Introduction
Obtaining informed consent is one of the basic ethical obligations for all research involving human participants. Informed consent is not just a form. It is a process of information exchange that takes place between the participant and the investigator (or the study team), before, during and sometimes after the completion of the study. The amount of information that needs to be presented both in writing and verbally is directly related to the risk that the study presents and the complexity of the study design and related procedures.
Federal regulations state that all research "utilizing human participants requires the informed consent of those participants." These regulations apply to all research whether behavioral or clinical in nature.
Important Points to Consider
Before you undertake human subject research, there are two important points you must consider:
1. Creation of an informed consent process.
2. Developing an informed consent document.