Conditions of Legality of Medical Human Subject Research

Abstract

The article examines international acts and national legislation and highlights the conditions for the legality of medical research with human participation.
 The provisions of the Nuremberg Code (1947), the Helsinki Declaration of the World Medical Association «Ethical principles for medical research involv- ing human subjects» (1964), the Universal Declaration on the Human Genome and Human Rights (1997), the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997) and the Addi- tional Protocols to the Convention, Regulation of the European Parliament and of the Council (EU) No 536/2014. The support of the recommendation to ratify the Convention on Human Rights and Biomedicine and its additional protocols in Ukraine has been expressed.
 It has been established that international acts stipulate that the design and implementation of each human subject research must be clearly described in the research protocol. In addition, research protocols must be subject to prior review by the Ethics Committees.
 It has been substantiated that international acts set for medical research standards, which are based on the principles of respect for dignity and human rights, the priority of interests of the person over the interests of society or sci- ence, compliance with safety requirements and prevention of harm to humans, mandatory permission to conduct medical examination, research and control- lability of the research process and its results, compensation for any damage caused by medical research.
 Conditions of legality of medical research can be divided into general (obser- vance of which is always necessary if a person participates in experiments) and special (additional conditions of legality, which are put forward depend- ing on the field or object of research, namely in the field of experiments com- bined with medical care , human genome research, in vitro embryo research, in the field of clinical trials of drugs).