•     Application for Non-Research Student Projects
              (v05/01/09)
•  
•     Application for Non-Human Subjects Research
               (v05/01/09)
•  

•     Documentation of Review and Approval
              (v05/01/09)
•  
•     Expedited Research Checklist (v05/01/09)>
•  
•     Summary Safeguard Statement (SSS) (v05/01/09)
•  
•     Informed Consent Template (v05/01/09),
              as applicable
•  
•     Informed Consent Template - Spanish (v05/01/09)
•  
•     Delegation of Authority to Consent (v05/01/09)
•  
•     Include all supporting documents, e.g. clinical investigator,
        recruitment materials, surveys, questionnaires, brochures,
        advertisements, drug package inserts, etc.
•  

Studies subject to HIPAA may also include:

•     Authorized Medical Record Request Form
•  
•     Authorization -Template for the Release of
              Health Information (v05/01/09)
•  
•     Authorization - Template for the Release of
              Health Information - Spanish (v05/01/09)
•  
•     Authorization- Healthy Subjects (v05/01/09)
•  
•     Authorization - Healthy Subjects - Spanish
              (v05/01/09)
•  
•     Authorization - Minors Template (v05/01/09)
•  
•     Authorization - Minors Template - Spanish
              (v05/01/09)
•  
•     Covered Entity Checklist (v05/01/09)
•  

     Depending on your study, Additional forms may be necessary

•     Delegation of Authority to Consent (v05/01/09)
  

---

    For studies involving children:

•     Assent To Participate in Research Template
              (v05/01/09) Unless a waiver of assent will
              be required.
•  
•     Assent To Participate in Research Template
              Spanish (v05/01/09)  
              Unless a waiver of assent will be required.
•  
•     Request Form for the Inclusion of Children
              in Research (v05/01/09)  

---

    For studies involving individuals who are cognitively impaired:

•     Request Form for the Inclusion of Inclusion of
              Cognitively Impaired Individuals
              (v05/01/09)

---

    For studies involving pregnant women:

•     Request Form for the Inclusion of Request
              Form for the Inclusion of Inclusion of
              Pregnant Women, Human Fetuses,and
              Neonates (v05/01/09)

---

    For studies involving prisoners:

•     Request Form for the Inclusion of Prisoners
              in Research (v05/01/09)

•     Documentation of Review and Approval (v05/01/09) 
•  
•     Summary Safeguard Statement (SSS) (v05/01/09)
•  
•     Informed Consent Template (v05/01/09)
•  
•     Informed Consent Template - Spanish (v05/01/09)
•  
•     Request Form for Waiver of Informed Consent
              for Planned Emergency Research (v05/01/09)   
•  
•     Supporting documents, e.g. recruitment materials,
        surveys, questionnaires, etc.
•  
•     Protocol Template (v05/01/09)
              (For guidance, if needed)
•  
•     IDE Checklist (v05/01/09)
•  
•     IND Checklist (v05/01/09)
•  

 Studies subject to HIPAA must also include:

•     Recruitment Checklist (v05/01/09)
•  
•     Authorization -Template for the Release of
              Health Information (v05/01/09)
•  
•     Authorization - Template for the Release of
              Health Information - Spanish (v05/01/09)

     Depending on your study, Additional forms may be necessary

•     Delegation of Authority to Consent (v05/01/09)
  

---

    For studies involving children:

•     Assent To Participate in Research Template
              (v05/01/09) Unless a waiver of assent will
              be required.
•  
•     Assent To Participate in Research Template
              Spanish (v05/01/09)  
              Unless a waiver of assent will be required.
•  
•     Request Form for the Inclusion of Children
              in Research (v05/01/09)  

---

    For studies involving individuals who are cognitively impaired:

•     Request Form for the Inclusion of Inclusion of
              Cognitively Impaired Individuals
              (v05/01/09)

---

    For studies involving pregnant women:

•     Request Form for the Inclusion of Request
              Form for the Inclusion of Inclusion of
              Pregnant Women, Human Fetuses,and
              Neonates (v05/01/09)

---

    For studies involving prisoners:

•     Request Form for the Inclusion of Prisoners
              in Research (v05/01/09)

•     Continuing Review/Closeout Report Instructions
               (v05/01/09)
•  
•     Closeout Report (v05/01/09)
•  
•     Continuing Review - Closed to Enrollment (v08/01/09)
•  
•     Continuing Review - Open to Enrollment (v08/01/09)

   Guidelines for Determining an Amendment Type

•     Amendment Form (v05/01/09)
•   *Please note: Requested changes should be highlighted or
•     otherwise shown (Use 'track changes' feature in Word) on
•     the applicable forms and/or documents.

•     Noncompliance Reporting Form (v05/01/09)

•     Prompt Reporting Form (v05/01/09)

•     WIRB Eligibility Checklist
•  
•     IU Application for Protocol Review by WIRB
              (v5/01/09)
•  
•     Authorization for the Release of Health
              Information (v05/01/09)
•  
•     Authorization for the Release of Health
              Information - Spanish (v05/01/09)
•  
•     IU WIRB Informed Consent Template
•  
•           WIRB Initial Review Submission Form,
              see:    WIRB Website Forms
•  
•           WIRB Investigator Submission Form for Multi-Center
              Protocols, see:    WIRB Website Forms

•     NCI CIRB Facilitated Review Form (v05/01/09)
•  
•     NCI CIRB Review Cover Sheet (v05/01/09)

•     VA Research Project Submission Checklist
•  
•     VA Waivers for Recruitment (v05/01/09)
•  
•     Investigator Data Sheet - VA Form 10-5368
•  
•     Project Data Sheet - VA Form 10-1436
•  
•     VA Data Security Appendix (C-D)
•  
•     VA R&D Committee Research Study Submission Form
•  
•     VA Consent Form - VA Form 10-1086
•  
•     Investigational Drug Information Record
              - VA Form 10-9012
•  
•     Research Protocol Safety Evaluation
              - VA Form 10-0398
•  
•     Pathology and Laboratory Impact Estimation
              Worksheet
•  
•     Memo for Authorization to Transport VA
              Sensitive Information
•  
•         Application for An Off-Site Tissue Banking Waiver
              - VA Form 10-0436
•  
•           VA Research Participant Brochure:
               Available here
•  
•           To order the VA Research Participant Brochure:
               Click here