Greater Than Minimal Risk Consent Form Templates

Greater than Minimal Risk projects typically involve clinical interventions, such as drugs, devices, or surgery.

Templates for Adults

Consent form templates for Greater Than Minimal Risk research involving adult subjects. Select the section that aligns with your IRB application:

all

MCW IRB is the reviewing IRB for a local site (MCW, Froedtert Hospital, Children's Wisconsin, Versiti Blood Center of Wisconsin)

Clinical Interventions Template (DOCX)
For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy. A Spanish Version of the Clinical Interventions Template (DOCX) is available

Clinical Interventions – CW Resources (DOCX)
For studies involving clinical interventions such as drugs, surgery, or psychotherapy. This template is for use with adults, when the project is being conducted at or utilizing resources from Children's Wisconsin.

Clinical Interventions - Early Phase
This template is for projects involving early phase interventions (e.g. drugs, devices, surgery, psychotherapy). If you believe your project is eligible to use this form please contact the IRB Office for the template.

NCI Template Local Review (DOCX)
This template is for NCI-cooperative group sponsored projects being reviewed by the MCW IRB. 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 - Local 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. A Spanish Version of the Standalone HIPAA Authorization - Local Projects (DOCX) is available.

Another site is relying on MCW IRB

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.

Local site (MCW, Froedtert Hospital, Children's Wisconsin, Versiti) is relying on 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.

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.

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. A Spanish Version of Standalone HIPAA Authorization - Deferred Projects (DOCX) is available.

Templates for Minors

Consent form templates for Greater Than Minimal Risk research involving minor subjects, including age of majority, or subjects who reach the age of majority. Select the section that aligns with your IRB application:

all

MCW IRB is the reviewing IRB for a local site (MCW, Froedtert Hospital, Children's Wisconsin, Versiti)

Age of Majority Consent (DOCX)
This template is for projects where a subject was enrolled as a minor and must be consented at the age of majority.

Age of Majority Addendum (DOCX)
To be used for minimal risk research when a subject reaches the age of majority while enrolled in a research project and the remaining activities do not warrant a full consent form to be signed.

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. A Spanish Version of the Assent Template (DOCX) is available.

Clinical Intervention (Assent/Consent) Template (DOCX)
For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.

Another site is relying on MCW IRB

Age of Majority Consent (DOCX)
This template is for projects where a subject was enrolled as a minor and must be consented at the age of majority.

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 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.

Local site (MCW, Froedtert Hospital, Children's Wisconsin, Versiti) is relying on 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.