Study of The Legal and Jurisprudential Status of The Clinical Trial Contract

With the development of biomedical research, we are observing the emergence of new issues and, consequently, new legal challenges that it is necessary to study with legal and jurisprudential standards. A Clinical Trial is a kind of experimental research and the most valid type of research to prove the cause and effect relationship between therapeutic intervention and treatment. These types of research have wide jurisprudential and legal dimensions. Informed consent is the process by which a participant or their legal representative sees and understands information about the trial and agrees with it. Ambiguity in the legal status of the informed consent of the person participating in Clinical Trials is a challenge that requires attention and accuracy. The research method of this article is descriptive-analytical, and the method of collecting information is based on the library method. The study findings show that by comparing the consent of Clinical Trials (different from medical consent) with legal bases, it is clear that the specific status of the consent and its conditions and characteristics are such that it should be studied in the framework of indefinite contracts. The contract is generally subject to the general rules of the contract and is specifically subject to other relevant provisions in this field, including the "Ethical Guidelines for Clinical Trials". By examining the jurisprudential arguments and legal rules, it can be said that concluding Clinical Trial contracts to test a new method of treatment or medicine on the physical integrity of the volunteers is permissible even if there is minor or severe damage under particular conditions. Because often, these contracts are concluded in the direction of something rational and expedient interest