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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
Optional Sample Storage and Future Use
Pregnant Participant/Partner Follow Up
Q&A Parental Permission Form 07/2018
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 07/2018
Q&A Template and Consent Checklist for FDA Regulated Drug Studies 07/2018
Registries
Single Patient IND template 10/2018
Q&A Surrogate Decision Makers Consent Form 10/2018
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

Consent Templates - Minimal Risk
Form NameNotesDate Modified
Focus Group - without HIPAA
Survey - Anonymous without HIPAA
Survey - Not Anonymous without HIPAA
Survey - Not Anonymous with HIPAA

Consent form - Non-English Speaking Subjects - Additional information
Form NameNotesDate Modified
Instructions for using Short Form consents
Arabic
Burmese
Chinese -Mandarin
Chinese -Simplified
Farsi
French
Hindi
Korean
Laotian
Nepali
Russian
Somali
Spanish
Swahili
Vietnamese

Continuing Review (Renewal) and Closures - How to submit Continuing reviews
Form NameNotesDate Modified
Continuing Review Supplement 04/2018

Flexibility Documents 
Form Name Notes Date Modifed
Flexibility Project Description Use these documents if you would like to submit a study under the flexibility policy 11/2018
Flexibility consent template - Biorepository 11/2018
Flexibility consent template - Focus Groups with HIPAA 11/2018
Flexibility consent template - Minimal risk procedures 11/2018
Flexibility consent template - registry 11/2018
Flexibility Information Sheet - Focus Group, no HIPAA 11/2018
Flexibility Information Sheet -  Survey with identifiable information 11/2018

HIPAA/Waivers/Recruitment
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 10/2018
Notification letter template 08/2016
Re-consenting/ Informing research subjects about new information - Form 10/2016

Project Descriptions
Form NameNotesDate Modified
Exempt Project Description
Expedited Project Description 11/2018
Full Committee Project Description 08/2018
Not Human Subjects Research Download, complete, and email to humansubjects@kumc.edu 12/2015
Quality Improvement Determination Download, complete, and email to humansubjects@kumc.edu 10/2016

Protocols
Form NameNotesDate Modified
Protocol Template with Instructions 03/2015
Retrospective Protocol Template and Application 11/2018

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 10/2018
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 08/2018
Non-Compliance Summary Log 07/2018
Reportable Adverse Events Form 08/2018

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
Research Request for Human Specimens
Scientific Review and Administrative Certification (combined form)
Scientific Merit Form 03/2018

Last modified: Nov 08, 2018
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