Human Subjects in Research

Biomedical IRB Submissions

KUALI COEUS “KC” ELECTRONIC IRB APPLICATIONS
BEGINNING Monday September 28, 2015
The Biomedical IRB office will no longer accept paper applications for
NEW RESEARCH PROTOCOLS from faculty and students.

ALL NEW RESEARCH must be submitted via the new Kuali Coeus (KC) electronic application system.
If you have a currently active (KC) protocol with an IRB # beginning with the three digits 200,
please submit AMENDMENTS & CONTINUING REVIEWS in the new KC system.

Training for the KC IRB Application process is currently taking place as noted on the table below. 

In-Classroom Training for the KC system is available for the upcoming dates and locations. It is necessary to RSVP for your desired training session. Sessions may be cancelled if no participants register in advance. In order to reserve your space in the training session, please email Sarah Langlois (sarah.jasinkowski@utoledo.edu). Please include your full name, Rocket number, UTAD ID, University affiliation (student, faculty, etc.) and the department you will be doing research in or for. 
Date Time Location
September 22, 2016 9:00AM - 12:00PM

CANCELLED-no RSVP

October 14, 2016 1:00PM - 4:00PM Main Campus - UH 4530
October 18, 2016 9:00AM - 12:00PM Health Science - COB 2401
October 31, 2016 1:00PM - 4:00PM Health Science - COB 1220
November 8, 2016 1:00PM - 4:00PM Main Campus - UH 2530
November 18, 2016 9:00AM - 12:00PM Health Science - COB 1200
November 30, 2016 1:00PM - 4:00PM Health Science - COB 1220
December 8, 2016 9:00AM - 12:00PM Main Campus - UH 2530
Please click here to access instructions for using KC

If you have an ONGOING, LONG-TERM STUDY with an IRB# that begins in the 100 series, please continue
to submit the AMENDMENT, CONTINUING REVIEW, DEVIATION and FINAL REPORT documents listed below.

Thank you for your patience as we transition to the new electronic system!
     
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        

F.  NEW! - Straightforward Personnel Addition/Deletion   

Exempt Categories & Screening Questions

Exempt Research Application

This application was updated 08/01/2009

 

     Initial Convened Review Expedited Review

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

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 Final Reports
Retrospective Chart Review - see instructions below

For a Retrospective Chart Review, please complete an Expedited Application through the Kuali Coeus (KC) electronic application system.
Final Report Instructions

Final Report Form
Compliance Forms Miscellaneous Forms
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.

GRAD Approval Form

Elements of a Research Protocol

PI Responsibilities

Trade Secrets & Intellectual Property

Statement of Compliance

Activities Preparatory to Research     NEW!

Consent Forms

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.

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

Adult Assent Form

UT-PHS Joint Consent Forms

UT-PHS Joint Adult Consent form

UT- PHS Joint Assent Form

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: 9/21/16