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A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition
BACKGROUND: The composition of the Institutional Ethics Committee (IEC) with an equal respect plays a major role in evaluating research proposals to ensure the safety of the subjects and ethical quality of research project. It is mandatory that all research projects with an involvement of human subj...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Medknow Publications & Media Pvt Ltd
2017
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5384405/ https://www.ncbi.nlm.nih.gov/pubmed/28447019 http://dx.doi.org/10.4103/2229-3485.203041 |
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author | Kaur, Ramandeep Christopher, Ajay Francis Gupta, Vikas Bansal, Parveen |
author_facet | Kaur, Ramandeep Christopher, Ajay Francis Gupta, Vikas Bansal, Parveen |
author_sort | Kaur, Ramandeep |
collection | PubMed |
description | BACKGROUND: The composition of the Institutional Ethics Committee (IEC) with an equal respect plays a major role in evaluating research proposals to ensure the safety of the subjects and ethical quality of research project. It is mandatory that all research projects with an involvement of human subjects should be approved by the IEC before commencement. AIM: To find out the equality of respect to members of IEC irrespective of nature of their profession. MATERIALS AND METHODS: Methods include a cross-sectional study, the general information and member composition, multidisciplinary nature, independent performance, competence, decision capability, professionally biased of IECs in health research institutions of Punjab, India. A structured self-administered questionnaire was developed and provided to all health/research institutions providing the graduate/postgraduate education in medical sciences under the jurisdiction of Baba Farid University of Health Sciences, Faridkot, Punjab, India. RESULTS: Of the total 142 institutes, only 80 (56% response rate) institutes responded to the questionnaire. Of the 80 institutes which responded, 65 institutes (81.25%) had IEC, while 15 (18.75%) institutes lacked IEC. The compositions of only 22% IECs were in compliance to Drug Controller General of India (DCGI) guidelines and only nine (14%) institutes of the state of Punjab had approval from the DCGI. CONCLUSION: Study clearly indicates the carelessness of regulatory bodies and lack of fair practices toward constitution of the IEC. The ratio of nonscientific members (ethicist, philosopher, and layperson) in the IEC composition was incredibly low. This study also reveals the professionally biased and noncompliance with schedule Y guideline in relation to the representation of lawyers, ethicists, and nonscientific members. |
format | Online Article Text |
id | pubmed-5384405 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-53844052017-04-26 A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition Kaur, Ramandeep Christopher, Ajay Francis Gupta, Vikas Bansal, Parveen Perspect Clin Res Original Article BACKGROUND: The composition of the Institutional Ethics Committee (IEC) with an equal respect plays a major role in evaluating research proposals to ensure the safety of the subjects and ethical quality of research project. It is mandatory that all research projects with an involvement of human subjects should be approved by the IEC before commencement. AIM: To find out the equality of respect to members of IEC irrespective of nature of their profession. MATERIALS AND METHODS: Methods include a cross-sectional study, the general information and member composition, multidisciplinary nature, independent performance, competence, decision capability, professionally biased of IECs in health research institutions of Punjab, India. A structured self-administered questionnaire was developed and provided to all health/research institutions providing the graduate/postgraduate education in medical sciences under the jurisdiction of Baba Farid University of Health Sciences, Faridkot, Punjab, India. RESULTS: Of the total 142 institutes, only 80 (56% response rate) institutes responded to the questionnaire. Of the 80 institutes which responded, 65 institutes (81.25%) had IEC, while 15 (18.75%) institutes lacked IEC. The compositions of only 22% IECs were in compliance to Drug Controller General of India (DCGI) guidelines and only nine (14%) institutes of the state of Punjab had approval from the DCGI. CONCLUSION: Study clearly indicates the carelessness of regulatory bodies and lack of fair practices toward constitution of the IEC. The ratio of nonscientific members (ethicist, philosopher, and layperson) in the IEC composition was incredibly low. This study also reveals the professionally biased and noncompliance with schedule Y guideline in relation to the representation of lawyers, ethicists, and nonscientific members. Medknow Publications & Media Pvt Ltd 2017 /pmc/articles/PMC5384405/ /pubmed/28447019 http://dx.doi.org/10.4103/2229-3485.203041 Text en Copyright: © 2017 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-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. |
spellingShingle | Original Article Kaur, Ramandeep Christopher, Ajay Francis Gupta, Vikas Bansal, Parveen A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition |
title | A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition |
title_full | A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition |
title_fullStr | A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition |
title_full_unstemmed | A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition |
title_short | A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition |
title_sort | cross-sectional study: need of equal respect for all professionals in the institutional ethics committees' composition |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5384405/ https://www.ncbi.nlm.nih.gov/pubmed/28447019 http://dx.doi.org/10.4103/2229-3485.203041 |
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