Politic on bioethics of scientific research

The policy on bioethics of scientific research is designed to uphold bioethical principles, protect rights and security, and ensure compliance with humane, moral, and legal standards during scientific studies, experimental developments, and clinical trials involving patients (healthy volunteers), their biomaterials, and experimental animals.

The policy is based on:

  •   The Constitution of Ukraine;
  •   The Universal Declaration on Bioethics and Human Rights (UNESCO, 2005);
  •   The Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000);
  •   The International Ethical Guidelines for Health-related Research Involving Humans (Prepared by CIOMS in collaboration with WHO, 2016);
  •   The Nuremberg Code (1947);
  •   Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the Approximation of Laws, Regulations, and Administrative Provisions of the Member States relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use;
  •   Declaration of Helsinki (WMA General Assembly, 1964) – "Ethical Principles for Medical Research Involving Human Participants";
  •   European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (1986);
  •   The Law of Ukraine No 3447-IV (21.02.2006) "On the Protection of Animals from Cruel Treatment";
  •   The Law of Ukraine No 2297-VI (01.06.2010) "On Protection of Personal Data";
  •   General Ethical Principles of Experiments on Animals (First National Congress on Bioethics, 2001);
  •   The Order of the Ministry of Health of Ukraine No. 426 (26.08.2005) "On Approval of the Procedure for Examining Registration Materials for Medicinal Products Submitted for State Registration (Re-Registration), as well as the Examination of Materials on Making Changes to Registration Materials During the Validity of the Registration Certificate";
  •   The Order of the Ministry of Education and Science, Youth and Sports of Ukraine No. 249 (01.03.2012) "On Approval of the Procedure for Conducting Experiments on Animals by Scientific Institutions"; 
  •   The Order of the Ministry of Health of Ukraine No. 690 (23.09.2009) "On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Examination of Clinical Trial Materials and the Model Regulations on Ethics Committees";
  •   Other relevant regulatory legal acts on bioethics in scientific research.



Manuscript authors of scientific studies, experimental developments, or clinical trials involving patients (healthy volunteers), their biomaterials, or experimental animals must provide the editorial board with an expert conclusion from the Bioethics Commission of the institution where the research was conducted. The editorial board reserves the right to request such conclusions based on the review results and assessment of the presented data if human participants or experimental animals were involved in the research.