印度的伦理委员会与临床试验注册：机遇、义务、挑战及解决方案

Ethics committees and clinical trials registration in India: opportunities, obligations, challenges and solutions.

作者信息

Tharyan Prathap

机构信息

South Asian Cochrane Network, Christian Medical College, Vellore 632 002, Tamil Nadu, India.

出版信息

Indian J Med Ethics. 2007 Oct-Dec;4(4):168-9. doi: 10.20529/IJME.2007.066.

DOI:10.20529/IJME.2007.066

PMID:18630235

Abstract

Registering clinical trials is considered an ethical and moral imperative. The launch of the Clinical Trials Registry-India provides opportunities to all in India to fulfil this imperative. The CTRI requires prospective registration, disclosure of all 20 items in the WHO Trial Registration Data Set and proof of ethics and regulatory clearances. Registration in the CTRI is voluntary. However, institutional research ethics committees have obligations. This article reviews these obligations and provides an example of how this can be achieved.

摘要

注册临床试验被视为一项伦理和道德义务。印度临床试验注册中心的启动为印度所有人提供了履行这一义务的机会。印度临床试验注册中心要求进行前瞻性注册，披露世界卫生组织试验注册数据集的所有20项内容，并提供伦理和监管批准证明。在印度临床试验注册中心注册是自愿的。然而，机构研究伦理委员会负有义务。本文回顾了这些义务，并提供了一个如何实现这些义务的示例。