IRB Letter

PROTOCOL APPROVAL WITH MODIFICATIONS
DATE:

17 May 2017

TO:

Sarah A. Evans, Ph.D.
Fors Marsh Group

PROTOCOL:

Food and Drug Administration (FDA) Center for Tobacco Products -, TRC
Smokeless Wave 2 Creative Concept Testing – Focus Groups and In-depth
Interviews With Rural Youth (Pro00021668)

APPROVAL DATE:

16 May 2017

EXPIRATION DATE:

16 May 2018
IRB APPROVED DOCUMENTATION:

Protocol Version:

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Protocol, "TRC Smokeless Wave 2 Creative Concept Testing – Focus
Groups and In-depth Interviews With Rural Youth" (Dated May 8, 2017)

Consent Forms:

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Focus Groups 12-17 Assent Form (Chesapeake IRB Approved Version 16
May 2017)
In-Home Interviews 12-17 Assent Form (Chesapeake IRB Approved
Version 16 May 2017)
In-School Interviews 12-17 Assent Form (Chesapeake IRB Approved
Version 16 May 2017)
Focus Groups Parent of Children Age 12 Informed Consent Form
(Chesapeake IRB Approved Version 16 May 2017)
In-Home Interviews Parent of Children Age 12-17 Informed Consent
Form (Chesapeake IRB Approved Version 16 May 2017)
In-School Interviews Parent of Children Age 12 Informed Consent Form
(Chesapeake IRB Approved Version 16 May 2017)
Focus Groups Parent of Children Age 13-17 Notification Form
(Chesapeake IRB Approved Version 16 May 2017)
In-School Interviews Parent of Children Age 13-17 Notification Form
(Chesapeake IRB Approved Version 16 May 2017)

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Recruitment Material:

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TRC Smokeless Wave 2 Creative Concept Testing, Focus Group Initial
School Contact Scripts (Not Dated)
Focus Group High Level Overview: Upcoming Research Project (Not
Dated)
TRC Smokeless Wave 2 Creative Concept Testing, Focus Group Screener
(Not Dated)
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Other Material:

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TRC Smokeless Wave 2 Creative Concept Testing, In-Home Interview
Contact Script (Not Dated)
TRC Smokeless Wave 2 Creative Concept Testing, Initial School Contact
Scripts (Not Dated)
In-Depth Interviews High Level Overview: Upcoming Research Project
(Not Dated)
TRC Smokeless Wave 2 Creative Concept Testing, In-depth Interview
Screener (Not Dated)
TRC Smokeless Wave 2 Creative Concept Testing, In-Home Interview
Contact Notification (Not Dated)
Creative Concept Rating Worksheet (Not Dated)
Creative Concept Stimuli (Not Dated)
SLT Imagery Boards (Not Dated)
TRC Smokeless Wave 2 Creative Concept Testing, FG Concept Ranking
Worksheet (Not Dated)
TRC Smokeless Wave 2 Creative Concept Testing, FG Concept Rating
Worksheet (Not Dated)
TRC Smokeless Wave 2 Creative Concept Testing, Focus Group
Discussion Guide (Not Dated)
TRC Smokeless Wave 2 Creative Concept Testing, Pre-Session Activity
(Not Dated)
TRC Smokeless Wave 2 Creative Concept Testing, In-Depth Interview,
Activity (Not Dated)
TRC Smokeless Wave 2 Creative Concept Testing, In-Depth Interview
Discussion Guide (Not Dated)

The IRB approved the above referenced protocol and your site with the modifications listed below on 16 May
2017:
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Modifications to the Consent Forms
Revision to the Informed Consent Process: A Waiver of Documentation of Consent for the
collection of personal information for recruitment purposes has been granted for the Focus
Group Screener and the In-depth Interview Screener

The IRB also granted a Waiver of Parental Consent for the Parental Notification Forms.
The IRB reviewed the project in accordance with the 45 CFR Part 46, Subpart D Federal Regulations which
provide for additional protections for children as research subjects.
The IRB determined that the research study meets the criteria found in the risk category described as follows:


45 CFR 46.404: “Research not involving greater than minimal risk.” Permission of one parent is
required for 12 year old participants and in schools where the Principal requires parental permission
for all other participants.

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The above referenced recruitment material is available on your CIRBI workspace under the “IRB Issued
Documents” tab.
If there are any changes to the IRB approved material, IRB approval will be needed prior to use. This includes
changes in relative size and type of font in the material to be viewed by potential subjects.
Please review the IRB Handbook by accessing CIRBI™ (www.cirbi.net). Log on to your CIRBI homepage
(“My Home”) and select the “Reference Materials” tab for IRB requirements and guidance. A copy of the most
recent IRB roster is also available under “Reference Materials”.
Thank you for selecting Chesapeake IRB to provide oversight for your research project.

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