The ethics of withdrawal from study participation.
The ethics of withdrawal from study participation.
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退出研究参与的道德规范。
DOI：
10.1080/08989620600848645
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发表时间：
2006
期刊：
影响因子：
--
通讯作者：
Prohaska,ThomasR
中科院分区：
文献类型：
--
作者：
Gordon,ElisaJ;Prohaska,ThomasR
我们调查了知情同意书是否符合关于退出研究的联邦通用规则法规，描述了退出条款的语言，并评估了退出条款的研究差异。对来自中西部学术医学中心的114份知情同意书的随机样本进行了检查，以了解知情同意书中规定的退出参数的描述性内容。所有知情同意书均包括根据联邦法规（CFR）45 CFR（§46.116（a）（8））要求的关于退出的声明，并且所有知情同意书均遵守法规45 CFR（§46.116（B）（4）），包括退出不会影响所提供护理的声明。在114项研究中，有30项（26%）研究明确要求受试者/参与者在退出研究前进行进一步的行为。仅在4例（13%）病例中提及安全性作为额外访视或检查的原因。知情同意书均未提供退出研究对受试者健康或福祉的影响信息。同意书通常符合现行法规。未来的研究应检查受试者退出研究的经历，以帮助临床研究者和机构审查委员会（IRB）评估知情同意书在多大程度上表明了退出研究的障碍，并符合联邦通用规则法规。
We investigated whether consent forms adhere to Federal Common Rule regulations pertaining to withdrawal from research, described the language of withdrawal provisions, and assessed differences in studies by withdrawal provisions. A random sample of 114 consent forms from a midwestern, academic medical center were examined for descriptive content of withdrawal parameters stated within consent forms. All consent forms included the required statement about withdrawal pursuant to the Code of Federal Regulations (CFR) 45 CFR (§46.116(a)(8)), and all adhered to regulation 45 CFR (§46.116(b)(4)) by including a statement that withdrawal will have no affect on care provided. Of 114 studies, thirty (26%) studies explicitly requested subjects/participants to engage in a further behavior before withdrawing from the study. Safety was mentioned in only 4 (13%) instances as the reason for an additional visit or test. None of the consent forms provided information about the consequences to the subject's health or well being by withdrawing from study participation. Consent forms generally conform to current regulations. Future research should examine subjects' experiences of withdrawing from research in order to help clinical investigators and Institutional Review Boards (IRBs) assess the extent to which consent forms indicate barriers to withdrawal and for compliance with Federal Common Rule regulations.