Templates

Specialty Informed Consent Templates

IRBMED
Apr 17, 2018 3:30 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

    • Biorepository Informed Consent Template (with instructions) — Required Reading This informed consent document is only offered as a template at this time while both this document and the accompanying information sheet are undergoing slight modifications. 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.
    • 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. 
  • 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
    • One-Time Blood or Specimen Sample (Minimal Risk) Informed Consent Template 
      • 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.
  • 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
    • Survey Research Informed Consent Template
      • 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.
  • 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
    • Eligibility Screening Informed Consent Template
      • 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.
  • Humanitarian Use Device (HUD) Informed Consent Template

    See Humanitarian Use Device (HUD) guidance here.

    • HUD Informed Consent Template
      • 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.
  • FDA Expanded Access Informed Consent Template

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

    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

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: mhayward@umich.edu
Last Updated: May 30, 2018 3:00 PM