Institutional Review Board

 

IRB FORMS

GENERAL INSTRUCTIONS

Click on the name of the Application Form or Expand All | Contract All

To download the documents click on the document you want. A separate box will appear; click "Save Target As" or "Save Link As" and then choose folder and filename for the document on your computer.

  NOTE: The first page of Section I (front face sheet) of these applications must be printed on the appropriate color paper. Responses to questions and any additional items may be submitted on white paper. Paper may be obtained from The Nebraska Medical Center/UNMC Printing Services (559-4282).
 

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IRB Applications

Title

Version 

 

Front page color

Biomedical Research

08-18-09

Word

GOLDENROD

Social and Behavioral Research

08-18-09

Word

TURQUOISE

Exempt Research

08-18-09

Word

GREY

Medical Records Research

08-18-09

Word

WHITE

Human Biologic Material (Tissue)

08-18-09

Word

BUFF

Human Biologic Material (Tissue Banking)

08-18-09

 Word

 WHITE

Humanitarian Use Device

04-30-04

Word

WHITE

Request for Change in Protocol

08-21-09

 Word

 Canary

PEDIATRIC APPLICATIONS/FORMS      
Biomedical Research Application

08-18-09

 Word

 WHITE

Social and Behavioral Application 

08-18-09

 Word

 WHITE

"What do I need to know..."-CHMC English

11-02-09

 Word

 WHITE

Rights of Research Subjects in English

11-02-09

 Word

 WHITE

CONTINUING REVIEW APPLICATIONS      

CR Biomedical Research

08-25-09

Word

LILAC

CR Social and Behavioral Research

08-25-09

Word

LILAC

CR Medical Records Research

08-21-09

Word

LILAC

CR Human Biological Research (Tissue)

08-21-09

Word

 LILAC

Study Completion Report 

08-26-09

 Word

 LILAC

ADDENDA      
Addendum (B) - pregnant women  

08-18-09

 Word

 WHITE

Addendum (C) - prisoners

08-18-09

 Word

 WHITE

Addendum (D) - children

08-18-09

 Word

 WHITE

Addendum (E) - decisionally impaired

08-18-09

 Word

 WHITE

Addendum (F) - vulnerable population

08-18-09

 Word

 WHITE

Addendum (G) - genetic testing

08-18-09

Word

WHITE

Addendum (H) - children who are wards

08-18-09

Word

WHITE

Addendum (I)  - registry and data banking

08-18-09

 Word

 WHITE

Addendum (J)  - waiver/alter ICF-biomed

08-18-09

Word

 WHITE

Addendum (K) - waiver/alter ICF ssb

08-18-09

 Word

 WHITE

Addendum (L) - waiver/alter ICF child

08-18-09

 Word

 WHITE

Addendum (M)-  waiver of signed consent

08-18-09

 Word

 WHITE

Addendum (N)-  HBM banking

08-18-09

 Word

 WHITE

Addendum (Y)-   adults-joint pediatric

08-18-09

 Word

 WHITE

IRB Consents

Title

Version 

 

Front page color

Biomedical Consent Template

05-27-09

Word

WHITE

Social and Behavioral Consent Template

04-25-08

Word

WHITE

Peds Parental Biomedical Consent Template 

08-11-09

Word

WHITE

Humanitarian Use Device Consent Template

09-03-04

Word

 WHITE

Miscellaneous

Title

Version 

 

Front Page Color

Single Subject Protocol Deviation

08-18-09

Word

WHITE

Retrospective Violation Report

08-18-09

Word

WHITE

Potential Conflict of Interest Form 

08-29-09

Word

 WHITE

IRB Commercial Fee Form-Full Board Study 

09-09-09

Word 

 WHITE

IRB Commercial Fee Form-Expedited Study 

 09-09-09

Word

 WHITE

Emergency Treatment Report

08-18-09

Word

WHITE

Rights of Research Subjects in English

09-10-04

Word

WHITE

Rights of Research Subjects in Spanish

09-10-04

Word

WHITE

"What do I need to know..."-UNMC English

01-23-09 

Word

WHITE

"What do I need to know..."-UNMC Spanish

01-23-09 

Word

WHITE

"What do I need to know..."-UNO English  

01-23-09 

Word

WHITE

"What do I need to know..."-UNO Spanish  

01-23-09 

Word

WHITE

Non-Institutional Investigator Agreement

10-19-05

Word

WHITE

Inter-Institutional Agreement (IIA)

10-19-05

Word

WHITE

Investigator Checklist

09-17-07

Word

WHITE

Investigator Assessment of IRB 

09-17-07

Word

WHITE

Approval Expired-Request to Continue Current Subjects  

10-24-07

Word

WHITE

Investigational Drug Study Registry Form

12-07-07 

Word

WHITE

Drug Registry Form-Marketed Drugs

12-07-07 

Word

WHITE

Research Pharmacy Cost Estimator

08-05-09

Excel

WHITE

IRB FWA Registration Letter 

 09-09-09

 PDF

 WHITE

Examples

Title

Version

 
Sample Abstracts  08-31-09 Word 
Sample Child Information Sheet  08-31-09 Word 
Sample Youth Information Sheet 08-31-09 Word 
Sample Consent Form for Emergency Treatment (see Procedures & Process)

08-14-06

Word

Model Consent Form for Research Involving Excess Human Biologic Materials/Tissue Banking (standalone protocols)

06-22-99

PDF

Model Consent Form for Research Involving Excess Human Biologic Materials/Tissue Banking (addendum to therapeutic protocol)

06-22-99

PDF

Contraception Template for the Consent Document

10-15-08

Word

Hospital Consent Letterhead

08-26-08

Word