Abstract
The issue of insurance for clinical trial participants is one of the important factors in creating a “safe” research ecosystem. Clinical trials may encounter adverse outcomes, and researchers are focused on maintaining a balance between the safety of study participants and the bureaucratic obstacles in the legal aspect of the path to scientific discoveriesObjective. Develop recommendations for improving Kazakhstan's clinical trials insurance system based on the analysis of best practices conducted. We have conducted an analysis of the experience of 14 countries on issues of insurance of clinical trials according to 3 parameters: stability of the insurance institution; regulation of the insurance issue; mechanism for reimbursement of insurance payments; and tariff policy.Each country has its own standardized protocols and requirements for clinical trial insurance. Some countries make insurance "mandatory" by enshrining it in law (most European countries), while others make it advisory (USA, UK). Two forms of research insurance are practiced: "liability" of initiators and "accident" insurance for participants. Approaches to determining insurance limits also differ - some cover only insurance payments upon completion, while others set minimum coverage for an insured event. In Kazakhstan, a norm is regulated that obliges participants in clinical trials to be insured, but there is no mechanism, rules, or requirements for the process. The lack of clear requirements for the content of the document on life and health insurance for research participants is a barrier for sponsors. Conclusion. Based on the experience of international practices, it is necessary to consolidate a national model of insurance for clinical trials in Kazakhstan. The key aspects for promoting the clinical trials insurance system at the political level in Kazakhstan are the definition of insurance, insurance event, amount of insurance payments, insurance rates, the procedure for paying the insurance premium, the procedure for concluding the contract and its term, rights, and obligations of the parties to the contract and insured persons, the procedure for making insurance payments.Keywords: clinical research, subject insurance system.