M_IRB Approval Letter

M. IRB Approval Letter

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12 November 2020
Mary Kay Fox, M.Ed.
Mathematica
955 Massachusetts Avenue, Suite 801
Cambridge, MA 02139

RE:

Expedited research ethics review findings for: Second Study of Nutrition and Activity in Child
Care Settings (SNACS-II) (Review #791MPR20)

Dear Mary Kay Fox,
Protocols for the protection of human subjects in the above study were assessed through an expedited
research ethics review by HML Institutional Review Board on 03 – 12 November 2020.
This study’s human subjects’ protection protocols, as stated in the materials submitted, received research
ethics review approval in accordance with the requirements of the US Code of Federal Regulations for
the Protection of Human Subjects (45 CFR 46 & 45 CFR 46.110). 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, risks, 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.
HML IRB is authorized by the U.S. Department of Health and Human Services, Office of Human
Research Protections (IRB #1211, IORG #850), and has DHHS Federal-Wide Assurance approval (FWA
#1102).
Sincerely,

D. Michael Anderson, Ph.D., MPH
HML IRB Chair & Human Subjects Protections Director
dma@hmlirb.com

cc: Katherine Niland, Sarah Forrestal, Penelope A. Lantz, JD

HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1 202.246.8504
info@hmlirb.com www.HMLIRB.com

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