Supplementary Written Evidence Submitted by the Nuffield Council on Bioethics
We comment below on a number of the areas identified as part of the Committee’s Terms of Reference, with reference where appropriate to substantial work undertaken by the Nuffield Council on Bioethics on the ethical aspects of research in global health emergencies (GHEs), and on public health (PH).
1. The contribution of research and development in understanding, modelling and predicting the nature and spread of the virus
Ethically-conducted research is essential in providing an evidence base in order to respond effectively to a novel virus – and, by its nature, such research can only be initiated once the outbreak has begun, even though the emergency setting brings significant ethical challenges. Particular attention thus needs to be paid to ethical concerns to ensure that the value research can bring is maximised without exploiting participants.
It is important to be alert to the wide variety of disciplines where research can play a crucial role. In addition to the more high-profile disciplines of epidemiology, modelling, and biomedical research into diagnostic tools, vaccines and treatments, social science research has a very important part to play. It is central, for example, in understanding the concerns, priorities and attitudes of affected populations, and in taking account of the way social and cultural factors affect disease transmission (from ways of greeting, showing affection, and providing care, to patterns of social interaction and movement).
As we discuss further below, research prioritisation and design should incorporate the perspectives of affected or at-risk communities in order to ensure that their needs and interests are addressed. Respectful engagement by researchers with affected and at-risk communities has intrinsic ethical value, ensuring that research is conducted ‘with’ rather than ‘on’ those most affected (thus minimising risks of exploitation), and is more likely to be of relevance to their needs. It also has practical instrumental value in facilitating research participation and subsequent take-up of interventions.
2. The capacity and capability of the UK research base in providing a response to the outbreak, in terms of:
- advice to government, public bodies and others on managing the outbreak;
- the development of testing, diagnostic methods and technologies;
- the development and testing of vaccines; and
- the development and testing of therapeutics.
Advice to Government should include consideration of ethical aspects of the response, and the basis on which policy for managing outbreaks is developed. This includes broad and inclusive engagement with different communities and public interest; the identification of the values and interests that are at stake; clarity and transparency about the way in which these can, should and do inform decision making (alongside scientific advice); and fuller public explanation and justification of decisions reached.
In the early part of the response to the epidemic, advisory structures (for example reference to the Moral and Ethical Advisory Group or to the advisory group on the tracing app, or to other sources of ethical advice and expertise) have been obscure and lacked transparency.
3. The flexibility and agility of institutions and processes to respond on the above during a crisis including:
- the availability and responsiveness of funding; and
- the optimal functioning of regulatory and ethical processes
We know from experience that the UK system of ethical review can respond in an impressively prompt way to urgent research proposals. This emerged very clearly in the UK research response to the West African Ebola outbreak in 2014-16. We have no reason to believe that this system will be any less prompt and effective for COVID-19 studies, whether in the UK or with respect to research in other countries where UK research ethics committee review is required.
One issue, however, that it will be important for ethics committees to consider (and where necessary encourage researchers to take seriously) is the central role of public / patient involvement (PPI) in the design and conduct of ethically-robust studies. As a minimum, committees should expect to see such involvement in the development of information materials for participants and consent forms. At its best, such involvement should be embedded throughout the research, from design (ensuring public and patient perspectives are incorporated thus maximising the likelihood that research will be sensitively conducted and relevant to actual, rather than presumed, needs) to the communication of study findings, in lay language, to communities that have been involved in the study.
The UK has an excellent tradition of supporting PPI, with well-established PPI groups associated with many major research centres. While input by such groups to date appears to have been patchy, particularly in the biomedical sector, there have been some excellent examples of patient and public input into study design and conduct in the social science sector. The Health Research Authority has also taken important steps to encourage and facilitate such engagement through establishing a ‘matching’ service to link researchers with groups able to critique COVID-19-related studies from a lay perspective within necessarily abbreviated timescales. Given the willingness of many PPI groups to respond promptly, it is unacceptable for researchers simply to cite ‘urgency’ as a reason for not seeking to engage in this way.
4. The capacity to manufacture and distribute testing, diagnostics, therapeutics and vaccines: – both standing capacity and capacity able to be mobilised
We have no observation to make on this question.
5. The capturing during the crisis of data of the quantity and quality needed to inform:
- decisions made during the crisis; and
- to maximise the learnings afterwards;
In the context of a public health crisis of such significance, the collection of data is essential to inform decision-making and learning so that interventions are properly informed, evidence-based, and proportionate. However, the amount of data collected, and the period for which they are kept – especially where this might be done without the explicit consent of those to whom the data relate – should be no more than is necessary for the specified purpose.
During the pandemic, data might potentially be shared between public health teams and researchers, and between different research teams. The effective sharing of these data plays an important part in effective response both during an outbreak, and in maximising later learning for future outbreaks. However, there are many barriers, both practical and ethical, to effective sharing. Addressing such barriers is an important part of improving emergency preparedness.
6. The mechanisms for communication of scientific evidence internationally, within national governments and with the public:
- including the handling of conflicting scientific opinions
As noted above, prompt and effective sharing of scientific evidence both between disciplines (eg public health and research teams) and between countries, is important to maximise the impact of research findings. We welcome the major steps forward evidenced by the scientific search community in this pandemic, both with respect to early international collaboration (for example with respect to sharing the genetic sequence of the virus), and to ‘open access’ arrangements by journals to ensure COVID-19 articles are not behind a paywall.
However, when making use of scientific evidence in policy-making and in communication with the public, such evidence must always be presented in context. Scientific knowledge is always provisional (not least in a rapidly-moving pandemic of a novel virus), with scope for varied and potentially conflicting opinions. Moreover, ‘science’ does not provide simple answers to policy decisions. Governments must be transparent not only about the scientific evidence that they are taking into account, but also about the values and judgments that are inevitably involved in decision-making. In the many Government references to ‘being guided by the science’, there has been a concerning lack of transparency regarding the values and judgment that have underpinned how the scientific evidence provided has fed into key policy decisions.
7. The UK’s readiness for future outbreaks, including a consideration of:
- the National Risk Register;
- the UK Pandemic Influenza Strategy; and
- PHE’s Global Health and Infectious Diseases Strategy.
We note that, while there was an ethical framework for pandemic flu, this was not (publicly) in evidence during the current outbreak of COVID-19. Future readiness should include a review of, and maintenance of, an ethical framework that could better help inform response. The development of such a framework, in ways that are open and accountable, could do much to develop and maintain trust when difficult value-based decisions need to be made in response to a future emergency.
 GHEs, paras 1.11–1.13.
 GHEs, paras 5.26–5.30.
 GHEs, para 6.23.
 GHEs, recommendation 6, para 6.19, and recommendation 10, para 7.24.
 For a more detailed account of the importance of community engagement in research in emergencies, and examples of good practice in the UK, see our blog post We’re all in this together.
 See: https://www.hra.nhs.uk/about-us/news-updates/new-public-involvement-service-covid-19-studies/.
 PH, paras 4.39 and 4.43.
 GHEs, paras 9.19–9.22. While the discussion here relates primarily to low income settings, the same issues arise in the UK, as illustrated, for example, by the lack of public acceptance of the care.data project, and by ongoing debate over access to NHS data by private sector actors.
 GHEs, paras 9.29–9.37.
 See, for example, https://www.who.int/csr/don/12-january-2020-novel-coronavirus-china/en/.
 See, for example, Information sharing during the coronavirus outbreak.
 See, for example, “Following the science” in the COVID-19 pandemic.