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Ethics Committees: Structure, Roles, and Issues

An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmalefice...

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Autores principales: Mehta, Pankti, Zimba, Olena, Gasparyan, Armen Yuri, Seiil, Birzhan, Yessirkepov, Marlen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Academy of Medical Sciences 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10293659/
https://www.ncbi.nlm.nih.gov/pubmed/37365729
http://dx.doi.org/10.3346/jkms.2023.38.e198
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author Mehta, Pankti
Zimba, Olena
Gasparyan, Armen Yuri
Seiil, Birzhan
Yessirkepov, Marlen
author_facet Mehta, Pankti
Zimba, Olena
Gasparyan, Armen Yuri
Seiil, Birzhan
Yessirkepov, Marlen
author_sort Mehta, Pankti
collection PubMed
description An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It’s pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.
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spelling pubmed-102936592023-06-28 Ethics Committees: Structure, Roles, and Issues Mehta, Pankti Zimba, Olena Gasparyan, Armen Yuri Seiil, Birzhan Yessirkepov, Marlen J Korean Med Sci Review Article An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It’s pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study. The Korean Academy of Medical Sciences 2023-05-30 /pmc/articles/PMC10293659/ /pubmed/37365729 http://dx.doi.org/10.3346/jkms.2023.38.e198 Text en © 2023 The Korean Academy of Medical Sciences. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Review Article
Mehta, Pankti
Zimba, Olena
Gasparyan, Armen Yuri
Seiil, Birzhan
Yessirkepov, Marlen
Ethics Committees: Structure, Roles, and Issues
title Ethics Committees: Structure, Roles, and Issues
title_full Ethics Committees: Structure, Roles, and Issues
title_fullStr Ethics Committees: Structure, Roles, and Issues
title_full_unstemmed Ethics Committees: Structure, Roles, and Issues
title_short Ethics Committees: Structure, Roles, and Issues
title_sort ethics committees: structure, roles, and issues
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10293659/
https://www.ncbi.nlm.nih.gov/pubmed/37365729
http://dx.doi.org/10.3346/jkms.2023.38.e198
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