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Pdf-based smart forms are 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.
  • The forms have been adopted by WIRB, NEIRB, MLIRB, Aspire, and CGIRB.

 

The forms below 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.



New Studies
Name

Version Number
Release Date

 Fillable
 Word		 Adobe PDF

WIRB Investigator Handbook "A Guide for Researchers"

  • Canadian guidelines supplement click here
 4.36
07/24/2018

PDF

Right-click the link and select 'Save Target As' or 'Save Link As' to download the file, and open the destination folder to open the form
Investigator Guidance (Sample SOPs) Moved to Miscellaneous Resources Tab

Initial Review submission Form

(Note: this version will expire January 7, 2019; new version will be posted here. Please plan to download the new version when that date approaches. If you have the expired April or November 1 version, and need to edit it, we can assist you.)

3.0.0.40
02/08/2018

Smart PDF
Right-click the link and select 'Save Target As' or 'Save Link As' to download the file, and open the destination folder to open the form

Clinical Use of a Humanitarian Use Device Submission Form (HRP-284)

1.1.1
09/19/2018

PDF
Right-click the link and select 'Save Target As' or 'Save Link As' to download the file, and open the destination folder to open the form

Financial Interest Disclosure Form 10/01/2009 Word
Initial Review Submission Form for International Sites - retired, Use Initial Review Submission Form above  
Request for Exemption Determination 01/06/2016 Word
Request for Exemption Determination - Canada 01/06/2016 Word
Single Patient Expanded Access Submission Form - retired, use appropriate form HRP-280, HRP-281, HRP-282 or HRP- 283 below instead. For more info, see the Expanded Access tab
Approval in Principle Request Form 04/10/2018 Word
New Jersey Requirements for Inclusion of Decisionally Impaired Subjects (New Jersey Statute 26:14-5) 05/14/2012r1 Word
Request for a Partial Waiver of Authorization for Recruitment (HIPAA Partial Waiver of Authorization) 12/15/2015 Word
Request for Full Waiver of Authorization under HIPAA 12/15/2015 Word
IRB Transfer Cover Letter Checklist & Summary Form 09/19/2016 Word

Retired:  Waiver of Consent Request for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable 

See July 2017 FDA guidance "IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects"

Retired

03/19/2018

  
Sample IRB Authorization Agreement (with WIRB filled in as institution A) 03/31/2011 Word
Addendum for Department of Defense Funded Research 05/04/2018 Word
Reliance Agreement 1 (formerly titled "Locations With Obligations to other IRBs - Dual Oversight - US Site") 07/07/2017 Word
Reliance Agreement 2 (formerly titled "Locations With Obligations to other IRBs - Dual Oversight - Canadian Site) 07/07/2017 Word
Reliance Agreement 3 (formerly titled "Locations With Obligations to other IRBs - Split Oversight") 07/07/2017 Word
Reliance Agreement 4 (formerly titled "Locations With Obligations to other IRBs - Split Oversight - Canadian Site") 07/07/2017 Word
Reliance Agreement 5 (formerly titled "Locations With Obligations to other IRBs - Waive Oversight to WIRB") 07/07/2017 Word
WIRB Consent Form Template 01/16/2018r1 Word
Pregnant Partner Template Consent Form (pregnant partner information release form ) 05/27/2016 Word
Pregnant partner information release form signature page addendum – for pregnant partners who require a legally authorized representative 06/17/2016 Word
Template Information Sheet for Waiver of Documentation of Consent 07/24/2014 Word
Single Patient Expanded Access Consent Form Template 02/03/2018 Word
Translation Request Submission Form
 
 10/02/2018

PDF

Right-click the link and select 'Save Target As' or 'Save Link As' to download the file, and open the destination folder to open the form

FORM: Emergency Use of a Drug or Biologic (HRP-280)

 

 

1.0.0
06/08/2018

Smart PDF
Right-click the link and select 'Save Target As' or 'Save Link As' to download the file, and open the destination folder to open the form

FORM: Emergency Use of a Device (HRP-281)
 

1.0.0
06/08/2018

Smart PDF
Right-click the link and select 'Save Target As' or 'Save Link As' to download the file, and open the destination folder to open the form

FORM: Compassionate Use of a Drug or Biologic (HRP-282)
 

1.0.0
06/08/2018

Smart PDF
Right-click the link and select 'Save Target As' or 'Save Link As' to download the file, and open the destination folder to open the form

FORM: Compassionate Use of a Device (HRP-283)
 

1.0.0
06/08/2018

Smart PDF
Right-click the link and select 'Save Target As' or 'Save Link As' to download the file, and open the destination folder to open the form


Studies in Progress
Name Version Number
Release Date		 Fillable
Word		 Adobe PDF
Change in Research Submission Form
2.0.0
08/19/2016

Smart PDF
Right-click the link and select 'Save Target
As' or 'Save Link As' to download the file, and open the destination folder to open the form 

Promptly Reportable Information Form
2.0.0
08/19/2016
  

Smart PDF
Right-click the link and select 'Save Target
As' or 'Save Link As' to download the file, and open the destination folder to open the form 

Recruitment Bonus Disclosure Form 10/01/2009 Word
Impartial Witness Form for Limited and Non-Readers 02/10/2013 Word
Consent addendum for subjects originally enrolled as children who are now adults 01/19/2011 Word
California Experimental Subjects' Bill of Rights 03/22/2017 Word
Emergency Use Post-Use Report Form 11/09/2016 Word
Contact Information Update Form 04/30/2018 Word

Continuing and Final Review
Name Version Number
Release Date		 Fillable Word Adobe PDF
Study Closure Report Form
2.0.1
09/07/2016

Smart PDF
Right-click the link and select 'Save Target
As' or 'Save Link As' to download the file, & open the destination folder to open the form 


Translated Short Forms for Consent 

(View an English version of this OHRP short form here: http://www.hhs.gov/ohrp/policy/ic-non-e.html#sample)

Name Version Date Word Adobe PDF
Albanian Short Form (Translation certification) 11/16/2017 Word
Amharic Short Form (Translation certification)11/16/2017 Word
Arabic Short Form (Translation certification) 11/16/2017 Word
Armenian Short Form (Translation certification) 11/16/2017 Word
Bengali Short Form (Translation certification) 11/16/2017 Word
Brazilian Portuguese Short Form (Translation certification) 07/06/2018 Word

Burmese Short Form (Translation certification)

You'll need to download the font Zawgyi-One to view and print the translation. Your IT department can assist you.

04/16/2018 Word
Cambodian Short Form (Translation certification) 11/16/2017 Word
Creole Short Form (Translation certification) 11/16/2017 Word
Edo Short Form (Translation certification) 11/16/2017 Word
European Portuguese Short Form (Translation certification) 11/16/2017 Word
Farsi Short Form (Translation certification) 11/16/2017 Word
French Short Form (Translation certification) 11/16/2017 Word
Greek Short Form (Translation certification) 11/16/2017 Word
Gujarati Short Form (Translation certification) 11/16/2017 Word
Hebrew Short Form (Translation certification) 11/16/2017 Word
Hindi Short Form (Translation certification) 01/23/2018 Word
Hungarian Short Form (Translation certification) 11/16/2017 Word
Italian Short Form (Translation certification) 11/16/2017 Word
Japanese Short Form (Translation certification) 11/16/2017 Word
Korean Short Form (Translation certification) 11/16/2017 Word
Nepali Short Form (Translation certification) 11/16/2017 Word
Polish Short Form (Translation certification) 11/16/2017 Word
Punjabi Short Form (Translation certification) 04/16/2018 Word
Russian Short Form (Translation certification) 11/16/2017 Word
Simplified Chinese Short Form (Translation certification) 11/16/2017 Word
Somali Short Form (Translation certification) 02/10/2016 Word
Spanish Short Form (Translation certification) 11/16/2017 Word
Tagalog (Translation certification) 12/14/2017 Word
Thai Short Form (Translation certification) 11/16/2017 Word
Traditional Chinese Short Form (Translation certification) 11/16/2017 Word
Turkish Short Form (Translation certification) 11/16/2017 Word
Urdu Short Form (Translation certification) 11/16/2017 Word
Vietnamese Short Form (Translation certification) 11/16/2017 Word
Wolof Short Form (Translation certification) 08/13/2018 Word
Yiddish Short Form (Translation certification) 11/16/2017? Word

Translations of the California Experimental Subject's Bill of Rights
Name Version Date Word Adobe PDF
Armenian California Experimental Subject's Bill of Rights (Translation certification) 08/03/2018 Word
Chinese (Simplified Chinese) California Experimental Subject's Bill of Rights (Translation certification) 04/27/2017 Word
Farsi California Experimental Subject's Bill of Rights (Translation certification) 04/27/2017 Word
French (Parisian) California Experimental Subject's Bill of Rights (Translation certification) 04/27/2017 Word
Japanese California Experimental Subject's Bill of Rights (Translation certification) 09/13/2017 Word
Korean California Experimental Subject's Bill of Rights (Translation certification) 09/13/2017 Word
Russian California Experimental Subject's Bill of Rights (Translation certification) 09/18/2017 Word
Spanish California Experimental Subject's Bill of Rights (Translation certification) 04/11/2017 Word
Tagalog California Experimental Subject's Bill of Rights (Translation certification) 04/11/2017 Word
Vietnamese California Experimental Subject's Bill of Rights (Translation certification) 08/03/2018 Word
 
Sending the forms to WIRB
Please complete and return your form(s) to WIRB via Connexus®, 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