论医学伦理审查委员会对受试者权益的保护

Medical Ethics Review Committee's Protection of the Right and Interest of Subjects

作为科研项目事前审查机构的医学伦理审查委员会对于保护受试者权益具有独特的价值。目前医学伦理审查委员会存在独立性不够、缺乏监督、缺少标准化流程的缺陷,为保护受试者的权益,建议医学伦理审查委员会实行法人化,对医学伦理审查委员会实行行政许可制度,建立有效的监督与救济。

Medical Ethics Review Committee,informed consent form,and strict liability can be called three carriages to protect rights and interests of the subjects.As a prior review agency of research projects,Medical Ethics Review Committee has a unique value to protect rights and interests of the subjects.Currently the defects of Medical Ethics Review Committee are lack of independence,lack of supervision and lack of standardized process.To protect the rights of subjects,Medical Ethics Review Committee should be established as a Corporation,as an administrative licensing system of implementation,and as an effective monitoring and remedy system.