[摘要]罕见病又称孤儿病，治疗罕见病的药物亦称孤儿药。药物临床试验是孤儿药研发上市的重要途径。鉴于罕见病患者特殊的病理特征和我国孤儿药可及性差的困境，伦理审查既是保障孤儿药临床试验受试者权益的重要手段，又是指导孤儿药临床试验规范操作的道德规范。本文对孤儿药临床试验方案、知情同意、隐私保护等方面的伦理保护进行探讨，以期提高对孤儿药临床试验伦理审查重要性的认识和关注。

    [关键词]罕见病；孤儿药；临床试验；伦理保护

    [中图分类号] R052 [文献标识码] A [文章编号] 1674-4721(2017)12(b)-0171-03

    [Abstract]Rare diseases are also known as orphan diseases，so drugs for rare diseases are also called orphan drugs.Drugs clinical trial is the prerequisite to the research of orphan drugs before they appear on the market.In view of the pathological characteristics of rare diseases patients and the inaccessibility of orphan drugs in China ......