Research in global health emergencies

Report

Published 28/01/2020

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Consent and beyond – the wider ethics ecosystem

See Chapter 7 of the full report

Even in non-emergency situations, there are well-recognised difficulties in seeking genuinely informed and voluntary consent to research – for example in providing clear explanations of a complex study, and making sure people feel genuinely free to refuse. In global health emergencies, factors such as disruption, family separation, lack of access to basic resources and services, and the fear, distress, and powerlessness associated with these experiences, add to these challenges. High levels of uncertainty and heightened risks for participants, both related and unrelated to the research, complicate things further. Sometimes people may feel that agreeing to take part in research is their only option.

Culturally appropriate and respectful consent processes that demonstrate equal respect for participants are as important in emergencies as in any other context. There are many existing examples of imaginative ways to present complex information, check understanding, and avoid stigma.

Examples of good consent practice

  • Asking participants to paraphrase what they understand
  • Using verbal consent procedures where written consent procedures create a risk of stigma
  • Using traditional games to explain randomisation
  • Using participatory drama to share information

However, consent alone is never the only requirement for research to be ethically acceptable. Good consent practices are one part of the wider ‘ethics ecosystem’ that supports ethical research conduct. This ecosystem includes the responsibilities of researchers and ethics committees to be confident that they have carefully scrutinised benefits and risks, justified those risks, and considered wider questions of social justice and social value. It also includes demonstrating equal respect for communities and community members by developing collaborative and inclusive processes across the lifetime of the research (as described in sections 4 and 5).

There are also recognised exceptions outside the emergency context where individual consent is impossible, for example if a person is unconscious. In some such cases, ethics committees may approve research with high social value on the basis of other protections that promote respect for participants – for example with prior community consultation about the research, and then permission from relatives. Any proposed waivers of consent in a global health emergency must be particularly closely scrutinised regarding the question of how equal respect for participants is to be secured.

We recommend that in emergencies ethics committees should consider:

  • whether the proposed consent processes are the most appropriate and sensitive that they can be in the circumstances;
  • what other actions might be needed to ensure the research shows respect for participants as people of equal moral worth; and
  • whether, in all the circumstances, what is being asked of participants can be justified as fair.

Once research has been concluded, providing information in accessible ways about what the research has found is an important part of respectful relationships between research teams and participants.

We recommend that funders should routinely require feedback to participants and wider communities about what a study has learned, with ringfenced funding for this purpose.

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