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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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2014-01-01
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| Series: | Perspectives in Clinical Research |
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| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2014;volume=5;issue=2;spage=66;epage=70;aulast=Walanj |
| _version_ | 1819292397432995840 |
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| author | Aparna Sanjiv Walanj |
| author_facet | Aparna Sanjiv Walanj |
| author_sort | Aparna Sanjiv Walanj |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-24T03:53:53Z |
| format | Article |
| id | doaj.art-5572068454b5421fb6be9c3cfe121bf1 |
| institution | Directory Open Access Journal |
| issn | 2229-3485 |
| language | English |
| last_indexed | 2024-12-24T03:53:53Z |
| publishDate | 2014-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj.art-5572068454b5421fb6be9c3cfe121bf12022-12-21T17:16:30ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852014-01-0152667010.4103/2229-3485.128022Research ethics committees: Need for harmonization at the national level, the global and Indian perspectiveAparna Sanjiv WalanjEthics 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.http://www.picronline.org/article.asp?issn=2229-3485;year=2014;volume=5;issue=2;spage=66;epage=70;aulast=WalanjAccreditationcentral reviewethics committeesharmonizationregistration |
| spellingShingle | Aparna Sanjiv Walanj Research ethics committees: Need for harmonization at the national level, the global and Indian perspective Perspectives in Clinical Research Accreditation central review ethics committees harmonization registration |
| 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 | Accreditation central review ethics committees harmonization registration |
| url | http://www.picronline.org/article.asp?issn=2229-3485;year=2014;volume=5;issue=2;spage=66;epage=70;aulast=Walanj |
| work_keys_str_mv | AT aparnasanjivwalanj researchethicscommitteesneedforharmonizationatthenationalleveltheglobalandindianperspective |