Article 10. Clinical trials of pharmacological agents or medicines

Clinical trials of pharmacological agents or medicines shall be conducted to study their pharmacological properties and to obtain information on adverse effects and interaction with other medicines for the purpose of determining safety and efficacy.

Clinical trials of pharmacological agents or medicines may be conducted in one treatment-and-prophylactic institution or, as a multicenter clinical trial, in more than one treatment-and-prophylactic institution according to a single protocol.

The decision to conduct clinical trials of pharmacological agents or medicines in humans shall be made by the Ministry of Health of the Republic of Uzbekistan.

The grounds for deciding to conduct clinical trials of pharmacological agents or medicines shall be:

results of preclinical studies confirming the safety and efficacy of pharmacological agents or medicines;

information that the potential risk of adverse effects from the use of the pharmacological agent or medicine is significantly lower than the expected beneficial effect.

Clinical trials of pharmacological agents or medicines shall not be permitted without a conclusion of an ethics expertise confirming that the conduct of such trials is ethically justified. Participation of a clinical trial subject in a clinical trial of a pharmacological agent or medicine shall be voluntary on the basis of his or her written consent. The head of the clinical trial must provide the clinical trial subject with a detailed explanation of the significance of the study method, the essence of the study, and the potential risk. A clinical trial subject has the right to refuse to participate at any stage of the study.

If a clinical trial of a pharmacological agent or medicine is conducted with the participation of a minor or a legally incapable clinical trial subject, written consent must be obtained prior to the start of the study from his or her parents or other legal representatives.

Before conducting a clinical trial involving minor clinical trial subjects, as a rule, a clinical trial must have been conducted in adult clinical trial subjects.

Prior to the start of a clinical trial of a pharmacological agent or medicine, the treatment-and-prophylactic institution conducting the trial or the legal entity that provided the pharmacological agent or medicine under study shall conclude with an insurer a civil liability insurance contract for harm caused to the life or health of the clinical trial subject.