[关键词]
[摘要]
论述《临床试验中对受试者疼痛管理的伦理考虑》的起草背景、制定依据和适用范围,以及临床试验中疼痛的主要来源,临床试验中对受试者疼痛管理的伦理一般考虑和临床试验中试验操作程序引起的受试者疼痛等负担的伦理考虑等,以期从伦理角度对临床试验中受试者疼痛管理提出指导意见。适用于伦理审查中对于受试者疼痛管理的伦理考虑,以及研究者制定临床试验方案和试验流程对受试者疼痛管理的关注。对临床试验中受试者疼痛予以更多关注,是保护受试者权益的措施之一,有助于保障临床试验顺利开展。
[Key word]
[Abstract]
Mainly discusses the drafting background, basis and the applicable scope of Ethical considerations for subject pain management in clinical trials, as well as the main source of pain in clinical trials, the general ethical considerations for subject pain management in clinical trials and ethical considerations for subjects pain caused by some test operation procedures in clinical trials, in order to provide guidance for the pain management of subjects in clinical trials from an ethical perspective. It is applicable to the ethical consideration of subject pain management in the ethical review, as well as the attention of researchers to subject pain management in the development of clinical trial protocol and trial procedure. Paying more attention to subjects' pain in clinical trials is one of the measures to protect subjects' rights and interests, which helps to ensure the smooth development of clinical trials.
[中图分类号]
R926
[基金项目]
国家“十三五”重大新药创制专项课题(2019ZX09734001)