J Korean Med Sci.  2023 Jun;38(25):e198. 10.3346/jkms.2023.38.e198.

Ethics Committees: Structure, Roles, and Issues

• Mehta P
• Zimba O
• Gasparyan AY
• Seiil B
• Yessirkepov M

• KMID: 2544011
• DOI: http://doi.org/10.3346/jkms.2023.38.e198

Abstract

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.

Keyword

Privacy; Beneficence; Research Subjects; Confidentiality; Human Rights; Ethics Committees; Research

Figure

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  Fig. 1 Timelines of events that led to the establishment of Ethics Committees.

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  Fig. 2 Recommended composition of the Ethics Committee.

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  Fig. 3 The factors assessed in the process of review of a study by an Ethics Committee.

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