Standard Informed Consent Template

Revised Common Rule informed consent template

At this time, only the working version of the informed consent template is available for download. The working version includes all instructions and required language in blue text boxes.

April 2020: New blue-box help text added to standard informed consent template

On April 11, 2020, a blue box was added to section 5.2 (What happens if I get hurt, become sick, or have other problems as a result of this research?). The information in the blue box recommends additional language for studies with COVID-19-related components.

This new box was the only April 2020 change; the main text of the template was unaltered.

• New Applications:  Please make sure to delete all instruction boxes, comments, and headers from the original working template. Also be sure to proofread the document for spelling, grammar, and formatting errors.
• Amendments: Per the IRBMED Document Revision Guidance, Naming Convention, and Version Control statement of practice, as part of an amendment modifying the consent(s)
  • Edit the most recent version of the CLEAN informed consent document found in 10-1.1. 

  • Turn on “Track Changes” feature in Word.

  • Save “Track Changes” version in .docx or .doc format.

  • Upload ONLY "Track Changes" document on the previous tracked-changes stack in 10-1.1 using the ellipsis (three dots) next to the version number column. 

  • Use the standard naming conventions for stacks from the Document Revision Guidance, Naming Convention, and Version Control​​​​​​​ statement of practice. Also be sure to proofread the document for spelling, grammar, and formatting errors.
• For informed consent documents that are uploaded in eResearch but are no longer in use, please simply change the document file name by adding the phrase “X - Not in use” or "X - Out of Date" to the file name. Do not delete these documents from the eResearch application.