Ethics of Challenge Studies

hand holding vaccine syringe with genetic code and viruses in background

Challenge studies are a form of research where healthy volunteers are deliberately challenged with an infection in order to enable research to take place. It is now being used to enable COVID-19 vaccine research to better establish the efficacy of  vaccine candidates, although it is controversial given the risk of harm to volunteers. In this series of papers, we explore the ethics of challenge studies.

Resources

Bambery, B., Savulescu, J., Selgelid, M., Weijer, C., Pollard, A., (2016) Ethical Criteria for Human Challenge Studies in Infectious Diseases, Public Health Ethics 9 (1): 92-103
(Cited in World Health Organisation’s Key criteria for the ethical acceptability of COVID-19 human challenge studies, 6 May 2020).

Grimwade, O., Savulescu, J., Giubilini, A., Oakley, J., Osowicki, J., Pollard, A. and Nussberger, A., (2020). 'Payment in Challenge Studies: Ethics, Attitudes and a New Payment for Risk Model', Journal of Medical Ethics, Vol: 46(12): 815–826 [PMC7719900] 

Schaefer, GO. , Tam, C., Savulescu,J.,  Voo, TC.,  (2020).   COVID-19 vaccine development: Time to consider SARS-CoV-2 challenge studies?, Vaccine 38,(33): 5085-5088 

James E Meiring,  Alberto Giubilini,  Julian Savulescu,  Virginia E Pitzer, Andrew J Pollard. (2019) Generating the Evidence for Typhoid Vaccine Introduction: Considerations for Global Disease Burden Estimates and Vaccine Testing Through Human Challenge, Clinical Infectious Diseases 69 (Issue Supplement 5): S402–S407

Anomaly, J., Savulescu, J., (2019). Compensation for Cures: Why we should a premium for participation in ‘challenge studies’, Bioethics 33(7): 792–797.

Pollard, A., Savulescu, J.,  Oxford, J., Hill, A., Levine, M.,  Lewis, D.J , Read, R. C., Graham, D, Sun, W., Openshaw, P., Gordon, S. (2012), Human microbial challenge: the ultimate animal model, Lancet Infectious Diseases 12(12):903-5.