Informed consent in Sri Lanka: A survey among ethics committee members
<p>Abstract</p> <p>Background</p> <p>Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.</p> <p>However, capacity for ethics review is no...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2008-05-01
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| Series: | BMC Medical Ethics |
| Online Access: | http://www.biomedcentral.com/1472-6939/9/10 |
| _version_ | 1818116249279791104 |
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| author | Siriwardhana Chesmal Athukorale Manjula Lekamwattage Manura Hewage Suwin Siribaddana Sisira Sumathipala Athula Murray Joanna Prince Martin |
| author_facet | Siriwardhana Chesmal Athukorale Manjula Lekamwattage Manura Hewage Suwin Siribaddana Sisira Sumathipala Athula Murray Joanna Prince Martin |
| author_sort | Siriwardhana Chesmal |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.</p> <p>However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.</p> <p>Methods</p> <p>We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.</p> <p>Results</p> <p>Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form.</p> <p>The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.</p> <p>Conclusion</p> <p>The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.</p> |
| first_indexed | 2024-12-11T04:19:31Z |
| format | Article |
| id | doaj.art-413f929a37564e04ba5ca62716354ad2 |
| institution | Directory Open Access Journal |
| issn | 1472-6939 |
| language | English |
| last_indexed | 2024-12-11T04:19:31Z |
| publishDate | 2008-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Ethics |
| spelling | doaj.art-413f929a37564e04ba5ca62716354ad22022-12-22T01:21:09ZengBMCBMC Medical Ethics1472-69392008-05-01911010.1186/1472-6939-9-10Informed consent in Sri Lanka: A survey among ethics committee membersSiriwardhana ChesmalAthukorale ManjulaLekamwattage ManuraHewage SuwinSiribaddana SisiraSumathipala AthulaMurray JoannaPrince Martin<p>Abstract</p> <p>Background</p> <p>Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.</p> <p>However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.</p> <p>Methods</p> <p>We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.</p> <p>Results</p> <p>Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form.</p> <p>The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.</p> <p>Conclusion</p> <p>The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.</p>http://www.biomedcentral.com/1472-6939/9/10 |
| spellingShingle | Siriwardhana Chesmal Athukorale Manjula Lekamwattage Manura Hewage Suwin Siribaddana Sisira Sumathipala Athula Murray Joanna Prince Martin Informed consent in Sri Lanka: A survey among ethics committee members BMC Medical Ethics |
| title | Informed consent in Sri Lanka: A survey among ethics committee members |
| title_full | Informed consent in Sri Lanka: A survey among ethics committee members |
| title_fullStr | Informed consent in Sri Lanka: A survey among ethics committee members |
| title_full_unstemmed | Informed consent in Sri Lanka: A survey among ethics committee members |
| title_short | Informed consent in Sri Lanka: A survey among ethics committee members |
| title_sort | informed consent in sri lanka a survey among ethics committee members |
| url | http://www.biomedcentral.com/1472-6939/9/10 |
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