Correspondence on “Changes in memory and cognition during the SARS-CoV-2 human challenge study”

The Declaration of Helsinki states that the purposes of medical research cannot take precedence over the rights and interests of individual participants, and that its ethical principles must be upheld during public health emergencies.¹

A human challenge study conducted in 34 healthy volunteers inoculated with the COVID-19 virus highlights the impact of SARS-CoV-2 infection on human cognition and memory.² Regretfully, this paper does not mention crucial ethical issues raised by the act of deliberately infecting healthy persons with a novel virus, in the absence of effective treatment, to gain scientific insights of potential public health value, which were a matter of much controversy during the COVID-19 pandemic. A 2020 WHO-issued guidance document³ proposed 8 ethical criteria for such studies, starting with the scientific justification of involving healthy subjects. However, these are not discussed in the paper, which also ignores ethical issues related to the informed consent sought from healthy volunteers: understanding of the risks; inducement and adequacy of financial compensation; management of immediate and prolonged adverse events; amount of time given to decide to enroll; insurance coverage provided for any needed medical care. This last issue is of special relevance given the impact of SARS-CoV-2 infection on cognitive and memory parameters found as the study’s key outcome.

As co-leaders of the VolREthics initiative that aims to advocate for the better protection of healthy volunteers in biomedical research globally,⁴ we wish that this paper had reflected better the essential principle that good science cannot exist without good ethics.

Contributors

All authors contributed equally to drafting, revising and finalising the manuscript's text.

Declaration of interests

None of the authors has any conflict of interest to declare.