药物临床试验容许性的刑法逻辑及限度

The Criminal-law Logic and Limits of Permissibility for Clinical Drug Trials

药物临床试验存在利害悖论,但医学的发展离不开药物临床试验,应当对其采取附条件允许的法律规制模式。关于药物临床试验刑法容许性的法理逻辑,科研自由难以优越于受试者的健康权或生命权,“科研自由论”显然不妥。“受试者承诺”的效力范围有限,无法使所有类型的药物临床试验正当化。“衡量理论”强调客观利益衡量,有悖于当下普遍认可的尊重患者自我决定权的思想。“被容许的风险理论”指出了正确的方向,但无法提供具体的判断基准。药物临床试验的容许根据及限度应当通过“正当业务行为论”予以判断。药物临床试验成为正当业务行为的要件是“医学正当性”和“受试者知情同意”。医学正当性属于客观判断要素,符合此要件可以减少试验行为的结果无价值,而具有受试者知情同意则可以减少试验行为的行为无价值。符合这两个要件的药物临床试验,即使不幸导致受试者出现伤亡的后果,作为正当业务行为也可阻却违法性,实现正当化。

There exists Stake Paradox in the Clinical Drugs Trials(CDT),the medical science cannot be developed without CDT,thus the mode of legal regulation of conditional permissionshould be adopted.Regarding the jurisprudential logic on the permissibility for CDT in the criminal law,"Theory of Freedom to Scientific Research"is obviously improper for the freedom to scientific research should not be prioritized over the trail subjects’rights to health or life."Theory of Trial Subjects'Promise"has limitation on its scope of effectiveness,failing to justify all types of CDT."Balancing Theory"puts emphasis on objective measurement of interests,which clashes with the thought of respecting patients’right of self-determination common recognized nowadays."Theory of Permitted Risks"indicates the correct direction but fails to provide any concrete decision-making criteria.The foundation and limits of permissibility for CDT should be decided through"Theory of Legitimate Professional Conduct Theory".The elements for CDT to qualify a justifiable professional conduct are"Medical justification"and"Informed Consent of Trial Subjects".The former is an objective decision-making criterion,the satisfaction of which may reduce unlawfulness in the consequence of the trial,while obtaining the informed consent of trial subjects may reduce the unlawfulness in the conduct of the trial.The CDT satisfying the two elements can achieve justification by excluding unlawfulness as a justifiable professional conduct even it causes the consequence of injury or death to the trial subjects.