Regulations on Human Trials Article 4
The trial conductor referred to in the preceding article shall possess the following qualifications:1. being a licensed physician, dentist, or traditional Chinese medicine physician with five (5) or more years of experience in clinical treatment.2. having received human trial related training of more than thirty (30) hours within the past six (6) years; being the trial conductor in Human Trials of somatic cells or gene therapy with additional five (5) or more hours of relevant training.3. taking medical ethics related courses for more than nine (9) hours within the past six (6) years.Those who have been subject to physician disciplinary or whose licenses have been suspended for more than one (1) month or abolished due to any violation of laws and regulations related to Human Trials shall not serve as a trial conductor.
中文原文 人體試驗管理辦法第4條
前條之主持人應具下列資格：
一、領有執業執照並從事臨床醫療五年以上之醫師、牙醫師或中醫師。
二、最近六年曾受人體試驗相關訓練三十小時以上；於體細胞或基因治療人體試驗之主持人，另加五小時以上之有關訓練。
三、最近六年研習醫學倫理相關課程九小時以上。
曾受醫師懲戒處分，或因違反人體試驗相關規定，受停業一個月以上或廢止執業執照處分者，不得擔任主持人。
一、領有執業執照並從事臨床醫療五年以上之醫師、牙醫師或中醫師。
二、最近六年曾受人體試驗相關訓練三十小時以上；於體細胞或基因治療人體試驗之主持人，另加五小時以上之有關訓練。
三、最近六年研習醫學倫理相關課程九小時以上。
曾受醫師懲戒處分，或因違反人體試驗相關規定，受停業一個月以上或廢止執業執照處分者，不得擔任主持人。