IRB Submission and Closure Processes

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.

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:

• Quality Improvement (QI) Self-Certification Tool

Tool For Determining IRB Level of Review for Secondary Use of Data and/or Specimens

This tool is designed to assist in understanding what level of Institutional Review Board (IRB) review may be required for studies in which the only research procedure(s) is secondary use of data and/or specimens.  The data/specimens must have already been collected for some other purpose (e.g., clinical care, quality improvement, or another research study) prior to being reviewed and obtained for use in the current study.

Once you have completed the survey, please click the "Submit" button for the option to download a copy of your responses and the corresponding guidance or to have a copy emailed to you.

• Tool For Determining IRB Level of Review for Secondary Use of Data and/or Specimens

Approved Protocols

Select the link appropriate to the type of activity to be communicated to the IRB.

ERMA 

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.

• Continuing Review

• Amendment

• Protocol Deviation Form (DOC)

• Adverse Event

The MUSC IRB is retiring the ERMA system.  Please use the ERMA to eIRB Conversion Guidance to convert your study to eIRB or scroll down to the IRB Study Closure Process section below for more information about closing your study in ERMA.

eIRB

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
• 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:

• 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.

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:
  • Protocol
  • 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.

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 log into the MUSC Intranet (login required).

Effective July 1, 2017, the IRB charges the following fees:

No Sponsor Initial Protocol Review

• MUSC Faculty: $100
  Expedited & Full Board Initial Protocols
  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: $750
  Annually or review period determined by the IRB.

• Amendments: $500
  Full Board & Expedited Amendments
  Does NOT apply to COI, personnel* or administrative change** unless requested by the sponsor.

  *with the exception of change in PI
  ** Administrative change as outlined in HRPP 3.6 Modifications to Approved Research