Is Longer Always Better?(Case Study‪)‬

A team of researchers proposes to conduct a study in which participants will be randomized to one of two versions of an informed consent form in order to compare their usefulness. Many argue that consent forms for research studies are often seriously flawed. They are growing in length and complexity, becoming ever more intimidating, and perhaps inhibiting rather than enhancing participants' understanding. Participants may not even read them, much less understand them. The study is part of a larger project aimed at developing a new treatment for avian influenza. The goal of the protocol is to find ways of generating and collecting viral antibodies from the blood of healthy subjects after injecting them with an avian flu vaccine. The vaccine--already approved by the Food and Drug Administration at a lower dose--has been studied in about 450 people. The approximately 150 people participating in the new study will receive the highest dose used in previous studies, which about fifty people have received without serious side effects. They will be randomized to have the vaccine injected into either their buttocks or an arm to see which location is better for producing viral antibodies. Blood will later be drawn on three or more occasions so that researchers can extract antibodies.