•    Exempt Research Checklist
• 
  
•     All research instruments, e.g. recruitment materials,
       surveys, questionnaires, etc.

•     Documentation of Review and Approval
• 
  
•     Expedited Research Checklist
• 
  
•     Summary Safeguard Statement
• 
  
•     Informed Consent Template, as applicable
• 
  
•     Supporting documents, e.g. recruitment materials,
        surveys, questionnaires, etc.

Studies subject to HIPAA only:

•     Recruitment Checklist
• 
  
•     Authorization for the Release of Health Information
              for Research

     Depending on your study, Additional forms may be necessary

•     Documentation of Review and Approval
• 
  
•     Summary Safeguard Statement
• 
  
•     Informed Consent Template, as applicable
• 
  
•     Supporting documents, e.g. recruitment materials,
        surveys, questionnaires, etc.
• 
  
•     Protocol (see Sample Protocol Template
•             for guidance, if needed)

Studies subject to HIPAA only:

•     Recruitment Checklist
• 
  
•      Authorization for the Release of Health Information
               for Research

     Depending on your study, Additional forms may be necessary

    Please submit the following:

•     Amendment Form   
• 
  
•     Summary Safeguard Statement
• 
  
•     Informed Consent Template, as applicable
• 
  
•   Supporting documents, e.g. recruitment materials, surveys,
      questionnaires, etc.
• 
  
•     Protocol (for full board studies only: Sample Protocol
              Template for guidance, if needed)
• 
  
•     Other documents as applicable

Studies subject to HIPAA only:

•     Recruitment Checklist
• 
  
•     Authorization for the Release of Health
              Information for Research   

    *Please note: Requested changes should be highlighted or
      otherwise shown on the applicable forms and/or documents.

    Please submit the following:

•     Amendment Form
• 
  
•     Exempt Research Checklist
• 
  
•     Supporting documents, e.g. recruitment materials,
        surveys, questionnaires, etc.

    For research that does not meet the definition of human subjects
    research but still requires review by the IRB, please submit the
    Application for Non-Human Subjects Research.

•     Application for Non-Human Subjects Research

    For studies involving children:

•     Assent To Participate in Research Template
              Unless a waiver of assent will be required.
• 
  
•     Children Request Form

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    For studies subject to HIPAA:

•     Authorization for the Release of Health
              Information for Research Unless a waiver
              of authorization will be requested.

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    For studies involving individuals who are cognitively impaired:

•     Inclusion of Cognitively Impaired Individuals
  

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    To report an event of noncompliance to the IRB:

•     Noncompliance Reporting Form

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    To report an unanticipated problem to the IRB:

•     Prompt Reporting Form

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    For studies targeting pregnant women:

•     Inclusion of Pregnant Women, Human Fetuses,
              and Neonates

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    For studies involving prisoners:

•     Prisoner Request Form