Main Article Content
Abstract
The COVID-19 pandemic has elicited reactions of various magnitudes from various stakeholders and countries. Interventions have come from stakeholders with matching veracity. Some have proposed hydroxychloroquine and azithromycin, green tea, traditional herbs, anti-retroviral drugs, religious magic, etc. An interesting intervention that has been championed by scholars such as Arthur Caplan (2020) is human challenge studies. This is giving healthy human volunteers with trial COVID-19 vaccines and then infecting them with the virus to test the vaccine’s efficacy. Challenge studies involve volunteers motivated by altruism and a desire to help humanity. In addition, the payment of study participants would motivate many volunteers to enroll in the study, especially if the offer was encouraging. Several ethical questions have emerged when implementing challenge studies: Are participants who participate in a study only to obtain money regarded as volunteers? Is exposing humans to a virus that could affect them negatively—even causing death, the best intervention for COVID-19? This paper argues that COVID-19 challenge studies are unacceptable based on existing research on human regulations, Christian views of human dignity, and biblical instructions on treating humans. This documentary study employed available literature on human challenge studies from secondary sources. The conclusion suggests a way to guide the policy and practice of existing and other possible COVID-19-related studies.
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References
- Bambery, B., Selgelid, M., Weijer, C., Savulescu, J., & Pollard, A. J. (2016). Ethical criteria for human challenge studies. Public Health Ethics, 9(1), 92-103.
- Caplan, A. (2020, May 14). Is it ethical to give someone coronavirus to create a vaccine? Yes. https://www.bostonglobe.com/2020/05/14/opinion/is-it- ethical-give-someone-coronavirus-create-vaccine-yes/
- Cohen, B. (1990). The ethics of using medical data from Nazi experiments. Journal of Halacha and Contemporary Society, 19, 103–126.
- Durbin, A. P., & Whitehead, S. S. (2017). Zika vaccines: Role for controlled human infection.
- The Journal of Infectious Diseases, 216(S10), S971–75.
- Eyal, N., Caplan, A., & Plotkin, S. (2022). COVID vaccine efficacy against the B.1.351 (“South African”) variant—The urgent need to lay the groundwork for possible future challenge studies. Human Vaccines & Immunotherapeutics, 18(1). https://doi.org/10.1080/21645515.2021.1917240
- Eyal, N., Lipsitch, M., & Smith, P. G. (2020, June 1). Human challenge studies to accelerate coronavirus vaccine licensure. The Journal of Infectious Diseases, 221(11), 1752–1756. https://doi.org/10.1093/infdis/jiaa152
- Hope, T., & McMillan, J. (2004). Challenge studies of human volunteers: Ethical issues.
- Journal of Medical Ethics, 30, 110-116.
- Jamrozik, E., & Selgelid, M. J. (2021). Human challenge studies in endemic settings: Ethical and regulatory issues. Springer.
- Kopelman, L.M. (2004). Minimal risk as an international ethical standard in research. The Journal of Medicine and Philosophy, 29(3), 351-378. https://doi.org/10.1080/03605310490500545
- Palacios, R., & Shah, S. K. (2019). When could human challenge trials be deployed to combat emerging infectious diseases? Lessons from the case of a Zika virus human challenge trial. Trials, 20 Supplement 2(1), 1-8. https://trialsjournal.biomedcentral.com/articles/supplements/volume-20-
- Savulescu, J., & Hope, T. (2010). The ethics of research. In J. Skorupski (Ed.), Routledge Companion to Ethics (chapter 65). Routledge.
- Tanne, J. H. (2010). President Obama apologises to Guatemala over 1940s syphilis study. BMJ (Clinical Research Ed.), 341, c5494. https://doi.org/10.1136/bmj.c5494
- The Academy of Medical Sciences. (2018). Controlled Human Infection Model Studies: Summary of a Workshop held on 6 February 2018. The Academy of Medical Sciences (pp. 1-33). London.
- U.S. Code of Federal Regulations, 45 CFR 46 (1991). Federal policy for the protection of human subjects. (The Common Rule.) Federal Register, 56, 28003–28016.
- World Health Organization. Product Research and Development Team. (2000). Operational guidelines for ethics committees that review biomedical research. World Health Organization. https://apps.who.int/iris/handle/10665/66429
- World Medical Association. (2015). http://www.wma.net/en/30publications/10policies/c8/
- Zenilman, J. M. (2013). Ethics gone awry: the US Public Health Service studies in Guatemala; 1946–1948. Sexually Transmitted Infections, 89(4), 295-300. https://doi.org/10.1136/sextrans-2012-050741
References
Bambery, B., Selgelid, M., Weijer, C., Savulescu, J., & Pollard, A. J. (2016). Ethical criteria for human challenge studies. Public Health Ethics, 9(1), 92-103.
Caplan, A. (2020, May 14). Is it ethical to give someone coronavirus to create a vaccine? Yes. https://www.bostonglobe.com/2020/05/14/opinion/is-it- ethical-give-someone-coronavirus-create-vaccine-yes/
Cohen, B. (1990). The ethics of using medical data from Nazi experiments. Journal of Halacha and Contemporary Society, 19, 103–126.
Durbin, A. P., & Whitehead, S. S. (2017). Zika vaccines: Role for controlled human infection.
The Journal of Infectious Diseases, 216(S10), S971–75.
Eyal, N., Caplan, A., & Plotkin, S. (2022). COVID vaccine efficacy against the B.1.351 (“South African”) variant—The urgent need to lay the groundwork for possible future challenge studies. Human Vaccines & Immunotherapeutics, 18(1). https://doi.org/10.1080/21645515.2021.1917240
Eyal, N., Lipsitch, M., & Smith, P. G. (2020, June 1). Human challenge studies to accelerate coronavirus vaccine licensure. The Journal of Infectious Diseases, 221(11), 1752–1756. https://doi.org/10.1093/infdis/jiaa152
Hope, T., & McMillan, J. (2004). Challenge studies of human volunteers: Ethical issues.
Journal of Medical Ethics, 30, 110-116.
Jamrozik, E., & Selgelid, M. J. (2021). Human challenge studies in endemic settings: Ethical and regulatory issues. Springer.
Kopelman, L.M. (2004). Minimal risk as an international ethical standard in research. The Journal of Medicine and Philosophy, 29(3), 351-378. https://doi.org/10.1080/03605310490500545
Palacios, R., & Shah, S. K. (2019). When could human challenge trials be deployed to combat emerging infectious diseases? Lessons from the case of a Zika virus human challenge trial. Trials, 20 Supplement 2(1), 1-8. https://trialsjournal.biomedcentral.com/articles/supplements/volume-20-
Savulescu, J., & Hope, T. (2010). The ethics of research. In J. Skorupski (Ed.), Routledge Companion to Ethics (chapter 65). Routledge.
Tanne, J. H. (2010). President Obama apologises to Guatemala over 1940s syphilis study. BMJ (Clinical Research Ed.), 341, c5494. https://doi.org/10.1136/bmj.c5494
The Academy of Medical Sciences. (2018). Controlled Human Infection Model Studies: Summary of a Workshop held on 6 February 2018. The Academy of Medical Sciences (pp. 1-33). London.
U.S. Code of Federal Regulations, 45 CFR 46 (1991). Federal policy for the protection of human subjects. (The Common Rule.) Federal Register, 56, 28003–28016.
World Health Organization. Product Research and Development Team. (2000). Operational guidelines for ethics committees that review biomedical research. World Health Organization. https://apps.who.int/iris/handle/10665/66429
World Medical Association. (2015). http://www.wma.net/en/30publications/10policies/c8/
Zenilman, J. M. (2013). Ethics gone awry: the US Public Health Service studies in Guatemala; 1946–1948. Sexually Transmitted Infections, 89(4), 295-300. https://doi.org/10.1136/sextrans-2012-050741