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The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subjects questions, ensuring that the subject has comprehended this information, obtaining the subjects voluntary agreement
Principles of informed consent The patient must be mentally competent to give consent. Details of the research experiment or treatment must be fully disclosed. The patient must indicate his understanding of the information he received. The patient must comprehend that his participation is voluntary.
Function The nature of the procedure or intervention. The risks and benefits of the procedure or intervention. Reasonable alternatives. The risks and benefits of alternatives. An assessment of the patients understanding of these elements [10][11]
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