Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D
…What are the requirements for informed consent in emergencies?
Individual informed consent is a fundamental ethical requirement for research. Prospective research participants must be able to weigh the risks and benefits of participation. This can be particularly challenging in a public health emergency because of uncertain risks and the perception that any research-related intervention must be ‘better than nothing’. Consequently, researchers and review bodies have an obligation to ensure that research activities do not proceed unless there is a reasonable scientific basis to believe that the study intervention is likely to be safe and efficacious and that risks to participants have been minimized to the extent reasonably possible.
Cultural and linguistic differences, as well as confusions about the dual role of the clinician/researcher, may be heightened for research conducted in this context, and so processes for obtaining informed consent, including the wording of documents and methods of obtaining and recording consent, should be developed in consultation with local communities. Finally, researchers should inform potential participants about the circumstances under which their data or samples might be shared…