General IRB Information

 

IRB Overview

All studies that meet both the ORHP definition of research and human subjects is required to be submitted through the IRB. There are three different levels of IRB study review: Full Board, Expedited, and Exempt. All three require a study application to be submitted. You can find more information about each below. Additional details about IRB submission can be found here. Additionally, you can be taken directly to the IRB homepage here. If it is your first time visiting, sign in with your NetID and password, and fill out the information.

PLEASE NOTE: Studies that qualify as quality improvement studies do not require IRB approval. You can access the self-assessment for MUSC quality improvement studies here. If you think your study may qualify as quality improvement, please reach out to Sam Bidwell or Dr. Akos Varga-Szemes for verification.

Types of IRB Applications

• Full Board: This review is required for research involving more than minimal risk to participants. Studies that involve vulnerable populations, such as children or prisoners, or procedures that might cause significant physical or psychological distress, are typically subject to full board review. The full board, consisting of diverse IRB members, convenes to discuss and vote on the approval of the research protocol. There are 3 separate boards at MUSC. For the Department of Radiology, all sponsored studies will be submitted to board 3, and all other non-sponsored studies will be submitted to board 1. If you are working on a full board study that is actively enrolling subjects, you are required to submit a Continuing Review to the IRB 30 days prior to the study's expiration date.
• Expedited: This review is suitable for research involving no more than minimal risk and for minor changes in previously approved research. Expedited review can be carried out by the IRB chairperson or designated experienced reviewers, rather than the full board. Examples include studies involving the collection samples from healthy adults, or non-invasive data collection methods.
• Exempt: Certain types of research are exempt from ongoing IRB review because they involve minimal risk and fit specific categories outlined by federal regulations. These categories include research on educational practices, surveys, interviews, or analysis of existing data where subjects cannot be identified. Despite being exempt, these studies must still be submitted to the IRB for a determination of their exempt status.
• Continuing Reviews: The IRB will conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.  The same criteria used for initial review of protocols will be followed during protocol renewal review.  This evaluation will include subject accrual and current status of all study participants, any study revisions (amendments) that have been approved by the IRB since the last review, any unanticipated problems, any subject complaints, any conflicts of interest, and any new information or findings relating to the risk/benefit assessment.  The informed consent process or document also be reviewed to determine if it is still acceptable or whether new information needs to be included as a result of the information provided to the IRB at the time the Continuing Review.

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