Bioethics committee members:
Bioethics committee at the State Institution «Sytenko Institute of Spine and Joint Pathology NAMS of Ukraine» was created by the Institute’s director order No. 38 “o” from 2001.05.21; it was reorganized by order No. 24 “о” from 2015.01.13. Bioethics committee works as a public association none like legal entity, guided by the Regulations of the Bioethics committee. (Orders & Thesis)
Bioethics committee meetings are held on Mondays at 1400 in the institute audience as the materials for bioethics expertise are accumulated.
Functions of the Bioethics committee:
- To provide an expert work on the assessment of conformity of scientific and clinical studies in the Institute according to bioethics rules and norms which are regulated by international agreements as well as national laws and normative requirements.
Main tasks of the Bioethics committee:
- To protect rights and safety of patients involved into clinical trials as well as the rights and interests of trial researchers;
- To protect animals from cruel treatment at scientific experiments as well as the safety of researchers and staff involved into the experiments process, other humans and the environment from the adverse effects of scientific studies;
- To protect human rights and dignity in case of using of dead people anatomical materials in scientific experiments as well as the rights and interests of researchers involved in the work with these anatomical materials.
Materials for bioethical expertise
- Scientific studies at the planning stage and after its final
- Dissertation manuscripts at the planning stage and after its final
- Clinical trials of medicinal products (projects, substantial protocol amendments, annual and final reports, etc.)
- Clinical trials of medical devices (projects, specialized assessment of research findings)
- Animals experimental studies
- Articles for printing in professional journals, other materials for publication
The order of materials submission for bioethical expertise
For bioethical assessment of scientific study materials at the planning stage (research works, dissertations, initiatives, etc.) the following documents must be submitted:
- Application of the Institute’s Scientific Council or study researcher addressed to the Chair of the Bioethics committee (sample statement);
- Study project or abstract-justification (plan-design) of the manuscript or initiative study indicating the objects, methods of study and treatment;
- Form of Informed consent from a patient or the patient’s parents in case of using of non-standard study and treatment methods (forms).
- Agreement on scientific and practical cooperation between the SI «Sytenko Institute of Spine and Joint Pathology NAMS of Ukraine» and co-executing institution in case of collaboration.
For bioethical assessment of scientific study materials at the final stage the following documents must be submitted:
- Application of the Institutes Scientific Council or study researcher addressed to the Chair of the Bioethics committee;
- Materials of the research findings (report, manuscript, article for publication, etc.).
For bioethical assessment of clinical trial materials the documents must be submitted is specified in «The procedure for conducting clinical trials of medicinal products and assessment of clinical trial materials…» (Order of the MH Ukraine No. 690 from 2009.09.23 with all amendments).https://zakon.rada.gov.ua/laws/show/z1010-09
Bioethics committee has the right to request additional materials and information from researchers in case of need to fulfill their responsibilities to qualified bioethical assessment.
PhD Barkov Oleksandr
PhD Pidgaiska Olga
PhD Nikolchenko Olga