Western IRB (WIRB)

wirb

The UIC has entered into an agreement with the Western Institutional Review Board (WIRB) to become the IRB of record for Industry Sponsored Clinical Trials. The WIRB is AAHRPP accredited, conducts rigorous reviews of the materials provided to them, and ensures that the informed consent and HIPAA Authorization documents meet the institutional requirements set forth in the memorandum of understanding between UIC and WIRB. Western IRB will also serve as the Privacy Board for research protocols sent for their review and approval.

WIRB

Which research studies qualify for submission to WIRB?

Studies eligible for review by the WIRB include:

Phase II / III / IV clinical trials (sponsor holds all INDs/IDEs).
Research protocol is designed and written by the sponsor.
The sponsor is a for-profit entity or company (sponsor must agree to pay subject injury costs).
The research has not previously been submitted to the UIC IRB for review.
The research is greater than minimal risk.

Certain studies may not be eligible for review by the WIRB. For additional information, please refer to the Policy.

Research involving minors may qualify for submission to WIRB depending on the design of the study. The OPRS WIRB Administrator will review the Protocol Synopsis to determine eligibility. Please note that UIC IRB review may be required when the institution deems that the rights and welfare of subjects would be better served by local review.

Registration of WIRB Studies with the UIC OPRS (Initial Review Process)

Investigators whose protocols meet the criteria for submission to WIRB must first register their protocols with the UIC OPRS via OPRS Live before submitting for WIRB review. “Western IRB” should be selected as the External Review Agency when initiating the submission.

The following must be submitted to the UIC OPRS before submission to WIRB:

UIC OPRS form Registration for Protocol Review by Western IRB:
1. Note that an Account Number must be provided in order for the application to be processed. If an Account has not yet been created, it is recommended that either the Department ICR (F&A) account be used or an anticipation account be established.
UIC supplemental materials (as applicable):
1. UIC Appendix P, Appendix A1, and/or Appendix A2
2. Documentation of review and approval by applicable UIC ancillary committees, e.g., Cancer Center Protocol Review Committee (CC PRC), Clinical Interface Core (CIC), Radiation Safety Committee (RSC), Institutional Biosafety Committee (IBC)
Sponsor Informed Consent Template
Sponsor Research Protocol
COI Statement of Significant Financial Interest – Disclosure and Management Plan (SFI-DMP), if applicable.

Please note that the protocol must also be submitted for a Coverage Analysis if the research utilizes services or resources provided by the University of Illinois Hospital and Clinics, UIC College of Medicine office-based clinics, Mile Square Health Center, or Ryan White Infectious Disease Clinics. Please refer to the OVCR website for additional information.

Materials are reviewed by the UIC OPRS WIRB administrator for completeness, and the investigator will be contacted via email to address any questions.

Once the submission has been verified as complete, OPRS will issue an Acknowledgement Letter that authorizes the investigator to submit to WIRB for review. Note that the WIRB application must include the UIC OPRS Acknowledgement Letter.

Initial Submission to WIRB

Initial Submission to WIRB

After the submission has received UIC Acknowledgement, the investigator submits directly to WIRB for review. When the submission is received by WIRB, they will correspond directly with the investigator regarding any questions.

The Investigator or individual submitting to WIRB will need to establish a User Name and Password as part of the initial Registration process within the WIRB Web Site.
WIRB documents are completed on-line through the WIRB site.
A copy of the UIC OPRS Acknowledgement letter will need to be uploaded before submitting the application to WIRB.
The review of Clinical Trial Agreements (CTA) will be completed concurrent with the review by WIRB:
- WIRB will present the final consent document to OPRS for review by the UIC Legal Counsel to ensure that the injury statement in the CTA and in the Consent Document is consistent.
- Any revisions will be sent to WIRB with a copy to the Principal Investigator for informational purposes.
- WIRB will coordinate the consent document review between the Sponsor and UIC.

Upon approval, WIRB will send UIC OPRS the approved documents, including the IRB Approval Notice, the informed consent document(s), and recruitment materials.

The UIC OPRS WIRB Administrator will review the WIRB Approved Consent document to ensure it follows the UIC policies, including that the Injury language is consistent with the coverage analysis and CTA.

If the language in the consent document is not consistent, all holds will remain and WIRB will be informed of changes to the injury section. The investigator will be cc’d on the email to WIRB.
The OPRS cannot release the approved documents until the Coverage Analysis has been completed.

Submission to WIRB – Other Review Types

Continuing Review

The investigator will receive email alerts from the WIRB regarding the need for continuing review of WIRB approved protocols.
Prior to expiration of WIRB approval, the investigator must seek continuing review approval or close out the study by submitting a final report. For continuing review or to close the study, the investigator should submit all protocol documents directly to WIRB following the guidelines provided by WIRB.
WIRB will contact the investigator with questions about the submission after receipt. WIRB will send all approved documents directly to the investigator. A copy will be sent to UIC OPRS by WIRB.

Amendments

Amendments to the research should be submitted directly to the WIRB following the guidelines provided by WIRB, with the exception of research personnel changes and changing Principal Investigator.
UIC HSPP mandates that all individuals who are engaged in the research, including but not limited to, being involved in the conduct, review, or oversight of human subject research, complete initial and continuing education. Individuals involved in research using PHI must also complete the HIPAA research training requirement.
For Amendments involving Research Personnel and/or a change in the Principal Investigator, the investigator should prepare a submission to UIC OPRS that includes the WIRB Change in Research Form; updated Appendix P, and, if applicable, updated informed consent document(s), updated HIPAA Authorization(s), and updated recruitment materials.
Amendments requiring changes to the informed consent document, specifically the Compensation for Subject Injury and/or Costs section(s) will be held by WIRB until UIC Legal reviews the consent document against the Clinical Trial Agreement to assure consistency.
1. Any changes to the consent document will be forwarded to WIRB for correction.
2. If there are no changes and the language is consistent with the CTA, WIRB will be informed to release any hold on the documents.

Unanticipated Problems or Other Events Requiring Prompt Reporting

Unanticipated problems, protocol deviations or other events requiring prompt reporting and/or serious or continuing non-compliance that involve the UIC study site must be promptly reported to both UIC OPRS and to the WIRB. Investigators should follow the guidelines for UIC OPRS Prompt Reporting and follow the guidelines provided by WIRB.

Final Reports

The investigator should submit the WIRB Study Closure Report Form and all required protocol documents directly to WIRB. WIRB will contact the investigator with questions about the submission after receipt. WIRB will send all approved documents directly to the investigator. A copy will be sent to UIC OPRS by WIRB.

WIRB Fees

The OVCR charges a processing/administrative fee for the WIRB review of all industry sponsored human subject research. Charging industry sponsors for their share of the costs associated with the IRB review process allows UIC to continue to provide the level of service required by our faculty.

All PIs submitting industry sponsored human subject research protocols for review by the WIRB should include a line item in the clinical trial agreement/study budget for the IRB review fees. Facilities and University administrative costs (i.e., indirect cost/ICR/F&A) will not be applied to the IRB review fees. Payment of these IRB review fees is considered a contractual obligation of the sponsor.

These processing fees are assessments of real costs associated with protocol review by the IRB and are charged regardless of IRB approval or eventual project funding status.

The PI is required to provide a FOAPAL code, indicating which account OVCR should charge the fees associated with IRB review, on the initial submission application form for each industry-sponsored protocol submitted to the UIC IRB. The OVCR will bill the account at the time of protocol review.

The processing/administrative fee for the WIRB will be determined by Review Type. Refer to the UIC OPRS IRB Fees website for the fees to be charged.

The Administrative Fees are subject to change.

Forms and Additional Information

UIC Registration for Protocol Review by Western IRB (WIRB)

WIRB Forms (links to external page)

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Office of the Vice Chancellor for Research