Research in global health emergencies

Report

Published 28/01/2020

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An inclusive approach to study design and review

See Chapter 6 of the full report

The time pressures, disruption from normal life, and distress associated with global health emergencies can create challenges for both the design of research studies, and the procedures used to review them. It is important that researchers are alert to the heightened vulnerability of those affected by the emergency, and respond flexibly to the particular emergency context. The ethical compass provides a guide when considering how and when standard procedures might need to be adapted.

Study design

It is unethical to ask people to take part in research that is unlikely to produce useful results, and hence will not help reduce suffering. This highlights the importance of scientific rigour. It also emphasises the importance of study designs that are locally acceptable. Designs that cannot recruit sufficient participants, for example because of unaddressed local concerns, will not be feasible. Key questions to ask are:

  • Is this the right study for this location and this population / subpopulation? Who has been involved in identifying the problem that the research seeks to answer? Will local populations benefit from any positive findings?
  • Is this the right design for this location and this population? How have local needs, concerns, or preferences been taken into account?

We recommend:

  • Study protocols should be developed with the input of local communities, in order to ensure that proposed procedures are acceptable. Even in multisite trials, there will be elements that can, and should, be implemented differently in each site in response to engagement and feedback, without prejudice to study rigour.
  • Any exclusion criteria from studies should be clearly justified with reference to the risks and benefits for the group in question. There should not be an automatic exclusion of ‘vulnerable groups’ such as children, pregnant women, or older people. In practice, exclusion may make those groups more vulnerable.

Independent ethical review

Independent ethical review (both in the country affected and, where relevant, in other countries) provides an important safeguard for research participants, and provides reassurance to everyone concerned that proper scrutiny has taken place. In an emergency, the standard of review should not be compromised in any way. However, the review processes can, and should, be adapted as necessary to the context. Examples include fast-tracking genuinely urgent applications, and using flexible means to communicate with researchers, and discuss the proposal. Access to local expertise from affected populations to understand the possible risks of the research, and also the wider risks to which people are exposed through the emergency, is essential.

Support for strengthening ethical review structures in areas that are currently underserved is an important part of emergency preparedness. It is also essential to recognise that independent ethical review is only one part of the ‘ethics ecosystem’ and does not absolve researchers from their own ethical responsibilities. Evidence-gathering activities such as assessing needs and evaluating humanitarian response can also have ethical implications, even though they are not formally classed as ‘research’.

We recommend:

  • the development of collaborative systems, at national and international level (for example within WHO regions), to support rapid and responsive review in emergencies, including access to additional ethical expertise where needed; and
  • the inclusion of an explicit step of ethical consideration in plans for needs assessment or evaluation that raise similar ethical concerns to more formal research projects.
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