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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2010)

Informed Consent Process

R. K. Rishi

Introduction

Clinical trials are important in the process of drug development and may be conducted in healthy volunteers or patients depending on the objective. Recognising that risks are inherent to participating in a clinical trial, it is the common responsibility of all stakeholders involved in clinical trials to balance this risk with the potential benefits.
The drug regulatory agencies require that clinical trials must be "well-designed, well-conducted, performed by qualified investigators, and conducted in accordance with ethical principles acceptable to the world community". Before a clinical trial is initiated, the investigator should obtain the Ethics Committee’s approval for the written informed consent form (ICF) and all information being provided to the subjects and / or their legal representatives or guardians as well as an impartial witness. The information should be given to the subjects and / or their legal representatives or guardians in a language and at a level of complexity that is understandable to the subject(s) in both written and oral form, whenever applicable.

 

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