In some studies, all participants are in the experimental group. The FDA is the U.S. government agency that enforces laws on the manufacturing, testing, and use of drugs and medical devices. The FDA must approve a drug for marketing before it is made commercially available to the public. A human subject is a volunteer participant in a research study. Informed consent Informed consent is the participant's agreement to be in a study after being fully informed about what participating will involve.
Informed consent begins with a discussion between the researchers and the prospective participants.
Based on this discussion with the researcher, participants are asked to sign a consent form that includes this same important information in writing. Prospective study participants can take the consent form home to discuss it with family and friends before signing it. Once the form is signed, participants are given a copy of the signed consent form so that they can review it at any time. Participants should feel free to ask the researchers questions before, during, and after the study. Informed consent is an ongoing process.