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Concept approval is limited to an IRB application for a funded project where the funding agency has approved an initial period of time for development of the final protocol, questionnaires, data forms, or similar activities. Since the IRB may not approve "draft" protocols or Informed Consent Documents, concept approval shows that the IRB has approved the study in concept only, so that the Division of Sponsored Programs can award the funds for the preliminary work. Concept approval is therefore an administrative tool. It does not indicate approval for the enrollment of human subjects.
Human subjects may not be enrolled in a project given Concept approval. Concept approval is given via the expedited review procedure. Refer to the section on submitting modifications to the HawkIRB application to learn more about changing a project from Concept to Regular approval once the investigator is ready to enroll human subjects.