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Office of Research Integrity

WIRB

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 Phase III-IV 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 for a 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 before the study can be submitted. 

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.

Principal Investigator or PI Contact Pre-Submission Activities:

  1. The PI or PI Contact submits EPDS with Sponsor Agreement/Budget through his/her Department to ORSP.
  2. Prior to beginning the application process, the PI or PI Contact registers with WIRB to establish a login and password at WIRB.com website, and the applicant will receive instructions to call WIRB Client Services (800-562-4789) to receive his/her system login and password. This ID and password will be used for any contact the PI or PI Contact has with Connexus for any studies on which he/she works, similar to the ID/password system used to access MUSC’s eIRB system.
  3. Once a study has been identified for submission, the PI or PI Contact contacts WIRB Client Services to determine if the protocol has already been approved by WIRB.
       - If the protocol has been previously approved by WIRB, obtain the WIRB-assigned study number for inclusion in the application and the WIRB application for New Investigators should be completed. Previous review by WIRB considerably minimizes the Smartform data entry requirements for MUSC study staff.
       - If the protocol has not already been approved by WIRB, complete the WIRB application for New Protocols rather than that for new investigators.
  4. Initial applications are not submitted directly to WIRB. Instead, complete the WIRB application and uploads it into eIRB for MUSC IRB review.

NOTE: The application can be submitted for MUSC IRB review prior to the completion of the contract process but will not be uploaded to WIRB by the MUSC IRB until the contract has been finalized.

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 for studies which have not yet been reviewed by WIRB:

  1. Study Title taken from the protocol
  2. Short Title
  3. Brief description of the scientific or scholarly rationale
  4. Brief study summary
  5. Determination of whether this is a pilot study
  6. Selection of MUSC as the home institution
  7. Selection of External IRB Review
  8. Additional supportive documents required for upload:

·   WIRB Initial Review Submission Form

·   Protocol

·   Consent Document/s (Informed Consent Template  - please note: the grey-shaded language in the template is required)

·   HIPAA (HIPAA Authorization may not be included in the ICF [template ])

·   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 Committee approval

·   If a DRUG/BIOLOGIC study, a copy of the following:
   - Investigator’s Brochure
   - FDA Form 1572 with WIRB listed as the IRB
   - Evidence of active IND (either FDA letter or IND number on protocol cover)

·   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

The following items are required for studies which have been previously approved by WIRB:

1.     Study Title taken from the protocol

2.     Short Title

3.     Brief description of the scientific or scholarly rationale

4.     Brief study summary

5.     Determination of whether this is a pilot study

6.     Selection of MUSC as the home institution

7.     Selection of External IRB Review

8.     Additional supportive documents required for upload

·   WIRB Initial Review Submission Form Consent Document/s (Informed Consent Template  - please note: the grey-shaded language in the template is required)

·   HIPAA (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

·   Conflict of Interest Disclosure Form

·   If applicable, Hollings Cancer Center Protocol Review Committee approval

·   If applicable, Radiation Safety approval

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 and the sponsor’s commitment language regarding study related injury within the ICF has been verified.

MUSC’s designated WIRB Administrator/Liaison will respond in a timely fashion to the PI with a list of items requiring resolution or confirmation that the protocol has been uploaded to WIRB for review.

Western IRB requires authorization from the MUSC IRB WIRB Administrator/Liaison to be included with the submission materials and will not process MUSC applications without documented authorization by designated MUSC staff.

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 confirmation that the study was submitted to WIRB.

WESTERN IRB PROCESS

WIRB will work directly with the Principal Investigator (and/or designated contact person) regarding any questions or revisions.

Once WIRB has approved the study, the approval will be sent to the MUSC IRB for verification that all required language has been included in the documents. If documents are not complete, the MUSC IRB WIRB Administrator/Liaison will work with WIRB and the PI (and/or designated contact) to make the necessary changes. Upon the MUSC IRB’s authorization to release, all documents 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.

After study approval and release, WIRB will work directly with the PI (and/or designated contact) for the following:
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 FEES:

WIRB shall directly bill the sponsor for services rendered in accordance with its published fees in effect at the time that services are rendered.

If the sponsor does not remit payment to WIRB within 60 days, the study team can be billed by WIRB for services 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

Jackie Shedrow, CIP
Shedrow@musc.edu
792-3071

Paul J. Kelly, CIP
kellypj@musc.edu
792-6534

Western IRB Client Services Contact Information

www.wirb.com
1-800-562-4789
clientservices@wirb.com

Further guidance is available in the eIRB system at http://eirb.healthsciencessc.org/hssc/ in the "Education and Training Material" at the left.