The ethics of informed consent

Informed consent is vital to the conduct of clinical trials. The evolution of this process is reviewed. In the United States, specific steps must now be taken to assure institutional review bodies that all precautions have been taken to inform patients before they are enrolled in studies. These include (1) the procedure to be followed in the study, (2) the benefits for the individual, (3) the discomforts and risks that are reasonably expected, (4) the alternative methods of therapy, (5) the willingness of the investigator to answer inquiries, and (6) the right to refuse or to withdraw from the study without prejudice. The conditions are discussed in detail.