建立机构伦理委员会：挑战与解决方案——文献综述

Establishing institutional ethics committees: challenges and solutions - a review of the literature.

作者信息

Kuyare Mukta S, Taur Santosh R, Thatte Urmila M

机构信息

In-charge, Central Sterile Services Department (CSSD), Bhaktivedanta Hospital, Mira-Road (East), Thane, Mumbai, Maharashtra 401107.

Superspeciality Medical Officer, Department of Clinical Pharmacology, 5th Floor, "G" Building, TN Medical College and BYL Nair Charitable Hospital, Mumbai Central, Mumbai, Maharashtra 400 008 INDIA.

出版信息

Indian J Med Ethics. 2014 Jul-Sep;11(3):181-5. doi: 10.20529/IJME.2014.047.

DOI:10.20529/IJME.2014.047

PMID:25160969

Abstract

This review of the literature was conducted to identify the challenges faced while establishing institutional ethics committees (IECs) as well as to suggest some solutions. The search of the literature was carried out with the help of the PubMed search engine, using “research ethics committees” (MeSH] and “India” (MeSH]) as the key words for articles published between 2004 and 2012. We found 31 articles related to the topic, and the most common challenge mentioned was inappropriate functioning of IECs (n=17), followed by inappropriate structure (n=14). The authors identified many challenges related to the lack of oversight by regulatory bodies (n=14) as well as issues pertaining to the ethical training of IEC members and investigators (n=13). It is evident from the multitude of papers on the issue that the challenges related to the constitution and functioning of IECs must be given the attention they deserve to ensure that research participants in India are better protected.

摘要

进行此次文献综述是为了确定在建立机构伦理委员会（IECs）时所面临的挑战，并提出一些解决方案。借助PubMed搜索引擎，以“研究伦理委员会”（医学主题词）和“印度”（医学主题词）作为关键词，搜索2004年至2012年间发表的文章。我们找到了31篇与该主题相关的文章，其中提到的最常见挑战是IECs运作不当（n = 17），其次是结构不当（n = 14）。作者们确定了许多与监管机构缺乏监督相关的挑战（n = 14）以及与IEC成员和研究人员的伦理培训有关的问题（n = 13）。从关于该问题的大量论文中可以明显看出，必须对与IECs的组成和运作相关的挑战给予应有的关注，以确保印度的研究参与者得到更好的保护。