Human challenge trials: identifying and weighting risks and benefits
DOI:
https://doi.org/10.5007/1677-2954.2023.e98340Keywords:
Human challenge trials, Human challenge studies, Controlled human infection, Research with human beings, PandemicAbstract
Human challenge trials are characterized by the intentional infection of volunteers, in an environment in which risks are controlled and minimized, for the purpose of studying and analyzing diseases, as well as developing and testing medicines and vaccines, on a small number of participants who accept, in a free and informed way, to take part in the research. Although the practice has existed, with variations, for centuries, the Covid-19 pandemic has made the debate around the subject more evident, especially given the urgent need to develop vaccines. On the one hand, human challenge tests allow the understanding of the disease and the production of vaccines at a faster speed, generating benefits for public health and the community. On the other hand, they raise several ethical questions, mainly in relation to the intentional causing of harm to participants, which seems to violate the principles of beneficence and non-maleficence, in addition to referring to traumatic experiences. From this context, this paper seeks to present the premises for the ethical debate regarding human challenge trials. Using the bibliographic review method, through content analysis, this paper initially seeks to historically situate the practice, in connection with its recent applications. Furthermore, the main benefits and risks of using controlled human infection are presented and critically analyzed. In the end, the hypothesis is confirmed: human challenge studies can be carried out ethically, as long as they comply with strict regulatory standards, based on ethical-normative parameters.
References
ABO, Yara-Natalie et al. Strategic and scientific contributions of human challenge trials for vaccine development: facts versus fantasy. The Lancet Infectious Diseases, Vol. 23, Issue 12, 533-546, 2023.
BAMBERY, Bam et al. Ethical criteria for human challenge studies in infectious diseases. Public Health Ethics, v. 9, n. 1, p. 92-103, 2016.
BEAUCHAMP, Tom; CHILDRESS, James. Principles of biomedical ethics. 7 ed. Oxford: Oxford University Press, 2013.
BECKER, Gary. Nobel Lecture: the economic way of looking at behavior. The Journal of Political Economy, vol. 101, n. 3, 387-389, 1993.
BETHONY, Jeffrey et al. Soil-transmitted helminth infections: ascariasis, trichuriasis, and hookworm. Lancet, Vol. 367, Issue 9521, 1521-32, 2006.
BONELLA, Alcino Eduardo. A ética dos testes clínicos de desafio humano na avaliação de vacinas e tratamentos para a covid-19. In: TAUCHEN, Jair; CASTANHEIRA, Nuno; OLIVEIRA, Nythamar de (Orgs.). Bioethics & Neuroethics in Global Pandemic Times. Porto Alegre: Editora Fundação Fênix, 15-30, 2020.
BONELLA, Alcino; SINGER, Peter. Infectar voluntários é eticamente aceitável e pode acelerar produção de vacinas contra Covid-19. Folha de São Paulo, 31 jul. 2021.
BRITISH SOCIETY FOR IMMUNOLOGY. How have COVID-19 vaccines been developed so fast? Disponível em: <https://www.immunology.org/>. Acesso em 23 nov. 2023.
COHEN, Jon. The true test. Science, Vol. 352, Issue 6288, 882-885, 2016.
DARTON, Thomas et al. Design, recruitment, and microbiological considerations in human challenge studies. The Lancet Infectious Diseases, Vol. 15, Issue 7, 840-851, 2015.
DUARTE, Ana. Entenda como funciona a produção de uma vacina em cinco passos. Pontifícia Universidade Católica do Rio Grande do Sul, 27 mai. 2021.
ISMERIM, Flávio. Dupla de cientistas recebe Nobel de Medicina por desenvolver vacina contra Covid-19. CNN Brasil, 02 out. 2023.
JAMROZIK, Euzebiusz; SELGELID, Michael J. COVID-19 human challenge studies: ethical issues. The Lancet Infectious Diseases, Vol. 20, Issue 8, 198-203, 2020.
JAMROZIK, Euzebiusz; SELGELID, Michael J. Human challenge studies in endemic settings: ethical and regulatory issues. Gewerbestrasse: Springer, 2021.
KOTTOW, Miguel. História da ética em pesquisa com seres humanos. Revista Eletrônica de Comunicação, Informação e Inovação em Saúde. Rio de Janeiro, Vol. 2, 7-18, 2008.
KRAFT, Stephanie et al. Exploring ethical concerns about human challenge studies: a qualitative study of controlled human malaria infection study participants motivations and attitudes. Journal of Empirical Research on Human Research Ethics, Vol. 14, Issue 1, 49–60, 2019.
MALMQVIST, Erik. Are bans on kidney sales unjustifiably paternalistic? Bioethics, Vol. 28, Issue 3, 110-118, 2014.
MILL, John Stuart. On liberty. Edited by David Bromwich and George Kateb. New Haven: Yale University Press, 2003.
OLIVEIRA, Lucas Costa de. Gametas como mercadorias: a superação dos desafios ético-jurídicos da comodificação de gametas humanos. Indaiatuba: Editora Foco, 2023.
PIVETTA, Marcos. À procura de atalhos. Pesquisa FAPESP, edição 293, 19-23, julho de 2020.
ROSENHECK, Mabel. Risk, benefit, and social value in Covid-19 human challenge studies: pandemic decision making in historical context. Monash Bioethics Review, Vol. 40, 188–213, 2022.
SEKHAR, Amrita; KANG, Gagandeep. Human challenge trials in vaccine development. Seminars in Immunology, Vol. 50, 1-6, 2020.
SHERMAN, Amy Caryn et al. The future of flu: a review of the human challenge model and systems biology for advancement of influenza vaccinology. Frontiers in Cellular and Infection Microbiology, Vol. 9, Issue 107, 1-9, 2019.
SHIRLEY, Debbie-Ann; MCARTHUR, Monica A. The utility of human challenge studies in vaccine development: lessons learned from cholera. Vaccine: Development and Therapy, Vol. 1, 3-13, 2011.
SMITH, Adam. The wealth of nations: an inquiry into the nature and causes of the wealth of nations. Chicago: University Of Chicago Press, 1977.
STANCIOLI, Brunello. Relação jurídica médico-paciente. Belo Horizonte: Del Rey, 2004.
TAYLOR, Charles. The ethics of authenticity. Cambridge: Harvard University Press, 1991.
WORLD HEALTH ORGANIZATION. Human challenge trials for vaccine development: regulatory considerations. WHO Technical Report Series, n. 1004, 2017.
WORLD HEALTH ORGANIZATION. Key criteria for the ethical acceptability of COVID-19 human challenge studies. 6 May 2020.
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