Tait A R, Voepel-Lewis T, Siewert M, Malviya S
Department of Anesthesiology, University of Michigan Medical Center, Ann Arbor, USA.
Anesth Analg. 1998 Jan;86(1):50-3. doi: 10.1097/00000539-199801000-00010.
There is concern that the environment in which consent for anesthesia research is sought may be coercive. We therefore designed this study to determine the factors that parents consider in consenting to their child's participation in clinical anesthesia research. The study sample consisted of 246 parents who had been approached for permission to allow their child to participate in a clinical anesthesia study. Parents were asked to complete a questionnaire detailing the reasons for their decision to consent or decline their child's participation. There were no differences in the demographics of the consenters (n = 168) and nonconsenters (n = 78). Perceived risk and the importance of the study were the primary factors in the parents' decisions to consent or decline. Only 2.8% of nonconsenters strongly considered a lack of privacy as a deciding factor; 15.3% stated that they had insufficient time in which to make a decision, and 0% reported having felt pressured. Furthermore, only 3.1% of consenters strongly considered an obligation to consent. Results of this survey highlight factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research. We hope that this information will be important to researchers in providing an appropriate environment for obtaining consent for clinical anesthesia research studies.
Parents who are approached for permission for their child to participate in a research study must be fully informed and under no pressure to consent. This study describes factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research.
有人担心寻求麻醉研究同意的环境可能具有强制性。因此，我们设计了这项研究，以确定父母在同意孩子参与临床麻醉研究时所考虑的因素。研究样本包括246名被询问是否允许其孩子参与临床麻醉研究的父母。父母们被要求填写一份问卷，详细说明他们决定同意或拒绝孩子参与的原因。同意者（n = 168）和不同意者（n = 78）的人口统计学特征没有差异。感知到的风险和研究的重要性是父母决定同意或拒绝的主要因素。只有2.8%的不同意者强烈认为缺乏隐私是一个决定性因素；15.3%的人表示他们没有足够的时间做出决定，0%的人报告感到有压力。此外，只有3.1%的同意者强烈认为有同意的义务。这项调查的结果突出了影响父母决定同意孩子参与临床麻醉研究的因素。我们希望这些信息对研究人员在为临床麻醉研究获得同意提供合适环境方面具有重要意义。
被询问是否允许孩子参与研究的父母必须得到充分的信息，且在同意方面没有压力。这项研究描述了影响父母决定同意孩子参与临床麻醉研究的因素。
