Abstract
We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research centers even though they conduct CDTs (clinical drug trials). There is no national policy for the ethical review of non-clinical trials. We recommend the establishment of institutional review boards (IRBs) at medical institutes and research centers while at the same time building capacity at the national level to oversee and support the research ethics review system of the entire country.
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Notes
Guideline for Good Clinical Practice of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The Ethical Code of Uzbekistan Physician-Investigator. Sets out basic principles of ethical review of biomedical research involving human subjects.
Guidelines on Conducting Clinical Trials and Determining Clinical Sites.” The Guidelines are based on WHO Guidelines for Good Clinical Practice and reflect the following aspects: informing patients about CT; obtaining written informed consent from patients; independent ethical review; operational standard procedures.
Abbreviations
- CDT :
-
clinical drug trial
- IRB :
-
Institutional Review Board
- NEC :
-
National Ethics Committee
- REC :
-
Research Ethics Committees
- SOP :
-
standard operational procedures
- TIPME :
-
Tashkent Institute of Postgraduate Medical Education
- WHO :
-
World Health Organization
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Both authors contributed to the study conception and design. Data collection and analysis were performed by Dilfuza Aniyozova. Both authors commented on previous versions of the manuscript. Both authors read and approved the final manuscript.
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Aniyozova, D., Strosberg, M.A. Ethics Review of Biomedical Research in Uzbekistan: Policy and Program Gaps. ABR (2024). https://doi.org/10.1007/s41649-023-00273-2
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DOI: https://doi.org/10.1007/s41649-023-00273-2