According to the Georgian Legislation as well as internationally acknowledged standards, also in line with the TSMU Regulations for the Degree of Doctor of Philosophy all research projects which involve research on human beings as well as on biological material of human origin and associated data have to undergo ethical evaluation.
At Tbilisi State Medical University ethical review of research projects is carried out by TSMU Biomedical Research Ethics Committee (REC), which operates in accordance with existing legal framework and its own bylaws.
All research projects on human beings and/or biological material of human origin and associated data, including research projects developed in the framework of PhD Programmes shall be submitted for ethical review to TSMU REC.
TSMU REC was established in 2007 and during the following decade it reviews around two hundreds of research projects.
Since 2015 TSMU REC is registered in the database of Office for Human Research Protections (OHRP), which is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of U.S. Department of Health and Human Services (HHS). TSMU REC has also obtained Federal-wide Assurances (FWA) the same year.
The committee meets as needed, but not more than once in a month. The conclusion of the committee is issued within the week after the research project is reviewed.
Researchers have to submit the following documents for ethical review of the research project:
• Applicants letter
• Research project (protocol)
• Summary of the research project
• Informed consent form
• Biographical data of the responsible researchers (CV – Curriculum Vitae).