Аңдатпа
Background Clinical trials must be approved by ethics committees. Since 2007, local bioethical committees have been established in all research organizations and medical universities, reporting directly to the Central Commission for Ethics of the Ministry of Health of the Republic of Kazakhstan (Commission). Objectives: to assess the activities of the local bioethical committee (committee). Methods A retrospective analysis of 30 protocols approved by the committee in 2016. Characteristics of protocols (design, research size, researcher), a number of changes requested by the committee prior to approval, approval time and the amount of correction after approval were collected for each protocol by trained secretary. Results None of the work did not require consideration by the Commission. 18 protocols were approved without any changes within 16.7 days (95% CI: 14.96;18.38). 12 protocols required changes requested by the Committee. After the researcher's corrections, the protocol was approved on average for 31.4 days (95% CI: 19.43;43.43). When revisions were requested, the main reasons were related to information to the patient (9 protocols) and informed consent (5 protocols). The drugs were the subject of research in 5 approved protocols. The majority of the research (21 protocols) was in the framework of dissertation research. Conclusions Our analysis showed that 30 protocols were approved within one year and that the median approval time ranges from 16.7 days (if no modification) to 31.4 days. Key messages: Most studies that have passed through the local bioethical committee, held in the framework of the dissertation research. At seminars, the researcher should pay attention to writing informed consent and information to the patient.