Chapter Six: Research Ethics
David Wendler, “The Ethics of Clinical Research”, The Stanford Encyclopedia of Philosophy (Winter 2017 Edition), Edward N. Zalta (ed.)
Wendler provides an overview of clinical research, research abuses, guidelines for research ethics, and criticisms. Wendler also considers industry-sponsored research.
Seema K. Shah, et al. (22 May 2020) “Ethics of controlled human infection to address COVID-19,” Science
Shah et al. discuss controlled human infection studies (CHIs), which Eyal et al. call “human challenge studies” (in reading 6.2 from The Ethics of Pandemics). Shah et al. offer a robust framework with which to consider the ethics of CHIs. This framework includes: considerations of social value, assessment of risk-benefit profile, context-specific stakeholder engagement, suitable site selection, fair participant selection, robust requirements of informed consent, and proportionate payment.
Ruth Macklin (15 June 2020), “Human Challenge Studies for Covid-19 Vaccine: Questions about Benefits and Risks,” The Hastings Center Bioethics Forum [blog]
Macklin responds directly to Eyal et al. (reading 6.2 in The Ethics of Pandemics). Macklin questions whether challenge studies actually do determine whether a vaccine is effective more quickly than other trial designs. Macklin notes that although there is interest in participating in human challenge studies, it is not always clear whether those who have signed up to participate in such trials are well informed about the nature of the trials. Macklin is concerned that research participants will likely come from racialized groups and that they may have lower economic prospects. She concludes that it is not permissible to run challenge studies that intentionally inflict harm on a few to benefit the many.
Eloise Williams, et al. (9 June 2022), “Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop,” Vaccine, 40(26)
In reading 6.2 of The Ethics of Pandemics, Eyal et al. consider a prospective approach to the ethics of COVID-19 human challenge studies that had not yet been implemented. The United Kingdom was the first, and is so far the only, country to host human challenge studies for COVID-19. The authors in this article provide a retrospective evaluation of the ethics of these trials and whether the World Health Organization guidelines are sufficient.
Carl Elliott (2 June 2020), “An Ethical Path to a COVID[-19] Vaccine,” The New York Review of Books.
In the course of reviewing Jill A. Fisher’s book, Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals, Elliott contemplates issues of justice and equity that arise in human challenge studies by comparing them to Phase I clinical trials. Elliott asks what conditions must be in place for challenge studies to treat the participants fairly. He argues that if the worst happened, and a study participant fell ill or became permanently disabled, then a minimum condition of fair treatment would include paying the medical bills or providing ongoing support if the participant were no longer able to work. Elliott disagrees with the position articulated by Eyal et al. (in reading 6.2 of The Ethics of Pandemics).
Karen J. Maschke and Michael K. Gusmano (2020), “Ethics and Evidence in the Search for a Vaccine and Treatments for Covid-19,” The Hastings Center Bioethics Forum [blog]
Maschke and Gusmano are concerned that the rush to develop vaccines and treatments for COVID-19 might harm patients. They note that some trials have skipped testing in animals to go directly to human trials. They recommend that all trials report to a publicly accessible research database so as to help determine when a treatment is dangerous. At minimum, they argue, animal studies should run in parallel with human trials.
Natasha Crooks, et al. (2021), “Ethics of research at the intersection of COVID-19 and black lives matter: a call to action,” Journal of Medical Ethics, 47(4)
Black populations in the United States are often distrustful of medical science as a result of past medical abuses such as the Tuskegee Syphilis study. At the same time, COVID-19 has had a disproportionate effect on Black populations, and so Black people would especially benefit from vaccines developed to combat COVID-19. However, the participation of Black people in vaccine trials is low. Crooks, et al. provide recommendations for engaging Black populations in COVID-19 research, including the importance of recognizing the trauma caused by medical research in these communities.