Application Information

The IRB review data and deadline page at the Medical University of South Carolina (MUSC) provides essential dates for IRB meetings, submission deadlines, and important timelines for researchers submitting their studies for review. It details the schedule for Full Board reviews, noting specific submission deadlines to ensure studies are considered at the next available meeting. This information helps researchers plan and prepare their submissions to meet compliance and regulatory requirements. For full details, visit the MUSC IRB dates page.

The MUSC IRB provides several templates that investigators can use when creating protocols and informed consent documents. You can access these templates here.

CITI training is very important for the appropriate conduct of clinical trials and all research staff are required to complete training courses from research assistants all the way to physicians. The website you need to visit is located here. If prompted, log in with your NET ID and password. Then you will follow the directions on the web page. You will need to complete two courses: Group 1 Biomedical Investigators and Key Personnel, and GCP for Clinical trials with Investigational Drugs and Biologics (ICH focus). Please ensure that you take the basic courses and not the refresher or else you will need to do it again. It is important that the information (including email address) that you use for CITI training matches your IRB account information exactly so that your CITI training will correctly transfer into the IRB system.

The Research Master ID provides unique numeric identifier that links a research study across multiple MUSC electronic research systems. The purpose of the RMID is to allow for accurate identification of research studies, improve tracking and reporting of institutional research metrics, and increase data accuracy across the system.

The SPARCRequest (Services, Pricing, & Application for Research Centers) is a web-based research management system that provides a central portal to researchers and their study teams to browse for research services and resources as well as submit service and pricing requests with a focus on billing compliance and proposal/budget development. Some studies require that a SPARC protocol be created to process applicable reviews and requests. For more information, please contact research staff.

Any full board or expedited studies dealing with human subjects are required to have a PRA review completed by the Office of Clinical Research (OCR) prior to study initiation. This should be initiated via SPARC as soon as possible to avoid delays with study approval. This involves creating a request in SPARC to initiate the PRA process, as well as uploading applicable documents (protocol, budget, ICF, Contract, etc.). After the process has begun, a representative from OCR will follow up with further instructions. Below is the OCR policy on the PRA process:

“All human subjects research studies are required to have a PRA review to ensure compliance with federal billing regulations. All studies determined by IRB review to be IRB Exempt will be automatically deemed as PRA Exempt. A PRA review includes an objective analysis of all MUSC Health services and funding sources associated with a research study and a determination of what can and cannot be billed to third party payers using the National Coverage Determinations (NCDs) and the Local Coverage Determinations (LCDs) adopted by the Centers for Medicare and Medicaid Services (CMS), as well as clinical care guidelines. The PRA is used by the MUSC Health Revenue System as the source of truth to ensure items are billed correctly to third party payers, the patient, or the study account.”

Salaried MUSC employees must complete a conflict-of-interest disclosure annually – with the information disclosed corresponding to the preceding twelve months. MUSC’s yearly disclosure cycle is April 1 through 30. If an individual employee’s business/financial relationships change or develop during the course of the year, they must modify their conflict of interest disclosure within 30 days to reflect the change.

If you are uncertain if you need to disclose a relationship, please contact our staff.

If you are aware of an employee who has a conflict of interest but has not disclosed the relationship, contact a member of our office or call the confidential hotline at 800-296-0269 to report your concern.

Any MUSC employee who gives talks to outside groups or organizations for which they receive payment, an honorarium or reimbursement for travel must update their annual conflict of interest disclosure. Prohibited activities include speakers’ bureaus and promotional speaking.