Download Forms

Not sure what form to use? Contact Client Services at 1-800-562-4789 or e-mail clientservices@wirb.com.

IRB Forms:

Initial review forms:

• Initial Review Submission Form & Additional Sites Page
• Annotated Initial Review Submission Form
• Investigator Submission Form for Multi-Center Protocols
• Initial Review Submission Form for Sponsors and CROs
• Request for Exemption Determination
• Request for Review of Emergency Use

Supplemental initial review forms:

• New Jersey Requirements for Inclusion of Decisionally Impaired Subjects (New Jersey Statute 26:14-5))
• Request for a Partial Waiver of Authorization for Recruitment (HIPAA Partial Waiver of Authorization)
• Request for a Waiver of Consent under the Common Rule And Waiver of Authorization under HIPAA (HIPAA Full Waiver of Authorization)
• IRB Transfer Cover Letter Checklist & Summary Form
• Waiver of Consent Request for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
• Sample IRB Authorization Agreement (with WIRB filled in as institution A)

Forms related to ongoing research:

• Change in Research and Subject Recruitment Submission Form
• Screening Procedures Information Form
• Financial Interest Disclosure Form
• Unanticipated Problems Reporting Forms Updated - March 2009
• Study Closure Report Form

Miscellaneous resources:

• WIRB Investigator Handbook "A Guide for Researchers" Updated - April 20, 2009
• Legend Reasons for Change
• WIRB Consent Form Template
• Pregnant Partner Template Consent Form
• Continuing Review Report Form (CRRF) Work Sheet
• Continuing Review Report Form (CRRF) Instructions for Sites Using Humanitarian Use Devices (HUDs)
• Template Information Sheet for Waiver of Documentation of Consent

Downloading, Reading and Filling out the Forms
Sending the Forms to WIRB

WIRB Submission Forms
WIRB updates its submission forms as much as twice yearly to improve the review of research and protection of human subjects. Please be sure to use the most current version on this site when you prepare to submit research for review.

The intent of the forms below is to provide the Board with all required documentation at the point of submission.

Click here for FAQs (Frequently Asked Questions) or call Client Services at 1-800-562-4789 for more information.

Initial Review Submission Form
PDF Version        Word 2000 Version     

"INITIAL REVIEW Additional Sites" Page Only:  Word 2000 Version

Annotated Initial Review Submission Form
This annotated version of the Initial Review Submission Form (New Protocols) provides additional information for many of the questions. Download a copy for reference when preparing a new submission to WIRB.
PDF Version     

Investigator Submission Form for Multi-Center Protocols
WIRB now offers a shorter version of its Initial Review Submission Form for use by investigators participating in multi-center protocols which have already been reviewed by WIRB. If the protocol you are submitting has already been reviewed by WIRB, you may use this form; otherwise, you must use the full length Initial Review Submission Form (above). If you aren't sure if the protocol has already been reviewed, contact WIRB's Client Services at 1-800-562-4789 or e-mail clientservices@wirb.com.
PDF Version        Word 2000 Version

Initial Review Submission Form for Sponsors and CROs
WIRB can assist sponsors and CROs during the planning stages of a multi-center study by pre-reviewing the protocol and subject materials, including the consent form. Use this form to request "approvable" review. The fee for initial review applies.
PDF Version        Word 2000 Version

Request for Exemption Determination
Use this form if you wish to obtain a written opinion that a proposed project is exempt from the requirement for IRB review or does not require IRB review because the project does not involve research or does not involve human subjects.
PDF Version        Word 2000 Version

Request for Review of Emergency Use
Use this form to request prospective review of an emergency use of an investigational drug, biological product, medical device or other FDA-regulated test article with a human subject. Use of this form is optional, but recommended. For more information about emergency use, see WIRB's FAQ (Frequently Asked Question) on this topic.
PDF Version        Word 2000 Version

New Jersey Requirements for Inclusion of Decisionally Impaired Subjects (New Jersey Statute 26:14-5)
New Jersey Statute 26:14-5, also called the Access to Medical Research Act (included at the end of this form), requires an investigator to provide additional protections for subjects who are unable to consent for themselves. The questions on this supplemental form will assist the Board in determining whether your site will provide the required safeguards.
PDF Version        Word 2000 Version

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Request for a Partial Waiver of Authorization for Recruitment (HIPAA Partial Waiver of Authorization)
Researchers should use the WIRB Partial Waiver of Authorization submission form to request approval of access to Protected Health Information (PHI) for recruitment. For more information, please see the HIPAA page on this web site.
PDF Version        Word 2000 Version

Request for a Waiver of Consent under the Common Rule And Waiver of Authorization under HIPAA (HIPAA Full Waiver of Authorization)
Researchers should use the WIRB Full Waiver of Authorization submission form to request approval of access to Protected Health Information (PHI) for the entire research project. For more information, please see the HIPAA page on this web site.
PDF Version        Word 2000 Version

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IRB Transfer Cover Letter Checklist & Summary Form
PDF Version        Word 2000 Version

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Waiver of Consent Request for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
Based on FDA guidance issued April 25, 2006, WIRB will consider requests for waivers of consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable. Complete the form below and send it with your submission.
PDF Version        Word 2000 Version

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Sample IRB Authorization Agreement (with WIRB filled in as institution A)
PDF Version        Word 2000 Version

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Change in Research and Subject Recruitment Submission Form
Use this form to request Board review of any changes in research, administrative or otherwise and/or review of subject recruitment materials.
PDF Version        Word 2000 Version

"CHANGE IN RESEARCH Additional Sites" Page Only:  Word 2000 Version

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Screening Procedures Information Form
Use this form to request review of screening materials. Submitted materials should conform to the Board requirements included in the attached document.
PDF Version        Word 2000 Version

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Financial Interest Disclosure Form
Use this form to disclose to WIRB changes in previously reported financial interests.
PDF Version        Word 2000 Version

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Unanticipated Problem Reporting Updated - March 2009

• The following packet provides the instructions and form for reporting unanticipated problems that ARE adverse events.
  PDF Version        Word 2000 Version
  
• The following packet provides the instructions and form for reporting unanticipated problems that ARE NOT adverse events.
  PDF Version        Word 2000 Version

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Study Closure Report Form
WIRB will consider the study open at your site until a study closure report is received.
Please complete this closure form when:

• All subjects have finished their final visits and follow-up,
• The sponsor or the sponsor representative has indicated the study is closed at your site, and
• If the study was conducted under a Federalwide Assurance, all data analysis at the site is completed.

Do not submit this form until all of the above has been accomplished.
WIRB will close review of the study at your site after receiving the closure report. To avoid unnecessary reviews and fees, do not delay reporting a study closure to WIRB if the expiration date is approaching.
PDF Version        Word 2000 Version

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WIRB Investigator Handbook "A Guide for Researchers" Updated - April 20, 2009
Western Institutional Review Board (WIRB) is pleased to provide "A Guide for Researchers" containing general information about conducting research and using WIRB for review of research. The information is intended to provide practical guidance about submission questions, IRB review and oversight, as well as other topics that may be of interest to investigators and research staff.
PDF Version        Word 2000 Version

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WIRB Legend Reasons for Change
To find out more about why WIRB made a change in a consent form, note the superscript numerical code next to the change in the redlined consent and look up the corresponding reason on the Legend Reasons for Change.
PDF Version        Word 2000 Version

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WIRB Consent Form Template
The WIRB consent form template provides valuable guidance to consent form authors who will be submitting a consent form to WIRB for review. The attached template is a sample only and cannot be used to consent subjects. The attached template is subject to change without notice.
PDF Version        Word 2000 Version

WIRB Pregnant Partner Consent Form Template
If a protocol includes plans to obtain data about subjects’ partners who become pregnant during the research, the Board will require use of an approved research subject consent form to obtain the consent of the pregnant partner, unless waiver of consent or waiver of documentation of consent is appropriate. A sample consent form template that sites and sponsors may choose to use as a starting point for drafting a consent form for the pregnant partner is attached below.

The attached template is a sample only and cannot be used to consent subjects. The attached template is subject to change without notice.
PDF Version        Word 2000 Version

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Continuing Review Report Form (CRRF) Work Sheet
The CRRF work sheet is a guide to completing the WIRB CRRF for study coordinators and PIs.
PDF Version        Word 2000 Version

Continuing Review Report Form (CRRF) Instructions for sites using Humanitarian Use Devices (HUDs)
WIRB understands that some of the questions on its Continuing Review Report Form are not pertinent to the use of HUDs, but sites using HUDs must complete the applicable questions on the CRRF and mark the rest “NA”. See the document below for a sample form indicating which questions can routinely be marked “NA”.
PDF Version 

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Template Information Sheet for Waiver of Documentation of Consent
A waiver of documentation of consent is a waiver of the requirement for a signature on a consent form. See the Frequently Asked Question on this topic for more information.
PDF Version        Word 2000 Version

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Institutional Biosafety Committee Services (IBCS):

Institutional Biosafety Committee Services (IBCS) Forms and information are now available here: http://www.ibcservicepoint.com/

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Downloading, Reading and Filling out the Forms
You can either electronically fill out the form then save or print, or print and fill out manually. In order to save the form in Word 2000, go to the File menu and choose Save As. After filling out the form, return it to WIRB via e-mail, fax or regular mail.

The files that are in the Adobe PDF format require Adobe Acrobat Reader 6.0 or higher. If you do not have Adobe Acrobat Reader 6.0, click on the link below and follow the instructions to download this free utility. If you have previously installed an earlier version of Acrobat, you may need to un-install the old version before installing the most current version.

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Sending the Forms to WIRB