Download Forms


Many of WIRB's Word- format submission forms are now retired and replaced with dynamic, PDF-based submission forms!  
 
Pdf-based smart forms are now available below for sending initial reviews, changes in research, promptly reportable information, and study closure information.
 
Please note the following about our smart forms:
  • The smart forms must be completed using either Adobe's free Reader or Adobe Acrobat (version 11 or newer). Use of a program other than Adobe (version 11 or newer) to view or complete the forms will result in missing questions and non-functional fields.  To download Adobe Reader for free, please visit https://get.adobe.com/reader/. (If you do not have access to Adobe's Reader or Acrobat, please contact us to obtain an alternate, Word submission form).   
  • Because these smart forms are dynamic (change based on your responses), they must be completed electronically; therefore, you cannot print them out and complete them on paper. However, at any time during their completion, you can edit, save, print, or share with your colleagues.
  • We will continue to accept the old form until October 7, 2017.
  • The forms have been adopted by WIRB, NEIRB, MLIRB, Aspire, and CGIRB.​ 
A brief orientation and tutorial on the forms' functionality is available here:  http://www.cgirb.com/wp-content/uploads/2015/12/WCG-SMART- Forms-Training-Guide.pdf 

The forms provide WIRB with all the required IRB review information required.  Please provide a submission form with each protocol you submit for review. 
 
For questions or assistance, please see the WIRB Guide for Researchers available below, call 1-800-562-4789, or email clientservices@wirb.com.

WIRB Investigator Handbook A Guide for Researchers
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


Contact Information Update Form
Use this form if you want to add or change names, phone numbers and other contact information to insure that approval documents and other information WIRB sends goes to the correct people. For example, changes to sponsor contact, coordinator, etc., should be sent on this form. Do not use this form for other changes in research such as change in principal investigator or addition of a co-investigator. Use an initial review submission form to submit a change of principal investigator or addition of a co-principal investigator (also see related FAQ on how to submit changes of principal investigator or addition of a co-principal investigator).
 Word 2000 Version


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


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.
 Word 2000 Version


Pregnant Partner Template Consent Form
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


Guidance for Sites and Sponsors Planning to Use E- consent Technology
Electronic consent (“e-consent”) via web applications and/or electronic tablets such as an iPad is growing in popularity.  WIRB is a leader in this area.  WIRB reviews e-consent technologies during development and in their final form to ensure that they meet the regulatory requirements for the elements and documentation of consent.  WIRB suggests sites and sponsors review the FDA Guidance "Use of Electronic Informed Consent in Clinical Investigations, " the WCG white paper "Parameters for IRB review and approval of electronic consent documents, such as i-pad consent and video consent." and  the WIRB Guide for Researchers section on e-consent (which includes some best practices on how to prepare an informed consent IRB submission so that it is suitable for use in an electronic consent tool).

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


Investigator Guidance (Sample SOPs)
Provided below are sample SOPs for sites to adopt, adapt, or excerpt as needed.

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Name Effective Date Word Adobe PDF
HRP-070 POLICY - Investigator Obligations 09 Aug 2016 Word
HRP-071 POLICY - Prompt Reporting Requirements 09 Aug 2016 Word
HRP-802 INVESTIGATOR GUIDANCE - Informed Consent 09 Aug 2016 Word
HRP-803 INVESTIGATOR GUIDANCE - Documentation of Informed Consent 09 Aug 2016 Word
HRP-810 INVESTIGATOR GUIDANCE - Additional DOD Obligations 28 Feb 2017 Word
HRP-811 INVESTIGATOR GUIDANCE - Additional DOE Obligations 28 Feb 2017 Word
HRP-812 INVESTIGATOR GUIDANCE - Additional DOJ Obligations 09 Aug 2016 Word
HRP-813 INVESTIGATOR GUIDANCE - Additional ED Obligations 09 Aug 2016 Word
HRP-814 INVESTIGATOR GUIDANCE - Additional EPA Obligations 09 Aug 2016 Word
HRP-815 INVESTIGATOR GUIDANCE - Additional FDA Obligations 09 Aug 2016 Word
HRP-816 INVESTIGATOR GUIDANCE - Additional ICH-GCP Obligations 09 Aug 2016 Word
HRP-817 INVESTIGATOR GUIDANCE - Additional ISO 14155 Obligations 09 Aug 2016 Word


Sending the forms to WIRB
Please complete and return your form(s) to WIRB via Connexus (https://www.connexus.wcgclinical.com) , e-mail, fax, or postal mail.

WIRB
1019 39th Avenue SE Suite 120
Puyallup, Washington 98374- 2115
USA
E- mail: clientservices@wirb.com
Fax: (360) 252-2498


 
 
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