IRB Updates: Revised Consent and Parental Permission Templates


The IRB has updated the following consent and parental permission templates; clean and tracked copies are available on the IRB website at http://irb.utah.edu/forms/:

  • Consent Document
  • Consent and Authorization Document
  • Consent and Authorization Document for Minimal Risk Research
  • Consent and Authorization Cover Letter
  • Consent and Release of Information Authorization Document – Pregnancy Follow-up
  • Parental Permission Document
  • Parental Permission and Authorization Document
  • Parental Permission and Authorization Document for Minimal Risk Research


No changes have been made to the VA Consent and Authorization Templates, nor the Assent Templates.


Below is a summary of the changes that have been made:

For documents with an Authorization section, this has been combined with the Confidentiality section.  This change was made to reduce duplicate information.  The authorization language was also simplified for easier reading.

  • New studies submitted after 10/25/2013 must use the new template with these changes.
  • Currently-approved studies are not required to update consent documents with this revised language and style.  Consent and authorization documents using the old templates are still compliant.


For documents with an Unforeseeable Risks section, this was moved to immediately follow the main Risks section.

  • New studies submitted after 10/25/2013 must use the new template with these changes.
  • Currently-approved studies are not required to update consent documents with this revised language and style.  Consent and authorization documents using the old templates are still compliant.


Instances of “Primary Children’s Medical Center” have been changed to “Primary Children’s Hospital”.  

  • All studies conducted at Primary Children’s Hospital must incorporate this change.
  • Currently-approved studies must update this language at next continuing review.


Various instances of example language have been simplified.  

  • Example language is provided as suggestion only.  Revisions to currently-approved consent forms may be made at the preference of the study team.