IRB Approval - Battelle

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

IRB 0637100071230
Rev O.O

Battelle Institutional Review Board
Robert Alexander/ Lisa John

Principal Investigator/Project Manager:
Proposal/Project Title:

"National Tobacco Education Campaign - Creative Concepts Phase"

.
.
Plowshare Group (Client) /
nd .
Chent/Fu mg Agency.
Centers for Disease Control and Prevention (Funding Agency)
IRB 0637-100071230, Rev O.O
IRB No:
Date of Submission to IRB:
12/06/2016
CON00024586
Contract No:
Project No:
100071230-TASKE6
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 re utation.
This ruling applies to the scope(s) of work for Battei le (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/indepth interviews/focus groups 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 in the Focus Group will be documented via
the Focus Grou
uestionnaire.

While this study qualifies for a formal EXEMPTION from federal regulations ( 45 CFR 46, Subpart A) for the protection
of human subjects, IRB 0637-100071230 Rev O.O. will continue under Battelle IRB oversight to 5 December 2017.
Oversight requirements include:
•
•
•
•

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.

This phase of the project (IRB 0637: "Creative Concepts") follows the "Message Platform Testing" phase
(previously approved by the Battelle IRB as IRB 0627-100071230, Rev O.O). Data collection for the "Message
Platform Testing" phase has ended and the project is analyzing study data. Upon final analysis of data, IRB 0627
will be closed out.

IRB Member

Jyothi Nagaraja, MS

Title
Name
Primary Reviewer, Battelle Institutional Review Board (IRB)