7. 0810 Rough Cut KDH IRB Approval 8-16-2022

KDH Research & Communication Institutional Review Board
FWA00011177, IRB 00005850, IORG0004908

KDH RESEARCH & COMMUNICATION (KDHRC)
INSTITUTIONAL REVIEW BOARD
Disposition

Date:
To:
From:
Project:
Research Study:
KDHRC Job Code:
KDHRC IRB Protocol #:
Disposition:
Approval date:
Expiration date:

April 5, 2022
Kristen D. Holtz, Ph.D.
Principal Investigator
Eric C. Twombly, Ph.D.
KDHRC Institutional Review Board (IRB) Chairperson
The Real Cost Campaign
Online Quantitative Study of Reactions to Rough-Cut Advertising
Designed to Prevent Youth Tobacco Use (Copytesting)
19-0174-00-00
2022-02-08
Amended full approval
April 5, 2022 (amended by this action)
March 23, 2023 (unchanged by this action)

Discussion
Section 1. Previous IRB approval
On March 17, 2022, the IRB granted you full approved with a final disposition for your research
packet and all related items pertaining to the study entitled The Real Cost Campaign: Online
Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco
Use (Copytesting), KDHRC IRB Protocol # 2022-02-08. You then sought and received from the
IRB an amendment approval on March 23, 2022. In both cases, pursuant to the resulting
dispositions, the IRB informed you that if the packet and or any related items that were fully
approved by the IRB were changed in any manner, method, or form, then the packet, in its
entirety, may no longer be used by you or any other party without additional review and approval
by the IRB.

Section 2: Subsequent amendment request
On April 1, 2022, you submitted to me, via memo, a subsequent amendment request with minor
alterations to the study’s approach, which do indeed represent material changes to the IRB
approved packet from previous IRB determination, and you requested that I, as the IRB
Chairperson, review the amendment and rule on its approval for use in the study.
Section 3. Revised determination and fully approved disposition
Today, April 5, 2022, I reviewed your amendment request and offer the following outcomes:
Outcome 1:
I determined that the research study described in KDHRC IRB Protocol # 2022-02-08 and the
amendment continues to meet the criteria found in the risk category described in 45 CFR 46.404:
“Research not involving greater than minimal risk.”
Outcome 2:
I accepted the amendment and therefore the entirety of the revised packet for this study,
rendering it applicable for exclusive use in the research study described in KDHRC IRB Protocol
# 2022-02-08, but only in its fully approved form as determined by the IRB. Furthermore,
pursuant to your request, the expiration date of this packet remains unchanged as March 23,
2023.
Outcome 3:
If the packet and or any related items that are fully approved by the IRB in this disposition are
changed in any manner, method, or form, then the packet, in its entirety, may no longer be used
by you or any other party without additional review and approval by the IRB.
If you have any questions on this disposition, then please contact me immediately. I may be
reached at 404.668.3728 or [email protected].
Most sincerely,

Eric C. Twombly, Ph.D.
KDHRC Institutional Review Board Chairperson