Subject/Trial Subject :An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
对象/试验对象/受试者:参加一个临床试验,作为试验药品的接受者或作为对照的个人。
通俗解释:就是自主参加临床试验的志愿者,包括健康人、患者
弱势受试者Vulnerable Subjects:Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
指参加临床试验的个人,但其自愿参加临床试验的意愿,被预期不适当的影响了,例如被试验的获益吸引或者拒绝参加可能被上级报复。
简单来说,临床试验为了避嫌,应避免招募医院、医药公司的员工、纯粹被高额经济利益吸引的受试者、文盲人士、未成年人
许多人担心参加临床试验就相当于白老鼠任人宰割,其实这是非常错误的
在我国的临床试验法律、法规中,对临床试验受试者的安全保护始终贯穿其中