Western IRB (WIRB) is a commercial IRB under contract with Saint Louis University (SLU) to review eligible industry-sponsored, multi-center clinical trials. WIRB has formed partnerships with Affiliate IRBs (Copernicus Group, Aspire, Midlands and New England). Affiliate IRB studies that are part of the WIRB single review service (SRS) are available for central IRB reliance along with WIRB studies.
A clinical trial may be eligible for submission to WIRB if it meets all of the following criteria:
• Is an industry-sponsored, multi-center clinical trial
• Has already been pre-reviewed or approved by WIRB/Affiliate IRBs (submitted by sponsor or another site)
• Procedures take place at an authorized site (SLU, SSM Health SLU Hospital, and SSM Health sites)
• Is not an HUD
• SLU investigators do not hold the IND or IDE
• Study was not previously reviewed by SLU IRB
How do I get access to WIRB's system?
Investigators and regulatory support staff planning to submit to WIRB should request access to the WIRB CONNEXUS system (WIRB's electronic submission system) as soon as possible. This can be done on WIRB's website: www.wirb.com. Having WIRB CONNEXUS access will be necessary to submit to WIRB.
What steps do I take to submit to WIRB?
Step 1: Confirm that a study is eligible for WIRB review. Contact WIRB Client Services (firstname.lastname@example.org) to determine whether WIRB has the protocol (ask whether there is a WIRB protocol ID for that sponsor protocol). If WIRB or WIRB Single Review Service has the protocol, then review SLU eligibility criteria, above, to ensure submission to WIRB is allowable. Investigators are encouraged to consult with the SLU IRB Office to make eligibility determinations. Inquiries can be sent to email@example.com or call the IRB office at 314-977-7744. Note: it is recommended that you identify whether WIRB is acting as a "central IRB" for the study or a "local IRB" for the study. If acting as a central IRB, it is more probable that the sponsor/CRO will be willing to submit post-approval materials (such as protocol amendments) on behalf of the SLU site.
Step 2a: Investigator begins local processes necessary for all clinical trials at SLU. To get approval for submission to WIRB, the Clinical Trial Agreement (CTA) must be agreed upon and other necessary financial requirements must be met (for details, contact the Clinical Trials Office at 977-6335 or firstname.lastname@example.org). Note that the signed 1572 and signed SSM Health SLUH application must be submitted with the CTA for the SLUH review process, if applicable.
NOTE: If the study involves non Standard of Care radioactive materials, the RSC will need to review the study first. See the RSC webpage for more instructions.
When preparing study budgets, IRB fees should be included. There is a one-time SLU administrative review fee of $750 for WIRB studies which will be billed to the research department with the expectation that the sponsor ultimately provides payment. Additional WIRB review fees apply. WIRB fee schedules are available upon request to WIRB or the SLU IRB Office. WIRB prefers to bill the sponsor directly. Research teams should request a billing contact and permission for WIRB to bill the sponsor/CRO directly, and to include that contact information and supporting documentation in the WIRB submission.
All investigators listed on the study must also have annual disclosures on file with the conflict of interest office and must have completed training in human subjects research protections.
Step 2b: Prepare the SLU Central IRB Submission Authorization Form (SLU form) along with required attachments and submit to the SLU IRB office. The SLU IRB office facilitates the SLU administrative review process; submission to WIRB cannot occur until the Submission Authorization Form is approved. This process may occur concurrently with work on the CTA and financial arrangements.
Note that ONLY THE FOLLOWING DOCUMENTS will be required for the SLU Administrative Review Process:
• Completed SLU Central IRB Submission Authorization Form (SLU form)
• Completed WIRB Application (Initial Review Submission Form)
- A draft of the WIRB form should be provided to SLU IRB prior to submitting the application to WIRB. Make sure to list a sponsor contact in the billing section of the application and get documentation from the sponsor that they'll receive direct invoicing from WIRB.
• Sponsor's protocol, recruitment material, Investigator's Brochure/Package Insert/Device Manual
• Consent/Assent Documents previously approved by WIRB (WIRB can provide copy)
- SLU investigators will not be responsible for generating the SLU consents/assents. SLU has given WIRB required language for SLU consents, and any protocol specific language will be provided to WIRB as an appendix to the signed Central IRB Submission Authorization Form. WIRB staff will generate SLU consents/assents accordingly. You may want to provide SLU Injury Language (from SLU template consent) to sponsors in advance if there is reason to believe they will not accept it. All requests to deviate from SLU template injury language require review and approval by SLU OGC, so to save time, it is sometimes best to address this in parallel with the SLU administrative review process.
• HIPAA Documents
- SLU investigators will be responsible for drafting HIPAA Authorization Forms. Use the standard SLU template when preparing this document, and be sure to add the Central IRB to the list of PHI recipients. This document does not get submitted to WIRB.
The SLU IRB office will route materials to other SLU offices as needed (Clinical Trials Office, General Counsel, Biological Safety, Conflict of Interest, etc.) for review. However, if investigators are aware that approvals will be necessary from other offices or committees, they are encouraged to work with these groups directly as soon as possible to expedite processes.
If issues arise during SLU Administrative Review, the PI or study contact will be contacted and revisions may be requested.
Step 3: Submission to WIRB. Once SLU authorization (the signed Central IRB Submission Authorization Form) is received, the investigator can proceed with submission of materials directly to WIRB. The SLU Authorization Form with Appendix C should be included with the WIRB submission along with Departmental Letterhead for the consent materials and documentation that the sponsor will be directly billed for WIRB review fees. The HIPAA Authorization does not need to be submitted. The WIRB website and WIRB CONNEXUS system can be referenced for assistance in submitting materials (www.wirb.com). When asked if the research will be conducted through an organization which has a contract to use WIRB for services, insert "Saint Louis University" and our WIRB Institution Number: 74837.
Step 4: WIRB Review. WIRB will contact the investigator/contact person directly with questions about the submission, and with determinations of approval or disapproval. Once approved, all approval documents will be sent to the investigator. The SLU IRB Office is copied on correspondence. NOTE: WIRB will temporarily hold approval to allow SLU administrators and sponsors time to verify that the consent document contains all necessary information prior to release to investigators.
Step 5: Do not commence research until all institutional approvals are in place. Make sure that all institutional approvals and the clinical trial agreement are in place prior to beginning the study. IRB-stamped HIPAA Authorizations will be provided to the research team from the SLU IRB Office once central IRB approval is in place and consent materials have been accepted by the institution.
What do I need to do after approval?
WIRB and Saint Louis University each have responsibilities for overseeing this research, thus there are reporting requirements to both organizations. Reporting requirements are summarized in the Central IRB Post-Approval Submission Requirements table and described below.
SUBMISSIONS TO WIRB AFTER INITIAL APPROVAL:
Investigators should submit subsequent protocol documents, events or activities directly to WIRB according to guidelines provided by WIRB. Submissions to WIRB include:
• Protocol Amendments
• Continuing Review Requests*
• Unanticipated Problems (may or may not also be an SAE)*
• Safety reports or other event reports from sponsors that are not submitted to WIRB by the sponsor on the investigator's behalf*
• Closure Notifications
• Other submissions required by WIRB
Some sponsors/CROs will submit material on behalf of the SLU site; otherwise, the SLU research team is responsible.
* To fulfill monitoring responsibilities, copies of continuing reviews, safety event reports and site monitor reports should also be submitted to email@example.com.
SUBMISSIONS TO SLU IRB AFTER INITIAL APPROVAL:
To ensure appropriate institutional oversight of research activities, investigators should directly notify SLU IRB of the following events on WIRB protocols:
• SAEs that are not UPs (and thus not reported to WIRB)*
• Subject complaints not easily resolved by the research team*
• Breaches of confidentiality*
• Audit notifications*
• Monitor reports if not submitted to WIRB*
*Submit the above items in accordance with definitions and submission requirements detailed in the SLU IRB Requirements for Reporting Events Relating to Subjects/Subject Safety. SLU IRB will route information related to these reports to university officials as needed for review; however, investigators should also contact General Counsel and/or the SLU Privacy Officer when appropriate.
**Promptly submit these items to firstname.lastname@example.org. Changes to the local HIPAA Authorization form or research personnel should be submitted with tracked changes and approved prior to implementation.
Who should I contact if I have questions?
Questions about the WIRB process and SLU requirements should go to Emily Harrison at email@example.com or 314-977-7741.
Questions regarding WIRB submission and WIRB reporting requirements are best handled by contacting WIRB directly or by visiting www.wirb.com.