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24 Med., Health Care & Phil. 1 (2021)

handle is hein.journals/medhcph24 and id is 1 raw text is: Medicine, Health Care and Philosophy (2021) 24:1-2 https://doi.org/1 0.1007/si 1019-021-10001-y EDITORRIAL COVID-19 and the ethics of human challenge trials Bert Gordijn' - Henk ten Have2 Published online: 17 January 2021 © The Author(s), under exclusive licence to Springer Nature B.V. part of Springer Nature 2021 During the past year COVID-19 changed the lives of peo- ple globally. Its threat to health and economy triggered an unprecedented global research response, which resulted in the speedy development of various vaccines as well as rapid testing and assessment of medication. In the meantime, how- ever, the healthcare system had to deal with surging numbers of COVID-19 patients. The resolve to achieve progress in research and the need to provide patient care under testing circumstances triggered a variety of ethical difficulties. Ethical challenges The first three papers in the current issue highlight some of the ethical questions triggered by COVID-19. Solbakk et al. (2021) advance arguments against controlled human infec- tion studies making a case for upholding well-established research ethics guidelines, even under exceptional pandemic circumstances. Da Silva et al. (2021) look at problems in academic publishing such as keeping up the rigor of peer review and the quality of editorial decision making when dealing with a significantly increased manuscript flow and facing the urgency to work faster rather than slower. They advance six recommendations in order to minimize risks of publishing questionable original research on public health research related to COVID-19 (ibid.). Rashi (2021), finally, tackles the dangers that health care workers and their fami- lies are exposed to because of COVID-19. Should these risks be accepted by health care workers? What are the justifica- tions for the professional obligation to continue work under circumstances of increased risk? When do working condi- tions become unacceptably dangerous? The case against exceptionalism This editorial focuses on the first paper by Solbakk et al. (2021) about human challenge trials, i.e., experiments where human participants are intentionally exposed to pathogens. The pandemic has triggered a debate about these studies with advocates and opponents advancing a variety of argu- ments (see ibid. table 2 for references). Yet, our authors are not in favour of allowing any ethical exceptions or short- cuts (ibid.). On the contrary, especially when it comes to COVID-19 research they deem it pivotal to stick to existing research ethics guidelines, the priority of the individual principle being the most fundamental (ibid.). The inter- ests of individual trial participants should always trump those of society. Variations of this principle can be found in the different versions of the Declaration of Helsinki and in the UNESCO Universal Declaration on Bioethics and Human Rights. It remains unclear whether the authors assert that chal- lenge trials are categorically unethical or whether their claim is restricted to the specific case of COVID-19. The first interpretation is suggested where they generically claim that the primacy of the interests of individual research partici- pants should be upheld whatever the circumstances. There is no exception for times of crisis, or for instances where societal interests are large (ibid.). The second interpreta- tion is implied where they declare that the principle ... prohibits the conduct of SARS-CoV-2 challenge studies at the present time where the challenge virus would be the native virus with full virulence and where there is no rescue treatment yet available (ibid.). The two clauses indicate that if the challenge virus were not fully virulent and/or there was a rescue treatment, challenge trials might be acceptable after all. Be this as it may, two questions must be clearly distinguished. Bert Gordijn bert.gordijn@dcu.ie Dublin City University, Dublin, Ireland 2 Duquesne University, Pittsburgh, USA 9 Springer

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