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Office of Research Integrity

Submission Process

Click Here to Access eIRB

New Application - Determine the type of Application to Prepare

The Office for Human Research Protections (OHRP) provides Human Subject Regulations Decision Charts to guide IRBs, investigators and others to decide if an activity is research involving human subjects that must be reviewed by an IRB. The charts address decisions on the following:

  • whether an activity is research that must be reviewed by an IRB
  • whether the review may be performed by expedited procedures, and
  • whether informed consent or its documentation may be waived.

eIRB 21CFR Part 11 Compliance

Approved Protocols - select the link appropriate to the type of activity to be communicated to the IRB

ERMA has been in place since 2004. Any protocol with starting with HR (ex. HR11111) resides in ERMA. All Continuing Reviews, Amendments, Protocol Deviation and Adverse Event reports to be submitted on IRB-approved protocols with an HR number, should be entered in ERMA.

eIRB was activated in the fall of 2010. All protocols have a PRO prefix (ex. PRO00001111). All Continuing Reviews, Amendments, and reportable events to be submitted on IRB-approved protocols with PRO number, should be entered in eIRB.

Continuing Review
Amendment
Protocol Deviation
or eIRB
Adverse Event

Principal Investigator's Statement of Assurance

The Statement of Assurance certifies that the PI will carry out the proposed research in compliance with IRB policy.

In ERMA, this signature page is a separate document. If there is a change in PI of an approved study, then the new PI must submit a signed Statement of Assurance. The signed Statement of Assurance can be delivered or faxed to the IRB to complete the application process. By signing this statement, the PI's signature will no longer be required on IRB forms with two exceptions:

1) the electronic Change in Personnel Amendment must be submitted by the PI
2) the hard copy Conflict of Interest form requires the PI's signature    

In eIRB, the PI completes this online in submitting the protocol for review.

Guidelines for Research Involving Cancer patients, The Hollings Cancer Center (HCC) or Any Research Addressing Cancer

In accordance with the operational guidelines involved with the NCI designation of the Hollings Cancer Center and the Hollings Cancer Center Protocol Review and Monitoring System (PRC), the following procedures must be followed for securing approval to perform human subject research.

All protocols addressing any of these areas of research to be considered for full board, expedited or exempt IRB review must be reviewed and approved by the HCC Protocol Review Committee before IRB approval may be released.

In eIRB, protocols indicating use of either Hollings Cancer Center OR Cancer Patients will automatically be routed to the PRC.

IRB Fees - Effective August 2006, the IRB charges the following fees:

Initial Protocol Review
Industry Sponsored Study........................................$2500
No Sponsor - MUSC Faculty*......................................$100

*NOTE: There are no fees for trainees, students or VA submissions.

Continuing Review (Annually)
Industry Sponsored Study..........................................$500

Submission to Western IRB:

The Medical University of South Carolina (MUSC) is evaluating use of the Western Institutional Review Board (WIRB) for multi-site corporate-sponsored clinical trials. This project is available to all departments within the College of Medicine.

Please click Western IRB Submission Process for submission to WIRB.