Article 227. Biomedical Research Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

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1. Biomedical research may be conducted on living humans and experimental (laboratory) animals (subjects of the study), biological samples of living and deceased humans and animals, as well as on the basis of the use of clinical and epidemiological data and other medical information.

Biomedical research includes fundamental and applied biomedical research. Applied biomedical research includes biomedical experiments, preclinical (non-clinical) research, clinical research, and public health research.

2. The creation of human embryos for biomedical research purposes and human cloning are prohibited.

3. Biomedical research of human embryos or human fetuses, during which or after which the human embryo or human embryo is destroyed, is prohibited.

4. Clinical trials are conducted on condition that positive results of biomedical experiments and preclinical (non-clinical) studies are obtained.

5. Applied biomedical research can only be conducted if the following requirements are met simultaneously:

1) biomedical research is aimed at obtaining new scientific data and introducing them into practical healthcare;

2) the interests of the research subject are protected and the confidentiality of their medical information is ensured;

3) the consent of the research subject or his legal representative has been obtained to participate in the study or use his biological samples and medical information, including for filling out a biobank for scientific purposes;

4) interventional clinical trials of medicines and medical devices are conducted with the permission of the authorized body.

6. For the following categories of persons, biomedical research is conducted only when it cannot be conducted on other persons and there are scientific grounds to expect that participation in such biomedical research will bring them direct benefits outweighing the risks and inconveniences associated with biomedical research:

1) minors;

2) pregnant women;

3) the incapacitated;

4) students in cases where participation in biomedical research is related to their studies;

5) old-age pensioners in need of outside help;

6) military personnel and employees of law enforcement and special state bodies, civil protection bodies;

7) staff of medical organizations where biomedical research is conducted;

8) persons held in institutions of the penal system.

Interventional clinical trials on the categories of persons specified in the sub-paragraphs 1), 2), 3), 4) and 5) of paragraph 6 of this article, are conducted only to study the therapeutic effect.

Interventional clinical trials on the categories of persons specified in subitems 6), 7) and 8) of paragraph 6 of this article are prohibited.

7. Upon receipt of written consent to participate in a biomedical study, information must be provided to a volunteer or patient, the legal representative of a minor, or the guardian of an incapacitated person.:

1) about medical technology, pharmacological or medicinal product, the nature and duration of medical research;

2) the degree of safety, risks and expected effectiveness of a medical technology, pharmacological or medicinal product;

3) actions in case of unforeseen effects of the use of medical technology, pharmacological or medicinal products on the state of health;

4) about the terms of health insurance.

At the same time, before starting research, a volunteer or patient, the legal representative of a minor, or the guardian of an incapacitated person should be informed about the possibility of refusing biomedical research at any stage of the study.

8. Biomedical research is stopped at any stage.:

1) at the request of a minor participating in the research, his legal representative, guardian of an incapacitated person, patient or volunteer;

2) in the event of a threat to the life or health of a volunteer or patient, a minor, or an incapacitated person.

9. A positive conclusion of the bioethics commission is a prerequisite for conducting biomedical research, and for interventional clinical research, documents on life and health insurance of the study participant are also required.

10. The rules for conducting biomedical research and the requirements for research centers are determined by the authorized body.

11. The rules for the application of new methods of diagnosis, treatment and medical rehabilitation are determined by the authorized body.

The Code of the Republic of Kazakhstan dated July 7, 2020 "On the health of the people and the healthcare system

President

Republic of Kazakhstan

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