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KMID : 1172020220230020017
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Journal of Korean Bioethics Association
2022 Volume.23 No. 2 p.17 ~ p.39
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COVID-19 Pandemic and Pregnancy Clinical Research Ethics
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Fang Yin-Hua
Kim Ock-Joo
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Abstract
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The global spread of infectious diseases such as COVID-19 is always a concern for pregnant and lactating women. Many important issues remain unresolved, including the impact of COVID-19 on the severity of asymptomatic or mild infections, miscarriage, intrauterine fetal growth restriction, congenital anomalies, organ growth and neurodevelopmental outcomes. Currently, the evidence base for pregnant women and COVID-19 is limited. Given the unique physiology and sensitivities of pregnancy, responses to vaccination may differ from those of the general population. Evidence from research evaluations of vaccines during pregnancy could increase confidence among pregnant women in vaccines, thereby facilitating efforts to protect this population and achieve herd immunity in the entire population. Controlling the COVID-19 pandemic will require research to develop new approaches, which should address the needs of pregnant women as a population affected by COVID-19. Much more research is needed to clarify the impact of viral infection on pregnant women and fetuses in the data available to gather information about COVID-19 among pregnant women. This paper shows the ethical justification of inclusion of pregnant women in clinical research by applying four bioethics principles to this topic. Thereby, the authors argue that it is ethical imperatives to include pregnant women in COVID-19 clinical research. The knowledge gained from clinical research, including the immunological changes that may affect the course of infectious diseases in pregnant women, which will assist in responding to future infectious diseases. Facing current and future new epidemic outbreaks, clinical research and development of pregnant women will help optimize their prevention and treatment.
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KEYWORD
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COVID-19, pandemic, pregnant women, clinical research ethics, beneficence, nonmaleficence, autonomy, justice
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