As of July 19, 2006, investigators from UCHSC and its affiliates will be given the option of having their industry sponsored protocols be reviewed by an alternative IRB called WIRB (Western IRB).  WIRB is an independent central IRB located in Olympia, Washington. 

Please note that this is for industry sponsored protocols only.  Investigator-initiated, grant-supported or expedited/exempt protocols may not be reviewed by WIRB and must be reviewed by COMIRB.

WIRB Website 

WIRB Review Fees	Effective July 1, 2008
Full-Board Initial Review	$3,000
Full-Board Annual Continuing Review	$1,800

UCD and UCH:

• Initial Review:  The speed type provided by the department at the time of protocol submission will be used to pay the combined COMIRB and WIRB fee of $3,000 when the invoice is received from WIRB.  COMIRB will send an invoice template to the primary contact listed on the study which may be used to request reimbursement to the department from the sponsor.  
• 12-month Study Renewal:  The fee of $1,800 will be pulled from the same speed type provided by the department on initial submission.
• Any subsequent changes in speed type for the study should be e-mailed to   Marie.Wade@uchsc.edu to assure payment from the correct speed type.   
• Amendments, 6-month study renewals, or other changes:  Cost varies - WIRB will invoice Principal Investigator (PI) directly and PI will arrange payment to WIRB.
• Fees for initial and 12-month yearly renewals are payable to COMIRB.  
• Fees for Amendments, 6-month study renewals, or other changes are payable to WIRB.

TCH and DHHA:

• Initial Review:  The institution will be invoiced to pay the combined COMIRB and WIRB fee of $3,000 when the invoice is received from WIRB.  Payment to COMIRB is due within 30 days of invoice issue.
• 12-month Study Renewal:  The institution will be invoiced to pay the combined COMIRB and WIRB fee of $1,800 when COMIRB receives the invoice from WIRB.  Payment to COMIRB is due within 30 days of invoice issue.
• Amendments, 6-month study renewals, or other changes:  Cost varies - WIRB will invoice the PI directly and PI will arrange payment to WIRB.
• Fees for initial and 12-month yearly renewals are payable to COMIRB.  
• Fees for Amendments, 6-month study renewals, or other changes are payable to WIRB.

Any discrepancies related to billing fees should be resolved with WIRB directly. 
For any other questions about the billing process, please call Marie Wade at 303-724-1053.

Required Forms for WIRB Review. The following documents must be completed and sent to COMIRB.

WIRB Cover Letter
WIRB Eligibility Checklist
WIRB HIPAA Eligibility Checklist
WIRB Initial Review Submission Form
WIRB Initial Review Submission Form for Multi-Centered Studies
FDA Form 1572
HIPAA Authorization A form (if applicable)
HIPAA Authorization B form
WIRB HRRC Process for UCH Protocols
WIRB Consent Form Checklist
WIRB Assent Form

WIRB Forms Website

COMIRB Policy on Submitting Protocols to WIRB

Studies that have been previously reviewed by COMIRB must stay with COMIRB for future continuing review and the duration of the protocol.

In order to have a protocol reviewed by WIRB, the PI must go through a procedure called ‘opt-in.’ This can only be done during a limited time frame.  The next opportunity to participate in the opt-in process will be in the Spring 2008 (date yet to be determined).

Investigators will opt-in by informing their Department or Division Head, and also e-mailing Angela Wishon, Assistant Vice-Chancellor for Research, at Angela.Wishon@uchsc.edu

Once investigators opt-in, ALL of their initial review, industry-sponsored protocols must go to WIRB until the opt-out time period (the date will be announced, but will most likely be done on a yearly basis).  At that point, the investigator may stay with WIRB or opt-out, and return to using the COMIRB process for future initial review submissions.  Please note however, that all current WIRB protocols must remain at WIRB for the life of the study, unless there is a future change of COMIRB policy.     

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Note:

COMIRB will continue to have full jurisdiction over the WIRB protocols and has the authority to refuse to allow initial submission to WIRB or to suspend or terminate a study if it is deemed necessary.  Also, WIRB is only contracted to review particular types of protocols that meet certain criteria, so if WIRB determines that a protocol does not meet these criteria, the protocol will be returned and will need to be submitted to COMIRB.       

Please read the WIRB Policy in the previous section to determine if you are eligible to submit your research to the WIRB.

Initial Review Submission

• PI will get COMIRB # from the Protocol Manager available on this site.  Under Review options, please click on “Full Board.”
  
• PI will submit 2 copies of initial review packet to COMIRB.  COMIRB will forward the submission to WIRB.  THEY SHOULD NOT BE SENT TO WIRB DIRECTLY.
• COMIRB will do in-house review of packets for eligibility:  Packets that do not meet all eligibility criteria will be returned to the PI, and required to be resubmitted back to COMIRB for COMIRB full board review.  COMIRB also reserves the right to send any protocol back to the PI that they deem inappropriate to send to WIRB.  For any other questions or missing documents, the PI or primary contact will be contacted by COMIRB.
• COMIRB will send 1 copy of the packet to WIRB, and will aim to do this within 24 to 48 hours of receiving it in-house.  The PI and primary contact will be e-mailed the tracking number of the packet.  The other copy will be kept on file at COMIRB.
• HIPAA Authorization form(s) will be reviewed/noted by COMIRB.  The PI will be notified by COMIRB of any requested changes.  If no changes are needed, the PI will be sent a hard copy of the feedback letter noting the Authorization form(s), after the protocol is approved by WIRB.
• WIRB will send both the PI and COMIRB a copy of the Initial Review Approval Letter, Approved Consent Form, and any other approved documents.
• A copy of the approved consent form and noted HIPAA Authorization forms will be sent to DHHA or UCH if these are designated study sites.

For Subsequent Changes and Continuing Review

• PI will send Amendments, Continuing Reviews, and other miscellaneous changes (such as Personnel and Site changes) directly to WIRB, following their instructions.  All SAE’s should be reported to WIRB also following their instructions.  You will be charged for each of these by WIRB (see WIRB Fee Structure above).
• Please note that Personnel or Site changes must also be sent to COMIRB on the applicable COMIRB forms.  Remember that when adding an additional site (such as DHHA or the GCRC), the Clearance/Approval Letter from that site must also be sent to COMIRB.
• WIRB will send Approval Letters/acknowledgements for Amendments, Continuing Reviews and other changes to both the PI and COMIRB.

For Closures

• PI will send a copy of the closure request to both WIRB and COMIRB.  WIRB will send PI and COMIRB an acknowledgement letter.

For any further questions regarding the WIRB process, please call Marie Wade at (303) 724-1053