Download:
pdf |
pdfBRANY SBER IRB
DATE: 12/22/2020
TO:
Scott Vanderbilt, MAMC
FROM: Raffaella Hart, MS, CIP, BRANY SBER IRB (IRB00010793)
SUBMISSION TYPE:
PROTOCOL NUMBER:
STUDY TITLE:
SBER-Initial Review
20-075-821
HHS COVID-19 Public Education Campaign Vaccine Readiness Current Events
Weekly Tracker Survey
IRB ACTION:
EXEMPT
DETERMINATION DATE: 12/22/2020
ANNUAL REPORT DUE: 12/22/2021
REVIEW TYPE:
Exempt
Thank you for your submission for the above-referenced study.
1. BRANY SBER IRB Determination
BRANY SBER IRB has determined your submission is exempt from IRB review under categories 2 qne
5, as detailed in 45 CFR 46.104(d) and BRANY’s Standard Operating Procedures (category excerpted
below). *This determination requires that all procedures and activities are performed in accordance
with relevant state and local law (including tribal law when applicable).
(2) Research that only includes interactions involving educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or observation of public behavior
(including visual or auditory recording) with the following criteria is met:
(i) The information obtained is recorded by the investigator in such a manner that the identity of
the human subjects cannot readily be ascertained, directly or through identifiers linked to the
subjects;
(ii) Any disclosure of the human subjects' responses outside the research would not reasonably
place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial
standing, employability, educational advancement, or reputation;
(5) Research and demonstration projects that are conducted or supported by a Federal department
or agency, or otherwise subject to the approval of department or agency heads (or the approval of
the heads of bureaus or other subordinate agencies that have been delegated authority to conduct
the research and demonstration projects), and that are designed to study, evaluate, improve, or
otherwise examine public benefit or service programs, including procedures for obtaining benefits or
services under those programs, possible changes in or alternatives to those programs or procedures,
or possible changes in methods or levels of payment for benefits or services under those programs.
Such projects include, but are not limited to, internal studies by Federal employees, and studies
under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects
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
also include waivers of otherwise mandatory requirements using authorities such as sections 1115
and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the research and demonstration
projects must establish, on a publicly accessible Federal Web site or in such other manner as the
department or agency head may determine, a list of the research and demonstration projects
that the Federal department or agency conducts or supports under this provision. The research
or demonstration project must be published on this list prior to commencing the research
involving human subjects.
2. Documents Acknowledged with this Submission
a. SBER Study Application-2020-12-11-13-35.pdf
b. ABSTRACT - Current Events Weekly Tracker - FMG.docx
c. HHS COVID-19 Public Education Campaign Vaccine Readiness Current Events Weekly Tracker
Survey_12.11.2020.docx
d. ASPA_CET Weekly Survey_FINAL.docx
3. Provisions of BRANY SBER IRB’s Determination
Although this study has been determined to be exempt for further IRB review, any proposed
changes to the research must be reviewed by the BRANY SBER IRB prior to implementation. The
BRANY SBER IRB will evaluate the proposed change(s) and determine whether the activity remains
exempt.
4. Study Personnel
The following study personnel have provided the required evidence of training in human subjects
protection and conflict of interest disclosures, and therefore may participate in the conduct of this
activity.
a. Scott Vanderbilt
b. Erik Lund
c. Leah Hoffman
d. Lindsey Strausser
5. IRB Approval Period and Expiration of IRB Approval:
Research that has been determined to be exempt from BRANY SBER IRB review is not subject to
continuing review. However, BRANY SBER IRB requires you complete an annual report, or notify the
IRB if the study is completed before then.
Your Exempt Annual Report to BRANY SBER IRB is due on 12/22/2021. BRANY IRB requires you
"check in" at least annually to ensure your study status is up to date, and your study remains in
compliance. If your research is completed before then, you must submit a notification of study
closure to BRANY SBER IRB (submit via xForm in IRBManager).
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
File Type | application/pdf |
Author | Kimberly Irvine |
File Modified | 2020-12-30 |
File Created | 2020-12-23 |