How does Missouri State University define an enrolled subject?
The IRB considers a subject enrolled in a study when the subject signs a consent document. Any screening or testing done for research purposes to determine subject eligibility should not be conducted prior to the subject agreeing and documenting their consent to participate in the research (except where waiver approved). In cases where the IRB approves a waiver from the requirement for obtaining informed consent and/or a waiver from the requirement for documentation of informed consent, any individual on whom data has been collected should be counted as an enrolled subject.
