Appendix A - MIHOPE IRB Approval Letter

Institutional Review Board

IRB #0003522
FWA#00003694

DATE:

January 6, 2023

TO:
FROM:

Charles Michalopoulos
MDRC IRB

PROJECT TITLE:
STUDY #:
SUBMISSION TYPE:

[813822-24] Mother and Infant Home Visiting Program Evaluation (MIHOPE)

ACTION:
APPROVAL DATE:
EXPIRATION DATE:
REVIEW TYPE:

APPROVED
January 6, 2023
January 6, 2024
Expedited Review

REVIEW CATEGORY:

Expedited review category # (enter category, or delete line)

Continuing Review/Progress Report

Thank you for your submission of Continuing Review/Progress Report materials for this project. The
MDRC IRB has APPROVED your submission. This approval is based on an appropriate risk/benefit
ratio and a project design wherein the risks have been minimized. All research must be conducted in
accordance with this approved submission.
This submission has received Expedited Review based on the applicable federal regulations.
Please remember that informed consent is a process beginning with a description of the project and
insurance of participant understanding followed by a signed consent form. Informed consent must
continue throughout the project via a dialogue between the researcher and research participant. Federal
regulations require that each participant receives a copy of the consent document.
Please note that any revision to previously approved materials must be approved by this committee prior
to initiation. Please use the Modifications/Changes form for this procedure.
All UNANTICIPATED PROBLEMS involving risks to subjects or others (UPIRSOs) and SERIOUS and
UNEXPECTED adverse events must be reported promptly to this office. Please use the Adverse Events
form for this procedure.
All NON-COMPLIANCE issues or COMPLAINTS regarding this project must be reported promptly to this
office.
This project has been determined to be a MINIMAL RISK project. Based on the risks, this project requires
continuing review by this committee on an annual basis. Please use the appropriate forms for this
procedure. Your documentation for continuing review must be received with sufficient time for review and
continued approval before the expiration date of January 6, 2024.
Please note that all research records must be retained for a minimum of three years after the completion
of the project.
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If you have any questions, please contact Frederick Doolittle at (212) 340-8638 or
[email protected]. Please include your project title and reference number in all correspondence with
this committee.

This letter has been electronically signed in accordance with all applicable regulations, and a copy is retained within MDRC IRB's
records.

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