Peculiarities of Legal Responsibility for Offenses in the Field of Clinical Trials of Medicines

Abstract

The aim: Is to determine the features of legal liability for violations in the field of clinical trials of medicine remedies and justification of proposals to strengthen the protection of participants' interests in clinical trials through the use of various types of such liability. Materials and methods: The authors used the decisions of the European Court of Human Rights (ECHR) on medical research, international and national regulations, and publications of scholars in the field of medical law. The research was carried out on the basis of a systematic approach using the methods of dialectical and formal logic, general scientific and special legal research methods. Conclusions: In order to properly ensure the legal protection of public interests, as well as the rights and interests of research subjects and other entities involved in their implementation, the authors argue the need to use different types of legal liability.

Scientific Ethical Integrity and Human Research Subjects Protections Non-compliance Remediation: Commentary on Practical Considerations and Implications

“…[29][30][31][32] However, there is a 3rd informal option of Remediation, depending on whether the research is valuable, worthy, and can be redeemed through restitution and reclamation, restoration of trust, significant risk management, remorse and contrition, and establishing preventive plans of actions to avoid recidivism. [22,[33][34][35][36] Remediation offers scientific research institutions and agencies opportunities for reclaiming and salvaging otherwise worthwhile research studies that went astray due Human Research Subjects Protections noncompliance. [16,22,35,36]…”