Informed Consent

Information Regarding Informed Consent for WIRB Studies

 How to Prepare the Informed Consent Form for WIRB Submission

  • Use a Microsoft Word document template from the sponsor.  If possible, try to request a WIRB-approved informed consent form template from the sponsor; having a WIRB-approved template should reduce the amount of back and forth with the sponsor.
  • Use track changes for all of the modifications within the informed consent documents.
  • Use comment boxes to identify and provide short rationales for modifications made to the informed consent documents. By using comment boxes, the chances of having your submission placed on hold by WIRB will be reduced.
  • Apply the consent form guidance within the WIRB Initial Review Shared Check List to the informed consent form documents.
  • The WIRB Gateway Team accepts only tracked consent forms because the WIRB Gateway Team;and WIRB need to see what modifications have been made to the sponsor's template.

 UW Required WIRB Consent Template Language

In the case of studies deferred to WIRB, WIRB will monitor for language that UW requires to be included in consent documents approved by WIRB on behalf of the UW.  Below is a template document that includes the language UW requires in WIRB-approved consent forms.  The gray shaded text indicates UW required language, yellow shaded text has instructions for WIRB data entry personnel, and non-highlights text provided suggested WIRB template text.  NOTE: The gray shaded language sections of the consent template cannot be altered and will replace or appear in conjunction with the sponsor's template language.  All consent forms sent to WIRB from the UW need to follow this template.

 Required Checklist for Optional Consent Language

The UW study team uses this document to designate what required UW institutional language is applicable to their consent forms.  This document needs to be completed by the study team for each initial submission to WIRB.  The document is reviewed by a WIRB Gateway Team member, and submitted with the initial review application as consent material.

Consent Language Checklist (Version 14)

 Approval Period for a WIRB Informed Consent Form

You will not receive a newly dated informed consent form after the annual continuing review has been completed from WIRB.  WIRB does not apply expiration dates to informed consent documents they approve.  The only time the informed consent form "expires" for a WIRB study is when it is replaced by a revised informed consent document.  It is possible for the original approved informed consent form to exist for the lifespan of the study if no changes are made to the informed consent document.

Example Understanding the Consent

Pregnant Partner Consent Form

When a protocol includes instructions for collecting data on a pregnant partner, or a partner of pregnant trial subject, a separate informed consent and HIPAA Authorization must be approved prior to collecting such data.

WIRB addresses pregnant partner consents in the WIRB Investigator Handbook "A Guide for Researchers."  In part, the Guide states:

If plans for obtaining consent from the pregnant partner (or a request for a consent waiver) are not submitted at initial review, the Board may approve the research, but send a letter reminding the investigator and sponsor that pregnant partners and their infants cannot be followed-up until WIRB approves a consent plan for them.  Please note that no action is necessary until such time as a pregnancy occurs.

A sample information release form template for obtaining consent from partners who become pregnant and for collecting data about their infants is available in Appendix 4 of the Guide for Researchers and on the Download Forms page of  The template form cannot be used without WIRB approval.

Initial Review Submission

Please note that during initial review submission if a pregnant partner informed consent form has been previously approved by WIRB for a different participating  protocol site,  WIRB may place the initial review submission on hold to verify the necessity to include this type of informed consent for your site.   To avoid having your research being placed on hold, it’s best to inquire with your CRO or Sponsor prior to submitting your initial review application to determine if your site will need to submit a pregnant partner informed consent form.  If the sponsor has previously had a pregnant partner consent reviewed by WIRB, but such a submission is not required by your CRO or sponsor during the initial review submission, please request written documentation supporting this omission and submit the documentation with your initial review application.

Change in Research Submission

If the addition of a pregnant partner informed consent is required to your protocol please obtain the consent template from your CRO, Sponsor or WIRB. All posted WIRB Gateway guidance applies.

 CRU Information Sheet

When using the CRU, a stand-alone information sheet is required.  The WIRB Gateway Team reviews the information sheet as part of the submission process to WIRB.  WIRB reviews the information sheet not as a consent document but as subject material.

 Language Translation

If the use of a language other than English is required, contact a WIRB Gateway Team member to inquire into the latest institutional policy.

Keywords:ICF, information sheet, checklist for consent language, shared checklist, translation, template language, template language, confidentiality, expiration label, label, CRU label, ICF label,, compensation for injury, payment for injury, payment   Doc ID:22424
Owner:Mike B.Group:Western Institutional Review Boards
Created:2012-01-26 13:38 CDTUpdated:2016-05-19 07:40 CDT
Sites:Western Institutional Review Boards
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