Eurecnet - National Information: Ukraine

National Information: Ukraine

Historical background

In 1992, according to the Decree of the Supreme Rada of Ukraine from 22.11.91 № 1853-XII, Ukrainian Pharmacological Committee of the Ministry of Health (MoH) (now - State enterprise "State Expert Center of the MoH of Ukraine") was created. Its main task among others was to review clinical drug trials, to provide expert evaluation of submitted documentation for drugs (domestic and foreign) registration.

The structure of the Pharmacological Committee of the MoH of Ukraine included specialized expert committee on ethics. In 1995 it was reformed into Ethics Commission of Pharmacological Committee of the MoH, which provided ethical, moral and legal assessment of clinical trials of drugs.

In 2006, in order to protect rights and interests of subjects involved in clinical trials, as well as rights and interests of the researchers, and ensure ethical, moral and legal assessment of clinical trials according to the order of MoH of Ukraine № 485 from 17.07.2006, the Central Ethics Committee of the MoH of Ukraine was created, which was the successor of the Ethics Commission of the Pharmacological Committee of the MoH of Ukraine, and provided approvals for clinical trials.

In 2012, according to the order of the MoH of Ukraine № 255 from 11.04.2012, the activity of Central Ethics Committee MoH of Ukraine was stopped in order to conform with the Law of Ukraine “On medicines”.

In 1998, the Bioethics Committee at the Presidium of the National Academy of Science (NAS) of Ukraine was established for the purposes of research studies review and formation of national bioethics committees. In order to approve new research in research institutions (research projects and theses) it is necessary to ensure its bioethical review (if needed, bioethics committees are established at Scientific Councils of institutions).

With the aim of further bioethics development in Ukraine, the Bioethics Committee at the Presidium of the National Academy of Medical Sciences (NAMS) of Ukraine was created by the joint Order of MoH and the NAMS № 313/59 from 01.12.2000 “On further development of medical genetics and bioethics in Ukraine”. This Committee developed the General provision of Bioethics and Deontology Committee of the institution of the NAMS (which is not defined by regulations) only for research and healthcare institutions of the NAMS of Ukraine. According to this Provision, such Bioethics and Deontology Committees of the institution of the NAMS have the following tasks: systematic ethical review and evaluation of ethical, moral and legal aspects of all research plans and projects which are performed at research institutions of the NAMS of Ukraine (there are about 30 institutions) and their written approval.

Short description of REC system

There are about 400 RECs in Ukraine which can approve clinical trials. Their functioning is regulated by the Order of the MoH of Ukraine №690 from 23.09.2009 (with amendments).

Clinical trials of medical equipment and devices are reviewed by the Central Ethics Committee of the State Administration on Medicines and Drugs Control (The order of the MoH of Ukraine №616 from 03.08.2012). This document also describes the functioning of the local ethics committees which review clinical trials of medical equipment and devices. Order of MoH №630 from 10.10.2007 “On approval of Procedure for conducting clinical trials of tissue and cell transplants and examination of the clinical trials” aims to protect rights of the patients (volunteers), who are involved in clinical trials of tissue and cell transplants. This document also requires the approval of such clinical trials by a REC.

The current REC system of Ukraine includes:
• a) local RECs at health care facilities and scientific institutions which review:
  • clinical trials of drugs;
  • clinical trials of medical equipment and devices;
  • clinical trials of tissue and cell transplants.
  Among them there are above mentioned local committees at institutions which are subordinated to the NAMS of Ukraine – Bioethics and Deontology Committees.


• b) Bioethics Committee at the Presidium of the NAS of Ukraine whose functions include:
  • coordination of studies at institutions of the NAS and other institutions functioning in the fields related to bioethics problems;
  • analysis of the current state of scientific research related to bioethics issues in Ukraine and abroad, elaborating proposals pertaining to the most important and perspective directions in this field;
  • promotion of international collaboration in the field of bioethics;
  • publishing work, encouraging the publication of scientific works devoted to bioethical issues and increasing of national and global scientific communities’ awareness of bioethical research;
  • methodical and scientific support of institutions of the NAS in organizing research in compliance with bioethical norms and teaching bioethics courses in academic institutions;
  • organization of conferences, seminars, schools, symposia, National Congress on Bioethics;
  Bioethics Committee at the Presidium of the National Academy of Science of Ukraine currently does not review research projects.


• c) Bioethics Committee at the Presidium of the NAMS of Ukraine, whose functions include:
  • management and coordination of Bioethics and Deontology Committees of the institutions subordinated to NAMS;
  • methodological support and consultation of Bioethics and Deontology Committees of the institutions subordinated to NAMS.


• d) Central Ethics Committee of the State Administration on Medicines and Drugs Control, which can approve only clinical trials of medical equipment and devices.




Criteria of REC functioning

a) REC composition

Local RECs at health facilities which review clinical drug trials and clinical trials of medical equipment and devices should include no less than 5 persons – women and men (at least one person who is not a researcher, at least one person who is not an employee of the institution where REC was established).

Central Ethics Committee of the State Administration on Medicines and Drugs Control (reviewing only clinical trials of medical equipment and devices) should include no less than 5 persons – women and men (at least one person who is not a researcher). No less than 1 rotation per year should be performed.

RECs at research and academic institutions which review pre-clinical and other studies involving animals should consist of no less than 5 persons (RECs at research institutions subordinated to NAMS should include no less than 7 persons), but this is not regulatory binding. REC composition should be approved by the Director of the institution. It is recommended that such RECs include: a veterinarian experienced in laboratory work with animals,responsible for animals keeping in this institutions, researcher of this institution who is experienced in laboratory work with animals, institution’s employee who is not involved in the studies, lay member who represents society’s interests regarding animals keeping and use, a person who does not work with animals and is not an institution’s employee or close relative of any institution’s employee. However, these recommendations are not legally binding.

b) REC members’ election

Overall, the composition of RECs is formed and approved by the Director of the institution. Head, Deputy Head and secretary are selected at the first REC’s meeting by majority voting. The composition of Central Ethics Committee of the State Administration on Medicines and Drugs Control should be approved by the State Administration on Medicines and Drugs Control.

c) REC members’ background

REC members should have appropriate experience and qualification in order to oversee the assurance of research subjects’ rights, safety and well-being (in case of human studies) and to evaluate the ethical, moral and legal aspects of research. Specific qualifications or educational requirements are not defined.

d) Managing conflict of interests

There are no clear statements about managing conflict of interests in any regulatory documents or methodical literature. According to Good Clinical Practice Guidelines, only REC members who are not dependent on the investigator of clinical trials sponsor may participate in the research approval process. If the investigator is a REC member she or he may attend the REC meeting but cannot participate in the voting regarding approving of the research protocol.

e) Financing of the REC activities

Remuneration of REC members is not covered by any regulation or other requirements. According to legislation, organizational and technical support of RECs reviewing clinical trials should be provided by an institution.

f) Transparency
None of the RECs have their own web-site, however, some RECs publish at institution's web-site information which includes:
• statute of REC;
• composition;
• regulations (institutional documents);
• lists of documents required for submitting for ethics review;
• schedule of meetings.
Bioethics and Deontology Committee of the institution of the NAMS also publishes protocols of meetings at institution's web-site.
Any data about approved or rejected research protocols are available only to the authorized body (State Enterprise “State Expert Center of MoH of Ukraine” and MoH).




Research ethics and legislation

Biomedical research was first mentioned in the legislation of independent Ukraine in the Law of Ukraine “On Fundamental Legislation of Ukraine about Healthcare” (1992) Article 45 “Medical and biological experiments on humans”, which reads: “Medical and biological experiments on humans are permissible in case of its socially useful purpose, scientific validity, the benefits of the possible success of the risk of causing serious consequences to the health or life, publicity of experiment, fully, informed and voluntary consent of the person who is subject to experiment concerning its experiments conduction requirements, as well as maintaining a necessary medical confidentiality. Research experiments on the sick, prisoners of war and therapeutic experiment on humans which disease that has no direct connection with the purpose of the experiment without direct therapeutic benefit are prohibited. The procedure for conducting biomedical experiments is governed by the laws of Ukraine”. Later, in 2007, the phrase “voluntary consent of the person” was changed to “free consent of an adult capable individual”.

Further certain statements about biomedical studies were outlined in the Constitution of Ukraine (1996) in Article 28 “Everyone has the right to respect for his dignity” which indicates: “No one shall be subjected to torture, cruel, inhuman or degrading treatment or punishment. No human without his free consent can be subjected to medical, scientific or other experiments”.

In 1996, the Law of Ukraine “On Medicines” was developed and approved. It particularly contained a statement that clinical trials of drugs may be conducted after obligatory evaluation of their ethical, moral and legal aspects by RECs established and functioning at health care institutions where clinical trials are conducted.

In 2000, the "Model Regulations of the Ethics Committee" were approved by the order of the MoH of Ukraine from 01.11.2000 №281, which was further amended.

The Civil Code of Ukraine (2003) Article 281 “Right to Life”, p. 3 states: “Medical, scientific and other experiments can be conducted only on an adult, competentphysical person on the condition of his/her free consent. Clinical trials are conducted in accordance with the law”.

Article 321 of The Criminal Code of Ukraine (2012) established criminal responsibility for willful violation of the order of pre-clinical studies, clinical trials of drugs, falsification of results, and violations of the established order of state registration of drugs.

Based on the ICH E6 (R1) Guideline for Good Clinical Practice “Note for guidance on good clinical practice” (CPMP/ICH/135/95), guidelines “Drugs. Good Clinical Practice. ST-H MoH 42-7.0: 2008” were developed and approved by the MoH of Ukraine from 16.02.2009 № 95.

Also there is The Law of Ukraine “On Personal Data Protection” (2010) that regulates legal relations related to the protection and processing of personal data and is aimed at protecting the fundamental rights and freedoms of citizens, including the right to privacy in connection with the processing of personal data.

In Ukraine, there is non-equivalent regulation of human subjects’ research. Thus, the procedure of ethical review of clinical drug trials has the strongest legal regulation. Except of clinical trials, which are regulated by the Law of Ukraine “On medicines”, human research or biomedical research is not defined or regulated in general by any law.

In 2005, compliance with ethical and legal standards and requirements in the process of research became an essential element of scientific and academic staff attestation. On the 31st of March 2005, High Attestation Commission of Ukraine issued the Order “On additions to lists and forms of documents for attestation of scientific and academic staff” according to which decision of bioethics committee pertaining to ethical review of thesis research was included to the list of documents submitted to the Scientific Councils by candidates for an academic degree in medical, biological and veterinary sciences.

Networking between RECs

Ukrainian RECs act independently. Their subordination and coordination is not defined by the regulatory documents. However, according to the Statement of the Bioethics Committee of the NAMS of Ukraine, which has no regulatory power, Bioethics and Deontology Committees at the institutions of the NAMS are subordinated to the Bioethics Committee at the Presidium of the NAMS of Ukraine. Local RECs which review clinical trials of medical equipment and devices are under organizational and methodical management of the Central Ethics Committee of the State Administration on Medicines and Drugs Control. They should submit annual reports to the Central Ethics Committee of the State Administration on Medicines and Drugs Control, develop and submit proposals regarding temporary or final termination of the trial of medical devices at the health facility in case of violation of human subjects’ rights, safety and well-being, and ethical and moral principles.

In December 2016, in the State Enterprise “State Expert Center of the MoH of Ukraine” sector of coordination of ethics committees was established, whose responsibilities are to coordinate activities of ethics committees at health care settings, the training of their members, methodological support of these committees, the keeping of a register of ethics committees. This sector will provide the coordination and interaction of RECs at health facilities and Bioethics Committee at the Presidium of the NAMS of Ukraine.

National legislation pertaining to biomedical research in Ukraine

• The Constitution of Ukraine (1996) Article 28 (view)
• The Civil Code of Ukraine (2003) Article 281 (view)
• The Family Code of Ukraine (2002) Article 141 (view)
• The Criminal Code of Ukraine (2012) Article 321 (view)
• Decree of The Cabinet of Ministers of Ukraine « On approving the list of paid services provided to state and municipal health care institutions and medical schools» №1138 from 17.09.1996 (chapter 1 p.33) (view)
• Law of Ukraine «On Fundamental Legislation of Ukraine about Healthcare» (1992) Article 45 (view)
• Law of Ukraine «On Medicines», 1996 (Law) Articles6,7,8,12 (view)
• The Law of Ukraine «On Personal Data Protection» (2010) (view)
• The Law of Ukraine "On protection of animals against cruel treatment" (2006) (view)
• Guidelines «Drugs. Good Clinical Practice. ST-H MoH 42-7.0: 2008», approved by the MoH of Ukraine from 16.02.2009 № 95 (view)
• «Procedure for Conducting Clinical Trials of Drugs and Expert Evaluation of Materials of Clinical Trials», approved by order of the MoH of Ukraine №690 from 23.09.2009,with amendments (view)
• «Model Regulations of the Ethics Committees at health care settings which conduct clinical trials», approved by order of the MoH of Ukraine №690 from 23.09.2009, with amendments (view)
• «Rules for Conducting Clinical Trials of medical equipment and devices», approved by order of the MoH of Ukraine 03.08.2012 №616 (view)
• «Model Regulations of the Ethics Committees», approved by order of the MoH of Ukraine 03.08.2012 №616 (view)
• Order of the MoH of Ukraine №630 from 10.10.2007 «On approval of Procedure for Conducting clinical trials of tissue and cell transplants and examination of the clinical trials» (view)
• Order of the MoH of Ukraine №630 from 10.10.2007 «On approval of Procedure for Conducting clinical trials of tissue and cell transplants and examination of the clinical trials»
• Guidelines «Drugs. Good Laboratory Practice», approved by the MoH of Ukraine from 16.02.2009 № 95 (view)
• Guidelines «Drugs. Investigation of Bioequivalence", approved by the MoH of Ukraine from 12.01.2017 № 22 (view)
• Apendix 13 Guidelines «Drugs. Good Manufacturing Practice», approved by the MoH of Ukraine from 16.02.2009 № 95 with amendment (view)
• Order of the MoH of Ukraine N 944 from 14.12.2009 “On approval of the Procedure for onducting of pre-clinical studies of drugs and reveiwing of the materials of pre-clinical studies of drugs”. (view)
• Guidelines "Drugs. Pre-clinical studies of safety as a foundation for clinical trias involving humans and lisensing of drugs (ICH M3 (R2)) ST-N MoH 42-6.0:2014" approved by the Order of the MoH of Ukraine N 661 from 19.09.2014.

Authors: Maltseva Ia., Iankova L., Silantieva O., Ratushna K.

Contact: eurec@eurecnet.org