Needs Assessment Human Subjects Determination

359 Blackwell Street
Suite 200
Durham, NC 27701
fhi360.org

Office of International Research Ethics
HUMAN SUBJECT RESEARCH DETERMINATION

DATE:

March 22, 2024

TO:

Rebecca Ledsky, MBA

PROJECT #:

2175639-1

TITLE:

Needs Assessment Survey with WIC SAs/LAs for WIC Market Research

DETERMINATION:

NOT RESEARCH

Thank you for submitting the project entitled Needs Assessment Survey with WIC SAs/LAs for WIC
Market Research for review by the Office of International Research Ethics (OIRE). The proposed project,
as presented in your submission, has been reviewed.
The OIRE determined this project is NOT RESEARCH. Per U.S. regulations, under 45 CFR (Code of
Federal Regulations) 46.102(e)(l), NOT RESEARCH projects do not meet the regulatory definition of
human subject research and do not need to be regulated.
Based on this determination an exemption by the Office of International Research Ethics or approval by
the Protection of Human Subjects Committee (PHSC) is not required.
This determination is effective on March 22, 2024.
If any more than minor changes are made (i.e., involving the purpose or intended use of the findings)
these must be submitted to OIRE for review prior to implementation to confirm the changes do not have
an impact on this determination.
This determination does not affect any local laws, regulations, or other requirements that may otherwise
be applicable to this research's review.
This letter has been electronically signed in accordance with all applicable regulations, and a copy is
retained within FHI 360 records.

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