Ethical standard
The Regulation defines the purpose of establishing the Commission, its rights and scope of responsibility, and the fundamental principles of its operation. It also sets out the key requirements for assessing compliance with ethical, moral, and legal standards in research that may be conducted among the population or that uses existing data relating to individuals as research participants.
It covers: the procedure for determining the composition of the Commission; the procedure for planning and conducting Commission meetings and informing Commission members about meetings; the list of documents required for submission to the Commission; the procedure for submitting documents and the requirements for documents to be reviewed by experts; the timeframe for conducting a bioethical review; the procedure for adopting expert decisions; the nature of the decisions recorded in the Commission’s decision statement, and other related matters.
(1) Application for document review (online form);
(2) Research protocol;
(3) List and detailed description of the research methods and instruments;
(4) Informed consent form for participants;
(5) Confidentiality agreement form for the researcher (if required by the research design);
(6) Curriculum Vitae (CV) or background information of the Principal Investigator and members of the research team;
(7) Other supporting documents (if required by the research design or upon the Commission’s request).
Ethics Committee
The Ethics Committee of the Health Sciences Research Foundation public organization was established to protect the rights of individuals participating in research, minimize research-related risks, and ensure compliance with ethical standards and respect for human dignity in the planning and conduct of research involving human health.
The Regulation defines the purpose of establishing the Commission, its rights and responsibilities, and the fundamental principles governing its activities. It also establishes the basic requirements for assessing compliance with ethical, moral, and legal standards in research conducted with human participants or using existing data relating to individuals as research participants.
The Commission’s review procedure includes the receipt of an application and supporting documentation from the applicant, review of the submitted documents by the Commission during a meeting, appointment of responsible reviewers to conduct the ethical assessment, approval of the review results at a Commission meeting, notification of the applicant regarding the outcome of the review, and issuance of a decision statement.
World Medical Association Declaration of Helsinki: "Ethical Principles for Medical Research Involving Human Subjects" (available on the official website of the Verkhovna Rada of Ukraine).
Good Clinical Practice (ICH GCP) guidelines. A set of rules governing the planning, conduct, evaluation, and documentation of clinical trials of medicinal products; adherence to these rules ensures the accuracy of the data obtained, the protection of the rights of trial participants, and the confidentiality of their data.
A declaration adopted by the UN General Assembly on December 10, 1948, at the Palais de Chaillot in Paris. The Declaration was the result of the direct experience of World War II and represents the first global expression of the inalienable rights possessed by all human beings.
Developed by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). Ukrainian translation, 2018. The ethical principles set forth in these Guidelines should be adhered to during the ethical review of research protocols. The ethical principles are considered universal. Furthermore, the Guidelines should be read and interpreted as a whole. Some Guidelines contain cross-references to other Guidelines. The purpose of these cross-references is to assist the reader in navigating the Guidelines. However, the absence of cross-references to other Guidelines does not imply that other Guidelines cannot be applied.