IRB Review Documentation

IRB 0672100071230
2019 TIPS
Rev 1.1

Notice of Exemption from Federal Regulations
for the Protection of Human Subjects Form
Battelle Institutional Review Board
Tesfa Alexander / Lisa John

Principal Investigator/Project Manager:
Proposal/Project Title:

“National Tobacco Education Campaign – 2019 TIPS Campaign”

PlowShare Group (Client) /
Centers for Disease Control and Prevention (Funding Agency)
IRB 0672-100071230, Rev 1.1
Date of Submission to IRB:
04/01/2019
CON00024586
Project No:
100071230-OY1TASKE60

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
Pre-2018 Common Rule

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.
Amendment to incorporate 2019 TIPS changes and to change PI. 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 are U.S. residents who 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 (Pre-2018 45 CFR 46, Subpart A) for the
protection of human subjects, IRB 0672-100071230 Rev 1.1. will continue under Battelle IRB oversight to 30 August
2019.
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.

Human Protections Administrator

Gary M. Sapp, MS

Title
Name
Representative, Battelle Institutional Review Board (IRB)

Gary M. Sapp
Signature

Digitally signed by Gary M. Sapp
Date: 2019.04.01 15:37:19 -04'00'

Date