Published on:Nov, 2015
    Journal of Pharmacy Practice and Community Medicine, 2015; 1(1):12-17
    Review Article | doi:10.5530/jppcm.2015.1.4

    Informed Consent: A Real Challenge in Clinical Trials

    Authors and affiliation (s):

    Singh Shivani1*, Bhati Savita1, Ratthi Rajiv2, Sethi Vandana1, Bhalla Vijay1

    1Lloyd school of pharmacy, Greater Noida-201306, (U.P.)-India.

    2IIMT College of pharmacy, Greater Noida-201306, (U.P.)-India.


    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.

    Key words: Informed consent, Agreement, Assent, Documentation, Clinical trials.



    Cite this article as

    Shivani S, Savita B, Rajiv R, Vandana S, Vijay B. Informed Consent: A Real Challenge in Clinical Trials. Journal of Pharmacy Practice and Community Medicine. 2015;1(1):12-7. Abstract