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Human Research Protection Program

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
果冻影院 IRB is the reviewing IRB for a local site (果冻影院, Froedtert Hospital, Children's Wisconsin, Versiti Blood Center of 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.

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

IRB Consent Form Clinical Intervention Consent 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.

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

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

Another site is relying on 果冻影院 IRB
Multi-Institution 果冻影院 IRB of Record Consent Form Template - Clinical Interventions (DOCX)
For projects involving clinical interventions where the 果冻影院 IRB will be serving as the IRB of record for one or more sites engaged in research.
Local site (果冻影院, 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 果冻影院 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 果冻影院 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 果冻影院 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.

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
果冻影院 IRB is the reviewing IRB for a local site (果冻影院, 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.

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

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

Another site is relying on 果冻影院 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.

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.

Multi-Institution 果冻影院 IRB of Record Assent (DOCX)
This assent template may be used for multi-site projects involving minor subjects ages 7-13 where 果冻影院 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 果冻影院 IRB of Record Consent/Assent Clinical Interventions (DOCX)
For projects involving minors and clinical interventions where the 果冻影院 IRB will be serving as the IRB of record for one or more sites engaged in research.

Local site (果冻影院, 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 果冻影院 IRB defers review to another IRB.

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

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