IRB Approval Letter

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

PROTOCOL APPROVAL
DATE:

November 19, 2019

TO:

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

FROM:

Edward Morgan, IRB Chair

PROTOCOL:

FDA Youth Tobacco Prevention Broad Quantitative Research Package

MEETING DATE:

November 14, 2019

APPROVAL DATE:

November 19, 2019

EXPIRATION DATE:

January 31, 2022

IRB APPROVED DOCUMENTATION:
Materials submitted to the IRB
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Attachment A: Research Protocol
Attachment B: Email Invitation
Attachment C: Youth Screener
Attachment D: Adult Screener
Attachment E: Parental Notification and Opt-Out Form
Attachment F: Youth Assent Form
Attachment G: Adult Consent Form
Attachment H: Youth Questionnaire [for reference only]
Attachment I: Adult Questionnaire [for reference only]
Attachment J: Stimuli [for reference only]

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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)
Review and vote on the email invitation (Attachment B)
Review and vote on the youth screener (Attachment C)
Review and vote on the adult screener (Attachment D)
Review and vote on the parental notification and opt-out form (Attachment E)
Review and vote on the youth assent form (Attachment F)
Review and vote on the adult consent form (Attachment G)

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 conditional approval pending chair-only re-review of
requested changes:
Protocol - Attachment A
1. Request for change: make change to sentence structure under parental opt-out.
• Revisions made: changed sentence structure. See highlighted text on page 6 of protocol.
2. Request for change: update title of Table 2.
• Revisions made: updated title of table 2. See highlighted text on page 8 of protocol.
3. Request for change: add age breakdown for adult participants.
• Revisions made: added age breakdown. See highlighted text on page 8 of protocol.
4. Request for change: make change to sentence structure under parental opt-out.
• Revisions made: changed sentence structure. See highlighted text on page 9 of protocol.
5. Request for change: define “PII” on page 9 and delete definition on page 13.
• Revisions made: defined “PII” on page 9 and deleted definition on page 13. See
highlighted text on page 9.
Email Invitation: Attachment B
1. Request for change: delete “approximately” in first paragraph.
• Revisions made: deleted “approximately”. See highlighted text on page 1.
2. Request for change: change sentence structure in paragraph.
• Revisions made: changed sentence structure. See highlighted text on page 1.
3. Request for change: include placeholder for OMB clearance number.
• Revisions made: included placeholder for OMB clearance number. See header on page
1.
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4. Request for change: fix the following typos:
i. Page 1 – delete “d” on “and”.
• Revisions made:
i. Deleted “d” in sentence. See highlighted text on page 1.
Youth Screener: Attachment C
1. Request for change: update table heading.
• Revisions made: update table heading. See highlighted text on page 1.
2. Request for change: under question D12, change option G from “50-99 times” to “51-99 times”.
• Revisions made: updated option G. See highlighted text on page 5.
3. Request for change: under question D12a, change option E from “9-15 days” to “10-15 days”.
• Revisions made: updated option E. See highlighted text on page 8.
4. Request for change: under question D18, change option G from “50-99 times” to “51-99 times”.
• Revisions made: updated option G. See highlighted text on page 7.
5. Request for change: include placeholder for OMB clearance number.
• Revisions made: included placeholder for OMB clearance number. See header on page
1.
Adult Screener: Attachment D
1. Request for change: under question B5, include skip pattern under option C.
• Revisions made: included skip pattern. See highlighted text on page 4.
2. Request for change: include placeholder for OMB clearance number.
• Revisions made: included placeholder for OMB clearance number. See header on page
1.
3. Request for change: fix the following typos:
i. Page 1 – change “youth” to “adults”.
ii. Table 2 – change “youth” to “adults”.
iii. Table 2 – change “ho” to “who”.
iv. Page 5 – box under D8, delete “ever tried”.
• Revisions made:
i. Changed “youth” to “adults”. See highlighted text on page 1.
ii. Changed “youth” to “adults”. See highlighted text in table 1.
iii. Changed “ho” to “who”. See highlighted text in table 1.
iv. Deleted “ever tried”. See highlighted text on page 5.
Parental Notification and Opt-Out Form – Attachment E
1. Request for change: under reimbursement, restructure sentence to ensure that youth
participant and parent understand incentive system.
• Revisions made: restructured sentence. See highlighted text on page 2.
2. Request for change: include placeholder for OMB clearance number.
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Revisions made: included placeholder for OMB clearance number. See header on page
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Youth Assent Form – Attachment F
1. Request for change: include placeholder for OMB clearance number.
i.
Revisions made: included placeholder for OMB clearance number. See header on page
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2. Request for change: fix the following typos
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Page 2 – under “will I be paid for being in this study”, change “your” to “you”
• Revisions made:
i.
Changed “your” to “you”. See highlighted text on page 2.
Adult Participant Consent Form
1. Request for change: include placeholder for OMB clearance number.
i.
Revisions made: included placeholder for OMB clearance number. See header on page
1.
2. Request for change: fix the following typo
i.
Page 1: under “what will I do”, delete “his or her”
• Revisions made:
i.
Deleted “his or her”. See highlighted text on page 1.
Outcome 3: Revised materials were submitted to the chair, who reviewed and approved the changes on
November 19, 2019. The following documents received full approval after chair re-review. The IRB
issued final disposition forms showing approval of the documents for use in an external research
project.
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Attachment A: Research Protocol
Attachment B: Email Invitation
Attachment C: Youth Screener
Attachment D: Adult Screener
Attachment E: Parental Notification and Opt-Out Form
Attachment F: Youth Assent Form
Attachment G: Adult Consent Form

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

11-19-2019
________________________
IRB Chairperson

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Date
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