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Forms and Templates

All completed forms should be submitted through the electronic IRB system unless otherwise noted.

Please refer to the Initial Study Submission page for details on which forms may be required for a new study submission.


Forms and templates overview:

Consent Templates - Greater than Minimal Risk

Form Name Notes Date Modified
Child Assent Examples
Emergency Use 05/2021
Full Board Consent Template This template incorporates all full board templates: FDA regulated, non-FDA regulated, parental permission, surrogates, and optional future use. 04/2021
Key Information Section Tips

These examples are provided to help write the key information sections of the Q&A FDA regulated and Q&A non-FDA regulated consent templates.

     1: Key Information Randomized Trial Header Template with example 06/2019
     2: Key Information QA format template with Example 10/2019
Pregnant Participant/Partner Follow Up 05/2021
Single Patient IND template 05/2021
Withdrawal or Partial Withdrawal of Consent for Research Only use this form if the sponsor requests that withdrawing participants return for study visits other than the standard EOT visit and/or that they allow the ongoing collection of outcome data. 05/2021

Consent Templates - Minimal Risk/Flex Review

Form Name Notes Date Modified
These templates can be used for any minimal risk research whether flex review, exempt, or expedited. 
QA Minimal Risk research consent template 05/2021
Biorepository 05/2021
Focus Groups with HIPAA 05/2021
Focus Group - without HIPAA 05/2021
Minimal risk procedures (for Flex Studies only) 05/2021
Registry 05/2021
Combined survey templates This document includes all survey templates for anonymous surveys w & w/o HIPAA and identifiable surveys 03/2021

Continuing Review (Renewal) and Closures - How to submit Continuing reviews

Form Name Notes Date Modified
Continuing Review Supplement 07/2021

Flexibility Documents 

Form Name Notes Date Modified
  Documents for a Flex Review can be found in their respective sections such as the consent form templates for minimial risk section, the project description section, and the protocol section for secondary use of data. 

HIPAA/Waivers/Recruitment

Form Name Notes Date Modified
Application for Partial Waiver of HIPAA Privacy Authorization for Recruitment Purposes
PHI Checklist
Research Waiver Application

Modifications - How to submit modifications

Form Name Notes Date Modified
Informing Subjects of New Information - Guidance 12/2020
Informing Subjects of New Information - Form 12/2020
Notification letter template 08/2016

Project Descriptions

Form Name Notes Date Modified
Exempt Project Description Use for research that is federally funded or supported. Otherwise, use the Flexibility Project Description. 06/2021
Expedited Project Description Use for research that is federally funded or supported. Otherwise, use the Flexibility Project Description. 06/2021
Flex Review Project Description Please use this document for minimal risk research that is not federally funded or supported. The Flexibility Project Description applies to minimal risk behavioral or biomedical study activities. If the project involves only secondary analysis of data or specimens, use the combination protocol/application forms for secondary research posted under Protocols below. 06/2021
Full Committee Project Description - Industry Trials Use for Full Board/Greater Than Minimal Risk industry studies 06/2021
Full Committee Project Description - Investigator Initiated Trials Use for Full Board/Greater Than Minimal Risk researcher initiated studies 06/2021
Principal Investigator Supplement This has been revised so that both Industry Trials and IIT trials should use this one form. 07/2021
Not Human Subjects Research Download, complete, and email to IRBhelp@kumc.edu 12/2015
Quality Improvement Determination

Complete the REDCap request form. REDCap will notify the appropriate reviewers depending on the type of project and the source of data and participants. As you complete the form in REDCap, please upload any related project plans, data instruments, surveys or dissertation materials. After review, you will receive confirmation of the final determination or additional information on how to proceed.

03/2021
Secondary analysis  secondary analysis forms can be found in the protocol sub-section below

Protocols

Form Name Notes Date Modified
Protocol and Application for Secondary Research The secondary research forms serve as both the project description and the study protocol. They apply to research that involves only re-use data and specimens. 08/2020
Protocol Template with Instructions 03/2015

Reliance - IRB Reliance Resources

Please find all the Reliance forms on the KUMC Reliance Forms and Templates webpage

Supplemental Forms

Form Name Notes Date Modified
Administrative Certification for IRB Submission
Community-Based Participatory Research Supplemental Form 04/2017
Genome Wide Association Studies (GWAS) forms
IRB checklist 11/2020
Mobile App Guidance 06/2016
Mobile App Supplemental Form 02/2017
Nursing Impact Form 03/2016
Radiation Use Application Form RS06 08/2020
Research Request for Human Specimens
Scientific Review and Administrative Certification (combined form) Only a requirement in Wichita 03/2015
Scientific Merit Form 03/2018

Wichita Campus Documents

Form Name Notes Date Modified
Common Application Form 06/2020
Scientific Merit Form 03/2018
Wesley Reliance Studies Form 02/2020

Research Administration

University of Kansas
Medical Center

Research Administration
Mailstop 1039
3901 Rainbow Boulevard
Kansas City, KS 66160

OFFICE LOCATION:
Fairway North, 1000
4330 Shawnee Mission Pkwy
Fairway, KS 66205
Phone: 913-588-1261
Fax: 866-255-2129