Informed Consent for Clinical Drug Trials: Introspection to the Human Right Issues

  • Dr. Nikhilesh N.
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  • Dr. Nikhilesh N.

    Assistant Professor at School of Legal Studies, Kannur University, Kerala, India

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To regulate the doctor-patient relationship, the doctrine of informed consent has been established as a legal principle. This requirement consists of two distinct, but related legal obligations imposed on physicians: the first is to provide patients with information, and the second is to obtain their consent before administering treatment. Most doctors are hesitant to tell their patients about their disease, the treatment they are receiving to cure it, as well as the treatment's consequences and side effects. To compel physicians to inform patients about their illnesses, a strong legal framework is required. The doctrine of informed consent does not have the same application in the case of human trial and treatment. In treatment, a doctor extends the patient's knowledge about a known medicine and cure. But in the case of human trials, even the doctor cannot predict the results of such medication. If we analyse the international legal regime that regulates human experimentation, the entire process is regulated by this doctrine. From the Nuremberg Code to the Helsinki Declaration, informed consent is the unique standard upon which the trial is legalized. The doctrine of informed consent does have many limitations in regulating experimentations on human beings even though it is considered as a good tool to overcome the problem of medical negligence. Human rights issues in clinical drug trials are examined in this article.


Research Paper


International Journal of Law Management and Humanities, Volume 6, Issue 6, Page 320 - 343


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