Human Subjects Research Forms and Templates

Informed consent tools

• Decisional capacity assessment tool
• Surrogate self-certification tool
• Investigator certification of surrogate tool

Informed consent templates

• Adolescent assent (Age 13-17 Years)
• Adult consent
• Audio-recording consent
• Child assent (age 6 and under)
• Child assent (age 7-12 years)
• Experimental subject’s bill of rights – To be distributed to subjects when research involves medical procedures (blood draws, MRIs, etc.)
• GDPR Consent Addendum
• Parental Permission
• Video-recording Consent

Exempt agreement to participate templates

• Exempt agreement
• Exempt agreement – focus groups
• Exempt agreement – interviews
• Exempt agreement – surveys

Alternative HSR training forms

• Human Subjects Research (HSR) Ethics Training Equivalency Letter – Used to provide documentation of HSR training for foreign engaged investigators for whom CITI training is not available in their language BUT their institution has its own HSR training. 
• Local Community Research Assistant Field Training Pamphlet – Used to provide documentation of HSR training for foreign engaged investigators for whom CITI training is not available in their language AND they are not affiliated with an institution that has its own training.

Tools

• Recruitment guidance
• Data management and security considerations

HIPAA research authorization forms

• English
• Spanish
• Russian
• Mandarin