Institutional Review Board (IRB) - VA Nebraska-Western Iowa Health Care System
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VA Nebraska-Western Iowa Health Care System

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Institutional Review Board (IRB)

Training

 

CITI Training

Regulatory Guidance

 

VA Central IRB Review Process


Forms

Contact Lists for Research Administrative Office and Institutional Support:

IRB Submission Contact List

 

 

IRB SOP:

IRB Standard Operating Procedures

 

 

IRB Submission Forms for Human Studies:

Appendix K:

Human Studies Submission Guidelines

Appendix L:

Human Studies Protocol Submission Checklist

Appendix M:

Review of Medical Records and or Database Checklist

Appendix N:

Investigator Data Sheet and Codes

Appendix O:

Personal Data on VA Investigators

Appendix P:

Funding Source Codes

Appendix Q:

Request to Review Research Proposal - Project

Appendix R:

Abstract Guidelines

Appendix S:

Financial Conflict of Interest Statement (Fillable Form)

Appendix T:

Human Research Protocol Worksheet

Appendix U:

Definition of Risks

Appendix V:

Recruitment Letter

Appendix W:

Participating Research Team Members

Appendix X:

Research Recruitment Advertising Template

Appendix Y:

VA Research Consent Form

Appendix Z:

HIPAA Authorization

Appendix AA:

Waiver of Informed Consent

Appendix BB:

HIPAA Waiver of Authorization

Appendix DD:

Determination of Exempt Status

Appendix EE:

Investigational Drug Information Record (VA Form 10-9012)

Appendix FF:

Research Using Stored Human Biological Materials or DNA

Appendix GG:

Instructions for Narrative Description of Research Plan

Appendix II:

Letter of Support for Clinical Research and Example

Appendix IIa:

Request for Utilization of CRU

Appendix NN:

Checklist for Reviewing Privacy Confidentiality and Information Security

 

Reporting Forms for Ongoing Human Research:

Appendix I:

External Site Monitoring Visit Report/Checklist

Appendix CC:

HIPAA Revocation of Authorization

Appendix KK:

Continuing Review Submission Form

 Appendix KK2:

 Continuing Review Serious Adverse Event Reporting Form

Appendix LL:

Immediate Reporting of Serious Adverse Events or Deaths

 Appendix LL2:

 Unanticipated Problem Report Form

Appendix MM:

Amendment-Revised Protocol Form

Appendix PP:

Dual/Multiple Research Study Enrollment Waiver

Appendix UU:

Master Human Subject Enrollment List

 

 

 

IRB Committee/Reviewer's Checklist:

Appendix OO:

IRB Elements of Review Checklist

Consent Form Checklist

 

 QA/QI IRB Checklist

 

 

Emergency Use of a Test Article Notification and Consent:

Appendix F:

Notification of Emergency Use of an Investigational Drug, Biologic or Device

 

Clinical Research Fee Schedules:

Pharmacy Fee Schedule

Pulmonology Fee Schedule

Radiology Fee Schedule

Cardiology Fee Schedule

Laboratory Fee Schedule

 

IRB Guidance Documents:

Appendix B:

Human Research Protection Program

Appendix C:

Research Service Policies and Procedures for Allegations of Non-Compliance

Appendix D:

Conflict Interests of Investigators in Research

Appendix E:

Institutional Conflict of Interest (COI) in Research

Appendix QQ:

Existing Research Specimens

Appendix SS:

Examples of Informed Consent for Protocols Involving Bio-Specimens

Institutional Support Contact List

Suicide Prevention Procedure

VHA Handbook 1200.05 Protection of Human Subjects in Research

Interpreter Services for Non English Speaking Research Participants

Research Misconduct Policy

Procedures Applicable to Off-site Research

 Human Research Protection Program (HRPP)

 HRPP SOP

 Appendix 11: HRPP Determination Aid

Appendix 13: Recruiting Non-Veterans