Informed Consent Index
Find the new informed consent guidance resources here.
Consent Document Checklist
Learn more about how to create a consent document for your research study.
Key Information
Guidance
Guidance and models to help you write your consent document concise summary.
Translation Library
Translated short form consent documents can be found here.
Where are the Consent Document Templates?
Instead of consent templates, the University of Utah IRB offers detailed guidance and models to help you design your consent process.
Do I Still Need the IRB Approval Stamp Footer?
If you submit your consent documents to the IRB as a Word Document, the watermark footer field is still required. You can also submit a PDF with a blank footer.
Submitting Consent Documents to the IRB
All consent documents must be stamped by the IRB in order to be considered approved, and only documents that are not expired (as indicated in the IRB stamp) are valid for consenting research participants.
However, ERICA can stamp documents using two different methods:
- MS Word Documents: These documents must include the "mail merge" style watermark footer that has been
used by the IRB for many years.
- Adobe PDF Documents: ERICA can stamp these documents with an approval stamp image. However, you must leave enough space at the bottom of the document so the image can be placed correctly. Note: Tracked copies of revised documents are still required with your IRB submission, even if the final document submitted for approval is a PDF.
Documents are in Word [DOC] format unless otherwise noted.
| FORMS | Tracked Changes | Version Date |
|---|---|---|
|
COVID-19 Witness Signature & Attestation Page COVID-19 Person Obtaining Consent Attestation Page Research Consent Process Worksheet - Obtaining Signed Consent During the COVID-19 Pandemic |
03.30.2020 | |
| Assent Document Template | 02.08.2012 | |
| Blank Watermark Document | 02.01.2019 | |
| CTSI Consent Executive Summary Template (CTSI Document) | 07.12.2021 | |
| Debriefing Document Template | 07.20.2011 | |
| Pregnancy Follow-Up Consent and Release of Information Authorization Template [doc] | 04.21.2021 | |
| Translation Certification Letter Template | 12.27.2022 | |
| Signature Block Samples | 02.01.2019 | |
| Witness Signature Page | Tracked Changes | 11.20.2011 |
| Utah Population Database (UPDB) Consent and Authorization Requirements [PDF] | 02.01.2011 | |
| Humanitarian Use Device (HUD) Consent and Authorization Document Template | Tracked Changes | 09.03.2021 |
| Emergency Use Consent and Authorization Document Template | 01.06.2015 |
| FORMS | Tracked Changes | Version Date |
|---|---|---|
|
VA Authorization for Use & Release of Health Information Form 10-0493 (Note: Some users have reported difficulties viewing this document via an internet browser. Try downloading it/saving it to your desktop if you cannot view it online.) |
N/A | Sept 2015 |
| VA Checklist for Reviewing Privacy, Confidentiality, and Information Security in Research | 12.01.2010 | |
| VA Emergency Use Consent Document Template | 08.17.2015 | |
| VA Financial Conflict of Interest Statement | 11.2013 | |
| VA Humanitarian Use Device (HUD) Consent and Authorization Document Template | Tracked Changes | 08.17.2015 |
| VA IRB Documentation of Waiver of HIPAA Authorization for Research [PDF] | 07.2011 | |
| VA Revocation of Authorization for Use & Release of Health Information Form 10-10116 | N/A | Sept 2015 |
| FORMS | Tracked Changes | Version Date |
|---|---|---|
| Recruitment Letter Template | 05.14.2010 | |
| Simple Referral Template | 05.14.2010 |
| FORMS | Tracked Changes | Version Date |
|---|---|---|
| See: Preparation Packet for Investigator-Initiated Drug and Device Studies |
| FORMS | Tracked Changes | Version Date |
|---|---|---|
| Data Use Agreement (DUA) Template - UUHSC - Please contact PIVOT | N/A | |
| Data Use Agreement (DUA) Template - IHC | 06.09.2008 | |
| Material Transfer Agreement (MTA) Template- Please contact PIVOT | N/A |