Informed consent is a critical element of a good clinical trial. It's necessity and importance reach beyond clinical trial procedure and extend to the rights of patients and their essential comfort level.

In the USA and many other countries, state laws and federally funded and regulated studies require informed consent as a vital step in their conduct. As a participant in such studies, you are granted the right to clear, comprehensive information about your specific trial. You have the right to be informed of the possible benefits and uncertainties of the trial, and you, alone, will make the final decision whether or not you wish to participate in the trial.

Doctors and nurses are obliged to describe the trial and its components. You are then handed an informed consent form to carefully read and sign. If you decide to participate, you should sign the form; you can also decide not to participate at this point.

You should realize that the informed consent procedure in an ongoing process. You will constantly receive new information and updates after you enter a trial, and you can back out at any time, although you originally signed the consent form. It's entirely your choice to discontinue participation at any time during the study.