Specialty Informed Consent Templates

• Biorepository Informed Consent Template (with instructions) — Required Reading  This document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the University of Michigan Informed Consent Template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.
• Biorepository Informed Consent Informational Sheet (editable PDF)  Download this editable PDF document to your desktop computer. Then edit and save the PDF to reflect the details of your biorepository project before submitting it to IRBMED for review.
• If you are intending to utilize the University of Michigan Medical School Central Biorepository (CBR) to process, store, and distribute your specimens, visit the UMMS Central Biorepository website for further information. Participating projects are required to use the CBR’s master consent templates. 

You may not use this template if

• you plan to conduct genetic analysis on subjects’ samples
• you plan to submit subjects’ samples or data to a biorepository or data repository

This template may be used only for studies that

• involve a single blood or tissue sample
• pose minimal risk to subjects
• One-Time Blood or Specimen Sample (Minimal Risk) Informed Consent Template (two versions):
  • The Working Version of this document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the One-Time Blood or Specimen Sample (Minimal Risk) Informed Consent Template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.
  • The Outline Version of this document is to be used to complete the One-Time Blood or Specimen Sample (Minimal Risk) Informed Consent Template that is to be submitted to the IRBMED for review.

This template may be used only for studies that

• involve a survey and no other procedures
• pose minimal risk to subjects
• Survey Research Informed Consent Template (two versions):
  • The Working Version of this document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the Survey Research Informed Consent Template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.
  • The Outline Version of this document is to be used to complete the Survey Research Informed Consent Template that is to be submitted to the IRBMED for review.

This template may be used only for eligibility screening and only if screening procedures pose no more than minimal risk to subjects.

You may not use this template if

• you plan to conduct genetic analysis of subjects’ blood or tissue samples
• you plan to submit subjects’ material or data to a biorepository or data repository
• Eligibility Screening Informed Consent Template (two versions):
  • The Working Version of this document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the Eligibility Screening Informed Consent Template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.
  • The Outline Version of this document is to be used to complete the Eligibility Screening Informed Consent Template that is to be submitted to the IRBMED for review.

See Humanitarian Use Device (HUD) guidance here.

• HUD Informed Consent Template (two versions):
  • The Working Version of this document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the HUD Informed Consent Template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.
  • The Outline Version of this document is to be used to complete the HUD Informed Consent Template that is to be submitted to the IRBMED for review.

See Emergency Use guidance here.
See Expanded Access guidance here.

• FDA Expanded Access Consent Template
  • ​This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use.

For assistance with obtaining FDA and IRBMED approval to use an Expanded Access investigational medical product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu