Minimal Risk Consent Form Templates

Minimal risk projects typically involve observation, interviews, audio recording, surveys, or focus group discussion.

Templates for Adults

Consent form templates for 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, FH, CW, Versiti)

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 Consent Form Minimal Risk Consent CW Resources (DOCX)
For projects which involve minimal risk procedures (ex. Observation, interviews, audio recording, surveys, focus group discussion) and/or other minimal risk interventions/interactions (ex. Blood draws, MRI, community or educational interventions). This template is for use with adults, when the project is being conducted at or utilizing resources of Children's Wisconsin.

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.

Another site is relying on MCW IRB

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.

Local site (MCW, FH, CW, Versiti) is relying on another IRB

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.

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

Templates for Minors

Consent form templates for 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, FH, CW, 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.

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.

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.

Another site is relying on MCW IRB

Age of Majority (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 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.

Local site (MCW, FH, CW, Versiti) is relying on another IRB

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.

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