Article 17. Ethical Expert Examination

1. Ethical expert examination is carried out for the purpose of issuance of a conclusion on ethical feasibility to conduct a clinical trial of a medicinal product for medical use by the ethical council founded in the manner prescribed by the authorized federal executive body.

2. Representatives of medical, research and higher professional education institutions, as well as representatives of public and religious institutions and mass media may act as ethical council experts. Such experts shall in no way depend upon developers of medicinal products and other persons interested in the results of expert examination.

3. Remuneration to ethical council experts shall be paid under a contract concluded between the authorized federal executive body which founded the ethical council and an ethical council expert at the cost of budget allocations stipulated to authorized federal executive body, created ethical council, in the federal budget for corresponding year to ensure its activities in extent prescribed by the Government of the Russian Federation
(as amended by Federal Law of November 29, No. 313-FZ)

4. Ethical council experts bear responsibility in accordance with the legislation of the Russian Federation.

5. Ethical council composition, regulations on the council, requirements to qualification and experience of ethical council experts in expert assessment of scientific, medical and ethical aspects of clinical trials of medicinal products for medical use, procedures for arrangement and performance of ethical expert examination and a form of ethical council conclusion are established by the authorized federal executive body. The number of representatives of medicinal institutions shall not exceed a half of the total number of ethical council experts.

6. Information on ethical council composition, plan of operation and current activities shall be placed on the Internet official site of the authorized federal executive body in the manner prescribed by such body.