What is the difference between Expedited and Exempt?
Studies that qualify for a Claim of Exemption that fall within one of the designated categories as determined by the federal regulations (45 CFR 46.101 (b)) may be submitted to the IRB to concur with the investigator’s claim. It is the IRB’s policy that studies that are approved as exempt are exempt for the life of the study. However, if there is a change in the research, e.g., procedures, recruitment, consent documents, etc., the investigator must submit an amendment to the Claim of Exemption for review and approval. The study’s being determined exempt means neither that the protection of research subjects does not apply nor that the basic ethical principles of The Belmont Report (Respect for Persons, Beneficence, and Justice) do not apply to the exempt research.
