IRB Approval

IRB EXPEDITED Review WISEWOMAN APPROVAL LETTER.PDF

WISEWOMAN National Program Evaluation

IRB Approval

OMB: 0920-1279

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11 April 2019

Michaela Vine, MPH, Senior Health Researcher
Mathematica Policy Research,
955 Massachusetts Avenue, Suite 801
Cambridge, MA 02139
RE:

Expedited research ethics review findings for: Well-Integrated Screening and Evaluation
for Women Across the Nation (WISEWOMAN)

Dear Ms. Vine,
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 8 April – 11 April
2019.
This study’s human subjects’ protection protocols, as stated in the materials submitted, received
research ethics review approval for one year in accordance with the requirements of the US
Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46 & 45 CFR
46.109(e)). To be in compliance with Federal Regulations, please notify this IRB of any changes
in this study’s design, risks, consent, or other human protection protocols.
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
[email protected]

cc: Penelope A. Lantz, JD

HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1 202.753.5040
[email protected] www.HMLIRB.com


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