UNC Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
BMC Med Ethics. 2021 Jan 25;22(1):6. doi: 10.1186/s12910-021-00575-w.
Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs.
Necessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities.
In the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.
为了减轻新型冠状病毒病（COVID-19）大流行的传播而采取的关键公共卫生措施已经打乱了全球卫生研究，包括艾滋病毒预防研究。虽然已经为在这些具有挑战性的情况下进行负责任的研究提供了一般性指导，但 COVID-19 和艾滋病毒/艾滋病大流行的双重挑战为艾滋病毒预防研究提出了一些关键的伦理问题。在本文中，我们使用最近更新的艾滋病毒预防试验网络（HPTN）伦理指南文件（EGD）来确定和分析与 COVID-19 大流行期间进行艾滋病毒预防研究相关的主要伦理挑战，并根据这种前所未有的情况确定指导文件的潜在改进领域。
由于 COVID-19 大流行，艾滋病毒预防研究需要采取一系列必要措施，涉及到以下伦理问题：（1）风险缓解；（2）行为改变；（3）加剧脆弱性；（4）社区参与；（5）试验重新开放；（6）转移研究重点。
在艾滋病毒和 COVID-19 全球大流行的双重背景下，研究团队和赞助商必须通过对相关伦理问题保持敏感，灵活应对快速变化的环境。HPTN EGD 提供了一整套工具，可帮助识别、分析和解决其中许多问题。同时，通过提供有关研究中断和研究重新开放相关伦理问题的明确建议，可以加强 HPTN EGD 和其他研究伦理指南的未来修订。此外，应更多地考虑适当平衡风险领域（例如，身体风险与社会风险），解决研究人员和社区合作伙伴的脆弱性问题，并应对参与者和社区的意外附加护理需求。适当解决这些问题需要进行概念性工作，这将受益于仔细记录研究中遇到的实际伦理问题、为克服这些问题而实施的策略以及成功实施这些策略的情况。在所有这些努力中，必须牢记，在急于应对 COVID-19 大流行的过程中，不要忘记艾滋病毒大流行。
