1- Department of Criminal Law and Criminology, Faculty of Law and Political Science, Karaj Branch, Islamic Azad University, Karaj, Iran. 2- Faculty of Law, University of Judicial Sciences and Administrative Services, Tehran, Iran.
Abstract: (283 Views)
Background and Aim:Clinical trial is one of the most important and most common interventional or experimental researches that is done in order to improve the treatment status of patients or to advance medical science. Due to the importance of the issue and prevention of harm and fatal complications to human subjects and protection of patients' right to health, there is a need for the Iranian legislature to provide a platform for criminal interventions and differential treatment of crimes committed in this type of medical research and in line with Protecting the rights of patients and medical research, the possible negligence of the researcher should also be addressed. In this article, by examining the national and international laws and regulations regarding clinical trials, we are trying to present a penal policy in accordance with the global standard models while expressing the existing legislative challenges. Methods:This research is of a theoretical type and its method is descriptive-analytical and the method of collecting information is library-based and referring to documents, books and scientific articles. Ethical Considerations:In all stages of the research, in addition to observing the principles of trustworthiness and impartiality, the authenticity of the texts and honesty have also been observed. Results:Considering the possible risks against human subjects as well as respecting the rights of patients, it is necessary that the legislator has a special look at clinical trials and in order to prevent any harm and danger, he is not satisfied with the generality of criminal liability and criminal laws and regulations specific to Establish this type of medical research. Conclusion: Of course, conducting clinical trials or any biomedical research in general to achieve therapeutic interventions is inevitable, but this does not diminish the need to pay attention to the health of patients. Also, in clinical trials that are conducted with the aim of advancing medical science, the rules should be such that the applicants to participate in the trial are not viewed as just subjects. For this reason, it is necessary that the legislator, in order to adopt an efficient criminal policy, is aligned in line with the professional standards that have been developed internationally by the World Health Organization or the International Council of Medical Sciences Organizations and the legislative, judicial and executive measures are dynamic and appropriate to the requirements approve the day in line with the criminal protection of patients' rights.
Samavati Pirouz A, Daroudi H. Iran's Criminal Policy Regarding Clinical Trials in the Light of International Documents. HLJ 2023; 1 (1) :1-13 URL: http://healthlawjournal.ir/article-1-43-en.html