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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: Header format - randomized trial 03/2019
     2: Q&A format with graphic 03/2019
     3: Q&A format without graphic
03/2019
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 01/2019
Q&A Template and Consent Checklist for FDA Regulated Drug Studies 03/2019
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 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
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 01/2019
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 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
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 humansubjects@kumc.edu 12/2015
Quality Improvement Determination Download, complete, and email to humansubjects@kumc.edu 03/2019
Secondary analysis  secondary analysis forms can be found in the protocol sub-section below

Protocols
Form NameNotesDate Modified
Protocol Template with Instructions 03/2015
Secondary Research - Federally Funded The secondary analysis forms are considered a study's project description and protocol. 03/2019
Secondary Research - Flexible Review 03/2019

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 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 03/2019
Non-Compliance Summary Log 07/2018
Reportable Adverse Events Form 03/2019

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

Last modified: Mar 12, 2019
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