Templates

Specialty Informed Consent Templates

IRBMED
Jul 8, 2020 10:45 pm

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if they are to make an informed decision. We ensure respect for persons by providing information needed for thoughtful consent for a voluntary act.

Below is an overview of the Specialty Informed Consent Templates currently offered.

  • Biorepository Informed Consent Template

    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.

    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.

    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 Informed Consent Informational Sheet (editable PDF) 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. 

    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
  • One-Time Blood or Tissue Sample (Minimal Risk) Informed Consent Template

    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.
  • Survey Research Informed Consent Template

    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 hat is to be submitted to the IRBMED for review.
  • Eligibility Screening Informed Consent Template

    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.
  • Humanitarian Use Device (HUD) Informed Consent Template

    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.
  • FDA Expanded Access Informed Consent Template

    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

  • Exempt research template

    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.

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: bpsea@umich.edu
Last Updated: October 21, 2021