IRB Exemption

Notice of Exemption from Federal Regulations
for the Protection of Human Subjects Form

IRB 0840G32713.XX.X3
Rev 3.0

Battelle Institutional Review Board
Lisa John / Stephanie Peak / Andrew Davis
Principal Investigator/Project Manager /
Project Director:
National Tobacco Education Campaign – (NTEC / TIPS Campaign) Rough Cut Testing with
Proposal/Project Title:
Adults Who Smoke Cigarettes
PlowShare Group (Lead Organization) /
Client/Funding Agency:
Centers for Disease Control and Prevention (Funding Agency)
IRB 0840-G32713.XX.X3 Rev 3.0

IRB No:
OPP Number /
Contract No:

OPP226786 / CON00032713 –
No change planned at this time

Date of Submission
to IRB:
Project
Code:

Dated 9/24/2024; received by
IRB on 9/30/2024

G32713.XX.X3.303F.000001
(Formerly G32713.XX.X1.0001.OY1F10)

Subcontract to Battelle from:

N/A

Subcontract from Battelle to:

Sago (Adnan Habib; PM)

Level of Review:
Exemption from Regulation:
This research activity poses a
minimal risk to human subjects

Basis for Ruling
This is an Approval of
Amendments, including the
addition of a new study survey
expected to engage 10,800
respondents and the addition of
new study personnel (personnel
will not have access to identifying
information) Survey to include
minor edits from historic survey,
including OMB-updated categories
for demographic categories. No
planned deviation from previously
established panels.
Issued as Rev 3.0

Exemption per 45 CFR 46.104(b)(2)(i)
(2) Research that only includes interactions involving educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior (including visual or auditory recording) if at least
one of the following criteria is met:
(i) The information obtained is recorded by the investigator in such a manner
that the identity of the human subjects cannot readily be ascertained, directly
or through identifiers linked to the subjects;
Amendment to include a new survey to test 12 short ads. Survey research to
assess efficacy of proposed advertisements to promote cessation of use for
nicotine-containing products. This ruling applies to the scope(s) of work for
Battelle (data analysis/reporting), Plowshare (Lead Investigator) and for the Sago
organization and its partner panels (recruiting and data collection).
Perceived minimal risk to human subjects. Subject population will be legal adults,
English speakers, who have voluntarily chosen to use tobacco products and/or
other nicotine-containing products AND who have voluntarily chosen to take part
in focus groups/surveys/interviews administered participate in surveys/in-depth
interviews via the Sago online survey/questionnaire web-based data collection(s).
Respondents are self-described U.S. residents who have voluntarily agreed to the
terms of Sago’s and its associated vendor/panels’ published Privacy/Confidentiality
Policies. Data collection results will be maintained by Sago in accordance with
their established privacy policies and will be provided to Battelle (and, hence, to
Plowshare/CDC) with no participant’s identifiable, private information. All
results/project outputs will be reported in aggregate and there will be no
association between Sago-held information and project outputs. Respondents’
demographic information may include sensitive information but is voluntarily
disclosed and all privacy and data confidentiality measures are adequate. Small
remuneration offered for participation. The respondent’s agreement to participate
will be documented via the study recruiting screener.

While this study qualifies for a formal EXEMPTION from federal regulations (2018 Common Rule at 45 CFR 46, Subpart A)
for the protection of human subjects, IRB 0840-G32713.XX.X3 Rev 3.0 will continue under Battelle IRB oversight.
Oversight requirements include:
•
The IRB will request a status update of this project at least once every 365 days.
•
Events or other conditions potentially resulting in a loss of human subjects’ privacy or lapse of data confidentiality
must be reported to the IRB.
•
Any audit, inspection or inquiry by a federal agency must be reported to the IRB.
•
If changes, amendments, or addenda to the Work Plan are anticipated, advise the IRB. If the IRB determines
that an application for amendment is warranted, submit the application and supporting documentation to the
IRB before instituting Work Plan changes.

Approved on behalf of Battelle and the Battelle Institutional Review Board

30 September 2024

Human Protections Administrator
Title

Gary M. Sapp, MS, CIP, CIM
Name

Signature

Date

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Parties agreed to: Gary Sapp

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