Att 7_IRB Approval

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

IRB 0627100071230
Rev 0.0

Battelle Institutional Review Board
Robert Alexander / Erica Peters

Principal Investigator/Project Manager:

“National Tobacco Education Campaign”

Proposal/Project Title:

PlowShare Group (Client) /
Centers for Disease Control and Prevention (Funding Agency)
IRB 0627-100071230, Rev 0.0
Date of Submission to IRB:
04/14/2016
CON00024586
Project No:
100071230-TASKE6

Client/Funding Agency:
IRB No:
Contract No:

Subcontract to Battelle from:

N/A

Subcontract from Battelle to:

N/A

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
damaging to the subjects' financial standing, employability, or reputation.
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.

While this study qualifies for a formal EXEMPTION from federal regulations (45 CFR 46, Subpart A) for the protection
of human subjects, IRB 0627-100071230 Rev 0.0. will continue under Battelle IRB oversight to 22 April 2017.
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.

Co-Chair

Margaret Pennybacker, Ph.D.

Gary M. Sapp for Margaret Pennybacker1

Title
Name
Designated Reviewer, Battelle Institutional Review Board (IRB)
1

Approved: E-mail (Pennybacker to Sapp) on 25 April 2016 at 1:39 PM

Signature

4/25/20166
Date