Risks & Benefits

All subjects need to understand how the study that they are volunteering for will affect them. Although there are sometimes unexpected results when trying a new intervention, subjects should be aware of all consequences, both positive and negative, as much as can be predicted. The intentions of the study, how the study may affect subjects and the necessary procedures are usually communicated in the form of a written informed consent document. This document is explained in detail to the patient and signed to indicate agreement to participate. Under special circumstances; usually for telephone interviews, verbal scripts may be used to provide informed consent. Subjects have the right to refuse to participate in a trial and may discontinue their participation at any time.

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