The Local Ethics Committee (hereinafter referred to as the LEC) of the non-state educational institution “Kazakhstan-Russian Medical University” (hereinafter referred to as the National Educational Institution “KazRosmeduniversitet”) is a collegial body that independently assesses the degree of compliance of proposals for conducting research in the field of health with recognized ethical standards in the Republic Kazakhstan.
LEK protects the rights, safety and well-being of subjects and researchers, and also provides an ethical and moral – legal assessment of scientific research materials, the objects of which are a person or an animal.
LEK operates in accordance with the principles of objectivity and independence from political, administrative, managerial, departmental, collegial, financial and economic influences.
In its activities, the LEC is guided by the following documents: Declaration of Helsinki of the World Medical Association “Recommendations for physicians involved in biomedical research involving humans”; “International Guidelines for the Ethical Aspects of Biomedical Research in Humans” Council of International Organizations for Medical Sciences (CIOMS); Guidelines and recommendations of the UNESCO Ethics Office (UNESCO Ethics Office), the World Health Organization (World Health Organization); Constitution of the Republic of Kazakhstan; Code of the Republic of Kazakhstan “On the health of the people and the healthcare system.”
In addition, the LEC takes into account the current international regulations and acts of the Republic of Kazakhstan related to the activities of committees on ethics and research involving people or animals as participants (Universal Declaration on the Human Genome and Human Rights (UNESCO), Universal Declaration on Bioethics and Human Rights (UNESCO), European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (ETS No. 123),Declaration on Human Cloning (UN), Convention for the Protection of the Rights and Dignity of Man with regard to the Application of Biology and Medicine, Convention on Human Rights and Biomedicine (Oviedo Convention) and its additional protocols concerning the prohibition of human cloning, transplantation, biomedical research)
Target:
The main goal of the LEC is to consider and ensure compliance with ethical standards in the conduct of research related to health.
Tasks:
- Assessment of compliance of research documents related to health (including those involving animals) with ethical standards established by the legislation of the Republic of Kazakhstan;
- Consideration of issues related to compliance with ethical standards in the conduct of research related to health (including with the participation of animals), at the stage of their planning and conduct;
- An independent evaluation of the scientific merit of a health-related research project and its review in terms of ethical acceptability;
- Assessment of scientific validity, perceived efficacy and safety (risks) in health-related research;
- To promote the dissemination of bioethical principles in health research and further study of issues arising from their application and the development of related technologies;
- Performing peer review of research to ensure compliance with the legal requirements for such research. Legal aspects include observance of inalienable humanitarian human rights and fundamental freedoms in accordance with international human rights standards (rights to respect for human dignity, privacy, life and health, information), as well as civil rights (to receive medical care and refusal, to informed consent).
Chairman of the LEC – Doctor of Medical Sciences, Professor Mansharipova M.T. (Secretary of the Academic Council)
LEC Secretary – Ph.D. Severova E.A. (chief specialist of the department of scientific work)
Contacts: e.severova@medkrmu.kz
LEK members – representatives of the teaching staff NUO “KazRosmeduniversity”, students of “KazRosmeduniversity” and the public.
The decision of the LEC is NOT issued by the secretary, but directly by the members of the LEC, the secretary prepares and issues a documented decision of the LEC in the form of an extract.
Document forms for submission to LEC
List of documents to be submitted to LEK MUA (in paper and electronic versions):
A detailed list of documents (dates and version numbers) is attached to the dossier in paper (1 copy) and electronic form.
The electronic version is sent in one archived letter to e.severova@medkrmu.kz, with the last name and within which the work is performed (for example, Bekbergenovamaster student.zip or Bekbergenovamaster student .rar.).
Each document in the archive folder must be properly named (for example, Bekbergenov’s Application, Bekbergenov’s Application, Bekbergenov’s Protocol, etc.). After checking the electronic version, if there are any comments, it is necessary to correct them within 3 working days and send the complete corrected set of documents, i.e. not only the corrected version. After the electronic version is accepted, hand over the paper version of the documents in 1 copy at the address: Almaty, Abylaikhan Ave., 51/53 room. 804, having previously coordinated the meeting with the secretary. Documents must be signed, must be provided in a folder, separated by separators, in the order of the list below.
Important!!! Documents sent by mail that do not comply with the above recommendations will not be checked.
Important!!! Investigators are required to submit documents BEFORE START. Project leaders and principal investigators must submit documents MINIMUM 10 working days before the deadline for submitting documents to the competition.
List of documents for R&D involving a human as a research subject without intervention (prospective):
- Application addressed to the Chairman of the LEC;
- Application for primary examination;
- Research abstract (for dissertators and applications for the competition);
- Information for the participant;
- Informed consent with information for the patient/healthy volunteer, provided in Kazakh and Russian;
- For studies involving minors, relevant documents with information and an informed consent form for a parent (legal guardian), for a teenager 14-17 years old and (if available) adapted information for a child from 10 years old). (Form A-3);
- Questionnaires, questionnaires, scales, etc., intended to be filled in by the research doctor (if any);
- Diaries, questionnaires, questionnaires, etc., to be filled out by patients participating in the study (if any);
- Research participant card (if any);
- Case registration forms;
- Research budget, justification;
- Research contracts.
List of documents for R&D involving a human as a research subject without intervention (retrospective):
- Application addressed to the Chairman of the LEC;
- Application for primary examination (Annex 1);
- Research abstract (for dissertators);
- Research protocol (Appendix 2) and accompanying documents:
- Information for the organization;
- Informed consent forms for the organization;
- Research participant card (if any);
- Case registration forms;
- Resume of the researcher (CV) and his supervisor (in the case of a dissertation research).
List of documents for R&D involving a human as the subject of an intervention study:
- Application addressed to the Chairman of the LEC;
- Application forms for primary examination;
- Research abstract (for dissertators);
- Research protocol (Appendix 2) and accompanying documents:
- Information for the participant;
- Informed consent with information for the patient/healthy volunteer, provided in Kazakh and Russian;
- For studies involving minors, relevant documents with information and an informed consent form for a parent (legal guardian), for a teenager 14-17 years old and (if available) adapted information for a child from 10 years old). (Form A-3);
- Document on the guarantees of respect for the rights of patients participating in the study in case of harm to their health during the study;
- Materials, including promotional materials that inform about the study and used to attract patients to participate in it, instructions for the use of drugs and devices (if any);