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, either as a recipient of the test article or as a control. Informed consent Informed consent is the participant's written agreement to be in a study after being fully informed about what participation will involve.
Informed consent begins with a discussion between the researchers and the prospective participants.
An IRB is a committee, comprised of medical, scientific and non-scientific members, whose responsibility it is to review all research projects involving human subjects being considered by an institution. The primary purpose of the IRB review is to assure the protection of the safety, rights and welfare of the human subjects. Placebo A placebo is an inactive substance. In blinded studies it is usually made to look like the active product. The principal investigator is the individual responsible for the conduct of a clinical trial at a trial site.