Legal Protection of Human Subjects through Informed Consent in Clinical Trials: An Analytical Study

Author

Asst. Prof. Kalichand B. Govardhan


Abstract

 Clinical trials are an essential component of modern medical research and contribute significantly to the development of new medicines, vaccines, medical devices and therapeutic interventions. However, clinical research involves human participants who may be exposed to physical, psychological, social and economic risks. The principle of informed consent has therefore emerged as one of the most important safeguards for protecting the autonomy, dignity, privacy and rights of human research subjects. Informed consent is not merely the signing of a consent form; it is an ethical and legal process through which a participant voluntarily agrees to participate in research after receiving adequate information regarding its nature, purpose, procedures, foreseeable risks, potential benefits and available alternatives.

In clinical trials, informed consent is a is a legal requirement for new drug discovery and treatment.

 The Indian Council of Medical Association’s makes a requirement for informed consent before undergone the medical treatment for new drug development. Fundamentally, both ethical and legally, subjects have the right to receive information and ask questions about treatment in clinical trials, so that subject can take a decision about clinical trials.



Keywords

informed consent, clinical trials, ethical and legal requirements, medical treatment. 



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References


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