Research Microscope Lab

Consent Form Templates

Use the below templates to request informed consent for research.  

Templates

Templated Consent Forms for human subject research.
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Consent Templates

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.

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

Clinical Interventions Template (DOCX)
For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.

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 Humanitarian Device Exemption (HDE) Template (DOC)
For projects which involve the use of an HDE-cleared device in the course of clinical treatment. This consent template should only be used if the Sponsor has not provided any documents or information to provide patients.

Informational Letter Template (DOCX)
For minimal risk projects only and can be used for projects where the research activities are generally limited to surveys, interviews, focus groups, educational interventions, and/or observational research.

IRB Review Deferred Consent Form Template - Minimal Risk (DOCX)
For projects involving minimal risk procedures/interactions where the MCW IRB defers review to another IRB. 

IRB Review Deferred Consent Form Template - Clinical Interventions (DOCX)
For projects involving clinical interventions where the MCW IRB defers review to another IRB.

Minimal Risk Template (DOCX)
For projects which involve minimal risk procedures (ex. observation, interviews, audio recording, surveys, focus group discussion) and/or other minimal risk inventions/interactions (ex. blood draws, MRI, community or educational interventions. 

Multi-institution MCW IRB of Record Consent Form Template - Minimal Risk (DOCX)
For projects involving minimal risk procedures/interactions where the MCW IRB will be serving as the IRB of record for one or more sites engaged in research. 

Multi-institution MCW IRB of Record Consent Form Template - Clinical Interventions (DOCX)
For projects involving clinical interventions where the MCW IRB will be serving as the IRB of record for one or more sites engaged in research. 

Multi-institution MCW IRB of Record Assent (DOCX)
This assent template may be used for multi-site projects involving minor subjects ages 7-13 where MCW is the IRB of record for one or more sites engaged in research. The language used should be at a 2nd-3rd grade reading level.

Multi-institution MCW IRB of Record Consent/Assent Minimal Risk (DOCX)
For projects involving minors and minimal risk procedures/interactions where the MCW IRB will be serving as the IRB of record for one or more sites engaged in research.

Multi-institution MCW IRB of Record Consent/Assent Clinical Interventions (DOCX)
For projects involving minors and clinical interventions where the MCW IRB will be serving as the IRB of record for one or more sites engaged in research.

NCI Template_CIRB Deferred (DOCX)
For all NCI cooperative group projects that will be deferred to NCI CIRB for review. This template contains all required MCW language which must be incorporated into the NCI CIRB approved consent and should be used in conjunction with the Standalone HIPAA Authorization - Deferred Projects. 

NCI Template_Local Review (DOCX)
For all NCI cooperative group projects that will be reviewed by MCW/FH IRB. This template contains all required MCW language which must be incorporated into the NCI consent. This template should be used in conjunction with the Standalone HIPAA Authorization - Local Projects. 

NMDP Template BMT-CTN Deferred (DOCX)
For all BMT CTN projects that will be deferred to the National Marrow Donor Program IRB for review. This template contains all required MCW language which must be incorporate into the NMDP approved consent form.

Standalone HIPAA Authorization - Deferred Projects (DOCX)
For use in conjunction with Sponsor templates for deferred projects

Standalone HIPAA Authorization - Local Projects (DOCX)
For use in conjunction with MCW consent templates when the HRPP Office has agreed that a standalone authorization can be used.  

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

Assent Templates

These templates should be used for studies which will be enrolling subjects who are minors (under the age of 18). The assent template may be used with subjects ages 7-13. The Assent/Consent templates may be used for subjects aged 14+

  • Assent Template (DOCX)
    This assent template may be used for all project involving minor subjects ages 7-13. The language used should be at a 2nd-3rd grade reading level.
  • Clinical Intervention (Assent/Consent) Template (DOCX)
    For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.
  • Banking (Assent/Consent) Template (DOCX) 
    For projects which will be solely focused on the collection and banking of clinical records or biospecimens at MCW/FH (local banking).
  • Minimal Risk (Assent/Consent) Template (DOCX)
    For projects which involve only observation, interviews, audio recording, surveys, focus group discussion and/or other non-interventional activities.
Consent Modules for Special Cases

These modules can be inserted into the appropriate study-specific text boxes in the consent form templates.

  • Audio and video recording (DOC) When study involves audio or video recording.
  • Blood Draw Risks (DOC) Use this language for projects which involve blood draws to describe the possible foreseeable risks of this procedure.
  • Certificate of Confidentiality (DOC) This language can be inserted into the consent for project which have received a Certificate of Confidentiality from DHHS.
  • COVID-19 Project Injury Language (DOC) Use this language in place of standard MCW injury language for projects involved in COVID-19 related research. 
  • Device study descriptions (DOC) When study involves devices.
  • Distant Banking (DOC) When banking health information/ biospecimens only at a location outside of MCW/Froedtert Hospital.
  • Students, Residents or Employees as subjects (DOC) When projects involve the enrollment of students and/or residents.
  • Human Gene Transfer (HGT) Sample language (DOC) 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.
  • Magnetic Resonance Imaging (DOC) 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.

 


Short Form Consent Templates

Project Teams may use these short forms in the consenting process with non-English or Limited English proficient subjects if they unexpectedly encounter or choose to enroll a subject whose primary language is not English.

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


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)