Documents

Regulatory Ethical Documents

The committee conducts its activities in accordance with the Constitution of the Russian Federation, laws and other legal acts of the Russian Federation, and bases its work on the principles established in the following documents:

1. The Helsinki Declaration of the World Medical Association ‘Ethical Principles for Medical Research Involving Human Subjects,’ adopted by the 18th World Medical Assembly (Finland, 1964) in accordance with the current revised text;
2. Guidelines of the WHO and other international organisations;
3. Federal Law No. 323-FZ of November 21, 2011 'On the Fundamentals of Health Protection of Citizens in the Russian Federation' with subsequent amendments and additions;
4. Federal Law No. 152-FZ of July 27, 2006 ‘On Personal Data’;
5. GOST R 52379-2005 ‘Good Clinical Practice’;
6. GOST R ISO 14155-2014 ‘Clinical investigation of Medical Devices for Human Subjects — Good Clinical Practice’;
7. European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes;
8. The HSE University Charter, as well as this Regulation and Standard Operating Procedures.

Working Documents

Regulations on the Committee (PDF, 252 Kb) 

Rules and Schedule of the Committee (PDF, 209 Kb) 

Standard Operating Procedures (SOPs) (PDF, 304 Kb) 

Unified Document Forms (PDF, 319 Kb)