Medicine, University of Chicago, Chicago, Illinois, USA.
General Surgery, University of Chicago, Chicago, Illinois, USA.
J Med Ethics. 2021 Jan;47(1):7-11. doi: 10.1136/medethics-2020-106590. Epub 2020 Oct 12.
Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials.
临床试验如雨后春笋般涌现，因为 COVID-19 大流行迫切需要救生疗法。在提供试验性治疗的临床试验中，公平和公平的受试者选择应该是一个紧迫的道德关注点。受试者选择决定了风险和收益的分配，并影响研究结果对更大人群的适用性。虽然研究伦理委员会在每个试验中监测公平的受试者选择，但对于同一疾病的多个试验之间的受试者选择，没有标准的监督。借鉴美国一家学术医学中心的多个临床试验的经验，我们假设由于科学不确定性、缺乏透明度、稀缺性，以及最后，由于隐含偏见而加剧的公平结构性障碍，同期 COVID-19 试验可能会对受试者选择造成不公平和不平等。为了解决当前文献和国际法规中的关键差距，我们提出了新的研究设计和实施伦理准则，以加强公平和公平的受试者选择。虽然拟议的准则是针对 COVID-19 大流行期间同期试验的研究设计和方案量身定制的，但它们可能对单一的 COVID-19 试验具有更广泛的相关性。
