Law and Forensic Medicine
Abdul Hassan Kazemi; Ali Eslamifar; Mohsen Saberi Isfeedvajani
Volume 1, Issue 1 , June 2024, , Pages 53-69
Abstract
Background and Objective: One of the stages of approval a drug or treatment method as a standard product or method in legal centers is clinical trial involving human samples. Since the efficacy of the tested drugs and treatments have not been proven yet, individual participating in these trials face ...
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Background and Objective: One of the stages of approval a drug or treatment method as a standard product or method in legal centers is clinical trial involving human samples. Since the efficacy of the tested drugs and treatments have not been proven yet, individual participating in these trials face inherent risks. therefore, ethics and law demand the protection for these people and the prevention of risks and the compensation for damages resulting from adverse events.Methods: In this article, the ethical and legal issues of therapeutic and non-therapeutic clinical trials are investigated and the model of the best method for conducting clinical trials from an ethical perspective is presented.Results: Biomedical researches are conducted in different methods and clinical trials on human samples face the most ethical and legal issues and challenges. Among the most important challenges are unacceptable risks to the participants, obtaining informed consent, especially for individuals without mental capacity and children, negligence and negligence of researchers and compensation for possible damages to the participants.Conclusion: By modeling to the regulations related to clinical trials on human samples in EU member countries, including England, not only the right to freedom and individual independence of humans is respected; Rather, the lives and health of the participants are also safegaurded. This dual focus is also emphasized in Islamic jurisprudence. The legal issues of the use of specific populations such as prisoners, children, patients and cognitively impaired adults has not escaped the attention of legislators in leading countries.
