IRB Approval for INN Impact Evaluation

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RESEARCH TRIANGLE INSTITUTE
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS
Request for Exemption from IRB Review
To request approval for exemption from Institutional Review Board (IRB) review, the Project Manager (includes Project Director or
Leader, Principal Investigator, or Survey Manager) must complete this form and deliver the request to the an IRB Administrator. The
Project Manager will be notified if more information is necessary and the results of the determination.

Date: 08/28/10
RTI Project No.: 0212343.001.005
Project Title: Models of SNAP-Ed and Evaluation, Wave II (Iowa Nutrition Network)
Project Manager: Sheryl C. Cates
Sponsor: U.S. Department of Agriculture’s Food and Nutrition Service
Date Participation of Human Subjects Scheduled to Begin: 09/01/11
A. Brief Description of Study Procedures and Participant Population: RTI has been contracted by the U.S.
Department of Agriculture’s Food and Nutrition Service (USDA, FNS) to conduct an impact evaluation of the BASICS
and Pick-A-Better-Snack nutrition education interventions, which are being conducted by the Iowa Nutrition Network
(INN). The Iowa Nutrition Network is a partnership of the Iowa Department of Public Health, private organizations, and
communities dedicated to promoting healthy lifestyles among all Iowans, Both interventions aim to increase third grade
students’ intakes of fruit and vegetables by using family newsletters, family events, take home materials, and a social
media campaign. The purpose of the impact evaluation is to measure any changes in parents’ knowledge, attitudes, and
behavior regarding nutrition.
The study population for the RTI impact evaluation includes parents of third grade students enrolled in 11 schools located
in each of 3 Iowa school districts: Council Bluff/Waterloo, Des Moines, and Davenport. The latter will be assigned to
the control group. Concurrent with RTI’s impact evaluation, INN is conducting classroom surveys of students on their

knowledge, attitudes, and behavior regarding nutrition. We are working with INN to obtain parental consent for
their participation in the parent survey and their child’s participation in the student survey. There is one consent
form in which parents consent to their and their child’s participation in the study. Parents are informed that RTI
and INN plan to combine the data from the parent and student surveys when conducting analyses. RTI will
assign a unique identifier to the parent surveys and the same unique identifier will be used by INN for the
student surveys allowing us to match the data. When the student surveys are administered in the classroom by
INN, student consent will be obtained. RTI is not involved in conducting the student surveys.
We will work with INN and the schools to coordinate the data collection for the parent survey. INN will make the initial
contact with schools to encourage participation and RTI field interviewers will contact school principals and teachers as
appropriate to discuss study procedures and get buy-in. Further, we will offer the school a cash incentive of $250 to assist
with the study. We will ask teachers to send home with their students an invitation for parents to participate in the study
(see appendix A for study communications) and the pre-survey (see Appendix B for survey instruments). On the
informed consent/contact card, parents/caregivers will be asked to indicate whether they are willing to participate in the
study and consent to their child participating, and, if so, provide their contact information and return the card to the
school. Parents agreeing to participate will be asked to complete the survey and return the survey to RTI in the postagepaid enveloped provided. Whether or not they agree to participate in the study, parents/caregivers will be instructed to
return the consent/contact card in the provided envelope to their children’s teachers. Teachers will be asked to track the
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sealed envelopes and distribute a token incentive worth $1.00 (e.g., friendship bracelet, pencil) to the children who return
an envelope. To acknowledge their assistance, we will provide classroom teachers a cash incentive (up to $25) based on
the percentage of students who return an envelope, not the number of parents/caregivers who enroll in the study. Site
coordinators assigned by the school principals will be asked to collect the sealed envelopes for pick up by a RTI field
interviewer on a daily basis and will receive $50 for their assistance. RTI field interviewers will enter cooperating
parents/caregivers’ contact information into an electronic template, encrypt the data, and email it to RTI on a nightly
basis. Field interviewers will ship the hardcopy forms to RTI’s main office via FedEx on a weekly basis. The contact
cards will be shredded at the end of the study.
The pre-survey collects information on intake of fruit, vegetables, and milk and demographic information. Completed
surveys will be entered into an electronic database at RTI. Within 5 days, we will send a postcard to remind participants
to complete the survey. Within one week, we will make a minimum of 10 call attempts to nonrespondents to see if they
would prefer to complete the survey over the phone. The telephone surveys will be CATI and conducted by RTI
interviewers. The pre-survey will take 12 minutes to complete, and respondents will receive $10 for completing the presurvey. We will follow a similar approach for conducting the post-surveys, except that we will mail a pre-notification
letter to all participants the last week of the intervention and a second mail survey to nonrespondents one week after the
reminder/ thank-you postcards are sent. Telephone contact of nonrespondents will begin a week after the second mailing
with a minimum of 10 call attempts made to each working phone number. The post-survey will also collect the same
information as the pre-survey, plus information on intervention dosage (e.g., receipt of program take-home materials) and
program satisfaction from participants in the intervention group. The post-survey will take 16 minutes to complete, and
participants will receive $15 for completing the post-survey.

B. Description of Physical, Psychological, Social or Legal Risks to Participants: There are minimal psychological,
social, or legal risks to participating in the study. It is possible that participants’ answers to survey questions may be seen
by household members if they do not take precautions to keep their answers confidential when completing the survey;
however, we are not collecting information that is sensitive in nature. Participation in the study is completely voluntary,
and individuals can stop participating at any time and receive payment for the parts of the study completed to date.
Each participant will be assigned a unique ID number (corresponding to the parent and their child) after their contact
information is received. We will develop and maintain a link file with the participants’ ID number, names, and contact
information. Once this information is entered into the file, we will shred all hardcopies. Participants’ answers to survey
questions will be stored separately so that their names and contact information will not be stored with their survey
responses. At the end of the study, we will destroy the electronic copy of participants’ contact information. No participant
names or identifying information will be used in any reports.
C1. For educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview research with adults:
1. Is information recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the
subjects?
x Yes

No

NA

If yes, explain:

Each participating parent/child will be assigned a unique ID number. We will develop and maintain a link file
with the participants’ ID numbers, names, and contact information. Participants’ answers to survey questions will
be stored separately from identifying information.
2. Would any disclosure of the human subjects’ responses outside the research reasonably place the subjects at risk of criminal
or civil liability or be damaging to the subjects’ financial standing employability or reputation?
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Yes

x No

NA

C2. For research with existing data, documents, records, pathological or diagnostic specimens:
1. Are the sources of the data publicly available?
Yes

No

x NA

If no, explain:
2. Is information recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the
subjects?
Yes

D.

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No

x NA

If yes, explain:
Describe other categories of exempt research1 here:

Note: Categories C1 and C2 above are the most common types of research conducted at RTI that may be exempt from IRB review.
For a complete list of exemption criteria, please see below.

-------------------------------------------------------Space below this line for IRB use only.-------------------------------------------------------

Decision of IRB Coordinator or Chair
Name of IRB Coordinator or Chair making exemption determination: David Borasky
Please check appropriate answer(s):
I agree that this study is exempt [45CFR46.101(b)] from IRB review based upon the information provided by the Project Manager
above. (Check applicable category below.)
__(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and
special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
management methods.
_X(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of
public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the
subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be
damaging to the subjects' financial standing, employability, or reputation.
__(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of
public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for
public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout
the research and thereafter.
__(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are
publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to
the subjects.
__5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study,
evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible
changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
__(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that
contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to
be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S.
Department of Agriculture.

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10-04-2010
Date

Signature of IRB Coordinator or Chair named above
Version 11-30-00

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