C01 IRB Approval Letter

C01 IRB Approval Letter.pdf

2024–2025 National School Foods Study

C01 IRB Approval Letter

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APPENDIX C01. IRB APPROVAL LETTER

Attachments:
• Expedited Review Approved: IRB #2491.pdf

Expedited Review Approved: IRB #2491
To: Alice Ann Gola
Institution: Mathematica Policy Research (MPR)
From: HML IRB
Subject: Study #2491
Date: 02/22/2024
Dear Alice Ann Gola, PhD,
The protocol School Nutrition M eal Cost Study Plus, 2491 was assessed through an expedited research ethics review by HML Institutional
Review Board. This study’s human subjects’ protection protocols, as stated in the materials submitted, received research ethics review approval
on 02/22/2024 in accordance with the requirements of the US Code of Federal Regulations for the Protection of Human Subjects (45CFR46 &
45CFR46.110) and were expedited by (5) Research involving materials (data, documents, records, or specimens) that have been collected, or will
be collected solely for non-research purposes and (7) Research on individual or group characteristics or behavior.
You may rely on this IRB for review and continuing ethical oversight of this study. You and your project staff remain responsible for ensuring
compliance with HML IRB’s determinations. Those responsibilities include, but are not limited to: 1) ensuring prompt reporting to HML IRB of
proposed changes in this study’s design, subject risks, informed consent, or other human protection protocols; 2) investigators will conduct the
research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB,
except when necessary to mitigate hazards to subjects; 3) and to promptly report any unanticipated problems involving risks to subjects or others
in the course of this study.
The approval of your study is valid through 02/21/2025, by which time you must submit an annual check-in report either closing the study or
requesting permission to continue for another year. Please submit your report by 02/14/2025 so that the IRB has time to review and approve your
report prior to the expiration date. For instructions on how to manage an approved study refer to: How to Manage an Approved Study.
Please note that we have changed our fee schedule for 2024. For details, please see 2024 HML IRB Fees.
HML IRB is authorized by the U.S. Department of Health and Human Services, Office of Human Research Protections (IRB #00001211, IORG
#0000850), and has DHHS Federal-Wide Assurance approval (FWA #00001102).
If you have any questions, please contact us at admin@hmlirb.com.
Sincerely,

D. Michael Anderson PhD, MPH
IRB Chair & Human Research Protections Director
dma@hmlirb.com

Health Media Lab, Inc.
1101 Connecticut Avenue, NW Suite 450 Washington, DC 20036 USA
+1 202.246.8504 info@hmlirb.com www.HMLIRB.com


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File Created2024-02-28

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