Obtaining informed consent is one of the basic ethical obligations for all research involving human subjects. 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.
Important Points to Consider
Before you undertake human subject research, there are two important points you must consider:
1. Creating an informed consent process
2. Developing an informed consent document