IRB Approval Letter

PROTOCOL APPROVAL WITH MODIFICATION
DATE:

8 Dec 2017

TO:

Dana Wagner, Ph.D.
Rescue Social Change Group

PROTOCOL:

F.D.A. Center for Tobacco Products - 14913 - FE W3 CT, Multicultural
Campaign: Wave 3 Online Quantitative Study of Reactions to Rough-Cut
Advertising Designed to Prevent Multicultural Youth Tobacco Use
(Pro00023377)

APPROVAL DATE:

6 Dec 2017

EXPIRATION DATE:

6 Dec 2018
IRB APPROVED DOCUMENTATION:

Protocol Version(s):



Protocol (Version: 12.1.2017)

Consent Form(s):



PARENT / GUARDIAN CONSENT Opt-Out Form (Chesapeake IRB
Approved Version 6 Dec 2017)
PARTICIPANT ASSENT/CONSENT FORM (Chesapeake IRB
Approved Version 6 Dec 2017)


Recruitment Material:




Screener (Not Dated)
Social Media Advertisements (Addendum A)

Other Material:






Video Ad Stimuli (Addendum B)
Parent & Participant Electronic Communications (Not Dated)
Questionnaire (Not Dated)
Funding Documentation (HHSF223201750007A)

The IRB approved the above referenced protocol and your site with the modifications listed below:



Revisions to the Consent Form(s)
Revision to the informed consent process: A Waiver of Documentation of Consent is granted
for the use of the Screener for Recruitment Purposes only.

The IRB also approved a Waiver of Documentation of Consent for Subjects and with a Waiver of Parental
Consent.
Page 1 of 2

The IRB reviewed the project in accordance with 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.”

The above referenced recruitment material is available on your CIRBI workspace under the “IRB Issued
Documents” tab.
Please submit a final formatted copy of all recruitment material approved in script format only (e.g. television
or radio script in .mp3, .wav, or .wmf format). The final format must be in the format potential subjects will
see and hear.
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 located in the “Reference Materials” section of CIRBI™ (www.cirbi.net). A
copy of the most recent IRB roster is also available.
Thank you for selecting Chesapeake IRB to provide oversight for your research project.

Page 2 of 2

12/13/2017

Rescue SCG Mail - IRB Message Re: F.D.A. Center for Tobacco Products - 14913 - FE W3 CT

Carolyn Stalgaitis 

IRB Message Re: F.D.A. Center for Tobacco Products ­ 14913 ­ FE W3 CT 
1 message
[email protected] 
Reply­To: [email protected]
To: [email protected], [email protected], [email protected]

Wed, Dec 13, 2017 at 4:45 PM

CIRBI Link:

Pro00023377

Submission:

F.D.A. Center for Tobacco Products ­ 14913 ­ FE W3 CT

Protocol Title:

Multicultural Campaign: Wave 3 Online Quantitative Study of Reactions to Rough­Cut Advertising
Designed to Prevent Multicultural Youth Tobacco Use 

From:

Chesapeake IRB

Attachment(s): There are no items to display

Please note, the IRB approval with modification notice states that your PI has been approved (to
conduct this study) with the modifications listed on the notice. These are modifications made by the
IRB to the consent documents. All revisions to the consent documents per the approval notice are
incorporated in the approved material released with the approval notice. There is no further action
needed with the IRB unless additional changes are made. Let me know if you have any questions.
Thanks
Kind Regards, 
Amy Redmond  
443­283­1622 / [email protected] 
Please click on the CIRBI link Pro00023377 and use the Contact IRB to respond to the message. 

This communication and its attachments contain information from Chesapeake IRB or one of its subsidiaries or divisions,
and is intended for the exclusive use of the recipient(s) named above. It may contain information that is confidential and/or
legally privileged. Any unauthorized use that may compromise that confidentiality via distribution or disclosure is
prohibited. Please notify the sender immediately if you receive this communication in error, and delete it from your
computer system.  Usage of Chesapeake IRB email addresses for non­business related activities is strictly prohibited.

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