Office of Research Integrity
Western IRB Submission Process
College of Medicine
The Medical University of South Carolina (MUSC) offers the use of the Western Institutional Review Board (WIRB) for multi-site corporate-sponsored clinical trials to all departments within the College of Medicine.
The MUSC IRB has designated two IRB Administrators as WIRB Liaisons to assist the researchers with the submission process. Investigators should review the below eligibility requirements as guidance prior to making a submission.
Studies Eligible for WIRB submission
1. The trial is a phase III or IV, multi-centered, industry-sponsored and an FDA regulated drug or device study.
2. The protocol must be written and designed by the sponsor (without any scientific contribution by MUSC faculty).
3. The study must meet the National Institutes (NIH) definition of a clinical trial (A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions [drugs, treatments, devices, or new ways of using known drugs, treatments, or devices]).
4. The sponsor of the research must be a for-profit entity/company.
5. The principal investigator must meet MUSC requirements to serve as PI on a research study.
6. The contract between the research sponsor and MUSC must be completed and approved.
Studies NOT eligible for review by WIRB:
1. Phase I or II clinical trials.
2. Investigator-initiated protocols.
3. Protocols funded by a Cooperative Oncology Group.
4. Federally funded protocols.
5. Protocols where the PI holds the IND/IDE.
6. Protocols collaborating with the Charleston VA. The study cannot involve the Veteran’s Administration (i.e. use of VA facilities, equipment, or patients), may not be collaboration with an employee of the VA during his/her VA tour of duty; and may not be used by an employee to fulfill VA responsibilities.
7. Protocols involving planned emergency research, xenotransplantation, gene transfer, or embryonic stem cells.
*NOTE: The MUSC IRB reserves the right to withhold any new research study from being sent to WIRB for review regardless of industry sponsorship.
INITIAL PROTOCOL SUBMISSION PROCESS
The MUSC investigator must prepare all required materials for initial submission and submit these to the MUSC IRB for authorization. The Request for Submission to WIRB form is a Word document available for download.
HOW TO SUBMIT REQUIRED DOCUMENTS TO MUSC IRB
Requests for institutional consideration of external IRB review for studies are submitted and documented through the eIRB system. The process has been designed to streamline as much as possible the actions required from the study team. At this time, however, eIRB does not interface with WIRB’s electronic application system.
The following items are required:
- Study Title taken from the protocol
- Short Title
- Brief description of the scientific or scholarly rationale
- Brief study summary
- Determination of whether this is a pilot study
- Selection of MUSC as the home institution
- Selection of External IRB Review
- Additional supportive documents required for upload
- Completed Request for Submission to WIRB Form
- WIRB Initial Review Submission Form
- Consent Document/s
- HIPAA Template (HIPAA Authorization may not be included in the ICF)
- CV for Principal Investigator and each Sub-Investigator
- Current professional license for PI, showing the expiration date
- Other materials being provided to subjects (advertisements, questionnaires, subject diaries, etc.)
- Conflict of Interest Disclosure Form
- If applicable, Hollings Cancer Center Protocol Review Committee approval
- If applicable, Radiation Safety approval
- If a DRUG/BIOLOGIC study, a copy of the following:
- Investigator’s Brochure
- FDA Form 1572 with WIRB listed as the IRB
- If a DEVICE study, provide device manual and ONE of the following:
- FDA letter granting the Investigational Device Exemption (IDE); or
- Letter from sponsor stating that the study is a non-significant risk device study; or
- Letter explaining why the investigation is exempt from the IDE requirements under 21CFR812.2(c) or otherwise exempt
MUSC PROCESS OF REQUEST FOR WIRB PROCESSING
After receipt of the submission, the MUSC IRB’s WIRB Administrator/Liaison will review the materials to ensure the following:
1. The research is appropriate for submission to WIRB and the PI meets the MUSC requirements to serve as PI on a research project.
2. The application is complete and includes all required WIRB documents as well as the required signatures.
3. The PI, co-investigators and key personnel have completed the required CITI human subjects training.
4. The contract between MUSC and the sponsor of the research is finalized.
MUSC’s designated WIRB Administrator/Liaison will respond in a timely fashion to the PI with a copy of an approved authorization form or items requiring resolution.
PLEASE NOTE: Submission to WIRB cannot proceed until the Request for Submission to WIRB Form is signed and provided to WIRB by the MUSC IRB. Western IRB requires that this authorization be included with the submission materials to WIRB, and will not process MUSC applications without documented authorization by designated MUSC staff (signed Request for Submission to WIRB Form).
Once the MUSC IRB authorizes submission to Western IRB, all materials will be sent by the WIRB Administrator/Liaison to WIRB via an electronic process. The PI (and/or designated contact) will receive a notice of MUSC IRB’s authorization of the submission to WIRB (signed Request for Submission to WIRB Form), along with confirmation that the study was submitted to WIRB.
WESTERN IRB PROCESS
After receipt of the submission, WIRB will work directly with the Principal Investigator (and/or designated contact person) regarding any questions, revisions, etc.
Once WIRB has approved the study, the IRB approval will be sent directly to the Principal Investigator (and/or designated contact) by WIRB. A copy will be sent concurrently to the MUSC IRB by WIRB.
Amendments: All amendments will be submitted directly to WIRB by the Principal Investigator and do not need prior authorization by the MUSC IRB. WIRB will submit approvals directly to the Principal Investigator (and/or designated contact). MUSC IRB may receive a copy of the approval.
Continuing Reviews: These applications will be submitted directly to WIRB by the Principal Investigator and do not need prior authorization by the MUSC IRB. WIRB will submit approvals directly to the Principal Investigator (and/or designated contact). MUSC IRB will receive a copy of the approval.
Adverse Events/Protocol Deviations/Unanticipated Problems: These applications will be submitted directly to WIRB by the Principal Investigator and do not need prior authorization by the MUSC IRB. WIRB will submit approvals directly to the Principal Investigator (and/or designated contact). MUSC IRB will receive a copy of the approval/outcome.
WIRB shall directly bill the sponsor for services rendered in accordance with its published fees in effect at the time that services are rendered.
MUSC IRB FEES:
The MUSC IRB charges a one-time fee of $1000.00 for the processing of industry-sponsored protocols submitted to the Western IRB for review. The contract agreement will include this fee to be paid to MUSC by the sponsor.
MUSC IRB Contact Information – WIRB Administrator/Liaison
MUSC IRB Contact Information – WIRB Administrator/Liaison
Jackie Shedrow, CIP
Paul J. Kelly
Western IRB Client Services Contact Information