Western IRB
Updated 9/29/08, 7/15/08. 03/18/08, 01/08/08, 10/4/2007: *Change in informed consent template language, 12/2008, 3/2009, 7/1/09, 8/14/09, 11/4/09.
NEW! Effective November 4, 2009, All WIRB New Project applications must be submitted electronically. Please read below for complete instructions. Form B and the Informed Consent Template have also been revised.
New! August 14, 2009 An approved Record of Consent is now available to be used for all WIRB studies. Download the Record of Consent template here and view the complete instructions below. The WIRB informed consent template has been revised. Download the new template here and read about the changes below. Forms A, B, and C have been revised to reflect UIHC Joint Office for Compliance information and the new Record of Consent. Download all forms and view the complete changes below.
Please note! Effective July 1, 2009. Forms A and B have been revised to reflect UIHC Joint Office for Compliance information. Download all forms and read about the update below.Please note! Effective June 1, 2009. WIRB Fee Schedule has changed. Please review the WIRB Fee Schedule links found at the bottom of this page for additional information. Further clarification or an explanation of WIRB Fee Charges can also be found on the WIRB website as well as calling WIRB Client Services.
Effective 3/21/2007. During any absences of the UI/WIRB Coordinator, the Human Subjects Office will no longer guarantee a 24-hour turnaround in the processing of WIRB proposals during the absence. This processing includes the assignment of Form A tracking numbers and the acceptance of any Form C WIRB packets to be sent to WIRB. For UI/WIRB Coordinator absences of 1 week or more in duration, we will post notice in advance of the absence on this web page.
Western Institutional Review Board (WIRB)
NEW protocols that are both industry-sponsored AND industry-initiated are sent to a commercial IRB for review. The University of Iowa IRB will not be the IRB of record for these projects. The University of Iowa has contracted with the Western Institutional Review Board (WIRB) for the review and oversight of these projects conducted at the UI. No other commercial IRB review will be allowed. Projects previously approved by IRB-01 will not be transferred to WIRB.
The information provided below is to assist UI investigators with the UI/WIRB process for submission of applications.
Clicking on the links below will take you directly to the answer.
What studies are eligible for WIRB submission?
How do I submit a project to WIRB for review?
What other University of Iowa entities need to review my project before submission to WIRB?
What happens after I submit my project to WIRB for review?
What are my responsibilities as an investigator after I have received WIRB approval of my new project?
What if I have questions about or need assistance with the UI/WIRB process?
Will there be a cost associated with review by WIRB?
What studies are eligible for WIRB submission?
Studies may be submitted to WIRB automatically if they meet the below condition:
- The study has funding from DOD and requires the institution to sign a DOD addendum to the UI FWA.
Studies may be submitted to WIRB if they meet all of the following conditions:
- The project is a study that involves human subjects and is designed to evaluate prospectively the safety and/or effectiveness of new drugs or devices or behavioral interventions.
- The protocol for the project was designed and written by the sponsor.
- The sponsor holds all INDs/IDEs for the protocol.
- The only sponsor of the research is a for-profit entity/company.
- The UI investigator has not previously submitted the study to another UI IRB. [Only new projects as of November 1, 2005 will be eligible for WIRB review. No transfers of projects already submitted to IRB-01 will be allowed]
- The project does NOT involve any of the following:
1. Xenotransplantation
2. Embryonic stem cells
3. Review and approval by the UI Institutional Biosafety Committee (e.g.studies that involve recombinant DNA)
4. Any research funds from a federal or other not-for-profit funding source.
VAMC studies. The VAMC does not currently accept commercial IRB review. Therefore, projects reviewed by WIRB may not be conducted at the VAMC. This includes projects which propose the use of Veteran's Administration facilities, equipment or patients. Full-time VA employees may not be involved as PI, Co-I, or Sub-I in any project submitted to WIRB.
Special NOTE: The UI IRB reserves the right to withhold any new research protocol, regardless of industry sponsorship, from being sent to WIRB for review.
How do I submit a project to WIRB for review?Summary of Procedures: New!
a) Complete and submit Form A to the HSO via email.
b) Complete and submit Form B to the HSO via email. As directed on Form B, attach to the email all applicable other committee approvals and consent/assent documents.
c) Receive an approval memo for submission to WIRB from the HSO.
d) Complete a New Protocol application on the WIRB website. Include the HSO approval memo as an attachment. WIRB will not accept your new project submission unless you attach the approval memo.
New project applications are submitted to WIRB via the online application on the WIRB website. However, WIRB will not accept your application until you receive an approval memo for submission from the Human Subjects Office.
Follow these steps to receive the approval memo from the HSO.
- FORM A. The UI Checklist for WIRB review eligibility.
The Human Subjects Office will notify the UIHC Billing Compliance Office if the study meets the criteria noted in item #10 of Form A. UIHC Billing Compliance will have instructions in the future months regarding creating a research billing plan.
a) If the project meets the criteria for WIRB submission, email the form to uiwirb@uiowa.edu for confirmation and to receive a UI tracking number
----OR----
b) If your project does not meet criteria for WIRB submission, you will be directed to submit your application through HawkIRB.
IRB Fees Agreement (Optional). This is an optional agreement for use by the University of Iowa investigator.
The purpose of this agreement is to provide the investigator financial protection. At the point an investigator submits a WIRB application, any WIRB or University of Iowa coordination fees not paid by the sponsor are the responsibility of the investigator and his/her department as noted on FORM B under the DEO assurances. If the sponsor requires the UI to process WIRB payments through the University, then you must build WIRB fees into your budget along with 25% F&A. Please see information about the WIRB fee schedule below.
The University of Iowa $700 WIRB submission coordination fee will be deducted from your research account as soon as the account is activated. Therefore, this fee should also be included in your budget. There will be no F&A assessed on this $700 fee.
- Consent Document(s). Download the applicable UI/WIRB consent form(s) and record of consent to develop the document(s) starting with the templates below:
UI/WIRB consent template
There are two sections of required UI language which can not be modified in the UI/WIRB consent:
a) Authorization to Use and Disclose Information for Research Purposes (including new language about the
Record of Consent)
---- AND ----
b) Compensation for Injury
Please note that the Summary section is no longer available for use. These two sections, which are highlighted on the template, must remain in your consent document as they appear in the template. NO changes from the UI language in these sections will be allowed. UI HSO staff will review the consent form for these sections only and will return the consent to you if altered or absent.
UI/WIRB Record of Consent template
A contact person(s) from the research team must be listed on the record of consent. This should be someone who can be contacted any time. The project information must be completed on this form, including details about the study drug, potential complications, and/or any other important information.
This document is only reviewed by the Human Subjects Office; it will not be sent to WIRB. The completed Record of Consent must be emailed to the HSO with Form B and the rest of the required attachments. Upon approval of the study by WIRB, the HSO will release the Record of Consent to the PI and contact person via email.
Current open projects will not be required to submit a Record of Consent, however it is strongly recommended to do so in projects where a record of consent may be appropriate or required by UIHC. If you wish to submit one it should be emailed to uiwirb@uiowa.edu. The document must be approved and stamped by the HSO. If you do choose to add a Record of Consent to an existing project approved by WIRB, a modification submission to WIRB will be required to update the informed consent template language for the use of the Record of Consent.
Important! It is the PI's responsibility to update the Record of Consent, as appropriate, if study procedures, contact personnel, or other information changes during the course of a study. Changes to the Record of Consent do not need to be submitted to the HSO or to WIRB.
3. FORM B: The UI Checklist for New Protocol Submissions to WIRB.
New! Form B has been completely revised to be more user-friendly. The HSO can no longer accept previous versions of Form B.
Use Form B as a guide to determine what other UI Committees may require review of the protocol, and what attachments must be submitted to the HSO. Prior to sending Form B to the Human Subjects Office, you must send the appropriate information to the Division of Sponsored Programs and have the review and approval of all applicable other University Committees. See What other University of Iowa entities need to review my project before submission to WIRB? for further information.
4. Email Form B to uiwirb@uiowa.edu along with all required attachments indicated on the form. The HSO is not able to hold incomplete submissions. The email will be returned if it is incomplete. The HSO will review Form B and attached documents to ensure The University of Iowa requirements are being met.
NOTE: You no longer need to submit Form C with your materials.
5. The HSO will email the PI and contact person an approval memo for online submission to WIRB. You can now submit the application to WIRB. On the WIRB website, click on Begin Online Submission to use the online submission process. Click on Download Forms to access the WIRB Initial Review Submission Form. You also have the option to log into WIRBNet and complete the new "smartform" application.
Make sure to attach the HSO approval memo to your submission to WIRB. WIRB will not review the submission without this attachment! If you have any questions about completing the WIRB online application, please contact:
Refer to #1 on Form B. If your project requires review by the CIRC, follow the directions provided on the CIRC website.
Click on the link for a the definition of "significant financial interest".
Division of Sponsored Programs (formerly Clinical Trials Office).
Refer to #2 on Form B.
Refer to #4 on Form B. If your project requires review by the PRMC, follow the directions on the following form: FORM B1
Refer to #5 on Form B. If your project requires PRMC review and P&T review, use FORM B1
Refer to #6 and the MRPC Appendix on Form B. Follow the directions on Form B to determine if your project requires MRPC review and approval. If MRPC review and approval is required, follow the directions on the following form: FORM B3.
Refer to #7 on Form B. At this time, only a notification is sent to the UIHC Joint Office for Compliance when Form A is approved. In the future months, a research billing plan or exemption must be obtained from the UIHC Joint Office for Compliance prior to sending application materials to the HSO for submission to WIRB. Instructions and information will be forthcoming.
Refer to #9 on Form B. The link above will take you to information about the NRC.
What happens after I submit my project to WIRB for review?
WIRB is now the IRB of record for your protocol.
- Any questions the PI may have regarding the process should be directed to WIRB.
- Any questions WIRB may have with regard to the submission will be directed to the PI of the project.
- After the contract has been finalized in the DSP, WIRB will notify the PI of its decision and will provide the PI with copies of all regulatory documents and approved consent forms.
- The HSO will email the PI the approved Record of Consent document.
- Consent Documents. For WIRB approved projects, you must use the WIRB-stamped Consent Document for enrolling subjects. You will NOT receive a Consent with an IRB-01 stamp on it because IRB-01 is not the IRB of record for the protocol.
- Record of Consent. Effective 08/14/09, a record of consent approved by the HSO must be used for all new WIRB studies. This document must be updated by the PI as changes to the protocol and/or staff dictate. Modified versions of the record of consent do not need to be submitted to the HSO or to WIRB.
- Post-approval submissions to WIRB. ALL of the following information should be submitted directly to WIRB following WIRB procedures:
a) Serious and/or unexpected adverse experiences.
b) Major protocol violations that result in additional risk to subjects.
c) Modifications to the approved protocol. [See # 4 below!]
d) Continuing review of the approved protocol.
e) Project Closure. WIRB will notify the UI HSO of project closures.
- UI Requirements with regard to Modifications to approved protocols.
HSO
Whenever you add a research team member through the modification process, UI policy requires that the added team member have training in human subjects protections. Research team members include the principal investigator and all other individuals (faculty, staff, or student) who have contact or interactions with research subjects or with their private, identifiable information must be certified. Technicians performing standard clinical procedures that are part of the research protocol, such as a blood draw, do not need to be named as a member of the research team and do not need to be certified.
The human subjects training certification of added research team members will be reviewed at routine monitoring visits conducted by UI HSO monitoring staff.
P&T
You must have review and approval by P&T prior to submission of the modification to WIRB if:
New drugs are being added to the protocol.
If your modification requires P&T review, submit 2 copies of all documents with changes (e.g. WIRB consent form(s), investigator's brochure, G-12, protocol, etc.) to Mary Ross (CC101 GH).
You will need to create and submit a new G-12 if new drugs are being added that are NOT FDA-approved.
MRPC
You must have review and approval by MRPC of any of the following modifications prior to submission of the modification to WIRB:
a) Change in the Principal Investigator [Submit revised MRPC cover page with new PI signature.]
b) Change in radiation prescriber [Submit revised MRPC Internal Radiation Form with new prescriber information.]
c) Change in the number of subjects receiving radiation [Submit justification (statistical power analysis) for increasing the number of subjects]
d) Change in the radiation protocol [Submit revised MRPC application and WIRB consent document(s)]
- UI Monitoring of WIRB approved protocols. The UI HSO monitoring staff may monitor any WIRB approved protocol.
- Record-keeping. You should establish record-keeping procedures for your files, and store WIRB documents, e-mails, notifications, and other correspondence just as you would for IRB-01.
You can contact WIRB at:
Telephone: 800-562-4789
FAX: 360-252-2498
E-mail: wirb@wirb.com
Mail: PO Box 12029
Olympia, WA, USA 98508-2029
You can contact the University of Iowa's WIRB coordinator in the Human Subjects Office:
Molly Schaefer IRB Coordinator
Telephone: 319-384-1736
FAX: 319-335-7310
E-mail: uiwirb@uiowa.edu
Mail: Human Subjects Office
340 CMAB
Iowa City, IA 52242-1101
The charge for the coordination of your WIRB submission by the HSO is a one-time fee of $700.
If you have any questions about any of the below referenced charges, please contact WIRB at 800-562-4789.
WIRB Fee Schedule - June 1, 2009 Please review the following attachments for the revised WIRB Fee schedule. Any questions or for further explanation on how to disseminate charges can be answered by WIRB Client Services.
Fee Schedule beginning June 2009
Fee Schedule for Multicenter Studies beginning June 2009
Fee Schedule explanation letter