VA Nebraska-Western Iowa Health Care System

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Institutional Review Board (IRB) Forms

 

Contact Lists for Research Administrative Office and Institutional Support:

IRB Submission Contact List (Rev 1-13) 

IRB SOP:

IRB Standard Operating Procedures (Rev 1-13) 

IRB Submission Forms for Human Studies: 

Appendix K:

Human Studies Submission Guidelines (Rev 1-13) 

Appendix L:

Human Studies Protocol Submission Checklist (Rev 1-13) 

Appendix M:

Review of Medical Records and or Database Checklist (Rev 1-13) 

Appendix N:

Investigator Data Sheet and Codes (Rev 12-09) 

Appendix O:

Personal Data on VA Investigators 

Appendix P:

Funding Source Codes (Rev 4-10) 

Appendix Q:

Request to Review Research Proposal - Project (Rev 1-13) 

Appendix R:

Abstract Guidelines (Rev 10-07) 

Appendix S:

Financial Conflict of Interest Statement (Rev 7-12) 

Appendix T:

Human Research Protocol Worksheet (Rev 7-12) 

Appendix U:

Definition of Risks 

Appendix V:

Recruitment Letter (Rev 2-11) 

Appendix W:

Participating Research Team Members (Rev 1-12) 

 

Appendix X:

Research Recruitment Advertising Template (Rev 1-12) 

Appendix Y:

VA Research Consent Form (Rev 1-12) 

Appendix Z:

HIPAA Authorization (Rev 3-11) 

Appendix AA:

Waiver of Informed Consent (Rev 1-13) 

Appendix BB:

HIPAA Waiver of Authorization (Rev 1-13) 

Appendix DD:

Determination of Exempt Status (Rev 3-11) 

Appendix EE:

Investigational Drug Information Record (VA Form 10-9012) 

Appendix FF:

Research Using Stored Human Biological Materials or DNA (Rev 2-09) 

Appendix GG:

Instructions for Narrative Description of Research Plan 

Appendix II:

Letter of Support for Clinical Research and Example (Rev 3-09) 

Appendix IIa:

Request for Utilization of CRU (Rev 1-13) 

Appendix JJ:

Safety Application Form (Rev 1-13) 

Appendix NN:

Checklist for Reviewing Privacy Confidentiality and Information Security (Rev 1-13) 

Reporting Forms for Ongoing Human Research:

Appendix I:

External Site Monitoring Visit Report/Checklist (Rev 5-12)

 

Appendix CC:

HIPAA Revocation of Authorization

Appendix KK:

Continuing Review Submission Form (Rev 1-13) 

Appendix LL:

Report of Problem (Rev 8-10) 

Appendix MM:

Amendment-Revised Protocol Form (Rev 7-12) 

Appendix PP:

Dual/Multiple Research Study Enrollment Waiver (Rev 1-12) 

Appendix UU:

Master Human Subject Enrollment List (Rev 8-11)

Safety Reports Received from Sponsor (Rev 6-07) 

Adverse Events Reporting Log (Rev 6-07) 

IRB Reviewers' Checklists:

Appendix OO:

IRB Elements of Review Checklist (Rev 1-13) 

Appendix TT:

Checklist for Criteria Allowing Exemption (Rev 8-10) 

 

  Consent form/HIPAA Elements Checklist (Rev 7-09)

Emergency Use of a Test Article Notification and Consent:

 

Appendix F:

Notification of Emergency Use of an Investigational Drug, Biologic or Device 3-11 

Clinical Research Fee Schedules:

Pharmacy Fee Schedule (Rev 10-11) 

 

  Pulmonology Fee Schedule (Rev 8-11)  
 

  Radiology Fee Schedule (Rev 9-11) 
 

  Cardiology Fee Schedule (Rev 10-11)  
 

  Laboratory Fee Schedule (Rev 8-11)  

 

IRB Guidance Documents:

 

Appendix B:

Human Research Protection Program (Rev 6-12) 

Appendix C:

Policies and Procedures for Allegations of Non Compliance (Rev 12-10)

Appendix D:

Conflict Interests of Investigators in Research (Rev 7-08)

Appendix E:

Institutional Conflict of Interest (COI) in Research (Rev 10-09)

Appendix QQ:

Existing Research Specimens (Rev 2-09)

Appendix RR:

FAQs Banking of Human Biological Specimens for Research

Appendix SS:

Examples of Informed Consent for Protocols Involving Bio-specimens
 

  Institutional Support Contact List (Rev 8-11)

Suicide Prevention Procedure (Rev 1-10) 

  VHA Handbook 1200.05 Requirements for the Protection of Human Subjects in Research

Interpreter Services for Non English Speaking Research Participants 
 

  Research Misconduct Policy (Rev 2-11) 

  Procedures Applicable to Off-site Research