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