Attachment E-1 Determination Notice for Non Human Subjects Research

Office of International Research Ethics
DETERMINATION NOTICE FOR NON HUMAN SUBJECTS RESEARCH

DATE:

March 30, 2023

TO:

Rebecca Ledsky, MBA

PROJECT #:

2036651-1

TITLE:

Market Research to Inform Enrollment and Retention Approaches:
Focus Groups with WIC-eligible persons or partners

DETERMINATION:

This project is not research as defined under the Department of Health
and Human Services Code of Federal Regulations

DECISION DATE:

March 30, 2023

Thank you for submitting Market Research to Inform Enrollment and Retention Approaches:
Focus Groups with WIC-eligible persons or partners for review by the Office of International
Research Ethics (OIRE). We are pleased to inform you OIRE has determined this project does
not meet the regulatory definition of research as defined under the Department of Health and
Human Services Code of Federal Regulations [45 CFR part 46.102(d)(f)].
Given this determination, further review and approval of this project is not required.
It is important to note this determination was based upon the project description submitted at this
time. Any changes or revisions made to this project must be submitted to OIRE for review prior
to implementation.

This letter has been electronically signed in accordance with all applicable regulations, and a
copy is retained within FHI 360 records.

FHI 360 HEADQUARTERS
359 Blackwell Street, Suite 200 | Durham, NC 27701 USA
T 1.919.544.7040 | F 1.919.544.7261 | www.fhi360.org

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