WIRB® Submission

The criteria for studies to be eligible for review by the WIRB include:

1. Research meets the 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)”. 
2. Research is a Phase II/III/IV clinical trial.
3. Protocol must be written and designed by sponsor.
4. The sponsor is a for-profit entity or company.
5. The sponsor holds all INDs/IDEs.
6. The research has not previously been submitted to the USA IRB for review.

Studies which involve any of the following are not eligible for submission to WIRB:

1. Phase I Studies (including I/II, studies)
2. Planned emergency research
3. Single patient emergency use or compassionate use situations
4. Embryonic stem cell or gene therapy research
5. Federally funded protocols
6. Protocols funded by a Cooperative Oncology Group/NCI sponsored trials
7. Investigator-initiated research
8. Industry sponsor that refuses to pay WIRB fees and/or the USA IRB fees
9. Research involving prisoners

USA may also require dual review by the USA IRB when the institution deems that the rights and welfare of subjects would be better served by local review.

How to Submit WIRB

Step	Action
Step 1: Investigator begins LOCAL processes for submission to USA IRB	WIRB Copernicus has partnered with IRBNet and the online submission portal will remain unchanged. Create a New Project in IRBNet Package 1: Upload the following items: USA IRB Part A Application IRB External Review Request Form (located in IRBNet) Sponsor Protocol   ICF with required USA Boilerplate language included PI must electronically sign package 1 for USA IRB local review All key personnel listed on Part A IRB application must have completed the required applicable human subjects training, ACRP (as applicable), and HIPPA for Research. Submit Package 1 for USA IRB pre-preview and acknowledgment. NOTE:   WIRB should be selected from the drop down menu and the WIRB link to the forms menu should be accessed for the appropriate submission forms.  Acknowledgment will be published in Package 1  NOTE:  Fees  IRB fees should be included in the study budget.  There is a one-time USA administrative review fee of $2000 for initial submissions. The contract agreement will include this fee to be paid to USA by the sponsor. The WIRB IRB fee schedule is available in the IRBNet Library WIRB will bill the sponsor directly, if allowed.  Include this information on the WIRB Billing Section of the Initial Review Form.
Step 2: Submission to WIRB	Create a New Package in IRBNet under the same project Package 2:  Standard Submission Requirements Include: Current WIRB initial review submission form (Note:  WIRB Institution #87329) site specific consent form PI’s current professional license (unless already on file) PI’s CV (unless already on file) site specific documents such as subject material and advertisements Attach acknowledgment from package 1 into package 2 - WIRB will NOT initiate protocol review until receipt of USA’s IRB acknowledgment. This acknowledgment will be published as a board document upon completion of USA IRB pre-review. Submit to WIRB Instructions on submitting your project are available from the WIRB website. (Access the WIRB Submission Forms)
Step 3: Review by WIRB	What happens after you submit Package 2 to WIRB? Package 2 will update from “work in progress” to “pending review” WIRB will issue a tracking number via email upon receipt of submission WIRB will contact the investigator/contact person directly with questions about the submission, and with determination of approval, modifications, or disapproval Once approved, all approval documents will be uploaded as published board documents in IRBNet.  Any questions that the PI/contact person may have regarding the WIRB review process should be directed to WIRB Consent Documents: For WIRB approved projects, the WIRB stamped consent document for enrolling subjects must be utilized.  The USA IRB is not the IRB of record for the protocol, and will not be USA stamped. NOTE:  Commencement of project should not begin until all approvals and the clinical trial agreement are in place

The WIRB is now the IRB of records for your study. You should refer to WIRB’s policy and procedures for their reporting requirements of continuing review, amendments, adverse events, protocol deviations, closure notifications, and any other submissions.

However, the USA IRB must still ensure adequate institutional oversight of research activities. Therefore, in addition to notifying WIRB, investigators should notify the USA IRB of any of the following events:

• Protocol deviations that may represent a systematic problem requiring local evaluation by USA IRB to determine that sufficient local resources are available for safe conduct of the study
• Study holds or suspensions that are not built into the study design from CIRB or Sponsor (eg: interim analysis or enrollment complete need not be reported)
• Study Closure
• Study Terminations from CIRB or sponsor
• Subject complaints
• Amendment to change PI or key personnel (NOTE: IRB Application Part A must be updated to reflect personnel changes)
• Conflict of Interest updates
• Breaches of confidentiality/HIPAA Privacy and/or Security violations
• Completion of annual check-in form (more information below)

Annual Check-In: This is not the same as a continuing review. Therefore, it may occur at a different time than the continuing review required by WIRB.

Project Personnel Updates: USA IRB application Part A should be updated, as needed, (i.e., study personnel, PI change and submitted to USA IRB)

Monitoring of WIRB approval protocols: WIRB will arrange for monitoring ongoing research, as its policies and procedures require.  The USA IRB/ Office of Research Compliance and Assurance may monitor any WIRB approved protocol as part of its quality assurance program.

Record keeping: Record keeping procedures for all files must be established, and WIRB documents, e-mail notifications, and other correspondence must be stored / filed as previously maintained through normal USA IRB approval.

The USA IRB local context consent language for WIRB provides an outline of sections which may need to be included in your consent form.  All sections may not be applicable, rather they are dependent on the study to be conducted. 

Review the USA IRB Local Context Language for WIRB to determine what specific USA language is required to be in the consent form. Generally, the HIPAA, Research Related Injury, Bill of Rights, ClinicalTrials.gov reporting, Reportable Income, and Source of Funding is required for the majority of studies.

USA IRB Local Context Consent Language for WIRB

Questions during Step 1 of submitting a new study- Submission to USA IRB for Pre-Review and for any USA IRB related issues:

 

SuzAnne Robbins
USA IRB Compliance Specialist
Office of Research Compliance and Assurance                                                                  Email: srobbins@southalabama.edu
Telephone: (251) 460-6308

Questions during Step 2 of submitting a new study- Submission to WIRB and for general questions while the study is open with WIRB:

WIRB Client Services
Telephone: (800) 562-4789
Email: clientservices@wirb.com
Web: www.wirb.com

Questions or concerns that WIRB Client Services cannot address:

Elaine J. Azarenko
Telephone: (360) 252-2446
Email: eazarenko@wirb.com
Web: www.wirb.com

WIRB Official Website

WIRB Reporting Forms

WIRB Investigator Handbook A Guide for Researchers

USA IRB Local Context Consent Language for WIRB

Instructions for Relying on Western IRB (WIRB)

IRB SOP 1101: Western IRB (WIRB)