Any study that does not meet the requirements of the other levels of review (non-research, non-human research, exempt, or expedited review) must go to full board review in accordance with 45 CFR #46.108, 109 and must meet the standards outlined in 45 CFR #46.111 in order to receive approval from the full board.
Full board review is considered the default type of review. The other classifications and review types (e.g., exempt and expedited) represent special cases with specific parameters that must be met. Having your study called to full board does not automatically mean that there are major issues with your protocol. It may only mean that the study did not meet the specific criteria for another classification. Protocols in which investigators requested another level of review (e.g., exempt or expedited) may still be routed for full board review if the ORSP Office and/or IRB determines the study does not meet the criteria for that classification.
Also attach, if applicable