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Research Microscope Lab
Human Research Protection Program

MCW Consent Form Templates

To find the appropriate Consent Form Templates, first select whether your project is considered Minimal Risk or Greater Than Minimal Risk.

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Minimal Risk

Minimal risk projects typically involve observation, interviews, audio recording, surveys, or focus group discussion. Other activities that may be considered minimal risk are blood draws, MRIs, and community or educational interventions.

Access consent forms for minimal risk
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Greater Than Minimal Risk

Greater than Minimal Risk projects typically involve clinical interventions, such as drugs, devices, or surgery. Certain additional activities, such as blood draws above a certain amount, biopsies, and x-rays are also considered greater than minimal risk according to federal regulations.

Access consent forms for greater than minimal risk

Additional Templates and Supplemental Documents

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Addendum

Addendum Template (DOCX)
For instances in which the Sponsor or Investigator need to provide specific limited new information about the project to subjects rather than having subjects sign an entire revised consent form.

Additional Modules

Audio and Video Recording (DOCX)
When study involves audio or video recording.

Blood Draw Risks (DOCX)
Use this language for projects which involve blood draws to describe the possible foreseeable risks of this procedure.

COVID-19 Project Injury Language (DOCX)
Use this language in place of standard MCW injury language for projects involved in COVID-19 related research.

Human Gene Transfer (HGT) Sample Language (DOCX)
Sample language sections from the NIH HGT Trials guidance document has been provided to assist study teams to comply with requests from the IBC to include certain pieces of information within the informed consent.

NIH-Funded Research (DOCX)
This document contains language pertinent to NIH-funded research, including recommended language for Certificates of Confidentiality and data sharing. A Spanish Version (DOCX) is available.

Magnetic Resonance Imaging (DOCX)
MRI Procedures and risks, including for optional gadolinium contrast agent.

Ophthalmology Recommended Consent Form Language (DOCX)
This module is available as a resource for projects involving research procedures at The Eye Institute and includes Ophthalmology consent form language recommended by The Eye Institute. Any questions regarding the language contained within the module should be directed to your Eye Institute contact.

Students, Residents, or Employees as Subjects (DOCX)
When projects involve the enrollment of students and/or residents.

Banking
Banking Template (DOCX)
For projects which will be solely focused on the collection and banking of clinical records or biospecimens at MCW/Froedtert Hospital (local banking). A Spanish Version of the Banking Template (DOCX) is available.

Banking (Assent/Consent) Template (DOCX)
For projects which will be solely focused on the collection and banking of clinical records or biospecimens at MCW/Froedtert Hospital (local banking).

Distant Banking (DOCX)
When banking health information/ biospecimens only at a location outside of MCW/Froedtert Hospital. A Spanish Version of Distant Banking (DOCX) is available.
EFIC/Treatment Use/HUD

EFIC Template (DOCX)
For projects involving planned emergency research. Consent prior to these interventions is waived because of the condition of the subject and urgency under which procedures need to take place. Template is to be used for obtaining consent for continued participation.

HUD Template (DOCX)
This template is for use of a Humanitarian Use Device. Please contact the IRB office prior to use of this template.

Treatment Use Template (DOCX)
This template (Emergency/Treatment Use) is for treatment uses involving investigational drugs/devices/biologics for the treatment of patients not in a clinical trial.

Short Form Consent Templates

Project Teams may use these short forms in the consenting process with non-English or Limited English proficient subjects, while study documents are undergoing translation, if they unexpectedly encounter or choose to enroll a subject whose primary language is not English. Please review the provided English version before use with a subject.

For more information, please review IRB SOP: Recruitment and Enrollment of non-English Speaking Subjects (PDF).

Trial Partner
Trial Partner Template (DOCX)
For projects which require the assistance/participation of a caregiver or trial partner in addition to the main study subject.

Which Template Should I Use?

If you have a question about which template is appropriate for your study (Clinical Intervention, Minimal Risk, NCI- or Banking) or have a special circumstance that does not fit the available templates, please contact IRB Office.

For additional guidance on unique situations relating to consent, find IRB Guidance on the IRB Policies and Procedures web page. 

New studies may use the Word templates below (Keep checking back for recently updated versions!)

All continuing studies and amendment applications should continue to use their already-approved consent forms

 

What if I Want to Change the Required Language?

Sample language, which can be used, modified, or deleted as needed for your study is in blue type.

IRB-required template language is in black type and can not be modified without IRB approval

If you propose a change to required language, complete and submit an ICF Template Change Form Request (DOCX)

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