EE IRB Approval Letters

ATTACHMENT EE IRB APPROVAL LETTERS

ATTACHMENT EE
IRB APPROVAL LETTERS

10/06/2015
Ponza, Michael
University of Michigan
Mathematica Policy Research
Oakland, CA 94612
Project Title: The Evaluation of SNAP Employment and Training Pilots
Project Number: 15-07-2107
Dear Dr. Ponza,
The Committee for the Protection of Human Subjects (CPHS) has reviewed and approved the above new project.
Included with the approval are the following item(s) beginning with project type:
Common Rule, Minimal Risk, Non-English Translation, Consent Form
This approval is issued under the California Health and Human Services Agency’s Federalwide Assurance
#00000681.
Pursuant to 45 CFR 46.109(e), CPHS cannot approve a project for more than one year at a time. Therefore, a
project must be renewed yearly. To continue your research or data analysis, submit a Continuing Review request
by your project's deadline date, September 2, 2016 . If your project is not approved again (renewed), it will
expire on October 7, 2016. Once a project is expired, all research, including data analysis, must cease (unless
discontinuance will have an adverse impact on research subjects).
You will receive courtesy email reminders from CPHS to renew your project. It is the Principal Investigator's
responsibility to submit their Continuing Review request on time and to notify CPHS of any changes in contact
information.
If a project has been completed or is no longer active, it must be submitted to CPHS for completion approval or
withdrawal approval. Instructions for these processes can be found in our Instructions for Researchers located on
the CPHS Homepage.
Any unanticipated problems, adverse events, protocol deviations, and breaches in data security must be reported
to CPHS via a Report Form within 48 hours of the event. File a report by logging into CalProtects and clicking on

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the protocol's "Protocol ID" number. A pop-up window will appear, select the "Start Report Form" option. Upon
completion of the form, click the "Submit Form" button on the left side of the screen. You must call CPHS staff
at (916)326-3660 to notify them of the report submission.
If you have any questions, you may call our office at (916) 326-3660 or email us at [email protected].
Sincerely,

Lucila Martinez
CPHS Administrator
(916) 326-3661
[email protected]

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_
DELAWARE HEALTH
AND SOCIAL SERVICES
Division of Management Services
___________________________________________________________________________________________
December 14, 2015

Mitchell Ponza, Principal Investigator
Mathematica Policy Research
505 14th St. Suite 800
Oakland, CA 94612
RE: “The Evaluation of SNAP Employment and Training Pilots”
Dear Mr. Ponza:
This is to advise you that based on the research proposal and revisions submitted to the DHSS Human Subjects
Review Board regarding The Evaluation of SNAP Employment and Training Pilots”, the DHSS Human
Subjects Review Board (has approved as of December 1, 2015 the above-referenced project.
Please take note of the following requirements:
Continuing review: In order to ensure ongoing protection of human subjects and fulfill our mandate as a
Board, we conduct periodic reviews of approved projects. The Board has determined that the nature of your
project makes it appropriate for annual review, which means that our next review of your project must take
place no later than one year from the date of the meeting at which we initially reviewed it, per federal
regulations.
Reporting: Our report template is available on our website:
http://www.dhss.delaware.gov/dhss/dms/epqc/files/projectreportform.pdf
To allow time for distribution of the report to the Board, and their scrutiny of it, I will need it (sent to me
electronically) at least one month prior to the one-year anniversary date (if the project is not yet over by that
time). Please send the final report and the final report unique to Delaware patients.
Project changes: Any subsequent changes in the research design must be reported to us prior to
implementation, along with an explanation of the reasons for the changes and implications related to client
safety/protection. Please communicate electronically in the interests of efficiency. If you do not hear from me
within a week, be sure to follow up by phone. Depending on the significance of the change, full Board review
and approval may be necessary before such changes can be implemented.
Unanticipated problems / adverse events: Any injuries sustained by research subjects resulting from the
project must be reported to us immediately, as well as any unanticipated problems resulting in harm or
potential harm to participants. Even if you feel that the “unanticipated problem” is inconsequential, we ask
that you err on the side of excessive reporting to us, rather than failing to report a problem that could have
serious implications. Measures proposed to deal with any such problems should be outlined. Again, please

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RE: Penn Center for Innovation in Personalized Screening: Comparative Effectiveness of Digital Breast Tomosynthesis”

use electronic media to communicate in the interests of efficiency, with phone follow-up if you do not hear
from me within a week.
 Consent Document: The signed consent documents are to be kept in a confidential secured location for a
minimum of three years.
If you have any questions or concerns, be sure to let me know.

Sincerely,

Rosanne Griff-Cabelli,
Chairperson, DHSS Human Subjects Review Board

cc: Ray Fitzgerald, Director, Div. of Social Services, DHSS

Brenda Fitzgerald, MD, Commissioner | Nathan Deal, Governor
2 Peachtree Street NW, 15th Floor
Atlanta, Georgia 30303-3142
www.health.state.ga.us

October 13, 2015
Michael Ponza
Principal Investigator et, Suite 800
Oakland, CA 94612

Project:

150906 - Evaluation of the Supplemental Nutrition Assistance Program (SNAP)
Employment and Training (E&T) Pilots

Project Status: Approved Until 10/13/2016
Dear Researcher,
The above-refereneced project was reviewed by the DPH Institutional Review Board in accordance
with expedited review procedures outlined in 45 CFR 46.110(b)(1), category(ies) 5&7
The Board has approved this study until 10/13/2016
If you wish to continue this project beyond the current approval period, please submit a "Continuing
Review Application" before the above expiration date. If you do not submit a renewal application before
the expiration date, the approval of your project will automatically terminate. Any involvement with
human subjects must cease on the above date unless you have received approval from the Board to
continue the project. It is the investigators responsibility to track the deadline.
This approval applies only to the protocol described in your application. IRB review and approval is
required before implementing any changes in this project except where necessary to eliminate
apparent immediate hazards to human subjects.
If you have any questions regarding this letter or general procedures, please contact the DPH IRB at
[email protected]. Please reference the project # in your communication.
Best wishes in your research endeavors,

Brian Kirtland, Ph.D.

Digitally signed by Brian Kirtland, Ph.D.
DN: cn=Brian Kirtland, Ph.D., o=Georgia Department of Public Health,
ou=Institutional Review Board, [email protected], c=US
Date: 2015.10.13 19:45:58 -04'00'

Agency of Human Services
208 Hurricane Lane
Williston, VT 05495
www.humanservices.vermont.gov

[phone]
[fax]

802-871-3009
802-871-3001

Health Care Operations, Compliance
and Improvement

August 20, 2015

Michael Ponza, Ph.D
Mathematica Policy Research
505 14th St., Suite 800
Oakland, CA 94612
Dear Michael:
As of August 4, 2015, the AHS IRB has approved your application for “The Evaluation of SNAP
Employment and Training Pilots”. If not completed, your study will be due for another
continuing review 12 months from now.
Please note that IRB approval does not supersede state law, as such it will be up to the individual
departments involved in your study to assure that the access that your team requests meets all
applicable Vermont state law and practices
Sincerely,

Shawn E. Skaflestad, Ph.D.
AHS IRB Chair