Helpful Links

• Food and Drug Administration FDA
  
• Office for Human Research Protections OHRP

New Forms !!!

• New Study Application
• Continuing Review
• Unanticipated Problem Report Form
• Consent Template
• Determination of Human Research Worksheet

Notice: Previous versions of these forms will be accepted through January 31, 2007. After that date, please use these revised versions.

Application Forms:

• New Study Application
  • Registration Form - Include only for your first submission to the IRB
  • SRC - Include if study is cancer related
  • Radiation Safety - Include as needed

• Protocol Modification (Amendments)

• Continuing Review
• Final Closure Report

• Unanticipated Problem Report Form
• Protocol Deviation Report Form

• One Time Emergency Use

• Human Cell Lines and Derived Products

• Conflict of Interest Disclosure

Consent Forms:

• Consent Template
• Consent Template - Tissue Banking
  • Patient Information Sheet - Tissue Banking
• Consent Form Addendum
• Child Assent Template
• Consent for Non-English Speaking Subjects
• Sample Consent for Emergency Use
• VA Form 10-1086 Consent Form Template

HIPAA (Research Privacy Forms)

Research Protocol Outline:

Note: Many of the .pdf forms above are optimized to be viewed and filled with Adobe Reader version 7.x. If you experience difficulty opening or using the forms, you can download and install the newest version of Adobe Reader at no cost.