At PRIM&R’s 2014 Advancing Ethical Research Conference, Dr. Anthony Fauci gave a keynote address where he shared his personal account of the ethical challenges of research during the HIV/AIDS epidemic. The urgency and fear that surround an outbreak like HIV/AIDS or coronavirus/COVID-19 bring into focus ethical risks of doing research during these times. As with the HIV/AIDS and Ebola crises, ethical considerations crucial to the evaluation of treatments and vaccines in viral outbreaks have arose again with the onset of the novel coronavirus disease, COVID-19. General issues that arise during health crises include:
- What are the research and medical communities’ obligations to strengthen global health framework to ensure it’s prepared for future and continuing threats? Should this research (e.g., COVID-19 research) be fast-tracked above all other research? The “disease du jour” is not the only condition affecting the global population.
- Who has the luxury of receiving adequate treatment and care? Shouldn’t comparable care be available to everyone?
- Is the United States ethically obligated to provide assistance to other countries? After all, without enhanced travel and border health measures, future disease outbreaks may eventually be introduced into US territory from the disease’s source location.
Another issue to be considered is the degree to which the principle of clinical equipoise will be met.
- What treatment arm is appropriate for subjects? Which treatment would be most beneficial?
- When the “gold standard” treatment is ineffective or non-existent, how can one be certain the experimental treatment to which it would be compared is better?
- Without equipoise, how can researchers instill sufficient trust to the affected individuals to conduct ethical research? How can subjects be ensured the risk they are taking to be part of the clinical study is worth it if they believe the researchers are just winging it?
Trial design is an additional concern as hastily and ineffectually planned trials will not only fail to improve the health of impacted individuals, but might cause added harm.
- How do the research and medical communities determine who should be prioritized to receive the resulting treatments?
- How do the research and medical communities ensure that fast-tracked trials meet minimum ethical standards and that the resulting therapeutics or vaccines are safe and effective?
Adding to the significance of these issues is that these ethical concerns can be amplified in circumstances, like global pandemics, where transnational political and social relationships shape our understanding of both the disease and those affected by them. Several research trials are underway on COVID-19 already, and it is necessary to remember the past so that the best, most ethical research can be performed during this and future times of crisis.