Local Ethics Commission | Корпоративный фонд "University Medical Center"

The local ethics committee of the University Medical Center corporate foundation (hereinafter referred to as the Commission) has been operating since May 19, 2016, and is an independent expert body of the Foundation, which includes leading scientists, representatives of public organizations that protect rights, safety and well-being subjects and researchers, ethical and moral legal assessment of the materials of the clinical trial / trial in cases of contentious issues at all stages of the clinical trial / trial, as well as after their completion.

The main objective of the Commission is to protect the rights, dignity, safety and well-being of the researchers (patients and volunteers) and researchers participating in clinical trials, biomedical experiments, as well as the moral, ethical and legal assessment of the materials of the clinical trial.

The main tasks of the Commission are:

1. ensuring security and human rights at the stages of planning and conducting research;

2. ethical and legal examination of clinical research materials carried out as part of scientific and technical programs, initiative (dissertation) works, scientific projects (including with the participation of international organizations), scientific publications;

3. development of documents on biological and medical ethics;

Meetings of the Commission are held at least 1 time per quarter and are considered competent if at least half of the members are present.

The commission carries out a bioethical expert assessment of clinical research protocols, patient information and informed consent forms, professional experience of researchers, research centers, health insurance documents for individuals participating in patient / volunteer studies, and other materials for up to 30 days.

List of documents to be submitted to the Local Commission on Ethics of CF “UMC”

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Composition of UMC IRB

1. Application for energy efficiency (see Application Forms);

Initial examination application form (clicking on a document opens)

Application form for the initial examination of the study protocol

2. The protocol of the study (see. Scheme of the protocol of the study);

Study protocol outline

3. Information for the patient;

4. Patient informed consent form (see informed consent requirements);

Informed Consent Requirements

5. CV of the researcher (professional autobiography);

6. CV of the supervisor;

7. Accompanying documents to the protocol (if any).

To submit an application to the Local Bioethics Committee of the “UMC” Corporate Fund, the following set of documents must be provided:

Application for conducting the study (Appendix 1);

Application form for ethical review (Appendix 2);

Study protocol (Appendix 3);

Informed consent form for study subjects in Kazakh and Russian (Appendix 4);

All questionnaires and other data collection forms (individual registration cards) in Kazakh and Russian (if applicable);

Curriculum vitae of the researcher(s), training certificates, including completion of Good Clinical Practice (GCP) / Good Laboratory Practice (GLP) / CITI courses;

Investigator’s brochure related to clinical trials;

Materials used for recruiting potential research participants;

Insurance agreement for study participants (if applicable);

Contract with sponsors and project budget (if applicable);

Decisions made by other ethics committees or official bodies regarding the proposed study (if applicable);