Article 43.  Rights of Patients Involved in Clinical Trial of Medicinal Product for Medical Use

1. Participation of patients in a clinical trial of a medicinal product for medical use shall be voluntary.

2. The patient or his/her legal representative shall be informed in writing of the following:

1) medicinal product for medical use and the nature of the clinical trial of this medicinal product;
2) safety, anticipated efficacy of the medicinal product for medical use, and the degree of risk for the patient;
3) conditions of the patient’s participation in the clinical trial of the medicinal product for medical use;
4) objective(s) and duration of the clinical trial of the medicinal product for medical use;
5) patient's actions in the event of unforeseen effects of the medicinal product for medical use on the patient’s health;
6) terms and conditions of compulsory life and health insurance for the patient;
7) guarantees of confidentiality for the patient’s participation in the clinical trial of the medicinal product for medical use.

3. The patient’s voluntary consent to participate in the clinical trial of a medicinal product for medical use shall be confirmed by his/her signature or signature of his/her legal representative on the patient information sheet.

4. The patient, or his legal representative, may withdraw from the clinical trial of a medicinal product for medical use at any stage of such trial.

5. A clinical trial of medicinal product for medical use with participation of children as patients shall only be permitted with written consent of their parents/adoptive parents. Children may only be considered as potential patients of such trial if the trial is required for promotion of children’s health or prophylaxis of infectious diseases in childhood, or where the objective of a clinical trial is to obtain data on the best dosage of medicinal product for treatment of children. In such cases the trial shall be preceded by a clinical trial of the medicinal product for medical use in adults.

6. It shall be prohibited to conduct a clinical trial of medicinal product for medical use in the following patients:

1) orphaned children/children without parental care;
2) pregnant and nursing women, except for clinical trials conducted on a medicinal product designed for said women where the information sought may only be obtained in respective clinical trials of medicinal products and when all the appropriate measures have been taken in order to exclude any risk of harm to the pregnant or nursing woman, the foetus or the baby;
3) military personnel, except where a clinical trial of a medicinal product specially designed for use in military operations, emergency situations, prophylaxis and treatment of diseases and damages resulting from the exposure to unfavourable chemical, biological or radiation factors. A clinical trial of such medicinal products may be conducted with participation of military personnel as patients, except for military personnel doing call-up military service, in accordance with the requirements established by this Federal Law with respect to civilians;
4) law enforcement personnel; and
5) individuals serving sentences at places of confinement, or individuals in custody at detention facilities.

7. It is allowed to conduct a clinical trial of a medicinal product for medical use designed for treatment of mental disorders in individuals with mental disorders recognized as disabled in accordance with the laws of the Russian Federation. A clinical trial of a medicinal product in this case shall be conducted subject to consent in writing having been given by legal representatives of said individuals.