Human research subjects and current practice of research ethics committees in Czech academic environment: national regulation is urgently needed

Abstract

Background: The primary objective of this study was to conduct a comprehensive questionnaire survey on the practices of research ethics committees that review academic research projects, specifically related to the Additional Protocol on Biomedical Research CETS No. 195, which was ratified and implemented in 2020. The study aims to provide an unbiased and objective assessment of the current practices employed by the research ethics committees. This research is unique and has never been conducted in Czechia. Methods: To assess the situation, we developed an online questionnaire containing 18 questions concerning several aspects of the functioning of research ethics committees. The questionnaire was in Czech language and was administered through the Qualtrics platform anonymously. The target group of 61 RECs at research institutions was approached by emails and we received 43 completely filled questionnaires, i.e., response rate of 67%. Results: We obtained valuable data on the functioning of research ethics committees in Czechia in three main domains: the mandate and composition of the committee; the scope of its agenda; the process of evaluation including the voting procedure. From the results is evident that even more than twenty years after the ratification of the Oviedo Convention ETS No. 164 and three years after the ratification of its Additional Protocol on Biomedical Research CETS No. 195, the responsible assessment of the ethics of research involving human subjects is still not satisfactorily addressed and established for routine practice in Czechia. Conclusions: The outcomes of our study revealed that the main problem of research ethics in Czechia is the lack of national legislation on research ethics governance. To address this problem, the country requires a legislation framework accompanied by supportive measures aimed at guiding and assisting research ethics committees in the Czech academic environment.