Ethics committee supervision is a vital part of all clinical trials. It acts to ensure that research is carried out in compliance with the international recommendations including the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice (ICH GCP), Directive 2001/20/EC of the European Parliament and Council and WHO recommendations etc. No clinical trial may be carried out with the prior approval of an ethics committee. In addition, ethics committees provide regular monitoring of clinical trials to ensure that trial conduct is adhering to national and international moral, ethical and legal standards.
For example, in Ukraine, the framework for the activity of ethics committees is as follows: there are two types of committees- the CEC of Ministry of Health of Ukraine (national level) and local ethics committees at healthcare institutions.
Ethics committees comprise specialists from various fields of medicine, as well as from other areas, and members of the public who monitor compliance with the rights and safety of research participants.
Evaluation and approval of clinical trials in Ukraine is carried out by the CEC of the Ministry of Health. Monitoring of the protection of moral, ethical and legal principles during trials is carried out by local committees under the guidance of CEC.
This system helps ensure the safety, well-being, and protection of rights of trial participants throughout the entire clinical research process. It also makes sure that the conduct of trials adheres to international and national principals and requirements.
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