Information about the activities of the Biomedical Ethics Committee of the FRC FTM

Biomedical Ethics Committee of FRC FTM – it is an independent permanent body, consisting of medical, scientific and other competent workers, protecting the rights, safety and well-being of research subjects and acts as a guarantor of such protection for society, in particular by considering, approval/approval of the study protocol, researcher nominations, research centers, as well as materials and methods, which are intended to be used to obtain and document the informed consent of research subjects.

The Biomedical Ethics Committee in its activities is guided by the provisions in accordance with the Declaration of Helsinki of the World Medical Association, Ethical principles for conducting scientific medical research involving humans (adopted at the 52nd WMA General Assembly in Edinburgh, Scotland, in October 2000 Mr., editions 2004 Mr., 2008 Mr.), The Constitution of the Russian Federation dated 1 July 2020 G, Fundamentals of the legislation of the Russian Federation in the field of protecting the health of citizens (approved. Supreme Court of the Russian Federation 22.07.1993 N 5487-1), Rules of clinical practice in the Russian Federation (approved. Order of the Ministry of Health of the Russian Federation No. 19.06.2003 G. № 266), National standard of the Russian Federation GOST R 52379-2005 "Good Clinical Practice" (approved. Order of the Federal Agency for Technical Regulation and Metrology No. 27 September 2005. N 232-st) and the Rules for carrying out work using experimental animals (approved. Order of the Ministry of Health of the Russian Federation No. 19.03.2003 G. №266). Order of the Ministry of Health of Russia dated 01.04.2016 N 200n”On approval of the rules of good clinical practice”(Registered with the Ministry of Justice of Russia 23.08.2016 N 43357.

In its activities, the Biomedical Ethics Committee:

  • Studies legal and ethical issues, concerning research projects and related technologies;
  • Provides protection of the rights of research subjects (subjects/patients);
  • Prevents and resolves ethical issues, arising from the provision of medical care, organization and conduct of scientific research;
  • Conducts ethical review of the application of approved and new diagnostic methods, treatment and prevention, rehabilitation, medicines, biologically active drugs, medical technology;
  • Develops rules for conducting and criteria for the admissibility of animal studies based on existing regulatory documents, as well as international recommendations and learning from the experience of other institutions, as in Russia, as well as abroad;
  • Monitors compliance with international rules for conducting experiments on animals;
  • Carries out an independent examination of research projects, involving work with the use of experimental animals, and makes conclusions on the admissibility of these projects;
  • Advise employees on bioethical issues;
  • Conducts ethical review of scientific articles, prepared for publication in accordance with the decision on the research project and provides documents on the review of the research materials by the EC to the authors of the manuscripts.