It is widely recognised that participation in research should be based on the ‘informed consent’ of the participant. Researchers should assure themselves that the potential participant is competent to make a decision about whether or not to take part; that they have sufficient information on which to base a decision; and that they are acting freely, without undue pressure from others (while recognising the legitimate role of discussion with those close to the person).
Where potential participants are unable to give consent for themselves, the Declaration of Helsinki states that this may be provided by a “legally authorised representative”, where this is allowed for by domestic law (including by those with parental responsibility in the case of children). In some contexts, it may also be appropriate to seek permission from community leaders before approaching individuals and their families about possible participation. Exceptionally, the need for consent in advance may be waived, for example where the research relates to treatment in an accident or other kind of emergency. The ‘secondary use’ of aggregated and anonymised data may also, in some circumstances, be permitted without explicit consent.
During a global health emergency, the conditions in which potential participants, their families, and communities make decisions about taking part in research are far from ideal. Factors such as disruption, panic, displacement, difficult material circumstances, and lack of access to necessary services may have profound effects on people’s abilities to make free, competent, and informed choices. Family separation or quarantine may make proxy decision-making impossible for children, for adults too ill to consent for themselves, and indeed for any family members where traditionally family heads have played a strong role in decision-making. The uncertainties inherent in a rapidly evolving situation may make it difficult for any specific decisions to be truly informed.
Even in less challenging circumstances, however, it is important to recognise that consent alone is not sufficient to ensure a research study is being conducted ethically. In many circumstances, particularly in low-income environments, taking part in a study may bring benefits, such as access to qualified healthcare professionals, that cannot be obtained in other ways; and people are very unlikely to refuse to take part. Other protections, such as independent scrutiny of the social value of the proposed research to local populations, and of the likely risks and burdens involved, are thus also essential. (See also section 3.)
11. Are you aware of any examples of when an emergency seemed to demand a different approach to making decisions about research participation? If so, please explain how any derogation from standard approaches might be ethically justified, and the relevance of the kind of research concerned (for example research involving physical intervention as opposed to research involving data only).
12. If we consider the giving of valid consent as one element in the ‘ethical ecosystem’ around research in emergencies, and recognise too that consent is often imperfect, what are the other essential elements of the ecosystem necessary for such decision-making to be considered legitimate?
13. Are there any circumstances in which participation in research should not be optional? (See also section 5, on public health)