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Research during a global health emergency can take many different forms. Most visibly, it includes efforts towards the rapid development of new medicines and vaccines for conditions where no effective treatments or preventative measures currently exist.[1] Other areas of research include: the development of more rapid or effective diagnostic tools;[2] anthropological work seeking to improve shared understanding of local health concerns and health beliefs;[3] development and evaluation of health interventions;[4] more effective forms of surveillance to enable early identification and mitigation of health threats;[5] and research underpinning the development of effective and resilient health systems.[6] Such research is complex and difficult to conduct for a range of reasons explored in this call for evidence – not least because of the specific context in which it takes place, which may include lack of security, poor access to affected populations, uncertainty about the future, poor governance, a weakened health system, and populations in a situation of high vulnerability.

The current lack of consensus on what is ethically acceptable during emergencies and what constitutes ‘good practice’ is one of the factors impeding the progress of valuable research. This may also contribute to the risks of unethical practice passing undetected, of communities being exposed to research that is unlikely to provide answers to their most important questions or address their needs,[7] and to an erosion of public confidence and trust in research where it is needed most. This situation – uncertainty about what constitutes ‘good ethical practice’ – is likely to be further exacerbated by developments in specialist research methods, such as increasingly sophisticated sequencing methods[8] and digital health technologies,[9] and by the increasingly diverse collaborative partnerships and consortia required.[10] Such developments, for example, increasingly rely on access to, and transfer of, biosamples and data, attitudes to the use of which vary widely across the globe and about which there is currently significant ethical disagreement.[11]

Ethical challenges highlighted in recent emergencies include:

  • lack of consensus over what constitutes ethical conduct of research in such circumstances, including the nature and scope of ethical scrutiny, acceptable trial design, participant selection, and the early release of data to help support effective response;
  • different regulatory and ethical approaches within the various elements of emergency response (including humanitarian initiatives, care services and public health measures) which nevertheless need to intersect with each other, and with research activities;
  • the challenges / dilemmas faced by front-line workers as a result of the close relationships between research and clinical care; and
  • uncertainty over the respective roles and responsibilities of major stakeholders in establishing fair and sustainable research partnerships.

These challenges have placed limitations on the contribution that research has been able to make during emergency responses, and may result in reluctance to contribute to research. Researchers and front-line workers have been left at times to make their own decisions, unsupported, in very difficult situations. Research ethics committee members, regulatory authorities, and funders may also feel very exposed and uncertain in their decision-making, both because of the lack of consensus on what is ethically acceptable, and a lack of knowledge of the particular context. While significant work has been undertaken on a number of issues such as the ethical aspects of trial design[12] and pandemic preparedness,[13] there remains an urgent need for comprehensive ethical analysis to support an approach to future research that recognises the complex relationships between research and other essential services in global health emergencies, that builds trust between researchers and affected communities, and that facilitates collaboration and cooperation between key stakeholders. Such analysis must take into account both the scope for significant diversity in the nature of future emergencies, and in the evolving nature of the indicated research methods.[14] It must also take into account the need to take seriously both the contextual variation in ethical views and the need for shared policies across multi-country initiatives.

The Nuffield Council working group established to explore these issues has the following terms of reference:

  1. To consider, in the light of recent developments, how research may ethically be conducted in global health emergencies, and how it may most appropriately be integrated into the wider response to such emergencies.
  2. To consider, in particular:
    1. the implications of the recognition that undertaking research can be an integral and necessary part of response to a global health emergency;
    2. the role of affected populations in shaping the role of research in emergency response, including recognising the potential for diverse views within those populations;
    3. the circumstances in which research activities during an emergency may offer the prospect of direct health benefit to participants, and the implications of this for ethical conduct of the research;
    4. whether there are circumstances in which the standard ethical requirements for the scrutiny and conduct of research should differ in emergencies; and if so, in what way, and with what justification;
    5. the ethical implications of the criteria for declaring a situation to constitute a ‘global health emergency’, and the implications for action before and after the period of the declared emergency if different ethical requirements are held to apply during emergencies; and
    6. the responsibilities of multiple stakeholders including research funders, the pharmaceutical industry and their insurers, non-profit organisations, intergovernmental bodies, and governments.
  3. In considering the issues above, to take into account:
    1. the diverse nature of what might constitute a global health emergency, including disease outbreaks, natural or industrial disasters, conflict, and widespread drug resistance;
    2. the speed of innovation in research and research methods; and
    3. the nature of national obligations to assist those beyond their borders.
  4. To write a report and make recommendations to improve the contribution that ethically conducted research may make to emergency response in the future.

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[1]    See, for example, Ali A, Wahid B, Rafique S et al. (2017) Advances in research on Zika virus Asian Pacific Journal of Tropical Medicine 10(4): 321-31; WHO (2018) Essential medicines and health products: Ebola, available at: http://www.who.int/medicines/ebola-treatment/en/.

[2]    See, for example, WHO (2017) New technology allows for rapid diagnosis of Ebola in the Democratic Republic of the Congo, available at: http://www.who.int/emergencies/ebola-DRC-2017/articles/rapid-diagnosis/en/.

[3]    See, for example, Stellmach D, Beshar I, Bedford J et al. (2018) Anthropology in public health emergencies: what is anthropology good for? BMJ Global Health 3(2).

[4]    See, for example, Okuyama J, Funakoshi S, Tomita H et al. (2017) Mental health and school-based intervention among adolescent exposed to the 2011 Great East Japan Earthquake and tsunami International Journal of Disaster Risk Reduction 24: 183-8. See also: Iwasa H, Suzuki Y, Shiga T et al. (2016) Psychometric evaluation of the Japanese version of the posttraumatic stress disorder checklist in community dwellers following the Fukushima Daiichi Nuclear Power Plant incident: the Fukushima health management survey SAGE Open 6(2): 2158244016652444.

[5]    See, for example, Gardy JL, and Loman NJ (2017) Towards a genomics-informed, real-time, global pathogen surveillance system Nature Reviews Genetics 19: 9-20; All Africa (27 March 2018) Nigeria: Lassa Fever outbreak slowing, but remains a concern – WHO, available at: http://allafrica.com/stories/201803270004.html. See also: Holmes EC, Rambaut A, and Andersen KG (7 June 2018) Pandemics: spend on surveillance, not prediction, available at: https://www.nature.com/articles/d41586-018-05373-w.

[6]    Shoman H, Karafillakis E, and Rawaf S (2017) The link between the West African Ebola outbreak and health systems in Guinea, Liberia and Sierra Leone: a systematic review Globalization and Health 13(1): 1; Hanefeld J, Mayhew S, Legido-Quigley H et al. (2018) Towards an understanding of resilience: responding to health systems shocks Health Policy and Planning 33(3): 355-67.

[7]    See, for example, Ellenberg SS, Keusch GT, Babiker AG et al. (2017) Rigorous clinical trial design in public health emergencies is essential Clinical Infectious Diseases: e-published ahead of print.

[8]    See, for example, Gardy JL, and Loman NJ (2017) Towards a genomics-informed, real-time, global pathogen surveillance system Nature Reviews Genetics 19: 9-20.

[9]    See, for example, Perakslis ED (2018) Using digital health to enable ethical health research in conflict and other humanitarian settings Conflict and Health 12(1): 23.

[10] As in the multiple consortia involved in the response to Zika in Latin America: https://zikalliance.tghn.org/zika-consortia/.

[11] See, for example, Bull S, Cheah PY, Denny S et al. (2015) Best practices for ethical sharing of individual-level health research data from low- and middle-income settings Journal of Empirical Research on Human Research Ethics 10(3): 302-13. See also: Chatham House (2018) A guide to sharing the data and benefits of public health surveillance, available at: https://datasharing.chathamhouse.org/.

[12] See, for example, Henao-Restrepo AM (2015) The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola BMJ: British Medical Journal 351: h3740; Global Forum on Bioethics in Research (2017) Ethics of alternative clinical trial designs and methods in low- and middle-income country research: 28-29 November, Bangkok, available at: https://www.wellcomeevents.org/WELLCOME/media/uploaded/EVWELLCOME/event_535/GFBR_Bangkok_summary_slides.pdf.

[13] WHO (2018) Pandemic preparedness, available at: http://www.who.int/influenza/preparedness/pandemic/en/; WHO (2018) Annual review of the blueprint list of priority diseases, available at: http://www.who.int/blueprint/en/.

[14] Flahault A, Geissbuhler A, Guessous I et al. (2017) Precision global health in the digital age Swiss Medical Weekly 147: w14423.

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