Specialty Informed Consent Templates

 

Biorepository
One-time blood or specimen sample (minimal risk)
Survey Research
Eligibility screening
Humanitarian Use Device (HUD)
FDA Expanded Access Use of an Investigational Agent

 

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 (with instructions) (version 1-23-2017) — 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 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.

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 (with instructions) (version 10-23-2015) — 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 Survey Research Informed Consent Template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.

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

Humanitarian Use Device (HUD) Informed Consent Template

See Humanitarian Use Device (HUD) guidance here.

  • HUD 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 HUD Informed Consent Template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.

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

 

Return to Informed Consent Templates page.

 

Page created 1-13-2014
Updated 3-31-2017