A section of the informed consent document that presents a concise and focused presentation of key information of the study to assist prospective subjects in understanding reasons to enroll in a protocol or not.

• The regulatory preamble lists 5 items that would generally be considered key information (but are not explicitly required as such by the regulations):
• that consent is being sought for research and that participation is voluntary; 
• the purposes of the research, the expected duration of the prospective subject’s participation, and the procedures to be followed in the research
• the reasonably foreseeable risks or discomforts to the prospective subject;
• the benefits to the prospective subject or to others that may reasonably be expected from the research; and 
• appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.