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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 template overview:

Consent Templates - Greater than Minimal Risk
Form NameNotesDate Modified
Child Assent Examples
Emergency Use
Humanitarian Use Devices 10/2018
Key Information examples

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

Tips to help write the key information section can be found here.

     1: Key Information Randomized Trial Header Template with example 06/2019
     2: Key Information QA format template with Example 06/2019
Optional Sample Storage and Future Use
Pregnant Participant/Partner Follow Up
Q&A Parental Permission Form 03/2019
One-page Parental Permission Addendum only use this form if enrolling adults and children into one study 07/2018
Q&A Template for NON-FDA Regulated Studies 03/2019
Q&A Template and Consent Checklist for FDA Regulated Drug Studies 03/2019
Single Patient IND template 10/2018
Q&A Surrogate Decision Makers Consent Form 03/2019
Surrogate Decision Makers Form: One-Page Addendum only use this form if enrolling individuals who can consent for themselves and individuals who can't into one study 08/2018
Surrogate Decision Makers Form: Mid-Study, One Page Addendum only use this form if enrolling individuals who can consent for themselves and individuals who can't into one study 08/2018
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 ongoing collection of outcome data.

Consent Templates - Minimal Risk/Flex Review
Form NameNotesDate Modified
These templates can be used for any minimal risk research whether flex review, exempt, or expedited. 
Biorepository 11/2018
Focus Groups with HIPAA 11/2018
Focus Group - without HIPAA 11/2018
Minimal risk procedures 04/2019
Registry 11/2018
Survey - Anonymous without HIPAA
Survey - Not Anonymous without HIPAA
Survey - Not Anonymous with HIPAA
Survey with identifiable information 11/2018

Consent form - Non-English Speaking Subjects - Additional information
Form NameNotesDate Modified
Instructions for using Short Form consents
Chinese -Mandarin
Chinese -Simplified

Continuing Review (Renewal) and Closures - How to submit Continuing reviews
Form NameNotesDate Modified
Continuing Review Supplement Please note this revised form will be required for all requests for continuing review, starting June 3, 2019. 05/2019

Flexibility Documents 
Form Name Notes Date Modifed
  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. 

Form NameNotesDate Modified
Application for Partial Waiver of HIPAA Privacy Authorization for Recruitment Purposes
PHI Checklist
Research Waiver Application

Modifications - How to submit modifications
Form NameNotesDate Modified
Guidance on re-consenting 04/2019
Notification letter template 08/2016
Re-consenting/ Informing research subjects about new information - Form 03/2019

Project Descriptions
Form NameNotesDate Modified
Exempt Project Description Use for research that is federally funded or supported. Otherwise, use the Flexibility Project Description. 01/2019
Expedited Project Description Use for research that is federally funded or supported. Otherwise, use the Flexibility Project Description. 03/2019
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. 04/2019
Full Committee Project Description - Industry Trials Use for Full Board/Greater Than Minimal Risk industry studies 01/2019
Principal Investigator Supplement - IndustryTrials Use for Full Board/Greater Than Minimal Risk industry studies 03/2019
Full Committee Project Description - Investigator Initiated Trials Use for Full Board/Greater Than Minimal Risk researcher initiated studies 01/2019
Principal Investigator Supplement - Investigator Initiated Trials Use for Full Board/Greater Than Minimial Risk researcher initiated studies 03/2019
Not Human Subjects Research Download, complete, and email to 12/2015
Quality Improvement Determination

Download, complete, and email to

For Thesis and Dissertation Projects, please also include the approved proposal 

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

Form NameNotesDate Modified
Protocol Template with Instructions 03/2015
Secondary Research - Federally Funded 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.  

Secondary Research - Flexible Review Use this combination protocol/application form for secondary research that does not have federal funding/support or involve FDA-regulated products or dietary supplements. Examples include: chart reviews, use of specimens collected for clinical purpose, and re-use of data or specimens collected under another research protocol. 04/2019

Reliance - IRB Reliance Resources
Form NameNotesDate Modified
Lead Investigator Supplemntal Form 04/2017
CTSA Partners Request for a Single IRB Review 01/2015
Generic - Request to Use an External IRB 04/2019
KUMC IRB Reliance Checklist 07/2017
KUMC Reliance Study Personnel Form
SMART IRB Checklist for Overall PI's and Lead Study Teams
SMART IRB Checklist for the Relying Investigator
SMART IRB Communication Plan Form
KUMC Local Context Questionnaire 07/2018

Reportable Events - How to submit Reportable Events
Form NameNotesDate Modified
Exception Request Form 10/2018
Non-Compliance Reporting Form 05/2019
Non-Compliance Summary Log 07/2018
Reportable Adverse Events Form 05/2019

Supplemental Forms
Form NameNotesDate Modified
Administrative Certification for IRB Submission
Community-Based Participatory Research Supplemental Form 04/2017
Genome Wide Association Studies (GWAS) forms
Mobile App Guidance 06/2016
Mobile App Supplemental Form 02/2017
Nursing Impact Form 03/2016
Radiation Safety Form RS06 08/2019
Research Request for Human Specimens
Scientific Review and Administrative Certification (combined form)
Scientific Merit Form 03/2018

Last modified: Aug 30, 2019
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