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    APPROVAL OF THE LOCAL ETHICS COMMITTEE

    All research involving a human as a research subject must be subject to mandatory ethical review, and prior to such research, it is necessary to obtain the approval of the ethics committee.

    “Medical Technologies” approves all research conducted by the company in the local ethics committee. During the study, all relevant information is taken into account in the EC. The purpose of the work of the local ethics committee is to protect the dignity, rights and well-being of participants in clinical trials, as subjects, as well as employees of the research center. The Ethics Committee also operates to ensure that the public is protected by research participants.

    Local Ethical Committee of “Medical Technologies” company consists of 11 representatives.
    The Ethics Committee meets at least 2 times a month or upon request.
    Documents are submitted to the LEC 5 days before the meeting. Consideration of documents is possible before obtaining permission to conduct a clinical trial by the Ministry of Health.

    List of documents required for submission to the LEK:

    • Guidance letter to the LEC;
    • Contract for ethical review;
    • Detailed list of submitted documents with version numbers and dates in electronic form;
    • Clinical trial protocol (for international clinical trials – in the language of the applicant country and Russian);
    • Patient information leaflet (information for the patient and the form of written informed consent of the patient) (for international clinical trials – in the language of the applicant country and Russian);
    • Form of individual patient registration card;
      Diaries, questionnaires to be filled out by patients participating in the study;
    • Brochure of the investigator (for international clinical trials – in the language of the applicant country and Russian);
    • List of clinical centers where the study is planned to be conducted;
      Сurriculum vitae (CV) of the researchers, dated and signed by the researchers;
    • Insurance documents;
    • Information on compensations and payments provided for the subjects of the study during the study;
    • Materials, including advertising, informing about the study and used to attract patients to participate in it;
    • Permission of the Ministry of Health to conduct research.

    For companies sponsoring clinical trials and medical trials, the organizational and technical support of ethical review is paid. You can get detailed information on payment from the secretary of the local ethics committee.
    Documents of the Local Ethics Committee include:

    • Regulations on the Ethics Committee;
    • Standard Operating Procedures:
      1) Approval of the composition of the LEK;
      2) The procedure for organizing meetings;
      3) Primary ethical examination;
      4) Repeated ethical examination;
      5) Accelerated Ethical Review;
      6) Consideration of notifications;
      7) Periodic ethical review;
      8) Consideration of safety reporting.
      Orders.

    In its activities, LEK is guided by the following regulations:

    • Declaration of Helsinki by the World Medical Association (revised 2013);
    • Federal Law No. 323-FZ “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”;
    • Federal Law of April 12, 2010 No. No. 61-FZ “On the circulation of medicines”;
    • International harmonized tripartite guidelines for good clinical practice (ICH GCP);
    • National Standard of the Russian Federation GOST R 52379-2005 “Good Clinical Practice”;
    • Order of the Ministry of Health of Russia dated April 1, 2016 No. 200n “On approval of the rules of good clinical practice”
    • Recommendations to Ethics Committees conducting WHO Biomedical Research Reviews;
    • Standard Operating Procedures (SOP) LEK;
    • Charter
    • Regulations on the Ethics Committee;
    • Other legal documents in the field of healthcare.

    LEC “Medical Technologies” has a well-established procedure for the ethical support of centers without their own LEC.
    You can contact the Secretary of the Ethics Committee.

    Contacts:
    Olga Koval – Secretary of the Ethical Committee “Medical Technologies”
    o.koval@mt.clinic

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