Ethics Committees: Structure, Roles, and Issues

被引:15
作者
Mehta, Pankti [1 ,8 ]
Zimba, Olena [2 ,3 ,4 ]
Gasparyan, Armen Yuri [5 ,6 ]
Seiil, Birzhan [7 ]
Yessirkepov, Marlen [7 ]
机构
[1] King Georges Med Univ, Dept Clin Immunol & Rheumatol, Lucknow, India
[2] Univ Hosp Krakow, Dept Clin Rheumatol & Immunol, Krakow, Poland
[3] Natl Inst Geriatr, Rheumatol & Rehabil, Warsaw, Poland
[4] Danylo Halytsky Lviv Natl Med Univ, Dept Internal Med N2, Lvov, Ukraine
[5] Teaching Trust Univ Birmingham, Russells Hall Hosp, Dudley Grp NHS Fdn Trust, Dept Rheumatol, Dudley, England
[6] Teaching Trust Univ Birmingham, Russells Hall Hosp, Dudley Grp NHS Fdn Trust, Dept Res & Dev, Dudley, England
[7] South Kazakhstan Med Acad, Dept Biol & Biochem, Shymkent, Kazakhstan
[8] DM Clin Immunol Med Univ, Internal Med, Lucknow 226018, India
关键词
Privacy; Beneficence; Research Subjects; Confidentiality; Human Rights; Ethics Committees; Research; INFORMED-CONSENT; BOARD APPROVAL; MEMBERS; PARTICIPANTS; DECLARATION; RETRACTION; CHALLENGES; PROTECTION; GUIDELINES; BIOETHICS;
D O I
10.3346/jkms.2023.38.e198
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
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页数:17
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