PHARMACOLOGY

 INFORMED CONSENT FORM ::

To be ethical they must evolve the Informed Consent Form of participating human subjects They are closely supervised by appropriate regulatory authorities All interventional studies must be approved by an Ethical Committee or the Institutional Review Board before permission is granted to run the trial 

            Informed Consent Form is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action The individual needs possession of relevant facts and also of his reasoning faculties such as not being mentally retarded or ill and without an impairment of judgment at the time of consenting Such impairments might include illness intoxication insufficient sleep and other health problems 

        The Ethics Committee or the Institutional Review Board is an independent body in an institute carrying out the clinical trial consisting of healthcare professionals and non -medical members whose responsibility it is to protect the rights safety and well being of human subjects involved in the trial and to provide public assurance of that protection by among other things expressing an opinion on the clinical trial protocol the suitability of the investigators involved in the trial and the adequacy of facilities and on the methods and documents to be used to inform trial subjects and obtain their informed consent 

Clinical trial of a drug can be divided into four phases 

Phase I : First in the human study 

Phase II : First in the patient study 

Phase III : Statistical evaluation 

Phase IV : Field trials and comparative trials