How Do You Write An Informed Consent?
An informed consent document is a vehicle in which to educate a person or his or her guardian about a clinical trial and enable them to legally take part in said study by signing the document. Most informed consents follow a standard template depending on the type of study being conducted. However, since they are required by law, there are 8 essential elements that all informed consents must have as defined by the Food and Drug Information. This article describes, in general, how to write these elements for informative purposes. Right of the bat, state that this study is research based. Typically, informed consent is not required for standard treatment modalities. Nevertheless, it is important to acknowledge this distinction immediately. Also explain why this is a research study, in other words, why is this study being conducted. Along the same lines, explain how the research will be performed. Think of questions that the potential participant may ask related to this topic, i.e. what d
