Informed Consent


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 Checklist to the informed consent form documents.
  • The WIRB Reliance 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.

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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. Please see the Initial Review page for the shared checklist, consent checklist, and consent template.

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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.

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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."

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.

For changes of protocol, 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 guidance applies.

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CRU Information Sheet

When using the CRU, a stand-alone information sheet is required. The Reliance 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.

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Language Translation

If the use of a language other than English is required, email submitwirb@medicine.wisc.edu to inquire into the latest institutional policy.

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Keywords:ICF, information sheet, checklist for consent language, shared checklist, translation, template language, template language, confidentiality, expiration label, label, CRU label, ICF label, clinicaltrials.gov, compensation for injury, payment for injury, payment   Doc ID:22424
Owner:Mike B.Group:Western Institutional Review Boards
Created:2012-01-26 12:38 CSTUpdated:2017-10-05 12:59 CST
Sites:Western Institutional Review Boards
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