Boston University, Boston, MA, United States.
Regeneron Pharmaceuticals Inc., Tarrytown, NY, United States.
Front Public Health. 2024 Mar 6;12:1359654. doi: 10.3389/fpubh.2024.1359654. eCollection 2024.
There is an urgent need for increased understanding of COVID-19 and strategies for its prevention, treatment, and mitigation. All participants in the research enterprise, including institutional review boards, have an ethical duty to protect participants and ensure that the benefits gained from such research do not conflict with the core principles that guided researchers prior to the pandemic. In this review, we discuss the ethical issues surrounding initiation and conduct of clinical trials, focusing on novel COVID-19 therapeutic, vaccine, or biospecimen research, using the principles of autonomy, beneficence, and justice. We discuss strategies to manage the practical challenges associated with the conduct of clinical trials, with an emphasis on maintaining the rights and welfare of research participants.
目前迫切需要增进对 COVID-19 的了解，并制定预防、治疗和缓解的策略。研究企业的所有参与者，包括机构审查委员会，都有道德责任保护参与者，并确保从这类研究中获得的益处不会与大流行前指导研究人员的核心原则发生冲突。在这篇综述中，我们讨论了与启动和开展临床试验相关的伦理问题，重点讨论了使用自主、受益和公正原则的新型 COVID-19 治疗、疫苗或生物标本研究。我们讨论了管理临床试验实施相关实际挑战的策略，重点是维护研究参与者的权利和福利。
