Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Department of Emergency Medicine, Oregon Health and Science University, Portland, Oregon, USA.
AJOB Empir Bioeth. 2021 Jan-Mar;12(1):24-32. doi: 10.1080/23294515.2020.1818878. Epub 2020 Sep 29.
Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment. To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis. Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members' attitudes; none reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES's domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful. IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies.
豁免知情同意 (EFIC) 法规详细说明了机构审查委员会 (IRB) 在某些特定情况下可以批准研究，即在受试者入组前无法获得知情同意的情况下。为了更好地了解 IRB 成员如何评估社区咨询 (CC) 和公开披露 (PD) 流程和结果，对具有 EFIC 经验的 IRB 成员进行了半结构化访谈，并使用主题分析进行了分析。对 11 名 IRB 成员的访谈揭示了审查 EFIC 研究的类似方法。大多数人使用 CC 活动摘要来确定社区成员的态度；没有人报告使用具体标准，也没有人回忆起任何导致 EFIC 研究修改或被否决的 CC 审查。大多数受访者认为基于社区声音的领域（可行性、参与者选择、沟通质量、社区认知、调查员/IRB 认知）的指标将是有用的。IRB 成员在审查 EFIC 研究方面有类似的经验和关注点。开发评估 CC 流程的指标可能对审查 EFIC 研究的 IRB 有用。
