncertainties and anxieties.
  • Ensuring appropriate resource: Providing adequately supported feedback could have considerable resource implications, both for Our Future Health and for the health service, which must be appropriately addressed from the outset. There are likely to be significant implications for healthcare professionals, including the need for training and support, and this must be taken into account as part of the decision-making process about the provision of feedback. The impact on the UK health system of large numbers of participants taking risk information back to their GP is not trivial. If these issues are not properly dealt with in advance, they risk damaging the reputation of the study and derailing its capacity to function effectively.
  • Analytical quality: Any feedback provided should meet the technical quality and other criteria applicable to clinical results, which often differ from the standards applied to research data. Laboratory results must be performed to clinical standards, or confirmed in a clinically accredited laboratory.
  • Improving the evidence base: There has been very little research to explore the implications of receiving such research findings, the value of receiving such information, and the most appropriate ways to provide information about risk status as part of research. There is significant potential to conduct research using the Our Future Health cohort to provide an evidence base about good feedback models, with an opportunity to set best practice. Such research should be carefully scrutinised as part of the access process to ensure it is of high quality, and participants should be asked to consent, as part of a Phase 2 study.

Box 3: Questions to consider when assessing the provision of feedback

What is the nature of the information being provided?

  • What is the evidence for the finding? Is the clinical validity known, or is the information still unproven or at research stage? Is this a ‘clinical’ or a ‘research’ finding?
  • What is the potential severity of the condition? What impact does it have on quality of life?
  • What is the utility of the information? What interventions are available? Can the condition, or the risk of developing a condition, be prevented, reduced or managed through an available intervention? Is the intervention a treatment, screening or lifestyle change?
  • With information about risk categorisation, what are the certainty bounds of the estimate? Do other known factors influence whether or not the risk manifests?
  • Is the effect the same for different populations? For example, polygenic risk scores have so far been developed on the basis of predominantly European white ancestry samples, which means that feedback could be much less accurate for participants from ethnic minorities. Are the results still useful across populations?

What are the implications for individuals?

  • What are the potential benefits or harms to individual participants, or particular populations, of knowing, or not knowing, the information? Are there specific psychological, social or behavioural benefits or harms?
  • Are there implications for insurance (see Box 5)
  • Is there a potential for stigmatisation as a result of the return of this information?
  • Are there implications for family members? Are there implications for those of child-bearing age?
  • What is the motivation for feedback? Is feedback primarily being given for clinical benefit, or as part of research purposes? Is this clear to the recipient?
  • Is feedback being given as part of recruitment to a further research study? If so, is it to trial an intervention? Is a control group being approached as well as those in a high-risk group, to facilitate learning from the intervention?

What are the practicalities of providing the information?

  • Is there valid consent? Is the feedback proposed within the boundaries of the expectations for feedback set during the initial (or most recent) consent process?
  • What support or interpretation will be needed?
  • Who will provide feedback, and how will it be given?
  • Will a GP or other healthcare provider be involved and, if so, have they agreed to be involved and what are the implications?
  • What are the resource implications for the cohort and for the NHS? Where relevant, what would be the implications of providing the feedback at scale? What is the chance of false positives, and are there any implications that need to be considered?
  • What is the timeframe? How long after initial (or most recent relevant) contact will the feedback be given?

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3.4.5 Other issues to consider

Providing feedback as part of recruitment to an additional study. Where the purpose is for recruitment to an additional study, there will need to be a mechanism to decide whether a proposed trial and associated disclosure of information is appropriate. Researchers will have to provide specific reasons to justify any feedback. The mechanism for recontact will need careful thought, recognising that if only at-risk groups are approached, information would be implicitly divulged before consent is obtained. As with any feedback, findings must be communicated clearly and responsibly, and appropriate support must be provided to help participants interpret the information. For Phase 2 studies, Our Future Health’s responsibility will be to ensure that proper care is in place, but it may be the responsibility of the researchers or their sponsors to actually provide it.

Providing information about risk profiles. Our Future Health may consider offering participants information about their risk status for certain diseases. It is important to recognise that methods of risk stratification could fall into two different categories: some will be clinically validated (for example 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 care. As discussed above (Section 3.4.2), information 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. It is probable than an increasing number of PRS will become adopted into clinical care during the lifetime of the cohort, as validating studies are completed, and so this will need to be kept under review. When providing any information about risk profiling, it is crucial that the inherent complexities and uncertainties are carefully managed and communicated responsibly.20 Providing this, whether or not through the NHS, would require careful planning and adequate ongoing resource and could be very challenging.

20 Uncertainties about many types of clinically used risk scores include: questions about the confidence intervals around risk estimates; the validity of the findings for different population groups; varying perceptions about the clinical utility of the information; the role of other unknown factors, including environment, generational effects or other genetic factors; public perceptions of genetic information (for example that it might be viewed as more ‘deterministic’ than other risk factors); and public understanding of risk.

Box 4: Ongoing support for participants

At various stages such as initial recruitment, when results are returned for whatever reason, and at recruitment to sub-studies, individuals may experience issues which are difficult for them and which may cause them confusion, anxiety or stress. A programme of this size must predominantly depend on electronic means of communication, but in our view 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. This could be provided by dedicated programme staff, by some part of the NHS or in other ways, but those providing the support will need to be properly equipped and trained for the task and resourced accordingly.

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Box 5: Implications of the provision of feedback for insurance

Life and health insurers have an obvious interest in methods of early detection of disease. Improving the overall health of the population is to their and societies’ advantage; but they are concerned that people who learn of a disease propensity and do not disclose that to their insurers may take out more insurance than they would have done, at rates which do not reflect the extra risk that they incur. A default assumption of most insurance is that the client is obliged to disclose all relevant known facts to the insurer at the time of taking out or renewing the insurance, and failure to do so may invalidate the policy. Some decades ago the UK Government came to agreement with the Association of British Insurers (ABI) (who represent many but not all UK insurance companies) as to how to fairly manage this potential conflict between the commercial interests of the companies and the interest of the Public health.

This is now regulated by a Code on Genetic Testing and Insurance.*

“The Code is a voluntary agreement between Government and the Association of British Insurers, whereby insurers signed up to the Code will never require or pressure any applicant to undertake a predictive or diagnostic genetic test, and only consider the result of a predictive genetic test for a very small minority of cases.”

For the purposes of Our Future Health, this clause is important:

Any predictive genetic test result obtained exclusively in the context of scientific research does not need to be disclosed to an insurer, regardless of the test or the level of cover.”

Since Our Future Health is a research project, and much of the work done on the cohort will be governed by separate embedded research projects, those participating will not need to declare any findings to their insurers.

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3.5. Stewardship of data and samples

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 must have rigorous and transparent governance processes to control access and use. These should be set out clearly in a detailed data management policy, which should address three aspects:

  • protecting confidentiality and keeping data safe (see Section 3.5.1);
  • how data will be added to the resource (see Section 3.5.2); and
  • how data will be accessed and used (see Section 3.5.3).

The importance of transparency cannot be overstated. Our Future Health should explain clearly to participants how data will be used and for what purposes, who will have access, what protections will be in place, and the accountability mechanisms. This should be grounded in the National Data Guardian(NDG)’s advice that there should be ‘no surprises’. This is particularly important given the involvement of industry partners and researchers. As discussed in Section 4.3.3, evidence suggests the public are often particularly concerned about commercial access to health data, and Our Future Health should address these concerns openly and proactively.

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. In addition to explaining how data might be used, the consent information should also set out “red lines”, providing clear information about uses of data that will never be allowed, for example participant’s data will never be passed to third parties for marketing purposes without consent.

Information provided during the consent process should be kept broad and high-level, to enable people to understand properly what they are consenting to. This should then be followed by the provision of further detail about data access as part of an ongoing conversation with participants. Given changing attitudes to uses of data across society, it will be particularly important to regularly engage with participants over the lifetime of the cohort to ensure the approach to data use is trustworthy.

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3.5.1 Confidentiality

Protecting patient privacy and confidentiality, and ensuring robust security safeguards is fundamental.

a) Data security

Our Future Health must have robust IT systems and appropriate security measures in place to protect data and reduce the risk of cyber threats. These should meet both the National Data Guardian’s data security standards and the Department of Health and Social Care’s Information Governance requirements.21 Our Future Health should make use of industry-standard technical controls to prevent unauthorised use of data, including a programme of risk assessment and regular testing and review. There should be verifiable audit trails, and a transparent process in place in the event of any data breach. Our Future Health should publish information about how data will be stored and de-identified.

Given the need to build confidence in data security, Our Future Health should undertake work to explore the most appropriate approach to allow access and analysis of data. For example, the model of a Trusted Research Environment could be used to ensure that data can only be used within a ‘safe setting’, with remote access strictly controlled and monitored, rather than allowing researchers to download data.22 Once approved, researchers should only be given access to the specific information they need for their study.

b) Meeting data protection requirements

Our Future Health must be fully compliant with the latest data protection legislation, including the Data Protection Act 2018. In line with the GDPR requirement for transparency, Our Future Health should have an easily accessible privacy policy, which meets best practice standards for accessibility and plain language.23 This should set out:

  • The purpose and legal basis on which Our Future Health will process both personal data, and ‘special category data’ (including ethnic origin and genetic data). 24
  • How the data minimisation principles will be met, including information about how data will be cleaned and de-identified.
  • Information about data retention. Because Our Future Health is a long-term resource, data will need to be kept for a significant time period but it will still be important to have a clear retention schedule.
  • The rights that are, and are not, available to participants in respect to Our Future Health’s use of data. Where rights do not apply, Our Future Health must be clear about the reasons for any exemptions.25
  • The approach that will be taken to Subject Access Requests.
  • The sanctions that will apply for any organisation or individual who attempts to breach a participant’s confidentiality or for any misuse of data.
  • The approach that will be taken if police or other law enforcement agencies request access to the data.

Our Future Health should also undertake a Data Protection Impact Assessment (DPIA), to help identify the potential impact on individuals and minimise the data protection risks. There must be a named Data Protection Officer and Our Future Health might also consider identifying a Caldicott Guardian. Given the sensitive nature of the data that will be collected and stored, Our Future Health should discuss the proposals from an early stage with the Information Commissioner’s Office to ensure appropriate measures are being implemented. Our Future Health will also need to comply with the common law duty of confidentiality, and it will therefore also be important to engage the NDG.

21 See, for example, the NHS Data Security and Protection Toolkit:
22 See work by Health Data Research UK:
23 See for example the Genomics England Privacy Policy: policy/
24 It is likely that Our Future Health will process personal data using Article 6(1)(f) – legitimate interests as the lawful basis, rather than consent, but this must be clearly explained to participants.
25 Genomics England’s privacy policy, for example, explains that the right to portability does not apply because Genomics England relies on a lawful basis of legitimate interests. The right to erasure does not apply because Genomics England relies on the exception in GDPR Article 17(3)(d) to allow them to keep data to inform a research programme.

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3.5.2 Adding new data into the resource

Our Future Health will initially collect information from NHS records and other health and social care datasets, and this must be clearly set out in the Phase 1 consent process. Particular thought should be given to the types of social care data that might be collected, recognising that this may be a cause of concern to some participants. Any linkage will need to have the necessary approvals in place (for example from the HRA Confidentiality Advisory Group, or from NHS Digital’s IGARD26), and must be clearly explained to participants.

Over the course of the lifetime of the cohort, there is also the potential that the Our Future Health programme might want to link other types of data, for example to add social and lifestyle information that could help build a more comprehensive picture of health or risk of disease. Types of data that Our Future Health might consider linking include:

  • administrative data, for example information about education, household, income and employment;
  • social media data; and
  • information collected from wearables or self-generated data.

Careful thought must be given as to how any additional datasets might be added to the resource. There must be a clear mechanism for making decisions about additional data linkage. This should be responsible, open and transparent, with criteria set out in advance. Each additional linkage must be justified, with an explicit reason and scientific rationale for extending data collection beyond conventional health data, which can be clearly explained to participants. The process should also consider issues of representation and potential bias in datasets. Different groups may be over or under-represented in different datasets, and it will be important to proactively consider this for each dataset, and consider ways to mitigate any bias in advance.

We recommend that additional data linkage beyond health and care datasets will need additional consent. This is important to ensure that participants have a choice about the addition of further information that goes beyond health and care data. It may also be necessary when third party data providers are involved, which may have restrictions on what data can be released. One possibility might be to consider having an opt-out approach to allow linkage of a few specific additional data sets but this principle would need significant further discussion by EFAG and consultation with participants.

26 advising-on-the-release-of-data

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3.5.3 Access to data and samples

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 access to any data generated in or utilising the resource is responsible and in the public interest. Decisions should be subject to careful scrutiny by an appropriately constituted and accountable governance process such as a Data Access Committee. Given the nature of access requests is expected to evolve over time, the criteria used will need to be flexible enough to be future proof, while giving participants confidence in the process by which access decisions will be taken.

Building on existing principles of best practice for access to the data and samples, Our Future Health should adopt the following approach:

  • 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.
  • All researchers, whether in universities, charities, government agencies or commercial companies, and whether based in the UK or abroad, should be subject to the same application process and approval criteria.
  • An appropriately constituted access committee, reporting to the Our Future Health Board, should be responsible for the access policy and for overseeing individual decisions about applications to access data and samples, following a transparent process. Application summaries and decisions should be made public. The mechanics of the access procedures should be as simple as possible, and the decisions should emerge in a timely fashion and at reasonable cost. The objective is to maximise responsible use of the dataset, not to unduly guard it for the benefit of a restricted user group. The role of the Access Committee is discussed further in Section 4.2.2.
  • For data use only, the assessment should take into account the following questions:
    • Is this appropriate research within the context of the participant consent
    • Is the research feasible and sensible? There is no intention of setting a high scientific quality bar, but approving work which, for example, cannot be carried out on this dataset is wasting time for both Our Future Health and the researcher
    • Is the research likely to be very controversial (to society, rather than scientifically)? This is not necessarily a bar, but the Access Committee must guard against bringing the Charity into disrepute.
  • Because data are not depletable, it is appropriate to approach data-only applications with the intention of approving them unless there is a reason not to.
  • Where access to data is approved, data must be de-identified and only the minimum amount of data required for the successful completion of the relevant research should be made available.
  • Access to biological samples that are limited and depletable should be carefully controlled and coordinated, according to a transparent policy. The focus must be much more competitive – only a limited number of uses are available over the lifetime of the resource, and only the highest quality applications should be supported. Judging both the quality of the science, and the importance of the issue being addressed, should be the responsibility of the Access Committee.
  • Requests for subject re-contact need detailed scrutiny, as discussed in Section 3.4. This work should be probably undertaken by a special Feedback advisory committee (see Section 4.4.5) working closely with the Access Committee.
  • Any researcher accessing data or samples will be required to sign a binding data access agreement, which includes a clause prohibiting the unauthorised re-identification of participants and setting out sanctions that will apply for any attempt to breach a participant’s privacy.
  • Researchers will be required to publish their findings and deposit their results within the Our Future Health resource so that the knowledge gained can be widely disseminated.

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3.5.4 Exclusive access

The interests of participants are served by making the resource as accessible as possible to as many high-quality researchers as possible. No party should be given exclusive access to the whole resource. However, there may need to be some arrangements for limited elements of exclusivity where a user has generated new data using the cohort. For example, where a company (or any other researchers) provide intellectual effort or funding to develop new data for the resource, they may be allowed exclusive access to that newly developed data for a time-limited period (the exclusivity period) to enable them to capitalize on their contribution and discoveries. After the exclusivity period is complete, the data must then be made available for other researchers to use. This is the approach that other research programmes have taken to partnerships for major additions to the dataset.

Decisions about limited elements of exclusivity are complex and need careful thought. The public have shown that they understand the need to reward effort but are suspicious of health data being unduly locked away from general research use, particularly by commercial entities. We recommend that Our Future Health should not accept limited exclusivity as an automatic right. Its existence and duration must be justified on a case-by-case basis.

The Data Access Committee should help to develop a process to guide future discussions, and agree who will be involved in decisions. It will be important to include the Participants Advisory Panel in discussions. The process should take into account the following aspects:

  • Arrangements for limited elements of exclusivity should apply equally to academic, charity-funded and industry researchers. Academics will want to publish and stake priority, industry researchers will want to get IP protection. They all make important contributions and may deserve time to capitalise on their discoveries.
  • The nature of the research and the need for a period of exclusivity
  • How to define the exclusivity period, including the start and end points, which may also depend on the type of research.
  • What the time period should be. There may be some push towards setting a standard time period for exclusivity, for example current practice is for about a year. However, despite its simplicity, we would urge caution because of the complexities of the issues involved and the variation in types of application that will be received.
  • There must be a clear justification for any exclusivity period, which should be openly explained and published.

The implications of preferential terms of access for industry partners are considered further in the discussion about commercial partnerships below (see Section 4.3.3).

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4.Structural and Governance Issues >