Forms and Resources

Download the following research forms for completion before sending to the Research Institute at Saint Alphonsus. All of the following forms are in a Word or Excel format and must be filled out completely.

IRB Research Forms

• Study Team Change Application
• Initial Submission Application
• Exemption Application
• Determination of Financial Interest
• Significant Financial Interest Disclosure
• Adverse Event Report
• Amendment Application
• Annual Review Application
• Permanent Study Closure Application
• Protocol Deviation Reporting Form 
• Application for Waiver of Authorization
• Humanitarian Use Device/Investigational New Drug-Initial, Amendment, or Continuing Review Submission 
• Waiver of Assent 

Study Submission Guidelines

• IRB Review Submission Guidelines
• IRB Meeting Dates
• Informed Consent Template
• Research Protocol Template

Additional Resources

• Human Subject Regulations Decision Charts
• HIPAA-Use and Disclosure of Protected Health Information Policy
• Office of Research Integrity
• Office of Human Research Protections
• U.S. Food and Drug Administration (FDA)
• CITI Program