Irb

Attachments:
• REVISED_Community Web-Panel Survey Consent Form.2023.07.24.pdf
• REVISED_Community Focus Group Consent Form.2023.07.24.pdf
• Expedited Review Approved by Chair - IRB ID: 2023/02/5.pdf

SOLUTIONS IRB

Approval Notification

To: Catherine Lesesne , [email protected]
From: Ayn O'Reilly, IRB Chair
Subject: Protocol #2023/02/5
Date: 07/25/2023
The protocol M enthol-Flavored Tobacco Products Policy Evaluation has been approved by the IRB Chair under the rules for expedited
review on 07/25/2023. The expedited review categories applicable to the study approval are:
(7) Research on individual or group characteristics or behavior
The approval of your study is valid through 07/24/2024, by which time you must submit an annual report either closing the protocol or requesting
permission to continue the protocol for another year. Please submit your report by 06/26/2024 so that the IRB has time to review and approve
your report if you wish to continue it for another year.
This project should be conducted in full accordance with all applicable laws and regulations, and must adhere to the project plan that has been
approved by Solutions IRB. You must notify Solutions IRB immediately of any proposed changes that may affect the status of
your approval or the risk to participants. You must also report any unanticipated problems involving risk to participants or others to Solutions
IRB immediately.
Any changes to the approved study documents must be approved prior to use.
Upon any inquiries or reports about the conduct of this study, or on the receipt of any participant or other complaints, or in conjunction with a
routine compliance audit, you may be asked to provide documentation to Solutions IRB related to this study and are expected to immediately
comply with any such requests.
Please refer to your sponsor/regulatory office guidelines on the timeline to send IRB decision letters, if applicable.
Upon completion of the research project, please notify Solutions IRB so that we can close out your study as appropriate.
We look forward to continuing to partner with you to ensure the ongoing protection of participant rights. If you have any questions or need
additional information, please contact us at [email protected] or call 1-​855-​226-​4472.

If you have any questions, feel free to contact me.
Thanks,

Ayn O'Reilly
IRB Chair
PO Box 1041
Yarnell, AZ 85362
855.226.4472
[email protected]

Application Sections Requested Files
Summary of Activities
Full Protocol/Investigator Brochure (if
applicable)

04/28/2023 Research Protocol.VF.2023.05.01.docx

Application Files
IRB CF Revisions

Recruitment M aterials

06/19/2023 Community Focus Group Consent Form.VF.2023.05.31_revised.docx
06/19/2023 Community Web-Panel Survey Consent
Form.VF.2023.05.31_revised.docx
05/01/2023 Focus Group Informational Advertisement.VF.2023.05.01.docx

Personnel Training Certificates

Data Collection Instruments

Personnel CV (resume)

Survey & Interview Questions
Grant Proposal
Email Correspondence
Consent Form

IRB Registration #: IORG0007116

05/01/2023 Web Panel Survey Informational Advertisement.VF.2023.05.01.docx
05/01/2023 Sample Social Media Focus Group Recruitment Ad.VF.2023.05.01.pdf
05/01/2023 Briana_Oliver_CITI_Training_Cert.pdf
05/01/2023 Katherine_Moran_CITI_Training_Cert.pdf
05/01/2023 Kelly_McAleer_CITI_Training_Cert.pdf
05/01/2023 CITI-Research-Certificate-of-Completion-LZakalik.pdf
05/01/2023 GGopez_CITI Training_CompletionReport9904770.pdf
05/01/2023 Lesesne CITI cert 2021-2024.pdf
06/27/2023 CompletionCertificate_EGwynn_062223.pdf
05/01/2023 Community Focus Group Guide.VF.2023.05.01_IRB.docx
05/01/2023 Screener_Community Focus Group Guide.VF.2023.05.01_IRB.docx
05/01/2023 Screener_Community Web-Panel Survey.VF.2023.05.01_IRB.docx
06/12/2023 OSH Menthol Cognitive Interviewing Tool.V1.2023.05.24.docx
05/01/2023 Briana_Oliver_Resume.pdf
05/01/2023 Katherine_Ann_Moran_Federal_Resume_CDC.docx
05/01/2023 Kelly_McAleer_Resume.docx
05/01/2023 Catherine (Cathy) Lesesne_CV 12-2021.docx
05/01/2023 GGopez ResumeV1.2023.01.10.docx
05/01/2023 lori-zakalik-deloitte-resume-March-2023.doc
06/27/2023 EPGwynn Resume.pdf
05/01/2023 Community Web-Panel Survey.VF.2023.05.01_IRB.docx
03/31/2023 Contract-Award-Notice.pdf
06/19/2023 IRB Solutions Revision Response.docx
07/24/2023 Solutions IRB Revision Response.V2.2023.07.24.docx
05/01/2023 Community Web-Panel Survey Consent Form.VF.2023.05.01.docx
05/01/2023 Community Focus Group Consent Form.VF.2023.05.01.docx
07/24/2023 REVISED_Community Web-Panel Survey Consent Form.2023.07.24.docx
07/24/2023 REVISED_Community Focus Group Consent Form.2023.07.24.docx
Federalwide Assurance (FWA) #: IRB00008523