Revised Standard Informed Consent Template

Effective March 9, 2018, IRBMED has revised its standard informed consent template.  The working version containing blue and orange text boxes has been updated with additional instructions and required language. The version formerly referred to as the ‘clean’ version is now titled as the ‘outline’ version. IRBMED’s recommendation is to use the working version as the template for creating the consent document.  If using the outline version, always use the blue-box working version as a companion document for additional instructions and required language.

You must now begin using the revised template if you have not already started creating your consent document in the prior version.  IRBMED will continue to review consent documents created in the previous template if submitted prior to Monday, April 2, 2018.  Consent documents submitted on or after April 2 must be created in this revised template. IRBMED approved consent documents using the previous template do not need to be amended to update to the revised 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:
  • Certificate of Confidentiality language has been updated to be in accordance with new NIH policy.
  • ClinicalTrials.gov language has been updated.
• 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.

Contact the IRBMED office with questions, either by email (irbmed@umich.edu) or by telephone (734-763-4768).