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The Local Ethics Committee is established at Federal State Budgetary Institution "National Medical Research Centre for Rehabilitation and Balneology" of the Ministry of Health of the Russian Federation (FSBI "NMRC RB" of the Ministry of Health of Russia) as an expert council to provide independent expertise and decision-making on ethical issues in biomedical research involving humans and/or animals in order to protect the rights, dignity, interests and health of participants.
Chairperson of the LEC - Elena Anatolievna Rozhkova, PhD (Biology)
E-mail: lek-nmicrk@nmicrk.ru
Phone: 8 (499) 277-01-05, ext. 1037
Secretary of the LEC - Tatyana Reonoldovna Filimonova, PhD (Medicine)
Phone: 8 (499) 277-01-05, ext. 1519
The documents for the expertise of the studies shall be submitted in writing (each of the above list in a separate file together with a binder) to the secretary in charge Filimonova Tatiana Reonoldovna (time - as agreed).
The applicant shall also submit copies of the documents, listed in the file, electronically on a memory stick or by e-mail, in addition to the paper version of the document package: lek-nmicrk@nmicrk.ru
The files should be stored in a separate folder. The name of the folder should include the applicant's name, type of research, topic, year.
Documents should be submitted to the LEC at least 7 days before the next meeting.
The Local Ethics Committee may require additional documents from the applicant in order to fulfil its duties.
LEC meetings are held on the third Thursday of the month at 15:00 at the address:
9, bld 1, Borisoglebsky lane, Moscow
- The Declaration of Helsinki of the World Medical Association, adopted at the 18th General Assembly of the WMA, Helsinki, Finland, June 1964, as further amended
- National Standard of the Russian Federation GOST R 52379-2005. "Good Clinical Practice" (approved by the Order of the Federal Agency for Technical Regulation and Metrology of 27 September 2005 No. 232-ст.)
- Federal Law of the Russian Federation of 12.04.2010 No. 61-ФЗ "On the circulation of medicines" (as amended and supplemented on 27 July, 11 October, 29 November 2010, 6 December 2011, 25 June, 25 December 2012, 2 July, 25 November 2013, 12 March, 22 October, 22 December 2014, 8 March, 29 June, 13 July, 14, 29 December 2015, 2 June, 3 July 2016)
- Federal Law of 21 November 2011 N 323-ФЗ "On the fundamentals of health protection of citizens in the Russian Federation" (as amended and supplemented on 25 June 2012, 2, 23 July, 27 September, 25 November, 28 December 2013, 4 June, 21 July, 22 October, 1, 31 December 2014, 8 March, 6 April, 29 June, 13 July, 30 September, 14, 29 December 2015, 5, 26 April, 3 July 2016)
- Federal Law No. 152-ФЗ of 27 July 2006 "On personal data", including the amendments
- Order of the Ministry of Health of the Russian Federation No. 300н of 16 May 2013 "On approval of requirements for medical organizations conducting clinical trials of medical devices and the procedure for establishing compliance of medical organizations with these requirements"
- Order of the Ministry of Health of the Russian Federation No. 200н "On approval of the rules of good clinical practice" of 1 April 2016
- Rules of good clinical practice of the Eurasian Economic Union (approved by the decision of the Council of the Eurasian Economic Commission on 3 November 2016 No. 79)
- GOST R ISO 14155-2014. "Clinical trials. Good clinical practice."
- Provision of the State Commission for Academic Degrees and Titles "On the procedure for conducting biomedical research in humans", published in the Bulletin of the State Commission for Academic Degrees and Titles (2002, No. 3) and other current international regulations and acts of the Russian Federation relating to the activities of ethics committees and the conduct of clinical trials, as well as the Provisions on the Local Ethics Committee at FSBI "NMRC RB" of the Ministry of Health of Russia version of 2023 and Standard Operating Procedures (SOP)
- SOP 01. Development. Approval. Modification procedure
- SOP 02: Expertise of clinical trials of medicinal products for medical use. Requirement to the dossier
- SOP 03: Initiative trials, procedure of ethical review
- SOP 04. LEC meetings, decision-making procedure, notification of applicants, rules for drawing conclusions
- SOP 05. Formation of the Local Ethics Committee
- SOP 06. Requirements to the patient/volunteer information sheet and informed consent form
- SOP 07. Monitoring, follow-up and review of approved clinical trial materials
- SOP 08: Archiving of research materials
- SOP 09. Confidentiality
- SOP 10. Selection of independent experts/consultants
- SOP 11. Review of protocol and brochure amendments
- SOP 12. Procedure of the Local Ethics Committee's work during the high alert regime, state of emergency, etc.