Local Committee on Biomedical Ethics FGBU “Yakut Science Centre of Complex Medical Problems” was established to provide an independent assessment, counseling and evaluation of the ethical, legal and social issues related to biomedical or other types of research with human participation. The thesises of the Ethics Committee have been developed based on the “Standard operating procedures of the ethics committees’ activity” of the Forum of Ethics Committees of CIS countries (FECCIS). These positions were approved by the Academic Council FGBU “Yakut Science Centre of Complex Medical Problems” Siberian Branch of the Academy of Medical Sciences № 16 (protocol number 8) on December 22, 2005.
Chairperson: Kononova S.K., PhD, senior researcher in the Department of Molecular Genetics FGBU “Yakut Science Centre of Complex Medical Problems ” of the RAMS Siberian Branch;
Secretary: Mikhailova M.N., Junior Researcher, Laboratory of Physiology and functional reserve of human ECHNIDD;
Members: Loskutova K.S., PhD, Head of Pathomorphology laboratory and study the effects of cold on the human body FGBU “YSC CMP”; V.P. Shadrin, PhD, head of information-analytical department of Children’s Hospital; R.N. Pavlov, PhD, Department of Traumatology and Orthopedics TsOMiD RH№1-NCM; O.G. Sidorova, a physician-geneticist, genetic counseling RH№1-NCM; I.A.Vinokurov, member of the public who does not refer to medicine and science.
EC meetings are held not less than 1 time per month for receipt of applications for candidates to conduct ethical review of the research protocol (RP) and the informed consent form (IC) of the study participant. RP is a shortened form of summaries of research or the abstract of the thesis of the applicant, specifying: Study objectives, relevance, objectives of the study; overview of published data on the study, the study sample volume; Inclusion / exclusion criteria of study participants, the study methods used. To the research protocol are applied two types of applications, number 1 and number 2, drawn up in the form of a questionnaire of 20 questions, which shows the data of the applicant, contact details of the research center, the duration of the study, the types of research (social health, genetic screening, epidemiological, etc. .), study groups, including other vulnerable groups (the elderly, children, pregnant women, etc.), the need for resources, including the use of ionizing radiation, new drugs, new medical equipment, procedures (invasive, non-invasive), etc.
The evaluation criteria for ethical review of research protocols:
Qualifications of the Researcher; Study objectives; Methodology; Criteria for inclusion / exclusion of study participants; Inclusion of vulnerable contingents; Voluntary recruitment of participants; Room, infrastructure and research center equipment; Involvement of local researchers and institutions in the development of RP, analysis and publication of results; Public contribution; Benefits the local community; Availability of clinical trial results; whether biological materials samples are sent abroad; are used in a study new drugs or medical equipment.
Information for researchers:
To conduct ethical review of research you have to submit to the meeting of the Ethics Committee (EC) at FGBU “Yakut Science Centre of Complex Medical Problems” following documents:
I. The research protocol (RP) (7 copies) in the free form of presentation (no more than 2 pages), which should include:
a. 1. Objectives of the study 2. Actuality 3. Research Objectives 4. A brief review of the references 5. Samples volume 6. Inclusion / exclusion criteria of study participants, 7. Used methods.
b. Informed consent of research participants (patients) (7copies).
II. The completed application forms number 1, 2 to RP required for reporting of the Ethics Committee.
III. Discuss with the deputy- Chairman of the EC on the date of the examination.
Do not hesitate contact us by phone. 32-14-73 Kononova S.K.