Question:
医学院的学生和研究者的家属属于弱势群体,能否参与临床试验呢?GCP要求对弱势群体需要加以特别的保护,如何体现进行了特殊保护呢?
Answer:
Definition of Vulnerable subjects can refer to ICH GCP R2 1.61 (including hierarchy relationship). 不过这个问题是说弱势群体能否参加临床试验,及如何体现特殊保护。
GCP 没有禁止弱势群体参加试验,对于弱势群体的保护,是IRB 职责的一部分,ICH GCP 3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.