COMIRB Forms

Protocol Templates

• Therapeutic Intervention, IND/IDE exempt 
• Observational or Non-Therapeutic Intervention 
• Exempt Categories 1, 2 or 3 
• Secondary Research Protocol Template  
• GCP Protocol Template for drug investigations 
• NIH Protocol Templates for Clinical Trials 
• HDE Protocol Template 
• Additional Protocol Guidance for Biomedical Research  
• Additional Protocol Guidance for Behavioral Research

Applications

Please note: the Applications cannot be opened in the browser. You must download the PDF and then open it from the downloads folder into Adobe Acrobat or another PDF viewer.

• IRB Application Form 
• Secondary Research Application 
  

Consent Templates

• Biomedical Consent Template With Compound Optional Procedures and HIPAA Authorization
• Social and Behavioral Consent Template without HIPAA Authorization
• Social and Behavioral Consent Template With Compound Optional Procedures and HIPAA Authorization
• Assent Template
• Information Sheet Template (Postcard Consent)
• Pre-Screening Script Template
• Compassionate Use/Treatment Protocol Consent Template
• Humanitarian Use Device (HUD) Consent Template
• Quality Control MRI for Research Consent Template
• Audio-Visual Release
• Standard Language Options - Resource Document
• Children's Hospital Colorado Consent Language - Resource Document
• NCCN Informed Consent Language (ICL) Database - Resource
• GDPR Addendum

HIPAA

• HIPAA A Form (Recruitment)
• HIPAA B Form (Enrollment)
• Spanish HIPAA A Form (Recruitment)
• Spanish HIPAA B Form (Enrollment)

Continuing Review

• Continuing Review Form
• Annual Aggregate Protocol Deviation/Non-Compliance Report Form
• Annual Aggregate Safety Report Form

Incident Reports

• Reportable Event Form (Unanticipated Problems)

Non-English Speakers

• Translated Short Forms and HIPAA Authorizations

Single IRB

• IRB Authorization Agreement Form 
• Individual Investigator Agreement
• Lead PI Responsibilities
• Local Context Form
• Relying Site Details Form
• Relying Site Details Form - Example
• Single IRB Plan Template for grant proposals
• Single IRB Oversight Plan, Minimal Risk Research
  

Amendments

• Change Form 

Other Forms

• Advertising Components Form 
• Human Fetal Attestation Form 
• IRB Fee Waiver Form 
• Investigator_Responsibilities
• Mentee PI Attestation Form 
  
• Mentor Agreement Form 
• PI Attestation Form