National Research Center , Dokki, Giza , Egypt.
Curr Med Res Opin. 2013 Oct;29(10):1411-7. doi: 10.1185/03007995.2013.815158. Epub 2013 Jul 10.
Globally, ethical issues in research are becoming of major importance, being well established in developed countries with little information about research ethics committees (RECs) in Africa to assess whether these committees are actually improving the protection of human research participants.
OBJECTIVE/AIM: To describe the establishment, structure, function, operations and outcome of the Medical Research Ethics Committee (MREC) of the National Research Center (NRC) of Egypt from 2003 to 2011.
The committee established its regulatory rules for human and animal research ethics based on the Declaration of Helsinki 2000-2008 and WHO regulations 2000-2011.
There were 974 protocols revised in the 7 years (2005-2011). The outcome of the committee discussions was to clear 262 of the protocols without conditions. A full 556 were cleared conditionally upon completion of modifications. Another 118 were deferred pending action and further consideration at a subsequent meeting. And 16 researchers did not reply, while 22 protocols were rejected.
Since 2005, the MREC in NRC Egypt has built up considerable experience of evaluating the ethical issues arising within the field of medical research.
在全球范围内,研究中的伦理问题变得越来越重要,在发达国家已经得到很好的建立,但非洲的研究伦理委员会(REC)的相关信息很少,无法评估这些委员会是否实际上改善了对人类研究参与者的保护。
目的/目标:描述埃及国家研究中心(NRC)医学研究伦理委员会(MREC)从 2003 年到 2011 年的设立、结构、功能、运作和结果。
委员会根据 2000-2008 年《赫尔辛基宣言》和 2000-2011 年世卫组织的规定制定了人类和动物研究伦理的监管规则。
在 7 年(2005-2011 年)期间,共修订了 974 项方案。委员会讨论的结果是无条件批准了 262 项方案。另外 556 项在完成修改后有条件地获得批准。还有 118 项被推迟,等待在随后的会议上采取进一步行动和审议。有 16 名研究人员未回复,22 项方案被拒绝。
自 2005 年以来,埃及 NRC 的 MREC 在评估医学研究领域出现的伦理问题方面积累了相当多的经验。