Batelle - IRB Approval

Notice of Exemption from Federal Regulations
for the Protection of Human Subjects Form
Battelle Institutional Review Board

IRB 0672100071230
2018 TIPS
Rev O.O

Amanda Berger/ Lisa John

Principal Investigator /Project Manager:
Proposal/Project Title:

"National Tobacco Education Campaign - 2018 TIPS Campaign"

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Chent/Fundmg Agency:

Plowshare Group (Client) /
Centers for Disease Control and Prevention (Funding Agency)

IRB No:

IRB 0672-100071230, Rev O.O

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Contract No:

Date of Submission to IRB:

CON OOO24586
______________ Project No:

Subcontract to Battelle from:

08/30/2017

100071230-0Y1TASKF20
N/A

Subcontract from Battelle to:

Exemption per 45 CFR 46.101(b)(2),

Level of Review:
Exemption

Basis for Ruling

2) Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or
observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects
can be identified, directly or through identifiers linked to the subjects; and (ii)
any disclosure of the human subjects' responses outside the research could
reasonably place the subjects at risk of criminal or civil liability or be
dama in to the subíects' financial standin , em lo abilit , or re utation.
This ruling applies to the scope(s) of work for Battelle (data
analysis/reporting) and for the Qualtrics organization (coordination - data
collection).
Perceived minimal risk to human subjects. Subject population are legal adults
who have voluntarily chosen to use tobacco products/E-cigarettes and to
participate in surveys/in-depth interviews via the Toluna web-based panel
services. Respondents have agreed to Toluna's published Privacy/
Confidentiality Policies. Qualtrics, Battelle and CDC will have no direct access
to any subject identifiers. Privacy and data confidentiality measures are
adequate. All project outputs will be recorded in aggregate. The IRB
acknowledges that a prospective subject's agreement to participate will be
documented via the survey process.
This work is a follow-on task to projects previously recorded as IRB 0627 and
IRB 0637.

While this study qualifies for a formal EXEMPTION from federal regulations (45 CFR 46, Subpart A) for the protection
of human subjects, IRB 0672-100071230 Rev O.O. will continue under Battelle IRB oversight to 30 August 2018.
Oversight requirements include:
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The IRB will request a status update of this project at least once every 365 days.
Unforeseen 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.

Primary Reviewer

Jyothi Nagaraja, MS

Title
Name
Designated Reviewer, Battelle Institutional Review Board (IRS)

3/01 ~11
Date