Ethics of Human Research: COVID-19

Part of the research completed in the process of developing a vaccine was done on humans. There were many volunteers who hoped that exposing themselves to the virus to aid with research would streamline the process of creating a vaccine. This form of human research came with many ethical considerations. Some countries considered human research ethical, while others did not. For example, the UK granted lifelong care for participants in case any harm was done. The U.S., however, does not allocate this kind of lifelong care and thus some believe these studies to be unethical.

Other ethical guidelines included the need for multiple justifications on why conducting SARS-CoV-2 challenges was necessary. Justification is the strongest when “studies aim to produce results of public health importance, especially to the extent that similar results could not feasibly be obtained as efficiently or expediently in other study designs involving less risk to human participants.” Some appropriate public benefits are increasing the development of vaccines, increasing the chance that the vaccine will become available, and augmenting awareness of SARS-CoV-2 infection and transmission. According to the WHO (World Health Organization), there are multiple criteria that must be met regarding ethical guidelines. One of them is that the potential benefits of SARS-CoV-2 studies overshadow the challenges. Assessments must be conducted of the potential benefits and risks, other study designs should be considered, and risks should be mitigated while benefits should be enhanced. Additionally, transparency to the public regarding studies should be maintained. Activities should be quick and informative, so that expert groups stay updated and knowledgeable. While the studies are being conducted, community involvement at local, national, and international levels should be undertaken immediately. Coordination between researchers and regulators regarding vaccine development should also take place. When more than one vaccine is being created, coordination facilitates safer decision-making and more organized data. Testing for SARS-CoV-2 should only occur in areas with plenty of resources and experience in conducting human research. Proper isolation settings should be located in these areas. In order to maximize benefits and minimize risks, those who participate must be young, healthy adults in the age range of eighteen to thirty.

References:

Emanuel EJ, Upshur REG, Smith MJ. What Covid Has Taught the World about Ethics. New England Journal of Medicine. 2022 Oct 27;387(17):1542–5. 

Kolstoe S. Human challenge studies: what we’ve learned from intentionally infecting people with COVID [Internet]. The Conversation. Available from: https://theconversation.com/human-challenge-studies-what-weve-learned-from-intentionally-infecting-people-with-covid-197767 

IRIS Home [Internet]. iris.who.int. Available from: https://iris.who.int 

COVID-19 Information & Resources | National Institute of Dental and Craniofacial Research [Internet]. www.nidcr.nih.gov. [cited 2024 Jul 25]. Available from: https://www.nidcr.nih.gov/research/covid19