Enhancing the Efficiency and Functionality of Local Bioethics Committees
Author(s)
Ayagyoz Umbetzhanova1, Gulmira Derbissalina, PhD, MD2, Vitaliy Koikov, PhD, MD3, Zhanagul Bekbergenova, MSc, MD4, Aruzhan Nuran, Master student5.
1Nur-Sultan, Kazakhstan, 2Astana medical university, Astana, Kazakhstan, 3RSE on REM, Nur-Sultan city, Kazakhstan, 4NJSC, Astana, Kazakhstan, 5Astana Medical University, Astana, Kazakhstan.
1Nur-Sultan, Kazakhstan, 2Astana medical university, Astana, Kazakhstan, 3RSE on REM, Nur-Sultan city, Kazakhstan, 4NJSC, Astana, Kazakhstan, 5Astana Medical University, Astana, Kazakhstan.
OBJECTIVES: Improving the processes of reviewing and approving clinical trials in accordance with international standards and ethical standards through a comprehensive analysis of the activities of the local ethics committee.
METHODS: Content analysis of local ethical committee work was performed, including the accordance with national and international standards and regulations, also review of clinical trial protocols over the past 3 years, including: the number of approved and rejected protocols, reasons for refusals, analysis of review dates and deviations from established standards. Identification of typical errors in the submitted protocols and key reasons for reconsideration.
RESULTS: study included data on protocols submitted during 2022, 2023 years. The percentage of those who passed the examination on the first attempt-38%, on the second attempt-45%, and more than 3 attempts-17%. The main reasons for the refusal were: weak justification of the scientific significance of the study non-compliance with ethical standards, submission of an inherently unethical study, gaps in documentation; for reconsideration, there were: correction of errors or clarifications, adjustments to the scientific aspects of the project, clarification of risk management and safety measures, complex or contentious aspects of the study; average terms of consideration of applications: about 30 days.The main mistakes when submitting documents: incomplete documentation, insufficient attention to ethical principles, limited knowledge of regulatory requirements.
CONCLUSIONS: The average delay in conducting research due to incomplete documents or inaccuracies is 4.5 months (137 days). The main mistakes are related to insufficient knowledge of ethical principles and standards of bioethics. In this regard, it is necessary to strengthen the training of young scientists and their supervisors in the field of bioethics standards. It is also important to make the application review process of the local ethics committee more transparent and algorithmic.
METHODS: Content analysis of local ethical committee work was performed, including the accordance with national and international standards and regulations, also review of clinical trial protocols over the past 3 years, including: the number of approved and rejected protocols, reasons for refusals, analysis of review dates and deviations from established standards. Identification of typical errors in the submitted protocols and key reasons for reconsideration.
RESULTS: study included data on protocols submitted during 2022, 2023 years. The percentage of those who passed the examination on the first attempt-38%, on the second attempt-45%, and more than 3 attempts-17%. The main reasons for the refusal were: weak justification of the scientific significance of the study non-compliance with ethical standards, submission of an inherently unethical study, gaps in documentation; for reconsideration, there were: correction of errors or clarifications, adjustments to the scientific aspects of the project, clarification of risk management and safety measures, complex or contentious aspects of the study; average terms of consideration of applications: about 30 days.The main mistakes when submitting documents: incomplete documentation, insufficient attention to ethical principles, limited knowledge of regulatory requirements.
CONCLUSIONS: The average delay in conducting research due to incomplete documents or inaccuracies is 4.5 months (137 days). The main mistakes are related to insufficient knowledge of ethical principles and standards of bioethics. In this regard, it is necessary to strengthen the training of young scientists and their supervisors in the field of bioethics standards. It is also important to make the application review process of the local ethics committee more transparent and algorithmic.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR69
Topic
Health Policy & Regulatory
Disease
No Additional Disease & Conditions/Specialized Treatment Areas