Packenham Joan P, Rosselli Richard T, Ramsey Steve K, Taylor Holly A, Fothergill Alice, Slutsman Julia, Miller Aubrey
Clinical Research Branch, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) , Research Triangle Park, North Carolina, USA.
Social & Scientific Systems, Inc. , Durham, North Carolina, USA.
Environ Health Perspect. 2017 Sep 25;125(9):094503. doi: 10.1289/EHP2378.
Research involving human subjects after public health emergencies and disasters may pose ethical challenges. These challenges may include concerns about the vulnerability of prospective disaster research participants, increased research burden among disaster survivors approached by multiple research teams, and potentially reduced standards in the ethical review of research by institutional review boards (IRBs) due to the rush to enter the disaster field. The NIEHS Best Practices Working Group for Special IRB Considerations in the Review of Disaster Related Research was formed to identify and address ethical and regulatory challenges associated with the review of disaster research. The working group consists of a diverse collection of disaster research stakeholders across a broad spectrum of disciplines. The working group convened in July 2016 to identify recommendations that are instrumental in preparing IRBs to review protocols related to public health emergencies and disasters. The meeting included formative didactic presentations and facilitated breakout discussions using disaster-related case studies. Major thematic elements from these discussions were collected and documented into 15 working group recommendations, summarized in this article, that address topics such as IRB disaster preparedness activities, informed consent, vulnerable populations, confidentiality, participant burden, disaster research response integration and training, IRB roles/responsibilities, community engagement, and dissemination of disaster research results. https://doi.org/10.1289/EHP2378.
公共卫生紧急事件和灾难后涉及人类受试者的研究可能会带来伦理挑战。这些挑战可能包括对潜在灾难研究参与者脆弱性的担忧、多个研究团队接触灾难幸存者导致研究负担增加,以及由于急于进入灾难现场,机构审查委员会(IRB)对研究的伦理审查标准可能降低。美国国立环境卫生科学研究所(NIEHS)关于灾难相关研究审查中IRB特殊考量的最佳实践工作组成立的目的是识别和应对与灾难研究审查相关的伦理和监管挑战。该工作组由广泛学科领域的各种灾难研究利益相关者组成。工作组于2016年7月召开会议,以确定有助于IRB审查与公共卫生紧急事件和灾难相关方案的建议。会议包括形成性的教学演示,并利用与灾难相关的案例研究进行了分组讨论。这些讨论的主要主题元素被收集并记录为15条工作组建议,本文对此进行了总结,这些建议涉及IRB灾难准备活动、知情同意、弱势群体、保密、参与者负担、灾难研究应对整合与培训、IRB角色/职责、社区参与以及灾难研究结果的传播等主题。https://doi.org/10.1289/EHP2378