OUR FORMS NO LONGER OPEN USING INTERNET EXPLORER - PLEASE USE GOOGLE CHROME

Please submit electronically via our electronic IRB system (https://eirb.providence.org). If you need assistance please contact us at institutional.review.board@providence.org

Application - 

• Application Checklist for New Submissions - Application Checklist, New Submissions (Version 6-15)  
• Application Form - Contact IRB
• Facility Approval Form - Facility Approval Form - (9-13) 

Conflict of Interest -

• Conflict of Interest Policy - See Policy and Procedures
• Conflict of Interest Form -  Conflict of Interest Disclosure Form, Version 6-15 

Consent Forms - Use of the ICF template is required. It has received full board review/approval. 

• Informed Consent-HIPAA Template - Informed Consent - HIPAA Template (11-15)
• Informed Consent/HIPAA Guidelines - Informed Consent-HIPAA Guidelines (11-11).doc 
• Patient Assent Template - Assent Template (1-17) REVISED 1-17
• Limited Participation/Withdrawal Consent - Limited Participation/Withdrawal Consent (11-15)
  
  • NOTE:  THIS DOCUMENT HAS BEEN APPROVED BY THE IRB AND EXCEPT TO INSERT STUDY INFORMATION MUST BE USED AS POSTED WITHOUT MODIFICATION 
• Limited Participation/Withdrawal Guidance Documents - Limited Participation/Withdrawal Guidance Documents (10-15)
• Required Parental Signatures Guidance - Parental signatutes on ICF (11-11).doc 
• Tissue Specimen Information Sheet - Contact IRB 
• Tissue Specimen Consent Template - Contact IRB
• Alternative Terminology Suggestions - Alternative Terminology Suggestions (3-10).pdf 

Continuing Review -  

• Continuing Review Request Form - Contact IRB 

Deviations/Violations - 

• Protocol Deviation/Violation SOP - See Policy & Procedures
• Major Deviation/Violation Report form - Major Protocol Deviaton/Violation Report Form - 2/15   
• Minor Deviation/Violation Reporting Form - Minor Protocol Deviation/Violation Reporting Form - 2/15 

Emergency Use Guidelines - 

• Emergency Use Policy - See Policy and Procedures
• Emergency Use Notification Form (11-14)  

Exemption Determination - 

• Exemption Determination - See Policy and Procedures
• Request for Exemption Determination Form - Exempt Determination Request Form (11-15)  

HIPAA Privacy Rule Information and Forms -  

The Health Insurance Portability and Accountability Act (HIPAA) requires researchers to obtain authorization from subjects to use and disclose their protected health information. Refer to the explanation memo and forms below for requirements.

• Application for Waiver of HIPAA Authorization - Application HIPAA Waiver, Version 11-16  
• Definition of Protected Health information (PHI) and the 18 Identifiers - See Policy and Procedures
• HIPAA Authorization Addendum - Part of Informed Consent Template, see above for link

 Modification (Sponsor Waiver or Exceptions) - 

• Modification (Amendment), Sponsor Waiver or Exceptions) SOP - See Policy and Procedures
• Change in Study Personnel SOP - See Policy and Procedures 
• Modification Request Form - Contact IRB