論述《臨床試驗中對受試者疼痛管理的倫理考慮》的起草背景、制定依據(jù)和適用范圍，以及臨床試驗中疼痛的主要來源，臨床試驗中對受試者疼痛管理的倫理一般考慮和臨床試驗中試驗操作程序引起的受試者疼痛等負(fù)擔(dān)的倫理考慮等，以期從倫理角度對臨床試驗中受試者疼痛管理提出指導(dǎo)意見。適用于倫理審查中對于受試者疼痛管理的倫理考慮，以及研究者制定臨床試驗方案和試驗流程對受試者疼痛管理的關(guān)注。對臨床試驗中受試者疼痛予以更多關(guān)注，是保護(hù)受試者權(quán)益的措施之一，有助于保障臨床試驗順利開展。

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.

R926

國家“十三五”重大新藥創(chuàng)制專項課題（2019ZX09734001）