IRB Updates

The IRB has made several changes to the IRB Consent Templates that are available online. IRB Consent Templates may be accessed by using the following links:

Main Campus Forms: www.research.utah.edu/irb/forms/mainCampusForms
HIPAA Forms: http://www.research.utah.edu/irb/forms/hipaa/index.html

All changes below will be enforced for new studies submitted on or after Feb. 05, 2011. Changes marked as (*) will be enforced at continuing review.

HIPAA Consent/Parental Permission Templates Summary of Changes

• Verbatim language has been added to the Confidentiality section of the template for use by studies that are required to register on ClinicalTrials.gov.
• The University of Utah has revised the verbatim Research-Related Injury Statement.

Main Campus Consent/Parental Permission Templates Summary of Changes

• In the signature block, the “Name of Researcher or Staff” has been revised to “Person Obtaining Consent”.

VA Consent Template

• Verbatim language has been added to the Confidentiality section of the template for use by studies that are required to register on ClinicalTrials.gov.
• The witness and PI signature block for the consent document has been deleted. The VA now only requires signatures from the participant/LAR and the personal obtaining consent.
• The HIPAA Authorization section has been separated from the main consent. This means that participants must sign the document twice: once for consent and once for authorization. The VA Consent Template includes all sections and signature blocks for consent and authorization in one document, meaning that you do not need to upload two separate documents into ERICA; however the IRB will no longer use an approval stamp on the bottom of the HIPAA Authorization section. Because of the complexity of the template, be careful to follow the instructions included at the beginning and throughout the template.

HUD VA Consent Template

• The witness and PI signature block for the consent document has been deleted. The VA now only requires signatures from the participant/LAR and the person obtaining consent.
• The HIPAA Authorization section has been separated from the main consent. This means that participants must sign the document twice: once for consent and once for authorization. The VA Consent Template includes all sections and signature blocks for consent and authorization in one document, meaning that you do not need to upload two separate documents into ERICA; however the IRB will no longer use an approval stamp on the bottom of the HIPAA Authorization section. Because of the complexity of the template, be careful to follow the instructions included at the beginning and throughout the template.

Please note that a separate listserv announcement will be sent providing additional detail for the changes affecting studies conducted at the VA. If you have any questions about these updates, please contact the IRB at 801.581.3655, or by email at IRB@hsc.utah.edu.