Standard Informed Consent Template

Jan 15, 2019 1:15 pm

Effective December 3, 2018, the pre-transition informed consent template is no longer in use. All new informed consent documents must be based on the revised Common Rule informed consent template below.

  • 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.

    IRBMED Transition to 2018 Regulations Grid

  • Summary of Changes to the Standard Consent Template

    The revised template includes changes to the following sections:

    • Section 1
      • Study teams are instructed to list only a study’s principal investigator and study coordinator in the consent document.
      • Key information about study participation has been reformatted.
    • Section 4
      • The genomic data sharing language has been updated.
      • Box C is now divided into Boxes C and D to distinguish “substudies” and “unspecified future use”
      • The following statements are now required:
        • With appropriate permissions, your samples and collected information may also be shared with other researchers, here, around the world, and with companies.
        • Your identifiable private information or identifiable biospecimens may be stripped of identifiers and used for future research studies or distributed to another researcher for future research studies without additional informed consent.
        • Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, and other entities, including companies, may potentially benefit from the use of the data or discoveries. You will not have rights to these discoveries or any proceeds from them.
    • Section 9
    • Section 11
      • Addition of State of Michigan HIV testing language has been included (this will eliminate the need to use the separate State of Michigan pamphlet).
    • Section 12
      • Signature boxes have had minor updates.
  • 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. 
      • Use the Upload Revision button to stack the new tracked-changes document on top of the tracked-changes stack. 
      • 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.
    • 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 “Not in use” to the file name. Do not delete these documents from the eResearch application.

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: bpsea@umich.edu
Last Updated: April 13, 2020