COMIRB Forms

Protocol Templates

• Therapeutic Intervention, IND/IDE Exempt 
• Observational or Non-Therapeutic Intervention 
• Exempt Categories 1, 2, or 3 
• Biorepository Protocol Template 
• Secondary Research Protocol Template  
• GCP Protocol Template for Drug Investigations 
• NIH Protocol Templates for Clinical Trials 
• HDE Protocol Template 

Applications

• IRB Application Form
• Secondary Research Application

Please note: since the Application is a Smart PDF, it cannot open in the browser (which is typically the default setting) and must be opened in Adobe Acrobat or another PDF viewer program. To open the form, follow these steps:

1. In the browser, click on the form link to download.
2. When you see the "Please Wait" message, click on the download arrow (top right corner, next to the print icon).
3. Save the form to your computer downloads, desktop, or another folder you’ll be able to find.
4. Do not try to open the document from the bottom of your screen if it pops up. Instead, go to the folder where you saved the form, right click it, and choose Open With > Adobe Acrobat.

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
• Biobanking Consent Template with 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 Template Language
• UCHealth Research Consent Template Language
• 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
• Interpretation and Translation Services

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 
• Mentee PI Attestation Form 
• Mentor Agreement Form 
• PI Attestation Form