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Institutional Review Board (IRB)

 
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Announcements

 

All of the forms provided during the Summer 2015 Rollout are now updated. Please contact us (Dr. Hudson or Denise Olsen) if you note any required changes.

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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

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 LL:

Report of Problem

Appendix MM:

Amendment-Revised Protocol Form

Appendix PP:

Dual/Multiple Research Study Enrollment Waiver

Appendix UU:

Master Human Subject Enrollment List

Safety Reports Received from Sponsor

Adverse Events Reporting Log

 

 

 

IRB Reviewer`s Checklist:

Appendix OO:

IRB Elements of Review Checklist

Appendix TT:

Checklist for Criteria Allowing Exemption

Consent form/HIPAA Elements 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

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Training

CITI Training

Regulatory Guidance

VA Central IRB Review Process

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