涉及病历记录及生物标本研究的伦理审查问题

Ethical Review of Research Involving Medical Records or Biospecimens

介绍了针对涉及病历记录及生物标本研究的伦理审查的不同方式,并对相关定义进行了说明,对是否属于涉及人的研究进行了分析。在此基础上提出,为了合理地保护受试者的权益,同时又不给研究者和伦理委员会自身增加不必要的负担,根据国际上的相关做法,可以基于研究的风险大小,对涉及病历记录或生物标本的研究,采取免除伦理审查与快速审查不同的伦理审查与管理方式。

In this paper,different modes and related concepts of ethical review of research involving medical records or biospecimens has been covered and if it is belongs to study involving human was also discussed.In accordance with the international practice,this paper proposed to apply exemption of review or expedited review to research involving medical records or biospecimens based on risk of the specific research,with the purpose of protecring human subjects properly,meanwhile lessen the burden for researchers and IRBs themselves.