Att. 4 Example Institutional Review Board Approval Letter

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

IRB 0840G32713.OY1F10
Rev 0.0

Battelle Institutional Review Board
Lisa John / Stephanie Peak

Principal Investigator/Project Manager:

National Tobacco Education Campaign – (NTEC / TIPS Campaign)

Proposal/Project Title:

PlowShare Group (Lead Organization) /
Centers for Disease Control and Prevention (Funding Agency)
IRB 0840-G32713.OY1F10, Rev 0.0
Date of Submission to IRB:
4/28/2022

Client/Funding Agency:
IRB No:
Contract No:

CON00032713

Project
Code:

G32713.XX.X1.0001.OY1F10
(OY1 - OY1TASKF10-Formativ)

Subcontract to Battelle from:

N/A

Subcontract from Battelle to:

N/A

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

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;
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) and for the Qualtrics
organization (data collection).

Basis for Ruling

Perceived minimal risk to human subjects. Subject population will be legal adults
who have voluntarily chosen to use tobacco products and/or other nicotinecontaining products AND to participate in surveys/in-depth interviews via the
Toluna web-based panel service(s). Respondents are self-described U.S. residents
who have agreed to the terms of Toluna’s published Privacy/ Confidentiality
Policies. Survey implementation assures that all collected study data will be
disconnected from respondents’ identities and IP address. Toluna will have no
access to study data and Qualtrics, Battelle and CDC will have no access to any
respondent’s identifiable, private information. Respondents’ demographic
information may include sensitive information but is voluntarily disclosed and all
privacy and data confidentiality measures are adequate. All project outputs will be
recorded in aggregate. Small remuneration offered for participation. The
respondent’s agreement to participate will be documented via the study 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.OY1F10, Rev 0.0. will continue under Battelle IRB oversight.
2023.
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
Title

Gary M. Sapp, MS, CIP, CIM
Name

Gary M. Sapp
Signature

Digitally signed by Gary M. Sapp
Date: 2022.05.01 08:11:24 -04'00'

Date