Templates, Forms and Guidance

Protocol must be submitted using the online submission system VERAS.

Below are some forms, templates and guidance that may be useful for your human subjects research submission.

Consent

• Consent Form Template – Standard (For non-exempt federally-funded protocols)
• Consent Form Template - NIH-Funded Studies
• Consent Form Template – Survey/Interview/Focus Group (For exempt protocols)
• Child Assent Form - Ages 3 to 12
• Teen Assent Form – Ages 13 to 17
• Parent/Guardian/LAR Permission Form
• Additions to Consent for NIH funded research and Clinical Trials
• Additions to Consent for research conducted outside of the United States

HIPAA and Personal Health Information or Human Biological Specimens

• HIPAA Authorization Form
• HIPAA Application Supplement Form

Not Human Subjects Research

• Guidance on Quality Assurance/Quality Improvement projects
• Guidance on Course-Related Activities involving human subjects

Data Use Agreements and Material Transfer Agreements

• Data Use Agreement Template
• Material Transfer Agreement Template

Guidance on Data Use Agreements (DUA) - As members of the Federal Demonstration Partnership (FDP) we are committed to using their forms. Please refer to the FDP website for templates and guidance charts on when and how to use the FDP templates. We are willing to use another institutions version of the DUA form if they are not a member of FDP.

Reliance Agreements

• Reliance Agreement Form

When possible, the University of Idaho uses SMART IRB to complete reliance agreements. To begin this process, please access SMART IRB and follow the access instructions under "Create an account for SMART IRB Reliance". You must have an approved IRB protocol in place prior to beginning this process. Contact irb@uidaho.edu with any questions.

IRB Compliance Self-Assessment

• Self-Assessment Worksheet

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