- How To Prepare the Informed Consent Form for WIRB Submission
- UW Required Consent Template Language
- Approval Period for a WIRB Informed Consent Form
- Pregnant Partner Consent Guidance
- CRU Information Sheet
- Language Translation
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.