药物在临床前及临床试验研究中的伦理问题综述

Review of Ethical Issues in the Preclinical and Clinical Trial of Drug

在药物研发的不同研究阶段面临的医学伦理学问题不同。在药物临床前试验阶段,实验动物是不可缺少的,医学动物伦理委员会需要审批和监管实验过程中动物使用是否坚持动物保护原则、动物福利原则和伦理原则。在药物进入临床试验阶段后,药物的受试者为人,医学伦理委员会要充分考虑到试验过程中特殊药物、特殊人群及疾病等因素产生的伦理学问题,制定详细且切实可行的条款,从而保障试验的科学性及受试者的权益,促进新药研发并与国际标准接轨。

The ethical issues are different at different research stages of drug discovery. At the preclinical trial phase, laboratory animals are indispensable. The medical animal ethics committees need to approve and supervise animal testing during the experiment whether it adheres to the principles of animal protection, animal welfare prin- ciples and ethical principles. At the phase of clinical trials, the subject of drug is human. The medical ethics com- mittee should take full account of the ethical issues arising from the special medicine, special populations and dis- ease in the process of trial and formulate detailed and feasible clauses, thus to ensure the scientificity of the trial and the rights and interests of subjects and promote new drug discovery and integrate with international standards.