Research@UIC > Protocol Review > Western Institutional Review Board

Review of Research by the Western Institutional Review Board (WIRB)

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The University of Illinois at Chicago (UIC) has contracted with Western IRB (WIRB), an established and AAHRPP Accredited independent IRB, for the review of industry-sponsored and industry-initiated research studies. As of February 1, 2010, UIC investigators will have the option of submitting industry-sponsored clinical trials, with some exceptions, to the WIRB for review and approval instead of the UIC IRBs.

Which research studies qualify for submission to WIRB?

• Research that meets the National Institute of Health (NIH) definition of a clinical trial, i.e. “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)”.
• Research is a Phase II / III / IV clinical trial.
• Research is designed and research protocol written by the sponsor.
• The sponsor is a for-profit entity or company.
• The sponsor holds all INDs / IDEs.
• The research has not previously been submitted to the UIC IRB for review.
• The research is greater than minimal risk.

Research that includes the following criteria may qualify for submission to WIRB depending upon the design of the study.  It is requested that the Protocol Synopsis be provided to the OPRS WIRB Administrator for review.

• Phase I studies (including I/II, Ib or similar studies)
• Research that involves subjects under the age of 18 (i.e., Children, Minors)

Any industry-sponsored study that meets any of the following criteria does not qualify for submission to WIRB:

• Planned Emergency Research
• Transplant Research, including Cadaveric Research
• Embryonic Stem Cell Research
• Research involving Jesse Brown Veterans Administration Medical Center
• Research that involves funds from a federal or non-profit funding agency
• Research that is investigator-initiated
• Research that involves the use of recombinant DNA and its derivatives, such as vectors, and infectious agents.

NOTE: The UIC IRB reserves the right to withhold any new research protocol, regardless of industry sponsorship, from being sent to WIRB for review.

How do I request submission to WIRB?

Investigators whose protocols meet the above criteria for submission to WIRB must complete the following and email with attachments to uicirb@uic.edu or deliver in person to the OPRS Office.  The subject line of the e-mail should be entitled “WIRB Submission”:

1. UIC OPRS form Application for Protocol Review by Western IRB (version 1.4, 12/16/2010);
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.
2. Note that if the PAF# is identified as “Pending”, an amendment must be submitted to OPRS when the PAF# has been obtained.
3. The following documents should be submitted for review by the UIC OPRS WIRB administrator with the UIC Application for WIRB Review:
   1. Appendix P and Appendix E
   2. Departmental Review (Appendix F) is not required.
   3. Documentation of Approval by Investigational Drug Service (IDS), Cancer Center (CC PRC), Clinical Interface Core (CIC), Radiation Safety Committee (RSC) and/or Institutional Biosafety Committee (IBC) approval, as appropriate.
   4. Sponsor Informed Consent Template
      1. Note that WIRB will reformat the Sponsor’s Consent and incorporate the required UIC language into the final Informed Consent Document.
      2. Note that if the research requires approval by the UIC Radiation Safety Committee (RSC), RSC requires that appropriate RS language is incorporated into the Sponsor’s Consent Template at the time it is submitted for RSC approval (see Section 5.2 in the Environmental Health & Safety Office website.)
   5. Sponsor- research protocol
   6. COI Statement of Explanation and Management (SEAM), if applicable.
2. WIRB Initial Review Submission Form and documents;
   1. Please note that 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
   2. Note these documents are completed on-line through the WIRB site
   3. A copy of the UIC OPRS Acknowledgement letter will need to be uploaded before submitting the application to WIRB;
3. The review of Clinical Trial Agreements (CTA) will be completed concurrent with the review by WIRB:
   1. Note that 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.
   2. Any revisions will be sent to WIRB with a copy to the PI for informational purposes.

What is the purpose of the initial UIC OPRS review of the WIRB submission?

Upon receipt, the UIC OPRS WIRB Administrator will conduct a pre-review of the submission to ensure it meets the criteria for WIRB review.  Submissions meeting the criteria will be issued a UIC OPRS Acknowledgement letter.  The Investigator will need to upload a copy of the UIC OPRS Acknowledgement letter with the final WIRB Submission before sending.   Note that WIRB will not process submissions without a copy of the UIC OPRS Acknowledgement letter.  WIRB will then communicate directly with the investigator with any queries and clarifications.   WIRB will send all approved documents directly to the investigator, and a copy will be sent to UIC OPRS.

What happens after WIRB has accepted my submission?

After the submission has been sent to the Western IRB for IRB review, WIRB will contact the investigator directly with questions about the submission and upon obtaining IRB approval, WIRB will send all approved documents directly to the investigator and a copy will be sent to UIC OPRS.

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.

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.

Unanticipated Problems

Unanticipated problems or other events requiring prompt reporting and/or serious or continuing non-compliance that involve the UIC study site must be promptly reported to the WIRB following 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.

What are the processing/administrative fees for WIRB Review?

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.
These fees apply only to industry sponsored research involving human subjects submitted for review by the WIRB.

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:          

How do I obtain more information regarding WIRB?

When using the WIRB, your contact within the UIC OPRS Office are the WIRB Administrators. The WIRB Administrators are the UIC OPRS liaisons between the UIC OPRS and WIRB and can provide guidance.

WIRB Administrators

Marissa Benni-Weis, M.S., C.I.P.
Office for the Protection of Research Subjects (OPRS)
Administrative Office Building, Room 203
1737 West Polk Street
Chicago Illinois 60612-7227
312.996-9299(ph)
mbenni@uic.edu

Kathleen Loviscek, M.S.
Office for the Protection of Research Subjects (OPRS)
Administrative Office Building, Room 203
1737 West Polk Street
Chicago, Illinois 60612-7227
312.413.1835 (ph)
lkathlee@uic.edu

Cynthia C. Tom-Klebba, M.A., C.I.P.
Office for the Protection of Research Subjects (OPRS)
Administrative Office Building, Room 203
1737 West Polk Street
Chicago Illinois 60612-7227
312.355.4006 (ph)
cklebba@uic.edu

Last updated: Wednesday, May 12, 2010.