DEPARTMENT OF SCIENTIFIC RESEARCH MANAGEMENT
1.1 science:
1.1.1. LOCAL ETHICS COMMISSION
chairman of the local commission on ethics
deputy chairman of the local commission on ethics
Secretary of the local commission on ethics
the local commission on ethics. Secretary
members of the local commission on ethics
* To item 1.1
Research management goals
Development of the direction of science defined in the strategies of the Ministry of health of the Republic of Kazakhstan and JSC "NCSC" to achieve the competitiveness of innovative medical technologies.
Tasks of the research management department
1) increase the share of scientific personnel trained in management and scientific research standards.
Systematic training in the following areas:
GCP relevant clinical practice
Research management
Relevant clinical laboratory practice-GCLP
GSP relevant scientific practice
2) development of scientific partnership.
Ministry of health of the Republic of Kazakhstan (agreements)
Ministry of Education and science of the Republic of Kazakhstan (certificate of agreements and scientific and technological progress)
Subordinate organizations of the Ministry of health of the Republic of Kazakhstan, the Ministry of Education and science of the Republic of Kazakhstan and representative offices of pharmaceutical companies.
3) implementation of scientific and technical programs.
Work within the framework of the program 009 "applied scientific research in the field of healthcare" :
"Scientifically based assessment of long – term consequences of the use of cellular technologies", cipher O 0454. implementation period 2008-2010 .;
"Study of the mechanisms of occurrence, development of scientifically based algorithms for the diagnosis and treatment of respiratory dysfunctions in chronic respiratory diseases", cipher O 0467. implementation period 2009 – 2011;
"Innovative technologies in the development of cell transplantation and restoration of functional activity of organs and tissues", code O 0519. implementation period 2010-2012.
"Innovative technologies in the diagnosis and treatment of progressive respiratory diseases". Implementation period 2012-2014
Works under the scientific and technical program within the framework of program-targeted financing of scientific and (or) scientific and technical activities:
The implementation period of" cellular innovative technologies in regenerative medicine " is 2013-2015.
The implementation period" stem (mesenchymal) cell transplantation in regenerative medicine " is 2017-2019.
217 work on grant financing of subjects of scientific and / or scientific and technical activities under the program" evaluation of the effectiveness of the use of a complex protein-amino acid and vitamin product (mare's milk) in the correction of immune status in autoimmune diseases " for the period of implementation 2018-2020.
4) obtaining scientific products and introducing new medical technologies into clinical practice.
* To item 1.1.1.
In accordance with the order of the chairman of the management board No. 139 dated October 17, 2006, a local commission on Bioethics was established at the Joint-Stock Company "National Scientific Medical Center". Over a long period of time, the local commission was created in JSC "NSC", one of the first in Kazakhstan, which works to this day.
To the present day:
In October 2016, Joint Stock Company "National Scientific Medical Center" (hereinafter referred to as JSC "National Scientific Medical Center") was accredited as a subject of scientific and (or) scientific and technical activities. Such services are provided to the order of the minister of Health and social development of the Republic of Kazakhstan dated June 29, 2015 No. 533 "on amendments to the order of the minister of Health and social development of the Republic of Kazakhstan dated March 10, 2015 No. 127" on approval of the rules of accreditation in the field of healthcare; Order of the Minister of health of the Republic of Kazakhstan dated November 19, 2009 No. 744" on approval of the rules for conducting clinical trials and (or) testing of pharmacological and pharmaceutical products, medical devices and medical equipment"; order of the Minister of health of the Republic of Kazakhstan dated November 12, 2009 No. 697" on approval of the rules for conducting medical and biological experiments, preclinical (non-clinical) and clinical trials"; as well as " relevant clinical practice. Basic provisions" and "relevant laboratory practice" in accordance with the state standards of the Republic of Kazakhstan, it is necessary to create a local Ethics Commission.
In accordance with this, by the order of the chairman of the management board of JSC" NSC", a local Ethics Commission (hereinafter referred to as the commission) was established and the regulations on the Commission and the composition of the Commission were approved. (Order No. 543 of December 7, 2016" on approval of the composition of the local commission on ethics of JSC" NNSMO").
The purpose of the commission's activities to ensure the protection of the health and well-being of persons participating in medical research is to establish guarantees of their safety and compliance with basic rights.
Tasks of the commission:
1) conducting an independent examination of documents for clinical studies of new medical technologies, medicines, pharmacological substances, medical equipment and medical devices;
2) independent assessment of safety and compliance with human rights at the stages of planning and clinical testing of new medical technologies, medicines, pharmacological substances, medical equipment and medical devices;
3) assessment of the compliance of the clinical research program with the relevant standards of clinical and scientific practice, as well as the qualifications of researchers and the technical equipment of the healthcare organization conducting this study;
4) assessment of compliance with international and national ethical standards in clinical studies of new medical technologies, medicines, pharmacological substances, medical equipment and medical devices;
5) participation in the development of documents on biological and medical ethics.
Functions of the commission:
The commission conducts an expert assessment of the investigator's brochure, clinical study protocol, patient information and agreed Information Form, professional experience of researchers, research centers, medical insurance documents of subjects and other clinical research materials for up to 30 calendar days.
The commission has the right to require the performers of a scientific study, including a person as a subject of research, to be registered in a publicly available database before accepting the subject of the first study.
Based on the results of the examination of the submitted documents and data, the following conclusions can be drawn:
Approval of clinical trials of new medical technologies, drugs, pharmacological substances, medical equipment and medical devices.
Approval of clinical trials of new medical technologies, medicines, pharmacological substances, medical equipment and medical devices with a proposal to make changes and additions to the materials of clinical trials of a drug in the working order. In this case, the conclusion is issued after answering the questions posed.
It is necessary to postpone the decision until the comments are eliminated, and then consider the materials of clinical trials at the next sic meeting.
It is not recommended to conduct clinical trials of new medical technologies, medicines, pharmacological substances, medical equipment and medical devices on the clinical basis of JSC "National Scientific and Medical Center".
The commission may require researchers, authors, sponsors, editors, and publishers to meet ethical obligations regarding the publication and distribution of research results. Researchers are required to make the results of their research on a human subject publicly available and are responsible for the completeness and accuracy of their reports. All parties must follow the accepted ethical guidelines. Negative and inconclusive, as well as positive results, must be published or otherwise made public. Sources of funding, institutional ties and conflicts of interest should be reflected in publications. Scientific reports that do not meet the requirements of the Notified Body and international principles of scientific ethics should not be submitted for publication.
The conclusion is submitted to the applicant and sent to the Ministry of Health and social development of the Republic of Kazakhstan to make a decision on conducting a clinical study of new medical technologies, medicines, pharmacological substances, medical equipment and medical devices.
If the applicant does not agree with the results of the examination, the commission reviews the clinical study materials with the participation of the applicant himself and independent experts.
Based on the results of its activities, the Commission annually sends a report to the Central Commission on ethics of the MHSD of the Republic of Kazakhstan.
The commission informs the media about the work carried out, the goals and objectives of the Commission and its role in protecting the rights of subjects, participates in the discussion of ethical aspects of clinical trials of drugs together with public organizations, supports and develops ties with the Ethics Commissions of other institutions.
The commission is involved in resolving ethical conflicts arising in the current work of a medical institution outside of research activities.
The commission monitors the compliance of researchers with the mandatory conditions for conducting clinical trials, draws up documents for life and health insurance of patients and volunteers participating in the study, and also ensures an ethical assessment of research materials.