HHS COVID-19 Public Education Campaign Creative Testing Focus Groups

BRANY SBER IRB
DATE: 11/23/2020
TO:
Kristin Pondel
FROM: Raffaella Hart, MS, CIP, BRANY SBER IRB (IRB00010793)
SUBMISSION TYPE:
SBER-Initial Review (Event ID# 176349)
PROTOCOL NUMBER: 20-069-821
STUDY TITLE:
HHS COVID-19 Public Education Campaign Vaccine Readiness Creative Testing
Focus Groups
IRB ACTION:

Approved - SBER

APPROVAL DATE:
EXPIRATION DATE:
REVIEW TYPE:

11/23/2020
Non-expiring
Expedited Initial Review

Thank you for your submission for the above-referenced study.
1. BRANY SBER IRB Determination
Your submission was APPROVED by the BRANY SBER IRB via expedited review under categories
6 and 7. This approval requires that all procedures and activities are performed in accordance
with relevant state and local law (including tribal law, when applicable).
2. Submitted Documents
a. SBER Study Application-2020-11-19-09-54.pdf
b. HHS COVID-19 Public Education Campaign Creative Testing Focus Groups Protocol
11.18.2020.docx (BRANY stamp 11/23/2020)
c. HHS COVID-19 Public Education Campaign Draft ICF 11.18.2020.docx (BRANY stamp
11/23/2020)
d. HHS COVID-19 Public Education Campaign Final Creative Testing Guide.docx (BRANY
stamp 11/23/2020)
e. HHS COVID-19 Public Education Campaign Draft Master Screener.docx (BRANY stamp
11/23/2020)
3. Provisions of BRANY SBER IRB Approval
a. This study requires consent of subjects to be obtained. You must continue to monitor
the subject’s willingness to be in the study for the duration of the subject’s
participation. Only use the current IRB-approved and stamped forms in the consent
process. Each subject must receive a copy of his/her signed consent/permission/assent
document. Consent forms signed by subjects in this study must be kept by the Principal
Investigator for at least 3 years, or longer if required by your institution.
b. All research must be conducted in accordance with this approved submission. Any
changes to the approved study must be reviewed and approved by the BRANY SBER IRB
prior to implementation, except when necessary to eliminate an apparent immediate
hazard to the subject.
BRANY | 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042 | 516.470.6900 T | 516-470-6903 F | www.brany.com
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BRANY SBER IRB
c. Unanticipated problems (including serious adverse events, if applicable) must be
reported to BRANY SBER IRB within 5 days of discovery using Form IRB-4 (Reporting
Form for Events that Require Prompt Reporting to the IRB).
d. Any complaints or issues of non-compliance must be immediately reported to BRANY
SBER IRB.
4. Study Personnel
The following study personnel have been approved to participate in this research project.
a. Kristin Pondel
b. Leah Hoffman
c. Lindsey Strausser
d. Stephanie Miles
e. Lauren Angel
5. Unapproved Study Personnel:
The following individuals are not approved to participate in this study because required
documents were not received by BRANY IRB, as detailed below.
a. Brian Greipentrog – BRANY COI disclosure form
To receive approval for the above, submit the indicated items to the IRB.
6. Non-Expiring IRB Approval Period:
This study was reviewed under the Revised Common Rule (2018 requirements) and therefore
does not require continuing review in accordance with 45 CFR 46.109(f)(1)(i).
However, BRANY SBER IRB requires you "check in" at least annually to ensure your study status
is up to date and in compliance. Your Annual Report to BRANY IRB is due on 11/23/2021. If
your research is completed before then, you must submit a notification of study closure to
BRANY SBER IRB (use the xForm called: SBER-Study Status Change (Closed/Enrollment Closed)).
If you have any questions or require any additional information, please call me at 516-470-6909 or send
an email to me at [email protected]. Thank you.

BRANY | 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042 | 516.470.6900 T | 516-470-6903 F | www.brany.com
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