ATTACHMENT D1 - UI IRB Package

ATTACHMENT D1: URBAN INSTITUTE IRB PACKAGE

THE URBAN INSTITUTE 2100 M STREET, N.W. / WASHINGTON D.C. 20037
TO:
THRU:
FROM:
DATE:
SUBJ:

Everett Madden, IRB Administrator
Rolf Pendall, METRO Center Director
Nancy Pindus, Principal Investigator
11/1/2012
Request for IRB Review

PD/Project (Name & No.): Study of the Food Distribution Program on Indian Reservations
(08322-20-000)
Type of Review Requested:
1. Initial IRB Review:
[ ] Full Review: attach six copies of materials, or
[ X ] Expedited Review: attach two copies of materials.
or
2. Annual Review or When There Has Been a Change to a Previously Approved Project:
[ ] No changes. I certify that there have been no changes in the following since the last IRB
review: purpose, methods and procedures, including study population and what is required of the
subjects to include —
Potential risks and benefits
Consent procedures to be followed
Data security plan
Survey instrument
[ ] There have been changes in the project since the last IRB review. Provide narrative
summary of changes and attach revised materials, highlighting the changed sections, as
appropriate.

_______________________
PI Signature

_________
Date

_______________________
Center Director Signature

_________
Date

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Request for Expedited IRB review
STUDY OF THE FOOD DISTRIBUTION PROGRAM ON INDIAN RESERVATIONS:
PRETEST OF DATA COLLECTION INSTRUMENTS
UI # 08322-020-00
This is a request for an expedited review for pretesting the data collection instruments of
a 3-year study of the Food Distribution Program on Indian Reservations that the Urban Institute
is undertaking between November 2011 and October 2014. The evaluation is being done under
contract to the U.S. Department of Agriculture, Food and Nutrition Service.
The Principal Investigator is Nancy Pindus, the Project Manager is Diane Levy, and
Urban Institute staff includes Doug Wissoker, Chris Narducci, Sophie Litschwartz, and Jennifer
Biess. Subcontractors involved in pretesting will be NORC at the University of Chicago, whose
staff includes Carol Hafford and Suzanne Bard; and Support Services International, Inc., whose
staff includes Walter Hillabrant and Judy Earp.
The pretest will be conducted in 2-3 FDPIR sites. Pretest participants will be recruited by
contacting tribes with whom NORC, UI, or SSI has an established relationship through prior
work. These tribes have indicated a willingness to assist in the pretest process and they are not
part of the sample selected for the study of the Food Distribution Program on Indian
Reservations. NORC will make the initial contacts with tribes for the pretest. While a full IRB
review will be requested prior to beginning primary data collection activities associated with
these surveys and interview guides, at this time we are requesting an expedited IRB review to
allow us to pretest the following data collection protocols (see attached table for a summary of
data collection instruments and respondents):
1. Case Record Review Form
The purpose of the case record review is to obtain information that will describe current
program participants and their characteristics. Information will be abstracted from
individual case records of several FDPIR programs. NORC will take the lead in testing
procedures for accessing case records and extracting data, as well as pre-testing the case
record review form itself. We plan to obtain and review 5 case records at up to 3 FDPIR
pretest sites.
Our working assumption is that the majority of FDPIR programs do not have automated
case record files. Therefore, the pretesting of the case record review form will be
conducted on-site at tribal FDPIR offices. The existing records that will be examined for
the case record review are the eligibility forms that are filled out by program applicants in
order to participate in the FDPIR program. Each tribe or Indian Tribal Organization
(ITO) maintains the records as part of its federally-approved program and according to
strict program implementation guidance issued by USDA/FNS.
Appendix 1 includes the Case Record Review Form and a sample FDPIR case record.
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2. FDPIR Participant Survey
NORC will take the lead in testing this primarily close-ended questionnaire designed to
assess household food needs and satisfaction with the FDPIR program. Topics covered in
the survey are food storage and preparation, FDPIR contribution to the household’s food
supply, access to the FDPIR program and access barriers, food costs, participation in
FDPIR and other food assistance programs, nutrition education and other health-related
services, and satisfaction with the program. The length of the survey interview is
estimated to be 45 minutes. For the pretest, a total of up to 8 interviews will be
conducted in 2-3 FDPIR sites. The respondents will be a convenience sample from the
list of participants provided by the Food Distribution Program on each of the reservations
in the pretest.
Pretest respondents will receive an incentive of $25 for their time and cooperation. With
the subject’s permission, we do plan to audio-tape pretest interviews to hear how the
question wording works and what questions the subjects have a difficult time
understanding. The Informed Consent form for the pretest of the Participant Survey also
includes a request for permission to audio-tape. The audio tapes will be destroyed when
OMB clearance has been received.
Upon completion of the pretest field work, a telephone debriefing session will take place
with the interviewers. A debriefing report will be produced and shared with FNS and the
Urban Institute in order to make revisions to the instrument.
The Participant Survey instrument is included in Appendix 2.
3. Participant/Eligible Nonparticipant Discussion Group Guide
NORC will take the lead in testing the discussion group guide designed for current
FDPIR participants and eligible nonparticipants. The discussion aims to collect
information from eligible FDPIR candidates on how they choose between different food
assistance programs and what they think about the food and related services offered in
FDPIR. For the pretest, 2 individuals (FDPIR participants and/or eligible nonparticipants)
will be selected to pretest the discussion guide in an interview format. The discussion
group pretest respondents will receive an incentive of $25 for their time and cooperation.
Pretest participants will be recruited as part of the process for recruiting for the
Participant Survey pretest. The interviews held to pretest the discussion guide will be
audio-taped (with the consent of the participant) and audio tapes will be destroyed after
the instruments have been revised and approved by OMB.
The contacts with tribes will also pretest their ability to identify nonparticipants as well as
participants and any concerns they may have about including nonparticipants and
participants in the same group. A debriefing will be held to discuss the pretest experience,
followed by a written report covering any suggested improvements and suggestions.

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The discussion group guide is included in Appendix 3.
4. On-Site Interview Guides
On-site interview guides will be pretested either on-site by NORC staff or over the
telephone by UI and SSI staff. This will maximize our flexibility in accommodating
respond schedules in the compressed time frame available for the pretest. On-site
interview guides are semi-structured and will be pretested with two Tribal leaders, two
FDPIR representatives, and two representatives of other programs that work with FDPIR
or serve FDPIR participants, such as IHS, WIC, and TANF (a total of 6 interviews). Pretest respondents may vary at each site depending on staff availability and the organization
of the FDPIR program. Pretest participants will be recruited as part of the process
described above for obtaining agreement from 2-3 non-sampled tribes to participate in the
pretest.
A debriefing will be held to discuss the pretest experience, followed by a written report
covering any suggested improvements and suggestions.
The on-site interview guides are included in Appendix 4.
HUMAN SUBJECTS AND DATA SECURITY ISSUES
This section identifies human subjects and data security issues that pertain to the pretests.
A. Pretest of Case Record Review Procedures and Form
Study populations. The Case Record Form will be will be tested with 5 case records in
each of 2-3 sites. No new data collection will be involved; rather, we will be using the site’s
existing participant case files.
How data will be collected. For the pretest, NORC staff will extract case file data onsite. A NORC researcher trained in the data abstraction procedures will conduct the case record
review. Data abstraction will be conducted manually using a pre-formatted template that has
been installed on a secure NORC laptop computer. NORC staff will conduct the case review in a
secure area of the FDPIR Program’s offices during working hours (typically 8.00 AM to 4.30
PM). It is advisable to have a member of the FDPIR staff available to answer questions (e.g., to
decipher handwriting on a form).
Use of Records Linked to Individuals. There will be no direct or indirect identifiers
linked to the subjects for the case record review. Although there is identifying information in the
case files to be reviewed, this information will not be abstracted, nor will it be linked to the
subjects for the case file reviews. Nor is there any linkage between the participant files reviewed
in the case record review and responses to the participant survey (i.e., they are mutually
exclusive). FDPIR eligibility forms/case records are usually maintained as paper files only. It
would impose a considerable burden on the tribe or Indian Tribal Organization (ITO) to
duplicate the case records and redact names, addresses, etc. in order to obscure this information

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from the researchers abstracting the information. We will not be abstracting any of the following
information that is present on the case record:
Name, phone, mailing address, city, county
Household members (name, birthday, SSN)
Prior application for or receipt of food stamps (SNAP)
Disqualification
Potential Risks. The information extracted from the case files will include sensitive
information, such as household characteristics and composition, and income and employment.
Although the risk is minimal, this information could compromise the privacy and integrity of
FDPIR participants if shared with the wrong party. Our data protection plan explains how we
will address these potential risks.
Informed consent procedures. NORC has received a Waiver/Alteration of Consent for
the Case Record Review from its IRB, as this component of the study meets the criteria as
specified: “Collection of data from records where the investigator will not directly interact with
the participants.” NORC’s request and approval are included in Appendix 5. If UI’s IRB agrees
with this decision, informed consent for the case record review will not be obtained from
individuals but from the Tribal leaders or Tribal Council through a tribal resolution. This
document will serve as a data sharing agreement with NORC to conduct the case record review.
A sample data sharing agreement is included in Appendix 6.
B. Pretest of Participant Survey and Participant Discussion Group Guide
Study populations. The Participant Survey will be will be tested on up to 8 individual
households in 2-3 different FDPIR service areas that have not been selected for the study sample.
The group discussion guide will be tested with 2 heads of Tribal households in FDPIR sites that
are not in the sample.
How data will be collected. For both the survey and discussion guide, data collection
will be conducted by staff from NORC and done in-person. Survey interviews and discussion
guide interviews will be audio-taped contingent upon permission of the subject in order to inform
question wording and probing. Notes will also be taken during the survey with paper and pencil.
The Data Security Plan discusses how such records will be handled. Following on-site data
collection, a debriefing will occur and a report produced of the findings from conducting the test.
Use of Records Linked to Individuals. NORC staff will never record identifying
information on the same forms as any forms containing survey data. Respondents will be
assigned code numbers (e.g., “Participant Pretest 1”) and these will be stored separately from the
respondent contact/identifying information. All recorded information will be stored in locked file
cabinets. Survey data will never be stored in the same place as identifying information. All
pretest surveys, notes, and recordings will be destroyed upon OMB approval of the data
collection plan and instruments.
Potential Risks. Much of the information collected in the Participant Survey and Group
Discussion will involve sensitive information, such as participants’ health and nutrition and
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needs, household characteristics and composition, and income and employment. Although the
risk is minimal, the survey and group discussion guide will contain sensitive information that
could compromise the privacy and integrity of interviewees if shared with the wrong party. Our
data protection plan explains how we will address these potential risks.
Informed consent procedures. Materials for gaining cooperation include an advance
letter, phone script, and brochure. Each household will be mailed an advance letter that will
include a description of the study and contact information for the Urban Institute Principal
Investigator and the NORC Project Director. It will be clearly stated that the household will be
contacted by a NORC interviewer. Also included will be the time commitment required.
Respondents will also have an opportunity to learn about the study at most sites through triballyorganized informational meetings, radio announcements, newspaper articles, word of mouth,
tribal websites, and advance letters for all sites. They will receive additional information and
clarifications from the interviewer or through calls they make to project and/or tribal officials.
With this outreach and advance notice, participants should be expecting a call or visit
from the NORC field interviewer. The main purpose of the first call or visit will be to inform the
respondent about the study, answer any questions they may have, be given time to make an
informed decision, and set up an appointment at a time convenient to the respondent.
Interviewers will also accept refusal during this call or visit. The phone script is integrated into
page 1 of the Participant Survey (Appendix 2). If the respondent agrees, the interview will take
place at the decided time. Any additional questions or concerns may be answered at this time.
The respondent will be read the informed consent statement on page 1 of the instrument and,
after agreeing, the 45 minute interview will begin. Proxies may also be requested for elders and
those who are unable to participate, but wish for someone else to answer for them. In such cases,
respondents will be asked to sign a form (integrated into the informed consent) giving permission
for the proxy to answer the questions of his or her behalf. The proxy permission is provided on
page 3 of Appendix 2.
The gaining of cooperation, informed consent, and interview procedures described above
for the study will be conducted for the pretest. Selection of participants will occur at the
discretion of the tribe, as will disclosure about the pretest. (We do not anticipate use of proxies
for the pretest). The Informed Consent form for the pretest of the Participant Survey also
includes a request for permission to audio-tape.
Specifically, the study’s informed consent procedures will include the following
information:
The purpose of the study, who is conducting it, and how the data will be used;
That participation is voluntary;
That the interview will be recorded;
That respondents can refuse to answer any question and/or quit the survey at any point
without penalty;
That respondents’ privacy will be protected; that the information collected will be
reported without identifying the individual interviewee;
That the identity of all households participating in the study will be kept confidential.
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In addition to these informed consent procedures planned for the evaluation, pretest
participants will be informed that their responses on the pretest will NOT be included in the
evaluation and that the information will be destroyed after the pretest. The research team will not
disclose to FNS, or to any others outside of the research staff indicated above, the individuals, or
tribal or program officials that have been selected for the pretest. Nor will we tell respondents
who else was selected for the pretest or who responded.
C. Pretest of in-person interview guides
Interview population. There will be 6 program-related pretest interviews with tribal area
administrators and officials. The guide, which is organized into topic-specific modules, will be
tested on two Tribal leaders, two FDPIR program directors, and two related-service program
directors in FDPIR program sites that are not part of study sample.
How data will be collected. For the pretest of the interview guide, data collection will be
conducted on-site by staff from NORC and over the telephone by Urban Institute and SSI staff.
Notes will be taken during the interview, but it will not be audio recorded. Following the pretest,
a debriefing will occur and a report produced of the findings from conducting the test.
Use of Records Linked to Individuals. Urban Institute, NORC, and SSI staff will never
record identifying information on the same forms as any forms containing interview data.
Respondents will be assigned code numbers (e.g., “Tribal Interview Pretest 1”) and these will be
stored separately from the respondent contact/identifying information. All recorded information
will be stored in locked file cabinets until it is no longer needed. Interview data will never be
stored in the same place as identifying information and interview data will be destroyed after the
pretest is complete.
Potential Risks. Some of the information collected in the guides will involve sensitive
information, such as perceptions of other federal, state, and local agencies, local populations, and
socioeconomic conditions. While the risk is minimal, these interviews will contain sensitive
information that could compromise the privacy and integrity interviewees if shared with the
wrong party.
Informed consent procedures. Introductory letters will be sent to interviewees prior to
scheduling the interview. See the introductory scripts to the guide in Appendix 3. Specifically,
the study’s informed consent procedures will include the following information:
The purpose of the study, who is conducting it, and how the data will be used;
That participation is voluntary;
That respondents can refuse to answer any question and/or quit the survey at any point
without penalty;
Taping of interviews will be done only with the permission of the respondent and the
respondent can request that the tape recorder be turned off at any time.
That respondents’ privacy will be protected; that the information collected will be
reported without identifying any individual interviewee.
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In addition to these informed consent procedures planned for the evaluation, pretest
participants will be informed that their responses on the pretest will NOT be included in the
evaluation and that the information will be destroyed after the pretest.

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Pre-test
Instrument

1. Case Record
Review

2. Participant
Survey

3. Discussion
group discussion
guide

4. On-site
Interview Guide
for: a) FDPIR
managers and
staff; b) other
service
providers; c)
Tribal leaders

Population
Definition
5 FDPIR case
records in each of
2- 3 FDPIR pretest
sites that are
NOT part of study
sample.
8 Heads of tribal
households
within 2-3 FDPIR
service areas that
are NOT part of
study sample.
2 Heads of tribal
households
within FDPIR
service areas that
are NOT part of
study sample.

2 Tribal Leaders;
2 FDPIR Program
Directors; and 2
Other Program
Directors in FDPIR
program sites
that are NOT part
of study sample.

Recruitment

Consent

Interview
Length

Informed
consent
required of
each pretest
respondent.
Consent
precedes
each pretest. See
Instruments
in Appendix
for exact
language.

Incentive
Payments

Written
notes

NA

45
minutes

Audio tape
and written
notes

$25 cash or
gift card
incentive

1 hour

Audio tape
and written
notes

$25 cash or
gift card
incentive

NA
The method of
contacting and
selecting the
pretest sites will
follow Tribal
research protocols.
We have
established
relationships and
contacts with
many Tribal areas
nationally that
would be good
candidates for pretesting, as well as a
cohort of AI/AN
interviewers
currently on NORC
staff to facilitate
pretesting.

Method of
Recording

1.5 hours

Audio tape
and written
notes

No
incentive

Data Security

All written and
recorded information
collected during the
pre-tests will be
subject to the same
data security
procedures described
in the Data Security
Plan section of the
IRB request. In
addition, information
collected for the
pretest will be
destroyed upon OMB
clearance.

Risk

Much of the information
collected in the Case record,
Participant survey, and
Discussion guide will involve
sensitive information, such as
participants’ health and
nutrition and needs,
household characteristics
and composition, and income
and employment. This survey
will contain sensitive
information that could
compromise the privacy and
integrity of interviewees if
shared with the wrong party.

Some of the information
collected in the guides will
involve sensitive information,
such as perceptions of other
federal, state, and local
agencies, local populations,
and socioeconomic
conditions. This information
could compromise the
privacy and integrity
interviewees if shared with
the wrong party.

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DATA SECURITY PLAN
This section describes how we will store, handle, report, and dispose of the data collected
through the pretest of the case record review form, participant survey, group discussion guide,
and guides for on-site discussions with program administrators and staff.
Data Identifiers. We will not be collecting any additional identifying information from the
pretest respondents. There will be no direct or indirect identifiers linked to the subjects for the
case record review. Also, there is no linkage between the subject files reviewed in the case
record review and responses to the participant survey.
In order to preserve the anonymity of any private persons and entities identified in the surveys or
interviews, unique case numbers will be assigned to Tribal organizations, service organizations,
and respondents, with respondent identification information kept in a separate file. The sensitive
information will be saved in a locked file cabinet in Chris Narducci’s office until the end of the
pretest, at which time all data from the pretest will be destroyed, as described below. NORC will
follow the same procedures for preserving anonymity of respondents and storing sensitive
information.
Data Storage at UI. While the pretest is underway, interview tapes will be uploaded to a
confidential drive on the computer network set up for this purpose and erased from the digital
recorder. Access to the confidential drive will be limited to UI research staff working on the
project who have signed the confidentiality pledge. Hard copies of interview notes will be stored
in a locked file cabinet when not in use. The locked file cabinet will be in Metro and Chris
Narducci, a UI Research Associate will be in possession of the key. Electronic files of interview
notes may also be prepared by researchers by typing notes after interviews. These notes will be
stored on the confidential drive using the assigned identifiers. Hardcopies of any necessary
printouts of sensitive data or electronic media will be kept in locked cabinets in Chris Narducci’s
office. All storage media that hold sensitive data will be marked “CONFIDENTIAL.” Any
printouts of sensitive data that are no longer needed will be shredded. At the end of the pretest,
we will follow the data destruction procedures described below. NORC will follow the same data
storage and destruction procedures.
Data Reporting. There will be no data reporting for the pretest. Reporting is limited to a memo
summarizing the pretest experiences and resulting modifications in data collection instruments
and procedures.
Printing. When confidential data are being printed, the pause feature in printing will be
employed so that the printout does not actually print until the sender is present at the printer to
retrieve the copies.
Destruction of other hardcopy documents and electronic media. At the conclusion of the
pretest, hardcopy documents will be shredded and electronic files, including backups, will be
securely deleted using PGP software.
Staff Confidentiality. All Urban Institute staff, NORC staff, and SSI staff will receive training
on the study’s confidentiality procedures. All of these individuals will sign a confidentiality
pledge agreeing not to divulge any information obtained as part of the data collection activities.
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A copy of the confidentiality pledge is included as Attachment A.
Since staff of other organizations will also be involved in pretest data collection, additional
procedures will be implemented to assure data security in the sharing of information. NORC and
SSI staff will be required to keep their notes and survey documents in a locked file cabinet when
not in use until the summary pretest report is completed. When pretest surveys/interviews are
completed, they will be asked to send all notes to Chris Narducci at the Urban Institute via
FedEx. Electronic copies of notes will be required to be kept secure either on a confidential drive
or a password-protected computer disk. When electronic copies of site reports or any other
material containing site visit information is transmitted to the Urban Institute, a passwordprotected computer disk or CD will be sent to Chris Narducci via FedEx. NORC has its own
institutional IRB and the pretest activities in which NORC staff are involved will require
approval from their IRB as well.
Attachments
A. Confidentiality Pledge

APPENDICES
1.
2.
3.
4.
5.
6.

Case Record Review Form and sample FDPIR case record
Participant Survey
Group Discussion Guide
In-person Interview Guide
NORC’s Request for Waiver/Alteration of Informed Consent and Approval Notice
Sample data sharing agreement

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STAFF CONFIDENTIALITY PLEDGE
Study of Food Distribution Programs on Indian Reservations (FDPIR)
Assurance of Confidentiality

The Urban Institute assures all respondents and participating organizations that the
information they release to this study will be held in the strictest confidence by the contracting
organization, and that no information obtained in the course of this study will be disclosed in
such a way as to identify individuals or organizations. Access to the data in this study is by
consent of the respondents who have been guaranteed confidentiality, except when the intent to
commit a crime or harm themselves is revealed to the researcher. Their right to privacy is
protected under law.
I have carefully read and understand this assurance that pertains to the confidential
nature of all information and records to be handled in this study. I have read a copy of the
Confidential Data at the Urban Institute – Guidelines for Data Security. I understand that I must
comply with all of data security requirements adapted from those Guidelines for this project as
approved by the Urban Institute Institutional Review Board. As an employee of, or consultant
to, the Urban Institute, I understand that I am prohibited from disclosing any such confidential
information that has been obtained under the terms of this contract to anyone other than
authorized contractor staff and, if I am an Urban Institute employee, I agree to follow the
procedures outlined to me during training. I understand that any willful and knowing disclosure
of information released to this study may subject an Urban Institute employee to disciplinary
action, up to and including termination of employment.

______________________
(Print Your Name)

______________________________
(Signature)

_____________________________________
(Date)
_____________________________________
(Witness signature)

______________________________________
(Date)

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APPENDICES

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