Volume 20, Issue 61 (4-2026)
MLJ 2026, 20(61): 439-453 |
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Arzhang A, Alizadeh F, Fakhralsadati S E. A Jurisprudential-Legal Analysis of the Challenges of Criminal Liability of Physicians in Clinical Research. MLJ 2026; 20 (61) :439-453
URL: http://ijmedicallaw.ir/article-1-1932-en.html
URL: http://ijmedicallaw.ir/article-1-1932-en.html
1- Department of Jurisprudence and Law, Faculty of Humanities, Yasouj University, Yasouj, Iran.
2- . Department of Jurisprudence and Law, Faculty of Humanities, Yasouj University, Yasouj, Iran.
3- Department of Law, Faculty of Theology, Meybod University, Meybod, Iran.
2- . Department of Jurisprudence and Law, Faculty of Humanities, Yasouj University, Yasouj, Iran.
3- Department of Law, Faculty of Theology, Meybod University, Meybod, Iran.
Abstract:
Background and Aim: Clinical research, as an indispensable component of medical progress, gives rise to complex legal and jurisprudential challenges concerning the criminal liability of the researcher-physician due to its experimental nature and inherent uncertainty. This study aims to elucidate the foundations and elements of the researcher-physician’s criminal liability within the Iranian legal system and to analyze the challenges of applying general criminal statutes to such activities.
Method: This research was conducted using a descriptive-analytical method and library-based resources, including domestic laws and regulations (notably the Islamic Penal Code), jurisprudential texts, scholarly articles, legal treatises and international instruments (such as the Declaration of Helsinki).
Ethical Considerations: In the present study, ethical principles and integrity have been observed.
Results: The findings reveal that the foremost challenge is the legislative lacuna and the paradigmatic incongruity between the traditional framework of therapeutic physician liability (centered on certainty) and the nature of clinical research (centered on uncertainty and knowledge generation). Existing general criminal laws predominantly address the classical therapeutic relationship and their application to research activities encounters considerable interpretative and evidentiary difficulties. Establishing the tripartite elements of criminal liability (legal, material and mental) in this context involves specific nuances. The legal element is marked by the absence of dedicated criminalization. In the material element, distinguishing between research misconduct and inherent risk and in the mental element, differentiating scientific error from culpable fault, necessitate objective criteria and meticulous expert assessment. Although the informed consent of the subject is a necessary condition for the legitimacy of the research, it can only exert a mitigating effect with respect to disclosed risks and in the absence of fault; it does not constitute authorization for intentional or negligent acts. Furthermore, specific offenses such as breach of confidentiality and the issuance of false certificates are independently conceivable within this domain.
Conclusion: Solutions such as expansive interpretation of general laws or recourse to practical jurisprudential principles are neither effective nor principled, as they conflict with the principle of legality of crimes and fail to secure legal certainty. The appropriate remedy is a shift toward "specific legislation" and the enactment of clear, comprehensive statutes. Such legislation must explicitly define criminal conduct by recognizing the distinctive character of clinical research. Establishing an objective standard of fault based on international benchmarks, prescribing proportionate penalties and reinforcing the role of oversight bodies such as ethics committees are among the prerequisites of this law. This approach would both safeguard the rights and dignity of research subjects and ensure judicial security for responsible researchers, thereby promoting the advancement of medical sciences within an ethical framework.
Please cite this article as:
Arzhang A, Alizadeh F, Fakhralsadati SE. A Jurisprudential-Legal Analysis of the Challenges of Criminal Liability of Physicians in Clinical Research. Medical Law Journal. 2026; 20: e29.
Method: This research was conducted using a descriptive-analytical method and library-based resources, including domestic laws and regulations (notably the Islamic Penal Code), jurisprudential texts, scholarly articles, legal treatises and international instruments (such as the Declaration of Helsinki).
Ethical Considerations: In the present study, ethical principles and integrity have been observed.
Results: The findings reveal that the foremost challenge is the legislative lacuna and the paradigmatic incongruity between the traditional framework of therapeutic physician liability (centered on certainty) and the nature of clinical research (centered on uncertainty and knowledge generation). Existing general criminal laws predominantly address the classical therapeutic relationship and their application to research activities encounters considerable interpretative and evidentiary difficulties. Establishing the tripartite elements of criminal liability (legal, material and mental) in this context involves specific nuances. The legal element is marked by the absence of dedicated criminalization. In the material element, distinguishing between research misconduct and inherent risk and in the mental element, differentiating scientific error from culpable fault, necessitate objective criteria and meticulous expert assessment. Although the informed consent of the subject is a necessary condition for the legitimacy of the research, it can only exert a mitigating effect with respect to disclosed risks and in the absence of fault; it does not constitute authorization for intentional or negligent acts. Furthermore, specific offenses such as breach of confidentiality and the issuance of false certificates are independently conceivable within this domain.
Conclusion: Solutions such as expansive interpretation of general laws or recourse to practical jurisprudential principles are neither effective nor principled, as they conflict with the principle of legality of crimes and fail to secure legal certainty. The appropriate remedy is a shift toward "specific legislation" and the enactment of clear, comprehensive statutes. Such legislation must explicitly define criminal conduct by recognizing the distinctive character of clinical research. Establishing an objective standard of fault based on international benchmarks, prescribing proportionate penalties and reinforcing the role of oversight bodies such as ethics committees are among the prerequisites of this law. This approach would both safeguard the rights and dignity of research subjects and ensure judicial security for responsible researchers, thereby promoting the advancement of medical sciences within an ethical framework.
Please cite this article as:
Arzhang A, Alizadeh F, Fakhralsadati SE. A Jurisprudential-Legal Analysis of the Challenges of Criminal Liability of Physicians in Clinical Research. Medical Law Journal. 2026; 20: e29.
Keywords: Criminal Liability, Physician-Researcher, Clinical Research, Islamic Penal Code, Fault, Legal Gap
Type of Study: Original Article |
Received: 2025/02/24 | Accepted: 2026/05/3
Received: 2025/02/24 | Accepted: 2026/05/3
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