When human subjects withdraw from clinical research, or they are terminated to participate by investigator, whether the investigator can use, study, or analyze the already collected data about the subject, orthe investigator continue to obtain data about the subject, At present our country still lack of related laws and regulations about this issues. This paper refered to the related guidelines in USA, prosed the following suggestions; drug clinical trials manged by the food and drug supervision and administration may not destroy the data; in scientific research subject study, researchers should think ahead this problem, the research approach and informed consent to make the corresponding provisions. Researchers can think about this according to the effectiveness of study, decide to agree or not the subjects'requirements of not using data, prior to inform, get the consent of the participants.%临床研究过程中受试者退出研究,研究者是否可以对已经采集的数据进行分析使用、甚至是否可以继续采集受试者的数据,目前我国尚缺乏相关法规条例对此问题进行规定,作者参考美国相关指南规定,提出如下建议:食品药品监督管理局管理的药物临床试验不得销毁已经采集的数据；科研课题研究,研究者应事先考虑到该问题,在研究方案和知情同意书中做出相应规定.研究者可以根据研究有效性的考虑,决定是否同意受试者不使用数据的要求,事先告知,征得受试者的同意后再入组.
展开▼
