It is necessary to submit documents for the ethical examination of clinical dissertation research after the approval of the research topic at a meeting of the problem commission

All documents are submitted in paper form, enclosed in separate files and filed in a folder, on which the title page is pasted.

A written statement addressed to the Chairman of the local Ethics Committee of StSMU. The statement indicates the full name of the study, provides a list of submitted documents, and contact person details to clarify emerging issues on the part of the Committee. 

An extended abstract to the planned research (signed by the contractor and the supervisor), which sets out the goals, objectives, materials and methods of research, substantiation of scientific novelty and expediency, expected results. 

Protocol (plan, scheme) of the study.

A list of clinical centers (departments) where the study is planned to be conducted, indicating their addresses. 

Basic information about the test product or method (including instructions for the use of the test products).

Information for the patient and the patient's informed consent form. 

Information for the patient and the informed consent form of the legal representative. 

The form of the patient's individual registration card.

The professional autobiography of the researcher.

The obligation of confidentiality. 

The title page (on a paper folder). 

Information about the completed amount of research. 

An extract from the minutes of the meeting of the problem commission.

The procedure for conducting an ethical examination of scientific research conducted on animals 

Order of the Ministry of Education and Science of the Russian Federation dated 02/24/2021 No. 118 "On approval of the nomenclature of scientific specialties for which academic degrees are awarded and Amendments to the Regulation on the Council for the Defense of Dissertations for the Degree of Candidate of Sciences, for the degree of Doctor of Sciences, approved by Order of the Ministry of Education and Science of the Russian Federation dated November 10, 2017 No. 1093" (Registered with the Ministry of Justice of the Russian Federation on 04/06/2021 No. 62998)

Please note that, if necessary, the local ethics committee may request a reviewer's opinion on a research paper.