Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

<p>Abstract</p> <p>Background</p> <p>International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethic...

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Main Authors: Siriwardhana Chesmal, Athukorale Manjula, Lekamwattage Manura, Hewege Suwin, Siribaddana Sisira, Sumathipala Athula, Murray Joanna, Prince Martin
Format: Article
Language:English
Published: BMC 2008-02-01
Series:BMC Medical Ethics
Online Access:http://www.biomedcentral.com/1472-6939/9/3
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author Siriwardhana Chesmal
Athukorale Manjula
Lekamwattage Manura
Hewege Suwin
Siribaddana Sisira
Sumathipala Athula
Murray Joanna
Prince Martin
author_facet Siriwardhana Chesmal
Athukorale Manjula
Lekamwattage Manura
Hewege Suwin
Siribaddana Sisira
Sumathipala Athula
Murray Joanna
Prince Martin
author_sort Siriwardhana Chesmal
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.</p> <p>Methods</p> <p>We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.</p> <p>Results</p> <p>Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.</p> <p>Conclusion</p> <p>Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.</p>
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spelling doaj.art-1343bf3cff6e453b8ea3ff85ae23527a2022-12-22T03:07:50ZengBMCBMC Medical Ethics1472-69392008-02-0191310.1186/1472-6939-9-3Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri LankaSiriwardhana ChesmalAthukorale ManjulaLekamwattage ManuraHewege SuwinSiribaddana SisiraSumathipala AthulaMurray JoannaPrince Martin<p>Abstract</p> <p>Background</p> <p>International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.</p> <p>Methods</p> <p>We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.</p> <p>Results</p> <p>Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.</p> <p>Conclusion</p> <p>Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.</p>http://www.biomedcentral.com/1472-6939/9/3
spellingShingle Siriwardhana Chesmal
Athukorale Manjula
Lekamwattage Manura
Hewege Suwin
Siribaddana Sisira
Sumathipala Athula
Murray Joanna
Prince Martin
Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka
BMC Medical Ethics
title Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka
title_full Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka
title_fullStr Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka
title_full_unstemmed Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka
title_short Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka
title_sort ethics review committee approval and informed consent an analysis of biomedical publications originating from sri lanka
url http://www.biomedcentral.com/1472-6939/9/3
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