Foundational Focus Groups

BRANY SBER IRB
DATE: 12/22/2020
TO:
Scott Vanderbilt, MAMC
FROM: Raffaella Hart, MS, CIP, BRANY SBER IRB (IRB00010793)
SUBMISSION TYPE:
SBER-Initial Review (Event ID# 177418)
PROTOCOL NUMBER: 20-078-821 /
STUDY TITLE:
HHS COVID-19 Public Education Campaign Foundational Focus Groups
IRB ACTION:

Approved - SBER

APPROVAL DATE:
EXPIRATION DATE:
REVIEW TYPE:

12/22/2020
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-2020-12-17-10-34.pdf
b. Foundational FG Abstract.docx
c. HHS COVID-19 Public Education Campaign Foundational FG Informed Consent
Form_FINAL 12.16.2020_CLEAN-20201221.pdf
d. HHS COVID-19 Public Education Campaign Foundational FG Informed Consent
Form_FINAL 12.16.2020_REDLINE-20201221.docx
e. HHS COVID-19 Public Education Campaign Foundational FG Screener_FINAL
12.16.2020.pdf
f. HHS COVID-19 Public Education Campaign Foundational FG Testing Guide_FINAL
12.16.2020.pdf
g. HHS COVID-19 Public Education Campaign Foundational Focus Groups Protocol.pdf
Modifications are in accord with those required by the IRB, and were incorporated as indicated in
the enclosed redlined version.
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 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.
BRANY | 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042 | 516.470.6900 T | 516-470-6903 F | www.brany.com
Page 1 of 2

BRANY SBER IRB
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.
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. Scott Vanderbilt, MAMC
b. Ashley Simpkins
c. Lindsey Strusser
d. Leah Hoffman
e. Erik Lund
5. 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 12/22/2021. 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 rhart@brany.com. Thank you.

BRANY | 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042 | 516.470.6900 T | 516-470-6903 F | www.brany.com
Page 2 of 2