Specialty Informed Consent Templates

There are two consent instruments that must both be used to obtain consent to participation in any biorepository project:

• a text-only informed consent document
• an illustrated informational sheet

Use the blue buttons below to download both types of consent instruments to use in your informed consent process.

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.

Biorepository text-only 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.

Below, select one of the two templates, depending on the type of repository you plan to submit to:

• the UM Medical School's Central Biorepostitory
• a non-CBR repository you plan to maintain yourself

Biorepository Illustrated Informational Sheet (editable PDF) Edit and save the PDF to reflect the details of your biorepository project before submitting it to IRBMED for review.

Below, select one of the two templates, depending on the type of repository you plan to submit to:

• the UM Medical School's Central Biorepostitory
• a non-CBR repository you plan to maintain yourself

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

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 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 document 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

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 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 document 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

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 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 document that is to be submitted to the IRBMED for review.

See Humanitarian Use Device (HUD) guidance here.

Template (two versions):

• The Working Version 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 template prior to submitting it to IRBMED for review. Investigators are responsible for understanding and following all instructions.
• The Outline Version is to be used to complete the document to be submitted to IRBMED for review.

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

FDA Expanded Access Consent Template​ is designed for use in both Compassionate Use and Emergency Use cases.

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

The expectation for all human subject research—whether exempt or not—is for researchers to inform the subjects regarding the research and seek/secure the consent of subjects.

Use the Exempt Consent Template for Exempt studies requiring Limited IRB review (categories 2(iii) and 3(i)(C). You may use it for other Exempt human subjects research that involves interaction/intervention (categories 1, 2, and 3).

Do not use this template for studies requiring comprehensive (regularly regulated) IRB review and approval.

1. Investigators are responsible for understanding and following the IRBMED Guidance for non-English speaking subjects before using the forms below. Please note, the instructions on this page are for filling out the form, NOT the guidance for using a short form with a subject. Be sure to read the Guidance.
2. Do not alter or add to the text of these forms.
3. Do not alter the header or footer.
4. The interpreter on hand during the consent conversation should fill in the needed blanks where information is to be provided and have the appropriate parties sign and date the form where indicated.
5. If a language or translation error on a foreign language short form is discovered, notify the IRBMED immediately so we can correct the problem.

The short form documents below were created in June 2018; all translations are certified by Babel Linguistics. For certification documentation, contact the IRBMED office.

IF YOU NEED A SHORT FORM IN A LANGUAGE THAT IS NOT LISTED, OR IF YOU NEED INSTRUCTIONS FOR USING THE FORMS, EMAIL IRBMED@UMICH.EDU.