论“非法人体试验罪”的设立

On Establishment of a New Crime of Illegal Human Experiment

人体试验造成被试者死亡或伤残的情形屡见不鲜,但相关法规很不健全。从主、客观统一的角度出发,结合生命伦理原则及对人体试验的宽容和法益保护平衡原则,建议确定以下三种行为构成非法人体试验罪:未通过试验前的审批或者以欺骗的方法获得审批的,无论其是否取得被试者的同意,只要造成了轻伤以上的结果或者将被试者陷于异常危险之中的;已经通过人体试验的审批,也取得了被试者同意,但损害结果超出了被试者同意的范围,且造成了被试者重伤或者死亡的,该超出的结果为试验人应该预见而没有预见到的;已经通过人体试验的审批,但未取得被试者同意,造成被试者重伤或者死亡结果的。

More than 800 new drugs have been used in human experiment each year. Because of the lack of relevant legal regulations, numerous people＇s life was deprived and health interests were damaged. So it＇s necessary to study human experiment and some basic issues as ethical control. Three kinds of actions should be regarded as the crime of illegal human experiment according to the unification of objectivity and subjectivity principle as well as the principle of bioethics, lenient principle and balance of legal interest protection. First, for those human experiments that were not approved before the test or using the way of cheating, no matter the experiments obtained the consent of the subjects or not, they should be regarded as the crime of illegal human experiment only if these experiments caused minor injuries to subjects or even worse, or pushec[ the subjects into a special danger. Second, for those human experiments that have already been approved and obtained the consent of the subjects, if they caused serious injury or even death which were beyond the subjects＇ consent, and the damage were what the actors could predict but did not, the actions should be regarded as the crime of illegal human experiment. Third, for those human experiments that have already been approved, but did not obtain the consent of the subjects, if these experiments caused serious injury to subjects or even death, they also should be regarded as the crime of illegal human experiment.