IRB:Protecting the Rights and Welfare of Human Research Subjects              
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IRB:Protecting the Rights and Welfare of Human Research Subjects
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Guidelines & Procedures


     393 E. Walnut St. 4th Floor
     Pasadena, California 91188
     Phone: (626) 405-3665
     Fax:     (626) 405-5186
     E-Mail: kpsc.irb@kp.org

kpsc_irb    

 

Listed below are the Kaiser Permanente Southern California Institutional Review Board Applications, Forms, and Reports.  These documents are available by contact the Kaiser Permanente Southern California Institutional Review Board.  

 New Research - IRB Applications

     KPSC Full Research Application

     Interregional  Research Application

     KPSC Exempt Request Form

    Humanitarian Use Device (HUD) Application

     KPSC Exempt Request Form

    HMORN Research Application Cover Sheet

 New Research -  IRB Forms

Ø     Principal Investigator Attestation and Risk Assessment (RAMP)

Ø     KPSC Conflict of Interest Policy Statement

Ø     KPSC Policies and Regulations Agreement

     HIPAA Questionnaire Application

     Research Use Of Internet Questionnaire

     Federal Project Budget Template

     Internal Project Budget Template

     Industry Project Budget Template

     Biographical Sketch Template

 Research Reporting Forms

     Modification Request Form

     Protocol Deviations, Violations, and Exemptions Summary

     Continuing Review Form

     KPSC Humanitarian Use Device (HUD) Progress Report and Continuing Review Form

     IRB Authorization Agreement - KPSC Ceding

     IRB Authorization Agreement -KPSC Reviewing to Research

     Unaffiliated Investigator Agreement

     Single Patient Use IND Application

 Principal Investigator Reportable Events and Incidents

Ø     Internal Unanticipated Serious Adverse Event Report

Ø     External Unanticipated Serious Adverse Event Repor

Ø     Unanticipated Adverse Device Effect Report

Ø     Emergent Modification 5 Day Report and Request

Ø     Unanticipated Problem Report

 Other Forms

Ø     45 CFR 46.118 Destination

Ø     Intention to Use PHI Prepatory to Research (RAPTOR)

Ø     Human Subjects Research Assessment

Ø     Determination of KPSC's Engagement in Research

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