The Local Bioethics Committee of the Non-Profit Joint Stock Company "Karaganda Medical University" is an independent expert body under the authorized body that protects the rights, safety and well-being of subjects and researchers, as well as the ethical and moral and legal assessment of scientific research materials, the objects of which are a person or an animal.
The Commission in its activities is guided by:
1) Laws and regulatory legal acts of the Republic of Kazakhstan:
- The Constitution of the Republic of Kazakhstan;
- Code of the Republic of Kazakhstan dated July 7, 2020 "On the health of the people and the healthcare system";
- Order of the Minister of Health of the Republic of Kazakhstan dated 21.12. 2020 No. RK MOH-310/220 “On Approval of the Rules for Conducting Biomedical Research and Requirements for Research Centers”;
- Order of the Minister of Health of the Republic of Kazakhstan dated December 11, 2020 No. MOH-248/2020 “On approval of the Rules for conducting clinical trials of medicines and medical devices, clinical and laboratory tests of medical devices, preclinical studies for diagnostics outside a living organism (in vitro), and requirements for clinical sites and the provision of public services Issuance of a permit to conduct a clinical trial and (or) testing of pharmacological and medicinal products, MI”;
- Standard of Good Laboratory Practice (GLP), Annex 1 to the Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated 04.02. 2021 No. MOH-15 "On Approval of Good Pharmaceutical Practices";
- Good Clinical Practice Standard (GCP), Annex 2 to the Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated 04.02.2021 No. MOH -15 "On Approval of Good Pharmaceutical Practices".
2) International guidelines:
- Declaration of Helsinki of the World Medical Association "Ethical principles for conducting medical research involving a person as a subject"
– WHO Guidelines for the work of ethics committees that review biomedical research TDR/PRD/ETHICS/2000.1;
- CIOMS Guidelines "International Ethical Guidelines for Health Research Involving Humans";
- Report of CIOMS Working Group VI "Management of Safety Information from Clinical Trials";
- CIOMS Guidelines "International Ethical Guidelines for Epidemiological Studies";
- CIOMS Guidelines "International guidelines for ethical review of epidemiological studies"
- ICH GCP Good Clinical Practice;
- Convention on Human Rights and Biomedicine (1997);
- European Convention for the Protection of the Rights of Vertebrate Animals Used for Experimental and Other Scientific Purposes (1986);
To pass the examination, researchers need to prepare a package of documents presented below at the link (Documents for applying to the LBC) and send it to the mail for verification firstname.lastname@example.org marked "for the examination of the LBC".
Acceptance of documents for consideration by the Local Bioethics Committee of NCJSC "KMU" is carried out on Thursdays from 14:00 to 17:00 at Gogol 40, room 256. A consultation is underway, the time and date of the consultation must be agreed in advance using the contact details listed below.
Documents are accepted by the secretary of the Local Bioethics Committee, Zhanabaeva Aizhan Sabyrovna. Phone number: +77473468271.