Basis for Subject Selection
The Basis for Subject Selection portion of the Consent Form should be limited to a statement as to why the prospective subject is eligible to participate in the research project.
Basis for Subject Selection, which is referred to as “inclusion criteria” in the protocol, includes specific information about the characteristics or status of the subjects making them appropriate candidates for the study. The approximate number of subjects to be involved in the study may be stated. Criteria for subject exclusion also should be stated (for example, pregnancy, age limitations, health restrictions).