Tait Alan R, Voepel-Lewis Terri, Malviya Shobha
Department of Anesthesiology, University of Michigan Health Systems, Ann Arbor 48109, USA.
Anesthesiology. 2003 Mar;98(3):603-8. doi: 10.1097/00000542-200303000-00005.
Central to the tenet of informed consent is the quality of disclosure of information by the investigator and the understanding thereof by the research subject or his or her surrogate. This study was designed to measure parents' understanding of the elements of informed consent for clinical studies in which their children had been approached to participate.
The study sample consisted of 505 parents who had been approached for permission to allow their child to participate in a clinical anesthesia or surgery study. Regardless of whether the parent consented (consenters, n = 411) or declined (nonconsenters, n = 94) to their child's participation in a study, they were interviewed to determine their understanding of 11 elements of consent. Two independent assessors who were familiar with the study protocols scored the parents' levels of understanding.
Parents perceived their overall understanding of the elements of consent as high (8.7 +/- 1.6; 0-10 scale); however, this represented a significant overestimation compared with the assessors' measures of parental understanding (7.3 +/- 1.8; P< 0.0001). Furthermore, consenters had greater understanding than nonconsenters (7.6 +/- 1.6 vs 6.1 +/- 1.9; P< 0.001). Several predictors of understanding were identified, including whether the parent consented, education level, clarity of disclosure, child in previous study, age of parent, parent listened to disclosure, and degree to which parent read the consent document. The day on which consent was sought had no impact on the level of understanding.
Parents approached for permission to allow their child to participate in a research study had less than optimal understanding of the elements of consent. As such, investigators must make every effort to enhance understanding and ensure that parents have sufficient information to make informed decisions regarding their child's participation in research studies.
知情同意原则的核心是研究者披露信息的质量以及研究对象或其代理人对该信息的理解。本研究旨在衡量家长对其子女被邀请参与的临床研究中知情同意要素的理解情况。
研究样本包括505名被邀请允许其子女参与临床麻醉或手术研究的家长。无论家长是否同意（同意者，n = 411）或拒绝（不同意者，n = 94）其子女参与研究，均对他们进行访谈，以确定他们对11项同意要素的理解。两名熟悉研究方案的独立评估者对家长的理解水平进行评分。
家长认为他们对同意要素的总体理解程度较高（8.7±1.6；0 - 10分制）；然而，与评估者对家长理解程度的测量结果相比，这存在显著高估（7.3±1.8；P<0.0001）。此外，同意者的理解程度高于不同意者（7.6±1.6对6.1±1.9；P<0.001）。确定了几个理解程度的预测因素，包括家长是否同意、教育水平、披露的清晰度、子女是否参与过先前的研究、家长年龄、家长是否听取了披露内容以及家长阅读同意文件的程度。寻求同意的日期对理解程度没有影响。
被邀请允许其子女参与研究的家长对同意要素的理解并不理想。因此，研究者必须尽一切努力加强理解，并确保家长有足够的信息就其子女参与研究做出明智的决定。
