nformed Consent: A Real Challenge in Clinical Trials

Abstract

Informed consent is an agreement to do something or to allow something to happen only after all the relevant facts are known. It has a long history starting from early 1947 to till now with recent amendments. Informed consent play a major role in the clinical trials and is crucial factor on which the success of any clinical trials is dependent. It is classified in several types like parental consent, Assent, Verbal and short form among which to get a informed consent in assent type is a real challenge. Assent is a child's (7-17yrs of age) affirmative agreement to participate in research and must be written at the appropriate reading level of the youngest subject in the age range using simplest terminologies. This review article discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent.