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FEDERAL STATE PUBLIC SCIENTIFIC INSTITUTION
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Biomedical ethics committee

Chairperson of the Committee on Biomedical ethics Irina M. Madaeva, Dr.Sc. (Med.) 

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Mission of the Committee includes the following: independent, competent and timely expertise of the proposed biomedical study before the beginning of the study, contribution to control of the study and to safeguarding the dignity, rights, safety, and well-being of all actual or potential research participants.

The Committee acts in accordance with international and national laws and guidelines on biomedical ethics in research.

The algorithm of ethical expertise by the Committee:

1.       Submitting documents to the Committee for ethical expertise (hard copy, 1 copy);

2.       Checking if all documents are present and how well they are processed and designed (1-2 days);

3.       Assigning the documents to a member of the Committee for ethical expertise (7 days);

4.       Holding a meeting of the Committee (whenever required, not rarer than 1 time per quarter);

5.       Extract from the protocol of the meeting (resolution) (in 2 copies).

Required documents for submission to the Committee (conducting a clinical trial):

Signed and dated application;

Protocol of the proposed study (clearly identified and dated), along with necessary supplements and related documents, in source language and with translation in Russian;

Description of ethical aspects of the research (this can be added to the protocol);

Information for patients and a copy of the informed consent form (clearly identified and dated), in source language and with translation in Russian;

Case report forms, diaries and questionnaires, which will be filled by the participants of the research;

The studied product (pharmacologic agent or medical device) must have description of its safety details, as well as pharmacological, pharmaceutical and toxicological details, along with description of the current clinical experience of usage of this product (for example, updated version of the drug brochure, publications, and characteristics of the agent);

Signed and dated investigators’ current CVs;

Materials (including the promotional) used for recruitment of potential participants of the study, in Russian;

Any materials, print or other, containing information for potential participants (clearly identified and dated) in Russian and, if necessary, in other languages;

Details on compensation for participation in the study (including coverage of expenses for medical assistance), if these data have not been mentioned in the materials for the patient or in the informed consent form;

Description of all insurance details for the participants of the study;

All significant previous decisions (for example, negative decisions or demands to change the protocol), made by other ethical committees or other competent authorities towards the proposed study (regardless of their location) and data on protocol alteration followed after the decision. Reasons for the negative decision should be provided.