Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure.
Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure.
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知情同意书的例外：IRB审稿人如何评估社区咨询和公众披露。
DOI：
10.1080/23294515.2020.1818878
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发表时间：
2021-01
影响因子：
--
通讯作者：
Richardson LD
中科院分区：
文献类型：
--
作者：
Chisolm-Straker M;Nassisi D;Daya MR;Cook JNB;Wilets IF;Clesca C;Richardson LD
知情同意例外(EFIC)条例详细说明了机构审查委员会(IRB)在特定情况下可以批准在受试者登记之前无法获得知情同意的研究。为了更好地了解IRB成员如何评价社区咨询(CC)和公共披露(PD)过程和结果，本研究对具有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成员的采访揭示了审查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；没有报告使用特定标准，也没有回忆起任何CC审查导致修改或否认EFIC研究。大多数受访者认为，基于社区声音领域的衡量标准(可行性、参与者选择、沟通质量、社区看法、调查员/IRB看法)将是有帮助的。IRB成员对审查EFIC研究有类似的经历和担忧。制定评估CC过程的指标可能对IRBs审查EFIC研究有用。
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.