Conditions of Legality of Medical Human Subject Research
Authors: Mendzhul M. V. 
Published: April 2021

The article examines international acts and national legislation and highlights the conditions for the legitimacy of medical research with human participation.

The provisions of the Nuremberg Code (1947), the Helsinki Declaration of the World Medical Association "Ethical principles of medical research with human participation as an object of study" (1964), the Universal Declaration on the Human Genome and Human Rights (1997), the Convention for the Protection of Rights and Dignity human rights in connection with the use of advances in biology and medicine: the Convention on Human Rights and Biomedicine (1997) and the Additional Protocols to the Convention, Regulation of the European Parliament and of the Council (EU) No 536/2014. The recommendation to ratify the Convention on Human Rights and Biomedicine and its additional protocols to Ukraine was supported.

It is established that international acts stipulate that the design and implementation of each scientific study with human participation as an object of study must be clearly described in the research protocol. In addition, research protocols must be subject to prior review by the Ethics Committees.

It is substantiated that international acts set standards for medical research, which are based on the principles of respect for dignity and human rights, the priority of its interests over the interests of society or science, compliance with safety requirements and prevention of harm to humans, mandatory permission to conduct medical research. research and controllability of the research process and its results, compensation for any damage caused by medical research.

Conditions of legality of medical research are divided into general (observance of which is always necessary if a person participates in experiments) and special (additional conditions of legality, which are put forward depending on the field or object of research, namely in the field of experiments combined with medical care, human genome research, in vitro embryo research, in the field of clinical trials of drugs).

Medical experiments are a necessary tool for medical progress, the invention of new drugs and methods of treatment, but their conduct cannot encroach on human dignity, which should be the main legal regulation of medical research. The legal basis for medical research is contained in international and national acts that must guarantee respect for the human person, his dignity, rights and freedoms. In the context of Europeanization of law in Ukraine, it is important to take into account international and European standards of legality of medical research with human participation, which necessitates the study. In the legal literature there are already a number of scientific papers on the analysis of ethical and legal foundations of medical research with human participation as foreign and domestic scientists. At the same time, the question of the legitimacy of medical experiments with human participation remains poorly understood and relevant. That is why the purpose of the article is to analyze international acts and national legislation in order to identify the condition of legality of medical research with human participation. Conditions for the legitimacy of medical research with human participation are established in a number of international acts, in particular: the Nuremberg Code (1947), contains ten principles (conditions) for conducting a medical experiment on humans; Helsinki Declaration of the World Medical Association "Ethical principles of medical research with human participation as an object of study" of June 1, 1964, which contains ethical principles of medical research with human participation as an object of study, including research on human materials and data can be identified; The Universal Declaration on the Human Genome and Human Rights of 11 November 1997, which sets out requirements in Article 5 for the study of the human genome; Convention for the Protection of Human Rights and Dignity in Respect of the Use of Advances in Biology and Medicine: Convention for the Protection of Human Rights and Biomedicine of July 4, 1997 (Chapter V defines the procedure for conducting scientific research); Additional Protocols to the Convention on Human Rights and Biomedicine (Additional Protocol on the Prohibition of Human Cloning of 12 January 1998, Additional Protocol on Transplantation of Human Organs and Tissues of 24 January 2002, Additional Protocol on Genetic Testing for Health) of 27 November 2008 and the Additional Protocol (ETS N 195) of 25 January 2005). Among these international acts, Ukraine has not yet ratified the Convention on Human Rights and Biomedicine and its additional protocols, which must be done as soon as possible.

Clinical trials can usually undergo many changes after their approval. These changes may relate to the behavior, design, methodology of the investigational or adjuvant medicinal product or the location of the clinical trial. If these modifications significantly affect the safety or rights of the subjects, the reliability of the data obtained in the clinical trial, they are acceptable subject to the procedure of their prior authorization (similar to the procedure of initial authorization). Regulation (EC) No 536/2014 of the European Parliament and of the Council of 16 April 2014 distinguishes between the terms "clinical trials" and "clinical trials". Thus, a clinical study is any study of humans that aims to: identify or test the clinical, pharmacological and other pharmacodynamic effects of one or more drugs; to detect any adverse reactions to one or more drugs; or to study the absorption, distribution, metabolism and excretion of one or more drugs; in order to establish the safety and / or efficacy of these drugs. A clinical trial means a clinical trial that meets one of the following conditions: the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within the normal clinical practice of the Member State concerned; the decision to prescribe the investigational medicinal products shall be made together with the decision to include the subject in the clinical trial or, in addition to the usual clinical practice, diagnostic or monitoring procedures shall be applied to the subjects. A clinical trial may be conducted only if: a) the rights, safety, dignity and welfare of the subjects are protected and outweigh all other interests; b) it is designed to obtain reliable data. Conducting clinical trials within the EU is possible only after obtaining a special permit.