CRC養成のための模擬患者によるインフォームド・コンセント研修の試み

抄録

Background: From the aspect of biomedical ethics, informed consent is essential for the participant's protection in clinical trials. Informed consent is a process of information disclosure, confirming the participant's understanding and autonomy-driven consent. As a medical professional, a clinical research coordinator (CRC) should possess training in communication skills for supporting the participants' decision-making processes. We conducted informed consent training with simulated patients (SP) for CRC trainees, and evaluated its usefulness as an educational tool.
Methods: Eight new CRC trainees participated in the training between 2003 and 2004. Before the training, all trainees were given an arranged informed consent form of the trial, and they prepared for the interview portion of the training. The trainees explained the trial's content and answered the questions of SP in 20 minutes. Ten items were evaluated for an assessment of basic communication skills by the trainees themselves, SP, and the instructor. This evaluation was scaled at four performance levels (4: excellent, 3: performed well, 2: poor, 1: under-performance).
Results: The average of the total scores evaluated by SP or the instructor was favorably high (34 points), whereas trainees evaluated themselves at a lower average (27 points). Among the items, trainee achievement tended to be lower in the understandable explanation of technical terms and the appropriate behavioral approach to the participant's anxiety.
Conclusions: The informed consent training with SP for CRC trainees is considered to be a useful tool as an evaluation of communication skills of CRC trainees, and when this training is repeated it can be expected to improve the skills of CRC trainees.