Special features of the legal status of the research subject in clinical testing of medicines

Abstract

Introduction: The issue of the content of the legal status of the research subject in clinical testing of medicines and its distinction from the patient’s legal status is of practical importance, related to the observance of ethical standards in the field of clinical trials, as well as ensuring the balance of public and private interests in this field. Although the subject of this study and the patient being treated are usually united in the intention to overcome the disease, these processes have different essence. The regulation of the legal status of the research subject should be done by legal means that are relevant to the nature of such trials and ensure the effective protection and security of the interests of these subjects. Normative regulation of the legal status of the research subject, unlike the patient, is insufficiently structured and characterized by fragmentation thus requires the doctrinal elaboration. The aim: The aim is to determine specific features of the legal status of the research subject and its difference from the patient’s legal status being provided with medical care; to reason about the necessity and content of propositions to amend the current legislation of Ukraine in order to ensure the rights and legitimate interests of the research subjects. Materials and methods: The authors used the judgements of the European Court of Human Rights (ECHR) on medical research, international and national regulatory acts, publications of scholars in the field of medical law. The research was carried out on the basis of the systematic approach using the methods of dialectical and formal logic, general scientific and specific legal methods of research. Conclusions: With the aim to ensure the proper legal protection of the rights and legal interests of the subjects of clinical trials the authors provided arguments for the need to amend the current legislation of Ukraine in order to correspond the international legal acts and ethical standards.