Appendix H Westat EPICCS IRB Approval Letter

APPENDIX H: WESTAT EPICCS IRB APPROVAL LETTER

DATE: February 3, 2016
TO: Roline Milfort

FROM: Kerry Levin
Chair, Institutional Review Board

SUBJECT: IRB Continuing Review and Approval
Project Name: CACFP IMPROPER PAYMENTS
Project: 6278.01
FWA 00005551
On February 2, 2016, the Westat IRB Continuing Review Committee conducted its continuing review of the
following: CACFP IMPROPER PAYMENTS, Project # 6278.01. Pursuant to 45 CFR pt 46.109(e), continuing review of
research studies occurs at intervals appropriate to the degree of risk but not less frequently than once a year.
In accordance with 45 CFR pt 46, the Board approved the continuation of this study. The next continuing review
will be due on or before February 2, 2017. In the interim, you are responsible for notifying the Institutional Review
Board (IRB) Office as soon as possible if there are any injuries to the subjects, problems with the study, or changes
to study design that relate to human subjects.
cc: Institutional Review Board - Sharon Zack

APPENDIX I: WESTAT EPICCS IRB APPROVAL LETTER

AMENDMENT REVIEW FORM
(TO ADD OR CHANGE PREVIOUSLY APPROVED RESEARCH)
All changes or new activities for previously approved studies require submission, review, and approval of
an Amendment Review Form. Please complete and upload this form to your project’s document library on
IRBTRAC along with all other necessary materials to be reviewed. Once the request has been reviewed, you will be
contacted. If this change or new activity requires a full Board review, those meetings occur on the second Tuesday of
every month. To check the date of meetings, please see the meeting schedule under IRB in WesInfo. Thank you for
your cooperation.
1. Today’s Date:

08 / 21 / 2015

Date of Original Approval:

03 / 16 / 2015

Project Name:

Erroneous Payments in Child Care Center Study or EPICCS
(Contract Name: CACFP Improper Payments Study)

Westat Project Number:

6278.01.00

Agency Grant or Contract Number:

AG3198C140015

Project Director:

Roline Milfort

Unit Ops Number/Study Area:

21.72.1

Area IRB Representative:

Alicia Sutherland

Ext. 8229

Ext. 8860

2. Indicate the type of addition or change being requested to a previously approved study.
(SELECT ALL THAT APPLY.)

Name(s) of investigators
Project number
Introduction of a new IRB or request for
Westat to serve as the IRB
Study design, survey questionnaire, or
procedure(s)
Informed consent process, consent form(s),
parent permission(s), or assent form(s)
Recruitment materials or strategies
Incentives
Survey instruments
Number or type of populations studied

AMENDMENT REVIEW FORM
January 2015 version

Review of final instrument such as interview
questions or data collection sites for a
previously approved study
Mode of administration of instruments in your
study (e.g., from mail or telephone to web or
Internet access)
Data access rights
Any other change in protocol that affects
treatment of human subjects:
(PLEASE SPECIFY)
Description of the proposed approach for
main study's contact of parents and
guardians for completion of a household
survey. Preparation for the interview and
incentive plans are revised.

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Amendment Review Form

APPENDIX I: WESTAT EPICCS IRB APPROVAL LETTER

3. Please provide a brief summary of your change or addition to previously approved research.
Previous approvals were obtained for pretest activities only. This submission provides details for the
main study.

4. How does each change or addition affect the risks to participants in your study? (SELECT ONLY ONE.)
a.
No change
b.

N/A – no risks

c.

Decreases the risk (SPECIFY):

d.

Increases the risk (SPECIFY ):

e.

Adds a new risk (SPECIFY ):

FOR HARD-COPY SUBMISSION, PLEASE SIGN HERE:
A signature is not required when you return this form electronically; however, please fill in the date of
completion.
The information provided in this request form is complete and correct.
Project Director/
Principal Investigator:

Date: 08 / 21/ 2015

Please attach:
§ One document that clearly identifies (through track changes, highlights, or italics) the
revision in the previously approved submission.
§ Another document labeled “corrected version.”
If you have any questions, feel free to contact Sharon Zack, the IRB Administrator, at x8828.
IRB Administration Use Only
Expedited review and approval for the modification(s) on this form:

Sharon Zack
2015-09-18 12:26 PM
I agree to the terms defined by the placement of my signature

IRB Chair / Associate Chair / Designee
IRB Office Only
APPROVED – NEXT CONTINUING REVIEW DATE BEFORE: 03 / 17/ 2016
CONDITIONAL APPROVAL (PLEASE SEE ATTACHED LETTER)
DID NOT QUALIFY FOR EXPEDITED REVIEW

AMENDMENT REVIEW FORM
January 2015 version

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