Western IRB

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Overview

Western IRB (WIRB) is an independent commercial IRB located in Olympia, WA. It has been contracted to act as one of Rutgers Health Science's IRBs to review, approve and monitor all industry-sponsored human subjects research.

ANNOUNCEMENTS
  • Notice of Recent Documentation Changes – August 2014 Updates: Beginning September 1, 2014, there will no longer be a Board Chair signature on WIRB's letters that further outline decisions made by the Board. There is no regulatory requirement of this signature. The exception to this rule will be correspondence outlining the Board's decision on Waivers from HIPAA and certain Canadian correspondence where signatures are required. WIRB is eliminating this signature as a small part of its renewed commitment to efficiency and customer service. As always, we remain devoted to meeting the highest standards of regulatory compliance.

Requirements for WIRB Review

All of the following requirements must apply:

  • Study is industry-sponsored, that is, the industry sponsor has written the protocol, is funding the research, and will monitor the conduct of the study
  • The research will be conducted at a Rutgers performance site. (Site is owned and operated by Rutgers)
  • The investigator(s) is (are) Rutgers employees
  • The investigator(s) is (are) in good standing with the Rutgers Health Sciences IRB (e.g., no compliance issues, no expired studies, etc.)
  • All study personnel involved in human subjects research have completed the Collaborative Institutional Training Initiative (CITI) Basic Course

Circumstances Requiring Review of Protocols by a Rutgers Health Sciences IRB

Under the following circumstances, protocols may not be reviewed by WIRB and instead must be reviewed by a Rutgers Health Sciences IRB when:

  • the research will be conducted at a non-Rutgers performance site (such as a CINJ-affiliated site, VA affiliates, etc.).
  • the research will have or could be perceived as having significant local impact on the University’s host communities, requiring special sensitivity to the University’s host communities’ attitudes and culture, and/or sufficient knowledge of the local research context.
  • the research will be conducted by investigators who have current compliance issues or are otherwise not in good standing with a Rutgers Health Sciences IRB.
  • research requiring Institutional Biosafety oversight, such as research involving the following:
    • Infectious agents,
    • Recombinant DNA/human gene transfer,
    • or Biologically-derived toxins

How to Submit

All new, initial applications must be submitted electronically via eIRB. Make sure that you select WIRB as your IRB of record (campus).

WIRB will not accept applications submitted directly from investigators.

Submission Process

  1. PI complete application in eIRB and selects "WIRB" when asked to select the PI's campus.
  2. HealthSci Newark IRB will receive your submission and conduct a review.
  3. Submissions ready for WIRB review will be sent to WIRB by the HealthSci Newark IRB.
  4. Upon receipt by WIRB, WIRB will issue a tracking number via email, directly to the investigator, by which the investigator can track their application. 
  5. WIRB will also notify the investigator directly via email of the approval or disapproval of the study after the WIRB meeting.
  6. WIRB will arrange for monitoring ongoing research, as its policies and procedures require.
***WIRB will contact the investigator directly about any issues that may arise during the review process, and about those matters relevant to the conduct of the study once approved.

Guidelines, Procedures and Policies

Types of Fees Charged

  1. WIRB Fees
  2. One-Time Administrative Submission Service Fee of $750 for initial applications. Sponsors will be billed separately by the Newark HealthSci IRB.

Billing Procedure

RBHS researchers submitting to WIRB, whether initial applications, continuing review applications and/or modifications of human subjects research must indicate the name and address of the sponsor or the investigator in the “Billing Information” section of the WIRB submission form, in accordance with the Clinical Trial Agreement or study contract. This information will make clear to WIRB who will be responsible for paying the WIRB fees and whom WIRB should bill. If the CTA or study contract indicates that the sponsor will only reimburse the investigator for WIRB reviews, instead of the sponsor paying WIRB directly, the researcher must establish a purchase order payable to WIRB. The investigator must provide the number and mailing address to RBHS-Accounts Payable in the “Billing Information” section of the WIRB submission form. This ensures that WIRB invoices will be paid as required by RBHS accounting policy. The RBHS Institutional Review Board does not pay WIRB fees. In addition to the WIRB invoice, a one-time HSPP administrative submission service fee of $750 is charged for initial applications. Sponsors will be billed separately for this charge by the HealthSci Newark IRB staff. If the sponsor will only reimburse the investigator for WIRB-related expenses, the researcher must identify who will receive the invoice in the “Billing Information” section of the RBHS Application for Review by WIRB. The invoice will be forwarded to the individual responsible for processing payment through a Banner Index number.

In addition to the WIRB invoice will be a one-time Administrative Submission Service Fee of $750 for initial applications. Sponsors will be billed separately by the Newark HealthSci IRB. RBHS researchers submitting WIRB initial review application of human subjects research will indicate the contact information for billing the HSPP service fee in the “Billing Information” section of the RBHS Application for Review by WIRB.

WIRB Study Submissions

Continuing Review

WIRB will provide the investigator with a continuation notice before the expiration of the study.  All continuation requests must be sent directly to WIRB by the investigator using a WIRB Continuing Review Report Form (CRRF).

Modification/Amendments

All changes to the study must be submitted directly to WIRB by the investigator using a Research/Subject Recruitment Submission Form.

The Rutgers IRB must also be notified via an eIRB Modification Request Form, if you are making changes to any of the following: Principal Investigator, Study Personnel, Performance Site(s), Change in Investigator.

Adverse Events & Unanticipated Problems

In the event of an adverse event or unanticipated problem involving risk to subjects or others, the investigator must submit a Promptly Reportable Information Form directly to the WIRB.

If the occurrence is serious (deaths or life-threatening events) and occurred at a RBHS performance site, a copy of the WIRB report form must be sent to the RHS Institutional Review Board within twenty-four(24) hours of discovery.

Community Representation

The WIRB contract provides that, where additional knowledge of the community is required, representatives of Rutgers community may participate in WIRB reviews by teleconferencing.

WIRB Forms and Templates

All WIRB Forms and Templates (wirb.com)

Help

Contact the Newark IRB for all WIRB Related Inquires regardless of your assigned IRB.