The consent form/information sheet must be written in language “understandable to the participant.” The IRB reviews consent forms very carefully to ensure that they would be understandable to a wide ...

Note: The IRB must be provided with “sponsor verification” in the form of a letter signed by ... In seeking informed consent, the following information will be disclosed to the participant unless ...

The goal of the informed consent process is to ensure that the research subject is treated with respect and human dignity. The process does this by safeguarding and advocating for the subject's right ...

An investigator should seek informed consent only under circumstances that: provide the prospective participant or the participant ... provided the conditions described on the waiver form are ...