Templates

Standard Informed Consent Template

IRBMED
Jun 14, 2021 3:45 pm

New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage.

Specialty Consent Templates may be appropriate for low-risk studies with simpler study methodologies.

  • Downloadable 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.

  • Summary of Changes to the Standard Consent Template

    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.

  • When uploading your informed consent form in eResearch

    • 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 Version Control of Informed Consent Documents 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 Version Control of Informed Consent Documents statement of practice. Also be sure to proofread the document for spelling, grammar, and formatting errors.
      • Further detail on Track Changes and Uploading Revisions
    • 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but are no longer in use, please simply change the document file name by adding the phrase “X - Not in use” or "X - Out of Date" to the file name.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.
Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: larkspur@umich.edu
Last Updated: July 12, 2021 3:15 PM