John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Perelman School of Medicine at the University of Pennsylvania.
Director of clinical research compliance at the Perelman School of Medicine at the University of Pennsylvania.
Ethics Hum Res. 2021 Mar;43(2):19-27. doi: 10.1002/eahr.500082. Epub 2021 Feb 9.
Employees are often considered a vulnerable research population due to concerns about consent and confidentiality, but there is insufficient guidance regarding their ethical inclusion in research. In the context of Covid-19, frontline health care workers comprise a particularly relevant research population in light of their risks of viral exposure and psychological strain, among other factors. They may therefore be targeted for research conducted at their place of employment and benefit from participating in such research. Beyond Covid-19, there are other circumstances in which health care workers may be considered for inclusion in research conducted by or with the involvement of their colleagues and employers. As investigators, sponsors, institutional review boards, and others assess the ethical permissibility of these scenarios, as well as relevant protections, we recommend systematic consideration of social and scientific value, validity, fairness, risks and benefits, voluntary consent, respect, and independent review. There is often good reason to specifically target health care workers for inclusion in Covid-19 research (beyond convenience), and they should not be excluded from research offering the prospect of direct benefit. However, additional safeguards may be necessary in employer-based research to avoid scientific bias, promote voluntariness, and solicit stakeholder input. Research personnel should be permitted to enroll in their own Covid-19 studies only when participation offers them the prospect of unique benefits.
员工通常被认为是脆弱的研究人群，因为人们担心他们的同意和保密问题，但对于将他们纳入研究的伦理问题，没有足够的指导。在新冠疫情背景下，鉴于前线医护人员面临病毒暴露和心理压力等风险，他们是一个特别相关的研究人群，因此可能会成为在其工作场所进行的研究的目标人群，并从参与此类研究中受益。除了新冠疫情之外，在其他情况下，医护人员也可能被考虑纳入由其同事和雇主参与或进行的研究。随着调查人员、赞助商、机构审查委员会和其他人评估这些情况的伦理可允许性以及相关保护措施，我们建议系统地考虑社会和科学价值、有效性、公平性、风险和收益、自愿同意、尊重和独立审查。出于（不仅仅是方便的原因）将医护人员特别纳入新冠疫情研究通常是有充分理由的，他们不应被排除在提供直接受益前景的研究之外。然而，在基于雇主的研究中可能需要采取额外的保障措施，以避免科学偏见、促进自愿性并征求利益相关者的意见。只有当参与研究为研究人员提供独特的受益前景时，才应允许他们参与自己的新冠疫情研究。
