Commission on Medical and Biological Ethics at the Institute of Gastroenterology of the National Academy of Medical Sciences of Ukraine created for supervision in accordance with the basic requirements for the assessment of ethical and moral and legal aspects and safety, well-being of patients (healthy volunteers) during their participation in clinical trials of medicines and medical devices and research and dissertation work in public institutions “Institute of Gastroenterology of the National Academy of Medical Sciences of Ukraine”.
In its work, the Commission is guided by the legislation of Ukraine (Order of the Ministry of Health of Ukraine 23.09.2009 90690, Articles 7, 8 of the Law of Ukraine “On Medicinal Products”) and international ethical standards (Directive 2001/20 / EC of the European Parliament and of the Council of April 4, 2001, Helsinki Declaration (Ethical Principles for the Medical Study of Human Participation as an Object of Research), Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine).
The main tasks of the commission on bioethics:
- Protection of the rights and interests of subjects involved in clinical trials of drugs;
- Ensuring ethical and moral evaluation of clinical trial materials;
- Bioethical protection of laboratory animals used for research and dissertation work;
- Protection of the rights and interests of researchers.
Rules of procedure of the Commission on Biomedical Ethics:
- The form of work of the Commission on Medical and Biological Ethics is a meeting.
- The Commission shall meet as necessary in closed session with a quorum.
- In the absence of the Chairman, his Deputy shall act.
- Decisions are made by open voting.
- Meetings of the Commission on Biomedical Ethics are recorded as minutes of meetings and stored in the archives for at least 5 years.
- The results of the work of the Commission on Medical and Biological Ethics are drawn up in the form of an extract and communicated to the customer within ten days after the decision.
Chairman of the Commission on Medical and Biological Ethics – Inna Anatoliyivna Klenina, Ph.D., Head of the Research Sector
Secretary of the commission– Dolgikh Lyudmila Nikolaevna
Tel .: (0562) 27-59-16, fax: (056) 760-33-05; mob. tel .: (050) 056-78-42, (096) 727-90-60
e-mail: gastro@amnu.gov.ua website: gastro.org.ua;