IRB Letter

PROTOCOL APPROVAL WITH MODIFICATIONS
DATE:

17 May 2018

TO:

Dana Wagner, Ph.D.
Rescue Social Change Group

PROTOCOL:

F.D.A. Center for Tobacco Products - 15543 - Strat Concepts Research,
Developing Strategic Concepts Designed to Prevent AI/AN Youth Tobacco
Use (Pro00024887)

APPROVAL DATE:

16 May 2018

EXPIRATION DATE:

16 May 2019
IRB APPROVED DOCUMENTATION:

Protocol Version:



Protocol (Not Dated)

Consent Forms:



Parent Guardian Permission Form (Advarra IRB Approved Version 16
May 2018)
Assent Form 12-17 Year Olds (Advarra IRB Approved Version 16 May
2018)
Parental Permission Verbal Script (Advarra IRB Approved Version 16
May 2018)



Recruitment Material:






Discussion Group Overview (Not Dated)
Screener Script (Not Dated)
Screener (Not Dated)
List of Federally Recognized Tribes in the Lower 48 States (Not Dated)

Other Material:












Moderator Guide (Not Dated)
Document Submitted As: Att 06 Individual Picture Sort Deck.pdf
Picture Sort Form (Not Dated)
Check-In Survey (Not Dated)
Document Submitted As: Att 09 ID Projection.pdf
Video Stimuli - Addendum A (Not Dated)
CHECK OUT FORM - YOUTH (Not Dated)
CHECK OUT FORM - ADULTS (Not Dated)
APPROVED PARTICIPANT LIST (Not Dated)
Grant Document (Not Dated)

Page 1 of 2

The IRB approved the above referenced protocol and your site with the modifications listed below on 16 May
2018:





Modifications to the Parent Guardian Permission Form
Modifications to the Assent Form 12-17 Year Olds
Modifications to the Parental Permission Verbal Script
Modification to the Informed Consent Process: A Waiver of Documentation of Consent is
granted for the use of the Screener Script and Screener for Recruitment Purposes only.

In addition, the IRB granted a waiver of consent for 14-17 year old’s parent/guardian, but opt-out consent is
allowed. Also, the IRB determined all minor participants must provide assent and consent from the
parent/guardian of 12-13 year olds must be provided.
If you wish to have the IRB reconsider the imposed modifications, you may follow the procedures outlined
below:
1. Submit supporting documentation that addresses the IRB’s concerns.
2. Provide a written justification for relief of any IRB imposed condition.
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.

The above referenced recruitment material is available on your Advarra CIRBI Platform 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.
If the study is expected to last beyond the approval period, you must request and receive re-approval prior to
the expiration date noted above. A report to the Board on the status of this study is due prior to the expiration
date or at the time the study closes, whichever is earlier. It is recommended that you submit status reports at
least 4 weeks prior to your expiration date to avoid any additional fees or lapses in approval.
Approved investigators and sites are required to submit to Advarra for review, and await a response prior to
implementing, any amendments or changes in: the protocol; advertisements or recruitment materials ("studyrelated materials"); investigators; or sites (primary and additional).
Approved investigators and sites are required to notify Advarra of the following reportable events, including,
but not limited to: unanticipated problems involving risks to subjects or others; unanticipated adverse device
effects; protocol violations that may affect the subjects’ rights, safety, or well-being and/or the completeness,
accuracy and reliability of the study data; subject death; suspension of enrollment; or termination of the study.
Please review the IRB Handbook located in the “Reference Materials” section of Advarra CIRBI™ Platform
(www.cirbi.net). A copy of the most recent IRB roster is also available. Thank you for selecting Advarra IRB
to provide oversight for your research project.
Page 2 of 2

5/30/2018

Rescue Agency Mail - Pro00024887 Clarifying Language and IAA

Samantha Jacobs 

Pro00024887 Clarifying Language and IAA 
Rebecca Fisher 
To: Samantha Jacobs 

Wed, May 30, 2018 at 11:16 AM

Hi Samantha,

Please see below:

The IRB Approval with Modifications Notice (Dated 17 May 2018) for the F.D.A. Center for Tobacco Products 15543 study
states the PI/site was approved to conduct this study with the modifications as listed on the notice. The first three bullet
points reference modifications made by the IRB to the consent/assent documents. All revisions to the consent/assent
documents per the notice are incorporated in the approved material released with the notice. There is no further action
needed from Rescue Social Change Group unless additional changes are made to the consent/assent documents.

In addition, per our conversation yesterday, you can reach out to [email protected] regarding IRB Authorization
Agreements.

Please let me know if you need anything further.

Thanks,

Rebecca (Reba) A. Fisher, B.A., CIP| Manager, Client Services 
O: 443­283­1522 | [email protected] 
Advarra – Advancing Better Research 
6940 Columbia Gateway Drive | Suite 110 | Columbia, MD 21046 | 410­
884­2900

From: Samantha Jacobs   
Sent: Wednesday, May 30, 2018 10:53 AM 
To: Rebecca Fisher  
Subject: Fwd: Pro00024887 Clarifying Language and IAA
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