Forms

Please use the following forms and guidance documents when preparing submissions to the Avera Institutional Review Board.  Note: Please do not submit the guidance documents to the IRB; they are intended to be used for your own submission guidance purposes.

Submission Forms

• Application for Initial IRB Review
• Continuing Review Request
• Local Serious Adverse Event/Unanticipated Problem Report
• Report of Emergency Use
• Human Subject Protocol template
• Informed Consent Document template
• Research Subject Authorization (HIPAA template)
• Assent Document template (Children)
• Request for Exempt Status
• Protocol Violation Report Form
• Request for Waiver of Informed Consent
• Request for Partial Waiver of Authorization for Recruitment
• FDA Form 1572 template

Guidance Documents

• New Study Submission Guidance
• Investigator Responsibilities
• Expedited Review
• Exemption Screening Questions
• Essential Documents
• Emergency Use of a Test Article
• Informed Consent Document Checklist
• Glossary of Medical to Lay Terms
• IRB Exempt Review Approval  

IRB Member Checklists

• Advertising Checklist
• Amendment Reviewer Checklist
• Continuing Review Checklist
• Emergency Use Checklist
• Expedited Review Checklist
• General Protocol Review Checklist
• Informed Consent Checklist