Conducting Science in Disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research.
Conducting Science in Disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research.
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DOI：
10.1289/ehp2378
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发表时间：
2017-09-25
影响因子：
10.4
通讯作者：
Miller A
中科院分区：
文献类型：
--
作者：
Packenham JP;Rosselli RT;Ramsey SK;Taylor HA;Fothergill A;Slutsman J;Miller A
在公共卫生突发事件和灾害发生后，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害研究参与者的脆弱性的担忧，多个研究团队接触的灾害幸存者的研究负担增加，以及由于急于进入灾害领域而可能降低机构审查委员会（IRB）对研究的伦理审查标准。NIEHS灾害相关研究审查中特殊IRB考虑的最佳实践工作组的成立是为了确定和解决与灾害研究审查相关的伦理和监管挑战。该工作组由广泛学科的各种灾害研究利益攸关方组成。该工作组于2016年7月召开会议，以确定有助于IRB审查与公共卫生突发事件和灾害有关的协议的建议。会议包括形成性的教学介绍，并利用与灾害有关的案例研究促进分组讨论。这些讨论的主要主题元素被收集并记录到15个工作组的建议中，总结在本文中，这些建议涉及的主题包括IRB备灾活动、知情同意、弱势群体、保密性、参与者负担、灾害研究响应整合和培训、IRB角色/责任、社区参与和灾害研究结果的传播。https://doi.org/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