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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...

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Autores principales: Kaur, Ramandeep, Christopher, Ajay Francis, Gupta, Vikas, Bansal, Parveen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2017
Materias:
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.
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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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