IRB Letter

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

Institutional Review Board Disposition

Date:
To:

February 22, 2022
Kristen D. Holtz, Ph.D.
Principal Investigator
From:
Eric C. Twombly, Ph.D.
KDHRC Institutional Review Board (IRB) Chairperson
Project:
The Real Cost Campaign
Research study (as needed): Media Tracking Study to Prevent Tobacco Use
KDHRC Job Code:
19-0174-00-00
KDHRC IRB PROTOCOL #: 2022-02-07

DISPOSITION:
Approval date:
Expiration date:

Full approval
February 22, 2022
February 22, 2023

Discussion
Section 1. Original submission
On February 17, 2022, at a meeting of the IRB, led by me as the IRB Chairperson and attended
by voting IRB members Angie Snyder, Ph.D.; Carol De Vita, Ph.D.; David Brant; and Brett
Pawlowski; you presented a packet of items from The Real Cost Campaign for the Media
Tracking Study to Prevent Tobacco Use study, KDHRC IRB Protocol # 2022-02-07, and asked
the IRB to review and issue a disposition on that packet. The packet included the following
reviewable items:
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•
•
•
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Research protocol
Email Invitation (Appendix A)
Parental Notification and Opt-out Form (Appendix B)
Youth Assent Form (Appendix C)
Screener (Appendix D)

•

Survey (Appendix E)

The IRB found minor issues with several items and therefore granted conditional approval of the
packet. The IRB provided you with specific, detailed, and written instructions on the necessary
revisions to the packet and, in the conditional approval disposition signed by me, allowed for
your resubmission of the packet upon your execution of the revisions.
Section 2. Revised submission
Today, February 22, 2022, I reviewed your revised packet of items in accordance with the 45
CFR Part 46, Subpart D Federal Regulations, which provides for necessary protections for
human subjects in research studies. Based on the review, performed, I provide the following
outcomes.
Section 3. Outcomes
Outcome 1:
You executed the required revisions satisfactorily and I accept the revised packet. Therefore,
effective today, February 22, 2022, the packet and all related items listed in Section 1 are fully
approved with a final disposition for exclusive use in The Real Cost Campaign for the Media
Tracking Study to Prevent Tobacco Use study, KDHRC IRB Protocol # 2022-02-07.
Outcome 2:
Pursuant to this disposition, the IRB grants the appropriate use of the packet and all related items
listed in Section 1, but only in their fully approved form as determined by the IRB, to February
22, 2023.
Outcome 3:
If the packet and or any related items listed in Section 1 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 can be
reached at 404.668.3728 or etwombly@kdhrc.com.
Most sincerely,

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