Human Subjects in Research

Biomedical IRB Submission Forms

     
Adverse Events Continuing Review
Summary Table

Deviation/Violation

UT Adverse Event Form

Adverse Event Policy

The UT Adverse Event policy was updated  and became effective 09/01/2008.

Convened Continuing Review Checklist       

Please complete and attach this checklist to your application.

Continuing Review Application  

This application was updated 08/01/2009                           

   
   
Amendments/Modifications Exempt Review

Convened Amendment Checklist 

Please complete this checklist and attach to your application.

Change Cover Sheet
     
A. Additions/Deletions

B. Protocol Change

C. Investigators Brochure or Safety Changes

D. Changes to Consent

E. Miscellaneous Changes            

Exempt Categories & Screening Questions

Exempt Research Application

This application was updated 08/01/2009

 

     
   
Assent Information Expedited Review

Adult Assent Form

Expedited Review Checklist

Please complete this checklist and attach to your application.

Expedited Research Categories

Expedited Application

This application was updated 07/2013

Waiver of Authorization for Use and Disclosure of PHI 

The Waiver form was updated 03/2014

   
   
Chart Reviews Initial Convened Review
Chart Review Plan

Please submit a Chart Review Plan to the IRB office before completing an application.  After the plan has been reviewed, the office staff will contact you with the name of the application you should complete.

Initial Convened Review Checklist

Please complete this checklist and attach to your application.

Initial Convened Application 

This application was updated 10/15/2010

Section E-2 Drug Information Attachment

          Section E-3 Device Information Attachment

 

 
Compliance Forms Final Reports
RSP Conflict of Interest Disclosure [RSP 103] --
Only for protocols not associated with a proposal or an award

Financial conflict of interest disclosure Website --
Under the new PHS, all faculty, staff and students who are responsible for the design, conduct or reporting of funded research are required to disclose financial conflicts of interest.
Final Report Instructions

Final Report Form
   
   
Consent Forms Miscellaneous Forms

Consent Instructions

Consent Template -- Form updated 10.29.2014      

Addendum to Consent

Waiver of Authorization for Use and Disclosure of PHI

The Waiver form was updated 05/2014

Cancellation or Modification of Participation in Research

Supplemental Consent for Genetics Research

GRAD Approval Form

Elements of a Research Protocol

PI Responsibilities

Trade Secrets & Intellectual Property

Statement of Compliance

Activities Preparatory to Research     NEW!

Central IRB Submission Information
The first two documents apply to the initial submission process for both WIRB & SAIRB. The third document is to be used to notify the UT DHRP of Personnel Changes to a CIRB reviewed study.

 

Central IRB Submission Process

Central IRB Submission Checklist

UT Notification of Central IRB Personnel Change
New form added 04.08.2015


Western Institutional Review Board (WIRB)


https://connexus.wirb.com/Account/Register.aspx

https://www.wirb.com/Pages/DownloadForms.aspx

UT WIRB Consent Template - Form updated 11.11.14


Schulman Institutional Review Board Associates, Inc. (SAIRB)


Schulman - eSubmission Walkthrough

UT SAIRB Consent Template - Form updated 11.14.14

 

 

 

 

   
Last Updated: 5/26/15