White Mary Terrell, Gamm Jennifer
Department of Community Health, Wright State University School of Medicine, P.O. Box 927, Dayton, OH 45401-0927, USA.
Account Res. 2002 Jan-Mar;9(1):1-16. doi: 10.1080/08989620210354.
Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.
众多立场文件已概述了关于生物样本采集、存储及未来使用的知情同意建议;然而,目前对于同意书中应包含哪些信息尚无共识。本研究旨在确定机构审查委员会(IRB)在对存储生物样本研究的知情同意要求方面是否存在差异,以及观察到的任何差异是否与工作量、IRB成员对基因研究伦理问题的熟悉程度以及IRB将两项政策指南中的任何一项作为资源使用等因素相关。向从人类研究保护办公室获取的邮件列表中的所有IRB主席发送了一份简短调查问卷。调查问题包括用于未来生物样本采集的同意书是否涉及当前指南和立场声明中推荐的六项条款中的每一项,以及IRB在审议过程中是否使用了研究风险保护办公室1993年的《保护人类研究对象:机构审查委员会指南手册》第5章(以下简称《IRB指南手册》)或国家生物伦理咨询委员会1999年的《涉及人类生物材料的研究:伦理问题与政策指南》第一卷(以下简称《报告》)。尽管回复率较低(22%,427名受访者),但结果表明IRB的做法差异很大。研究发现,条款被纳入同意书的程度与每年审查更多方案的IRB、在审议中使用国家生物伦理咨询委员会《报告》的IRB以及同时参考《报告》和《IRB指南手册》的IRB呈正相关。