UW-WIRB Agreement FAQs
IRB Review of Industry-Sponsored Clinical Trials
Updated on January 22, 2008
General
What is WIRB?
WIRB is Western Institutional Review Board. It is a commercial institutional review board (IRB) that does human subjects reviews, for a fee. It is the largest IRB in the world, with over 200 staff members. It is fully accredited by the Association for the Accreditation of Human Research Protection Programs.
Why did the UW enter into this cooperative agreement with WIRB?
The UW began negotiating the contract for this relationship in mid-2004, with two goals in mind: (1) Faster service for researchers; and (2) reduced burden for the UW IRB committees.
What research activities are eligible for review by WIRB?
All industry-sponsored clinical trials funded through the UW are eligible to be reviewed under the cooperative agreement between the UW and WIRB, with some exceptions (see below).
What is an “industry-sponsored” clinical trial?
An industry-sponsored clinical trial is one in which a private company has contracted with UW personnel to conduct a study of the safety and/or efficacy of drugs, devices, diagnostics, treatment, or preventive measures in humans.
What about Patient Registries?
An industry-sponsored patient registry may be reviewed by WIRB if the primary goal of the registry is to collect data on long-term safety and efficacy, and if the registry will be managed by the industry sponsor rather than the UW.
Are there exceptions?
Yes, there are some situations in which an industry-sponsored clinical trial would not be reviewed by WIRB. These include:
- Clinical trials conducted by VA researchers or involving VA patients as research subjects or using VA facilities. These trials will continue to be reviewed by the UW’s Committee V.
- Clinical trials conducted at Children’s Hospital and Regional Medical Center, or involving its patients, staff, or facilities. These trials will continue to be reviewed by CHRMC’s IRB.
- Investigator-initiated clinical trials (regardless of funding)
- An industry sponsor that refuses to pay WIRB fees
- Studies involving special local, social, economic, political, or cultural concerns
- Industry-sponsored clinical trials from members of the Cancer Consortium may be reviewed by either WIRB or the Cancer Consortium IRB at Fred Hutchinson Cancer Research Center (PI’s choice).
Can I request to have my industry-sponsored clinical trial reviewed by the UW’s IRB instead of by WIRB?
Yes. Researchers who wish to request an exception must file the request in writing to the Director of the Human Subjects Division (Mail stop 355752) identifying the name of the researcher and contact information, the title of the study, the name of the sponsor, the Office of Sponsored Programs number, and an explanation of why the trial should not be reviewed by WIRB.
What are the advantages associated with having my clinical trial reviewed by WIRB instead of the UW?
- The “turn-around” time for review and approval is generally much faster at WIRB than at the UW.
- WIRB staff can provide more individualized assistance with applications and supporting documents, including writing consent forms.
- For most large multi-site clinical trials, WIRB is likely to already be reviewing the industry sponsor’s protocol at other sites.
Can I transfer my clinical trial to WIRB if it has already been reviewed and approved by the UW IRB?
How do I find out if WIRB has already reviewed the protocol I am submitting?
Is WIRB going to review “emergency use” (compassionate use) requests and the required follow-up “emergency use” applications?
No. However, if an emergency request turns into an industry-sponsored clinical trial, then that trial will go to WIRB.
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Fees
What are the fees charged by WIRB?
WIRB charges a separate fee for each review activity: initial review, continuing review, review of modifications, and so on. See the WIRB Fee Schedule (Expires 3/31/08).
Note that the fee for initial review is substantially lower if WIRB has already reviewed a specific study protocol for another site. (You can find out whether WIRB has already reviewed the protocol you are submitting by calling WIRB Client Services at 1-800-562-4789.)
Who pays the WIRB fees? And are those fees negotiated as part of the contract between the UW and the sponsor?
WIRB will bill the sponsor directly. Researchers should arrange this directly with the sponsor. These fees are NOT negotiated or mentioned in the contract drawn up between the sponsor and the UW Office of Sponsored Programs. Because the fees are paid directly to WIRB by the sponsor, there are no indirect costs associated with the WIRB fees.
What if the sponsor refuses to pay the WIRB fees?
If the researcher has not yet applied for human subjects review, the investigator may petition the UW Human Subjects Division (HSD) to have the study reviewed by HSD instead of WIRB. Get more information on requesting review by UW IRB's.
If the sponsor refuses to pay the billed amounts after the study has been reviewed by WIRB, the researcher’s department will be responsible for the fees.
Is there still a UW fee?
Yes. Researchers must still pay a fee ($1,000 plus indirect costs) to the Office of Sponsored Programs to cover the costs of (1) the record-keeping and oversight that the UW HSD is still required to do; (2) coordination and interactions with WIRB; and (3) the UW’s continued or shared responsibility for such things as subject complaints and federal Certificates of Confidentiality.
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Applying to WIRB
How do I apply to WIRB for review of my industry-sponsored clinical trial?
See Application Instructions for WIRB Human Subjects Review. It is essential that you read these instructions as well as the generic application instructions at the WIRB web site. Please note that you must send WIRB the UW-WIRB Cover Sheet with your application. This Cover Sheet provides WIRB with the required UW authorization to perform the human subjects review. It must be signed by someone in the UW Human Subjects Division before you send it and your application to WIRB.
How do I obtain the HSD signature on the UW-WIRB Cover Sheet, and how long does that process take?
You may mail, email, or hand-deliver the filled-out UW-WIRB Cover Sheet to the Human Subjects Division. If you bring it to our office, we can sign and process it for you in about 10 minutes. If you mail or email it to us, we will mail it back to you in the next day’s mail pickup.
Does WIRB also do the review for Radiation Safety, Conflict of Interest, Biosafety, and other regulatory matters related to a clinical trial?
No. Although the WIRB application form mentions that WIRB can supply those services, the agreement between the UW and WIRB specifies that these reviews must continue to be handled by the appropriate UW offices. See the WIRB application instructions for more information about how to coordinate those reviews with the WIRB human subjects review.
Can I use the consent form templates on the WIRB web site?
No. You must use the template that the two institutions have negotiated. This consent template will not be posted on the WIRB web site.
Will WIRB write the consent form for my study?
Call WIRB’s Client Services at 1-800-562-4789 to discuss this possibility. If WIRB has already reviewed and approved a consent form for this study at another site, they may be willing to revise that consent form to conform to the UW requirements (as specified in the UW-WIRB consent form template). They will also re-format the consent form as necessary to meet WIRB’s formatting requirements.
What about HIPAA?
Use the UW HIPAA forms, and include them in your application packet to WIRB. They will be reviewed and approved by WIRB.
If I need a Confidentiality Agreement to obtain protected health information (PHI), which institution signs it?
The UW Human Subjects Division (not WIRB) signs Confidentiality Agreements for obtaining PHI without subject consent from the University of Washington Medical Center, Harborview Medical Center, the Seattle Cancer Care Alliance, and the other UW medical facilities. However, you should send WIRB a copy. See the WIRB application instructions for more information about how to complete the Confidentiality Agreement.
If I need a federal Certificate of Confidentiality, which institution signs it?
How can I document my completion of Human Subjects training for WIRB?
If you obtained your training through the UW (including the web-based CITI program), Fred Hutchinson Cancer Research Center (FHCRC), or the local Veterans Administration (VA), you do not need to document your completion of the training. The list of individuals who have completed this training is publicly available on our Human Subjects Division web site. WIRB has this web address, and will check the list there if you indicate on your application form that you completed your training at the UW, FHCRC, or the VA.
Can I submit my application to WIRB electronically or on a CD, rather than on paper?
What do I do if WIRB’s application instructions (as posted on their Web site) contradict the UW’s policies and guidelines?
The contract between WIRB and the UW states that WIRB will follow UW policies regarding human subjects review. For example, the UW feels it is important to use the word “subject” instead of “patient” in consent forms and in other materials that will be distributed to subjects, because it helps to make clear to subjects that the primary purpose of clinical trials is to do research rather than to provide clinical care.
Who should I list as “investigators” on the consent form?
For WIRB-reviewed industry-sponsored clinical trials, the consent form should list all individuals listed on the FDA Form 1572 and each signed consent form should have the printed name of the person who obtained the subject’s consent. This is different than the standard UW IRB procedure in which all study staff who interact with study subjects should be listed on the consent form.
Is there anything else I should know about applying to WIRB?
WIRB has a firm 30-day policy regarding responses from investigators. If the PI or designated contact person fails to respond to a WIRB review or question within 30 days, the study is closed to review.
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After receiving WIRB approval
How do I apply for changes to the consent documents or procedures, any other modifications and amendments, or continuing review (status reports)?
You may apply directly to WIRB, without going through the UW Human Subjects Division. Use the appropriate forms and instructions that are posted on the WIRB web site.
Where do I send adverse event reports or reports of unanticipated problems involving risk of harm to subjects?
Send them to WIRB, using the forms provided on the WIRB web site. If you are reporting an on-site adverse event that is unexpected or more serious than expected, report them to WIRB with a copy to the UW Human Subjects Division, within 24 hours.
If my trial is placed on hold, suspended, or terminated, should I notify the UW Human Subjects Division?
Yes. The UW office should be notified immediately. It does not matter whether the hold, suspension, or termination was initiated by the researcher, WIRB, the sponsor, the FDA, or any other agency.
If I need a Confidentiality Agreement to obtain protected health information (PHI) or I need to add someone to an existing Confidentiality Agreement, who signs it?
The UW Human Subjects Division (not WIRB) signs Confidentiality Agreements for obtaining PHI without subject consent from the University of Washington Medical Center, Harborview Medical Center, or the Seattle Cancer Care Alliance. After your study has been reviewed and approved by WIRB, send the original copy of the Confidentiality Agreement to the UW Human Subjects Division for our signature. We will then return it to you.
Who should subjects contact if they have concerns, questions, or complaints?
They may contact either WIRB or the UW Human Subjects Division, or both.
Who should I contact if I need to set up a Material Transfer Agreement, or a Research and Collaboration Agreement, in order to send or receive material or biological samples to a third party?
Contact the Invention Licensing group at the UW TechTransfer office. Any required IRB involvement will be handled by WIRB, not the UW Human Subjects Division.
What happens if my study is reviewed by WIRB, and then later I decide I want to add the VA or CHRMC as a study site or as a site where I am actively recruiting subjects?
You will need to submit a separate application to the UW IRB (for the VA activities) or to the CHRMC IRB (for CHRMC activities). Those activities cannot be reviewed by WIRB, because the VA and CHRMC do not have a cooperative agreement with WIRB.
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