Regulation of clinical trials and pandemic research : upholding ethical standards during a COVID-19 crisis

The COVID-19/SARS-CoV-2 pandemic presents an unprecedented and extraordinary challenge to global health. Cases, as well as mortality, continue to increase globally. To prevent the spread of disease and control the pandemic, numerous studies involving human participants are performed and many COVID-19 vaccine candidates, including multivalent ones, are currently in development. These vaccines are based on various platforms, including mRNA and DNA technologies, including viral vectors, subunit, inactivated, and live attenuated vaccines.1 Thus, vaccines to protect against COVID-19 are critical to mitigate the SARS-CoV-2 pandemic and to prevent future disease outbreaks. Given the speed at which vaccine development is occurring, researchers may be tempted to compromise quality control and rigor in a desperate race to find a cure and vaccine. However, crises are not a reason for lowering the bar of high ethical and scientific standards and ethicists have warned scientists not to cave into bad science.2 Unethical experiments involving human participants are disturbing; however, considering them is instrumental in understanding the consequences of these historical atrocities and their destruction of public trust and confidence in scientific developments.3 Currently, there are COVID-19 vaccine rollouts in many countries, including Australia. However, there is no guarantee that these new and emerging vaccines are entirely effective and safe. Further, it remains uncertain as to how long the protection/immunity lasts for those who receive the vaccine.4 Thus, there is a strong and urgent need to continue conducting studies and clinical trials on COVID-19 vaccines to improve their ongoing safety and efficacy, especially since COVID-19 vaccines for children under age 12 continue to be a work in progress and trials involving younger populations will require ongoing attention. This paper explores and critically analyzes the current regulation and governance of studies and clinical trials for the COVID-19 vaccine (with a focus on the Australian regulation) and examines whether and to what extent it ensures ethical treatment of all human trial participants in these studies.