Volume 19, Issue 60 (4-2025)
MLJ 2025, 19(60): 508-523 |
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Kolivand Z, Vaseghi M, Fallah Khariki M. Civil Liability Resulting from Human Subject Research in
Iranian and America's Law. MLJ 2025; 19 (60) :508-523
URL: http://ijmedicallaw.ir/article-1-1995-en.html
URL: http://ijmedicallaw.ir/article-1-1995-en.html
1- Department of Law, Ayatollah Amoli Branch, Islamic Azad University, Amol, Iran.
2- Department of Law, Payame Noor University, Tehran, Iran.
2- Department of Law, Payame Noor University, Tehran, Iran.
Abstract:
Background and Aim: Medical research involving human subjects, despite its essential role in advancing knowledge, is inherently associated with physical, psychological, financial and reputational risks to participants. Human research centers, as primary actors in the design, implementation and oversight of such studies, bear special civil liability for preventing and compensating harm. This article adopts a comparative approach to examine the nature, foundations and mechanisms of civil liability of such centers in the legal systems of Iran and the United States, aiming to clarify differences, similarities and practical challenges in compensating damages.
Method: This qualitative research employs a descriptive-analytical approach based on documentary and library sources in Iranian and America's Law.
Ethical Considerations: In the present study, the principles of integrity, honesty, impartiality and originality have been observed.
Results: Effective protection of research participants requires mandatory insurance and a unified compensation system in the United States, and in Iran, the strengthening of enforcement mechanisms and the adoption of risk-based compensation.
Conclusion: A comparative review shows that although both Iran and the United States largely base the civil liability of human research centers on the fault theory, their practical approaches and levels of protection differ. Iran’s legal texts and ethical guidelines provide broader provisions for compensating harm, but face implementation challenges, while the United States, despite having clearer frameworks for informed consent, offers more limited practical protection due to the absence of a unified compensation system and mandatory insurance.
Please cite this article as:
Kolivand Z, Vaseghi M, Fallah Khariki M. Civil Liability Resulting from Human Subject Research in Iranian and America's Law. Medical Law Journal. 2025; 19: e33.
Method: This qualitative research employs a descriptive-analytical approach based on documentary and library sources in Iranian and America's Law.
Ethical Considerations: In the present study, the principles of integrity, honesty, impartiality and originality have been observed.
Results: Effective protection of research participants requires mandatory insurance and a unified compensation system in the United States, and in Iran, the strengthening of enforcement mechanisms and the adoption of risk-based compensation.
Conclusion: A comparative review shows that although both Iran and the United States largely base the civil liability of human research centers on the fault theory, their practical approaches and levels of protection differ. Iran’s legal texts and ethical guidelines provide broader provisions for compensating harm, but face implementation challenges, while the United States, despite having clearer frameworks for informed consent, offers more limited practical protection due to the absence of a unified compensation system and mandatory insurance.
Please cite this article as:
Kolivand Z, Vaseghi M, Fallah Khariki M. Civil Liability Resulting from Human Subject Research in Iranian and America's Law. Medical Law Journal. 2025; 19: e33.
Type of Study: Original Article |
Received: 2025/06/14 | Accepted: 2025/09/9
Received: 2025/06/14 | Accepted: 2025/09/9
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