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.
About MUSC’s Quality Improvement (QI) Self-Certification Tool
The MUSC Quality Improvement (QI) Self-Certification tool (login required) allows study teams to make the decision about whether their project constitutes the definition of research under the Common Rule (45 CFR 46) independent of the IRB. The tool is designed to help determine whether the project constitutes research or whether it is quality improvement or program evaluation, such that IRB review isn’t required. If, based on the questions and responses in the completed tool, the project does not constitute research, the tool provides a certification. This certification can be printed off and used as documentation that the project does not constitute research and further IRB review is not required. This certification takes the place of a formal submission in eIRB and subsequent certification notice from the MUSC IRBs. If completion of the tool indicates the project may require IRB review, any indication of certification from the tool is considered invalid.
For more information:
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.
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.
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:
- The electronic Change in Personnel Amendment must be submitted by the PI.
- The hard copy Conflict of Interest form (DOC) requires the PI's signature.
In eIRB, the PI completes this online in submitting the protocol for review.
Applications That the IRB Determines Are Not Ready for Review
When the IRB receives an application that is prepared in such a way that the proposed research procedures are unclear or large components of the application are missing, reviewers will be unable to provide meaningful comments and guidance. In such cases, the application will be withdrawn in eIRB, and recommendations for additional resources and guidance will be provided to the PI. Below are some examples of scenarios in which the IRB may determine that an application is not ready for review:
- Missing or inadequately prepared essential documents, including:
- Consent form(s)
- Questionnaire(s) or focus group materials when the main component of the study is the administration of that material
- Documentation needed to determine the engagement level of any off-campus study sites
- Drug or device documentation
- Inconsistent or unclear description of procedures such that the reviewers are uncertain of what is being proposed
- Project described does not seem to constitute research with human subjects as written
- Recurrent errors throughout the application and attachments to the extent that a detailed review and revision of the entire application is needed Information presented in the SmartForm is not in agreement with the information provided in the protocol, ICF and other supporting documents
When an application is withdrawn in this manner, the recommendation from the IRB is to:
- Seek help from the free on-campus research support services at the SUCCESS center
- Talk with Principal Investigator’s Mentor to receive guidance on how to provide a complete application.
- Set up a meeting with the IRB Administrator and Chair
*Please refer to the SUCCESS center website to request regulatory services.
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 National Cancer Institute (NCI) designation of the Hollings Cancer Center (HCC) and the HCC Protocol Review and Monitoring System, all MUSC patient-oriented human subjects research involving cancer patients or cancer-related aims (including cancer-related epidemiological or diagnostic trials involving healthy patients) must be reviewed by the HCC Protocol Review Committee (PRC).
In eIRB, protocols indicating use of either Hollings Cancer Center or is Cancer-related research will automatically be routed to the PRC. Any prospective cancer-related institutionally sponsored trial must be PRC reviewed and approved PRIOR to IRB review. This includes trials that are led by MUSC and have outside funding or support. All other prospective cancer-related studies may have PRC review and IRB review occur simultaneously. However, the HCC PRC approval must be obtained and submitted in eIRB before an IRB approval is released.
For more information about studies subject to PRC review and the PRC review process, please contact the PRC at 843-792-9247 or 843-792-1753. PRC information is also located on the MUSC Intranet (login required).
Effective July 1, 2017, the IRB charges the following fees:
Initial Protocol Review
No Sponsor - MUSC Faculty: $100
(There are no fees for trainees, students, or VA submissions.)
Industry Sponsored Studies
Initial Protocol Review: $2,500
Regardless of the level of review
Continuing Review (Annually): $750
Full Board & Expedited (does NOT apply to personnel* or administrative change): $500
*with the exception of change in PI
Reliance on an External IRB
The MUSC IRB charges a fee of $1000.00 for the processing of industry-sponsored protocols submitted to an external IRB for review.
MUSC Serving the as the IRB of Record for a multi-site trial.
$2,506 Initial Non-MUSC Site Review per site
$1,093 Annual Management per site