A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent
A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent
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DOI：
10.1136/jme.2005.014878
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发表时间：
2007-05-01
影响因子：
4.1
通讯作者：
Gorman, Paul
中科院分区：
文献类型：
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作者：
McClure, Katie B.;Delorio, Nicole M.;Gorman, Paul
背景：引入《知情同意条例》的紧急例外情况，是为了在获得知情同意之前，为在紧急情况下对受试者进行研究提供一个场所。为了继续进行研究，机构审查委员会（irb）需要确定是否符合规定。目的：确定IRB成员在审查研究方案时使用紧急例外的知情同意经验。方法：本定性研究采用半结构化电话访谈的方式，于2003年秋季从美国各地挑选了10名IRB成员。选择IRB成员的原因是人们对他们对例外同意的看法知之甚少，他们的部分任务是保护研究中的人类受试者。面试问题集中在审查过程的长度、道德和法律考虑、向IRB成员提供的法规培训以及使用社区咨询和通知的经验。对访谈笔录进行内容分析。为了确保有效性，数据分析由不同背景的个人进行：三名急诊医生，一名IRB成员和一名外行。结果：答复者指出：(1)知情同意研究的紧急例外需要冗长的审查；(2)社区咨询和通报规定模糊，难以实施；(3)现行法规如果适用得当，可以保护人类受试者；(4)法律顾问是审查知情同意协议例外的重要方面；(5) IRB成员很少或没有接受过这些法规的正式培训，但能够获得审查此类协议所需的材料。结论：本初步研究表明，IRB成员发现知情同意研究的紧急例外情况比其他协议需要更长的审查时间，社区咨询和社区通知是法规中最难遵守的方面，但它们充分保护了人类受试者。
Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards ( IRBs) need to determine if the regulations have been met.Aim: To determine IRB members' experience reviewing research protocols using emergency exception to informed consent.Methods: This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB members were chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson.Results: Respondents noted that: ( 1) emergency exception to informed consent studies require lengthy review; ( 2) community consultation and notification regulations are vague and hard to implement; ( 3) current regulations, if applied correctly, protect human subjects; ( 4) legal counsel is an important aspect of reviewing exception to informed-consent protocols; and ( 5) IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols.Conclusions: This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects.