Fakhradiyev Lldar, Shamsutdinova Alfiya, Kulkayeva Gulnara, Sarymsakova Bakhyt, Menlayakova Darina, Manatova Almira, Saussakova Saniya, Ibrayeva Anel, Tanabayeva Shynar, Munir Kerim
S.D. Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan.
College of Medicine, Korea University, Seoul, South Korea.
Mater Sociomed. 2024;36(3):192-198. doi: 10.5455/msm.2024.36.192-198.
Sixteen RECs were randomly selected from various institutions across Kazakhstan, representing both public and private sectors and covering biomedical and socio-behavioral research reviews.
This research addresses a critical knowledge gap by providing empirical data on REC operations in Kazakhstan, facilitating a better understanding of how these committees align with international ethical standards and best practices. Furthermore, by situating our findings within the broader context of REC performance in LMICs, we aim to highlight specific challenges unique to Kazakhstan and propose evidence-based recommendations.
Data were collected using a culturally adapted, semi-structured questionnaire based on a validated self-assessment tool. Descriptive statistics were used to analyze the data.
The overall average score for the RECs was 71.9% out of a possible 100%, indicating generally effective functioning but highlighting significant areas needing improvement. Strengths included well-established organizational aspects, diverse membership, and adequate educational training. However, weaknesses were identified in the thoroughness of protocol evaluations and resource allocation, with low scores in "Review of Specific Protocol Items" (33.7%) and "REC Resources" (56.2%). Additionally, 38.5% of RECs were not registered with national authorities, underscoring the need for improved regulatory oversight.
While RECs in Kazakhstan demonstrate strengths in organizational structure and member training, critical gaps exist in protocol review processes and resource support. Targeted interventions - such as enhancing training programs for REC members, increasing funding and resources, and establishing a national accreditation system - are recommended to improve the quality of ethical oversight in research. Strengthening these areas will ensure comprehensive protocol reviews and better protection of research participants.
从哈萨克斯坦各地的不同机构中随机挑选了16个伦理审查委员会，代表公共和私营部门，涵盖生物医学和社会行为研究审查。
本研究通过提供哈萨克斯坦伦理审查委员会运作的实证数据，解决了一个关键的知识空白，有助于更好地理解这些委员会如何符合国际伦理标准和最佳实践。此外，通过将我们的研究结果置于低收入和中等收入国家伦理审查委员会表现的更广泛背景下，我们旨在突出哈萨克斯坦特有的具体挑战，并提出基于证据的建议。
使用基于经过验证的自我评估工具、经文化调整的半结构化问卷收集数据。使用描述性统计分析数据。
伦理审查委员会的总体平均得分为71.9%（满分100%），表明其运作总体有效，但也突出了需要改进的重要领域。优势包括完善的组织架构、多元化的成员构成和充分的教育培训。然而，在方案评估的彻底性和资源分配方面发现了弱点，在“特定方案项目审查”（33.7%）和“伦理审查委员会资源”（56.2%）方面得分较低。此外，38.5%的伦理审查委员会未在国家当局注册，这凸显了加强监管监督的必要性。
虽然哈萨克斯坦的伦理审查委员会在组织结构和成员培训方面表现出优势，但在方案审查流程和资源支持方面存在重大差距。建议采取有针对性的干预措施，如加强伦理审查委员会成员的培训计划、增加资金和资源以及建立国家认证体系，以提高研究伦理监督的质量。加强这些领域将确保全面的方案审查，并更好地保护研究参与者。
