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Research ethics committees: Need for harmonization at the national level, the global and Indian perspective
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 backd...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Medknow Publications & Media Pvt Ltd
2014
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3980546/ https://www.ncbi.nlm.nih.gov/pubmed/24741482 http://dx.doi.org/10.4103/2229-3485.128022 |
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author | Walanj, Aparna Sanjiv |
author_facet | Walanj, Aparna Sanjiv |
author_sort | Walanj, Aparna Sanjiv |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-3980546 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-39805462014-04-16 Research ethics committees: Need for harmonization at the national level, the global and Indian perspective Walanj, Aparna Sanjiv Perspect Clin Res Ethics 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. Medknow Publications & Media Pvt Ltd 2014 /pmc/articles/PMC3980546/ /pubmed/24741482 http://dx.doi.org/10.4103/2229-3485.128022 Text en Copyright: © Perspectives in Clinical Research http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Ethics Walanj, Aparna Sanjiv Research ethics committees: Need for harmonization at the national level, the global and Indian perspective |
title | Research ethics committees: Need for harmonization at the national level, the global and Indian perspective |
title_full | Research ethics committees: Need for harmonization at the national level, the global and Indian perspective |
title_fullStr | Research ethics committees: Need for harmonization at the national level, the global and Indian perspective |
title_full_unstemmed | Research ethics committees: Need for harmonization at the national level, the global and Indian perspective |
title_short | Research ethics committees: Need for harmonization at the national level, the global and Indian perspective |
title_sort | research ethics committees: need for harmonization at the national level, the global and indian perspective |
topic | Ethics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3980546/ https://www.ncbi.nlm.nih.gov/pubmed/24741482 http://dx.doi.org/10.4103/2229-3485.128022 |
work_keys_str_mv | AT walanjaparnasanjiv researchethicscommitteesneedforharmonizationatthenationalleveltheglobalandindianperspective |