IRB Letter

KDHRC Institutional Review Board
FWA00011177, IRB 00005850, IORG0004908
Edward Morgan, Chair

DATE:

October 24, 2019

TO:

Kristen Holtz, Ph.D.
Principal Investigator
KDH Research & Communication

FROM:

Edward Morgan, IRB Chair

PROTOCOL:

FDA Youth Tobacco Prevention Broad Qualitative Research Package

MEETING DATE:

October 24, 2019

APPROVAL DATE:

October 24, 2019

EXPIRATION DATE:

January 31, 2022

IRB APPROVED DOCUMENTATION
Materials submitted to the IRB:
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Attachment A: Research Protocol
Attachment B: Parental Permission Form
Attachment C: Youth Assent Form
Attachment D: Screener
Attachment E: Screener Contact Sheet
Attachment F: Discussion Guide (for reference only)
Attachment G: Concept Rating Sheet (for reference only)
Attachment H: Concept Ranking Sheet (for reference only)
Attachment I: Stimuli (for reference only)

Actions taken
The IRB reviewed the project in accordance with the 45 CFR Part 46, Subpart D Federal Regulations
which provide for additional protections for children as research subjects. The Principal Investigator
asked the IRB to take the following actions:
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Review and vote on the Research Protocol (Attachment A)
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Review and vote on Parental Permission Form (Attachment B)
Review and vote on Youth Assent Form (Attachment C)
Review and vote on the Screener (Attachment D)
Review and vote on the Screener Contact Sheet (Attachment E)

Outcomes
Outcome 1: The IRB determined that the research study meets the criteria found in the risk category
described as follows:
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45 CFR 46.404: “Research not involving greater than minimal risk.”

Outcome 2: The following documents received full approval after IRB review
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Research Protocol (Attachment A)
Parental Permission Form (Attachment B)
Youth Assent Form (Attachment C)
Screener (Attachment D)
Screener Contact Sheet (Attachment E)

Outcome 3: The IRB issued final disposition forms showing approval of the documents for use in an
external research project.
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Research Protocol (Attachment A)
Parental Permission Form (Attachment B)
Youth Assent Form (Attachment C)
Screener (Attachment D)
Screener Contact Sheet (Attachment E)

Conclusion
If there are any changes to the IRB approved materials and reference only materials, IRB approval will be
needed prior to use.

10-25-2019
________________________
IRB Chairperson

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Date

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