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Perspect Clin Res. 2014 Apr;5(2):66-70. doi: 10.4103/2229-3485.128022.

Research ethics committees: Need for harmonization at the national level, the global and Indian perspective.

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1
Clinical Research Department Head, Ethika Clinical Research Center, Prakruti Hospital, Thane, Maharashtra, India.

Abstract

Ethics committee (EC) organization and standardization is an important aspect of clinical research. There is a healthy trend worldwide to register and/or accredit research ECs reviewing clinical research. This article tries to focus on the existing model of ECs worldwide, as against the Indian backdrop. The article reviews literature, journals, websites, and studies conducted in 10 different countries and outlines the working model of ECs in these countries. The challenges faced during the ethical review, especially in case of multicenter trials, have been identified. A solution has been suggested to overcome these challenges, and to ensure the overall smooth functioning of clinical trials. The article proposes the development of national and regional central ECs to counter the current drawbacks in the ethical review mechanisms in India.

KEYWORDS:

Accreditation; central review; ethics committees; harmonization; registration

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