One internationally-recognised definition of a public health emergency that potentially has global impact, is that of a ‘public health emergency of international concern’ (PHEIC). Under the 2005 International Health Regulations (IHR), a PHEIC is “an extraordinary event which is determined, as provided in these Regulations: (i) to constitute a public health risk to other States through the international spread of disease; and (ii) to potentially require a coordinated international response”. The WHO suggests that this definition “implies a situation that: is serious, unusual or unexpected; carries implications for public health beyond the affected State’s national border; and may require immediate international action.” To date, four PHEICs have been declared since the IHR rules were amended in 2005: for the H1N1 pandemic in 2009; for Ebola and polio in 2014; and for Zika in 2016.
States are required by the IHR to notify the WHO of all events in their territory that may constitute a PHEIC. If the Director General subsequently determines this to be the case, the WHO is then required to notify all other states, sharing the information it has received to enable states to respond with their own public health measures. WHO is also empowered to issue recommendations, for example with respect to appropriate health measures and travel restrictions, to offer advice and technical assistance, and to mobilize other international assistance. It can also bring into action the ‘emergency use and listing procedure” (EUAL) to expedite the availability of medicines on the basis that, in an emergency, affected communities may be willing to tolerate less certainty about the efficacy and safety of products.
While it is not necessary for a PHEIC to be declared for such international support to be mobilised and resources to be released, in practice such a declaration may be seen as an indication of international recognition of the severity of a situation. Decisions whether or not to declare an event a PHEIC, and the timings of such declarations, have been controversial, for example with respect to whether health threats that might reach high income countries are perceived to be given greater weight.
The WHO’s Strategic framework for emergency preparedness takes a broader approach to ‘emergencies’. This framework includes ‘local and national’ outbreaks of disease in its list of emergencies arising from natural hazards, alongside pandemics, outbreaks of pathogens with pandemic potential, and emergencies arising out of geophysical or hydrometeorological events. A second category of ‘human-induced hazards’ includes technological hazards such as those arising from industry, and societal hazards such as armed conflict and terrorism. The impact on human health caused by these various form of emergency may be direct, and / or it may be indirect through associated disruption of health or other services. A rather different approach to the definition of an ‘emergency’ is taken by the UN Inter-Agency Standing Committee which refers to “a humanitarian crisis in a country, region or society, where there is total breakdown of authority … and which requires an international response that goes beyond the mandate or capacity of any single agency …”.
Categorisations of what constitute ‘global health threats’ or ‘public health threats facing the world’, are similarly variable. In its account of the public health challenges currently facing the world, the Independent Commission on Multilateralism, for example, first cites epidemics and pandemics, and then sets out a long list of ‘other health-related challenges’: these include non-communicable diseases, hunger and malnutrition, child mortality, mental health, substance abuse, road accidents, small arms and other weapons, and bioterrorism. It further identifies the impact of other global trends on health, including climate change, conflict, the interface between humans and animals, and migration and displacement. In contrast, a recent review of the UK’s aid response to ‘global health threats’ noted that in UK aid strategy such threats are interpreted as including epidemics and antimicrobial resistance, but not accidental or deliberate release of diseases, chemical and nuclear hazards, or non-communicable disease.
The terms of reference of our inquiry emphasise both the wide range of circumstances in which a global health emergency might arise, and the relevance of health-related research in responding most effectively to that emergency. In developing a working definition of a ‘global health emergency’ for the purposes of this inquiry, we have therefore focused not on the underlying cause of the emergency, but rather on those features of an emergency that may potentially render the standard rules and requirements for health-related research problematic. We therefore suggest that for the purposes of this inquiry, a global health emergency is characterised by the following features:
- It is triggered by a disruptive shock – a sudden and significant change from the ordinary course of events. This may, but need not, be relatively short-lived: a failure to respond adequately to an emergency may mean that it is protracted. Disease may itself be the disrupting factor, as in an infectious disease outbreak. Alternatively, disease or other adverse health effects may be the result of other sources of disruption: for example a natural disaster leading to a cholera outbreak or to a disrupted health system unable to deliver routine health care; widespread acute malnutrition because of famine; or conflict leading to exceptionally high levels of post-traumatic stress disorder (PTSD). Other forms of ‘human-made’ disaster include major food contamination and nuclear accidents. These health-related impacts of disruption may be exacerbated by wider social consequences, for example through impacts on the economy and on security.
- This disruption entails risks of significant harm to health both for individuals, and at population level. This would exclude circumstances involving minor and / or temporary health impacts, however widespread. It would also exclude risks of serious harm to individuals without wider public health consequences. In practice, the predicted seriousness of such harms may not necessarily eventuate, or the impact may not be as widespread as feared – for example because of the effectiveness of the response, or because of inevitable unknowns / uncertainties about the course of the emergency.
- The effectiveness of the response is directly linked to the timeliness with which the response is undertaken. This perceived imperative to act quickly may be in tension with routine elements of good ethical research practice, such as appropriate community engagement, a routine period of ethical review (especially where the emergency may have disrupted the bodies able to conduct review), and sufficient certainty with respect to the evidence of likely harm and benefit to proceed.
- The health threat may extend beyond national borders and is a matter of regional and international concern, in terms of the potential for direct impact on other countries and / or in requiring an international element in the response.
- There are barriers hindering effective response. This may be because of scientific uncertainty or other forms of lack of knowledge that prevent a prompt and effective response, regardless of questions of resource. It may also be because of a lack of resources: for example, in terms of finance, personnel, or infrastructure.
Characterised in this way, it is clear that global health emergencies often occur in contexts where certain types of research / research questions are of great value (in order to contribute to more effective response now and / or in the future) and yet also constitute ‘radically non-ideal’ circumstances for research to be conducted.
Such contexts may also be ‘radically non-ideal’ for research in a number of other respects:
- They may pose threats to autonomy, where the need to take action to protect the health of the population as a whole is so great that it may, exceptionally, outweigh respect for individual choices and / or privacy – for example with respect to the use of identifiable data for population-level research, without explicit consent.
- They are likely to be associated with panic, fear, distress, and anxiety, alongside the disruption of community structures and family life.
We reiterate that this suggested working definition deliberately focuses on features of emergencies that might challenge ‘standard’ approaches to research ethics and research governance. It therefore excludes many important health challenges: for example non-communicable diseases which are not linked with urgency arising out of disruption. This is not a judgment about relative importance either to public or individual health – but rather an acknowledgment that the research challenges generated by these major public health threats appear to be different in kind. It is not, for example, obvious why the very serious and foreseeable threats to global health posed by general antimicrobial resistance or by the growth in non-communicable diseases might require us to rethink what constitutes an ethical approach to research, although evidence about the scale of these threats could, and should, affect decisions about funding and prioritisation of such research. On the other hand, a specific outbreak of a drug-resistant variant of a well-known disease – or the traumatic effects on mental health of population displacement during a particular conflict – could constitute a ‘disruptive’ emergency that challenges assumptions about ethical research in the same way as the outbreak of the Zika virus in Latin America with its previously unknown serious impacts on the fetus.
It has also been argued that many of the features used to justify exceptional action in the West Africa Ebola outbreak could equally well apply in a much wider range of circumstances: not only in more limited or less lethal outbreaks, but also, for example, in the case of people with cancer for whom no therapy exists and who wish to access unproven interventions. This highlights the question of who may have the authority to determine that a particular set of circumstances does, or does not, meet these criteria. (See also section 5.)
 WHO (2016) International health regulations: third edition, available at: http://apps.who.int/iris/bitstream/handle/10665/246107/9789241580496-eng.pdf;jsessionid=C1D3CAC40A62D2EB35FB106FBB78F39A?sequence=1, at page 17.
 WHO (2015) Emergency use assessment and listing procedure (EUAL) for candidate medicines for use in the context of a public health emergency, available at: http://www.who.int/medicines/news/EUAL-medicines_7July2015_MS.pdf.
 See, for example, the recent response to the Ebola outbreak in the DRC, which at the time of writing had not been declared a PHEIC: WHO (18 May 2018) Statement on the 1st meeting of the IHR Emergency Committee regarding the Ebola outbreak in 2018, available at: http://www.who.int/news-room/detail/18-05-2018-statement-on-the-1st-meeting-of-the-ihr-emergency-committee-regarding-the-ebola-outbreak-in-2018.
 Gostin LO (2014) Ebola: towards an international health systems fund The Lancet 384(9951): e49-e51.
 WHO (2017) A strategic framework for emergency preparedness, available at: http://apps.who.int/iris/bitstream/handle/10665/254883/9789241511827-eng.pdf;jsessionid=0063EEB79F528D2D2A1446721363C3AA?sequence=1.
 Cited in IASC (2014) Recommendations for conducting ethical mental health and psychosocial research in emergency settings, available at: https://interagencystandingcommittee.org/system/files/1._iasc_recommendations_for_ethical_mhpss_research_in_emergency_settings_0.pdf, at page 9.
 Independent Commission on Multilateralism (2017) Global pandemics and global public health, available at: https://www.ipinst.org/wp-content/uploads/2017/10/Global-Pandemics-and-Global-Public-Health1.pdf, pp5-7.
 Independent Commission for Aid Impact (2018) The UK aid response to global health threats: a learning review, available at: https://icai.independent.gov.uk/wp-content/uploads/GHT-review_final.pdf.
 Note, for example, that MSF has worked for decades in some countries, such as South Sudan: MSF (2014) South Sudan conflict: violence against healthcare, available at: https://msf.lu/sites/default/files/msf-south_sudan_conflict-violence_against_healthcare.pdf, at page 10.
 Note the paradox that it could also be said to be a radically ideal place for research i.e., there are few other contexts in which research could be said to be as important or valuable: see for example the characterisation of epidemics as providing a “window of opportunity” in some cases to prove the efficacy of vaccines: WHO (2015) Second WHO high-level meeting on Ebola vaccines access and financing: summary report, available at: http://apps.who.int/iris/bitstream/handle/10665/149045/WHO_EVD_Meet_HIS_15.1_eng.pdf;jsessionid=E6829DDA23136059BF84CD64CBC893E3?sequence=1, at page 4.
 Note, for example, how the WHO declared the ‘end’ of the Zika PHEIC in November 2016 on the basis not that the outbreak had ended but that it had become endemic, and hence non-emergency resources needed to be mobilised in a sustainable manner to reduce transmission and disease burden: Jamrozik E, and Selgelid MJ (2018) Ethics, health policy, and Zika: from emergency to global epidemic? Journal of Medical Ethics 44(5): 343-8.
 Calain P (2018) The Ebola clinical trials: a precedent for research ethics in disasters Journal of Medical Ethics 44(1): 3-8.
- Call for evidence
- Response form and questions
- 2. Undertaking research in a global health emergency: whose voices should be heard?
- 3. Study design and review
- 4. Making decisions about participation in research
- 5. Duties at the interface of research, treatment, and public health
- 6. Obligations to / expectations of front-line research staff
- 7. What are the challenges of effective collaboration in global health emergencies?
- 8. Other issues / considerations