BB.1_Part Consent

APPENDIX BB.1:
PARTICIPANT SURVEY INFORMED CONSENT—ENGLISH

Informed Consent Information Sheet

Consent to Participate in Research

Title of Research: WIC Nutrition Education Study

Introduction

You are being asked to take part in a research study that is being paid for by the U.S. Department of Agriculture’s Food and Nutrition Service (FNS). The study is being conducted by RTI International. Before you agree to take part in this study, read this paper to understand what the study is about and what you will be asked to do. This paper tells you about being in the study, the risks and benefits, how your information will be protected, and who to call with questions.

Purpose

The purpose of this study is to learn about WIC nutrition education. You are one of about 800 WIC participants who will be asked to take part in this study. By participating, you will help us understand how to improve WIC nutrition education.

Procedures

If you decide to be in this study, you will be asked to fill out three surveys over the next 12 months. Also, at the end of the study period, your WIC State agency or site will provide us with your WIC status and the calendar dates when you visited your WIC clinic over the next 12 months and, if available, whether you received nutrition education during those visits.

Study Duration

If you are in the study, you will be asked to fill out the first survey today. Today’s survey has two sections. You will complete the first part before your WIC appointment, which will take about 10 minutes, and the second part after your WIC appointment, which will take another 10 minutes. We will mail you the second and third surveys over the next 12 months. Each survey will take about 20 minutes to fill out.

Possible Risks or Discomforts

There are almost no psychological, social, or legal risks to taking part in this study. You may refuse to answer any question, and you may quit the study at any time. Your participation in the study will not affect your WIC benefits.

Benefits

There are no direct benefits to you for taking part in this study. The survey answers will help us improve WIC nutrition education, which will help mothers and children in WIC.

Gift for Participation

We will give you a $20 gift card for filling out both parts of the first survey, a $15 gift card for filling out the second survey, and a $15 gift card for filling out the third survey. If you fill out the first survey while at the clinic, you will get your gift card then. If you mail in the survey, you will get your gift card by mail. We will mail you the gift card for filling out the second and third surveys.

Privacy

All of your information and responses will be kept private. We will use a study ID number instead of your name on your study information, and you will not be named in any reports. The Institutional Review Board (IRB) at RTI International and [Name of local IRB if applicable] has reviewed this research. An IRB is a group of people who make sure that the rights of people taking part in a study are protected. The IRB may review records of your study participation to make sure that proper procedures were followed.

Future Contacts

We may contact you in the future to ask you to take part in a paid discussion group.

Your Rights

Whether you take part in this study is completely up to you. You can choose not to answer any questions and can quit the study at any time. If you decide to be in the study and later change your mind, you will not be contacted again or asked for more information. Whether you take part in this study and the information you provide will not affect the services you receive from WIC or any other public assistance programs.

Your Questions

If you have any questions about the study, please call XXX at 1-866-800-XXXX. If you have any questions about your rights as a study participant, please call RTI’s Office of Research Protection at 1-866-214-2043. You may also contact Karen Castellanos-Brown, the Project Officer at FNS, at [email protected] with questions or comments about the study.

OMB Control Number: 0584-XXXX
Expiration date: XX/XX/XXXX

Contact Card Case ID: [FILL]

I have read and understand the risks and benefits of taking part in the WIC Nutrition Education Study. I agree to take part in this study, which includes (1) completing three surveys over the next 12 months and (2) giving WIC permission to provide information on my WIC status and the dates I visited my WIC clinic and, if available, whether I received nutrition education.

YES NO

If “YES,” please sign below and clearly PRINT your contact information below.

Signature: __________________________________________________

Mrs. Ms. Miss Mr. 

First Name: ____________________________ Last Name_________________________________

Mailing Address: ____________________________________________ Apt. Number: _____

City: State: ZIP Code: _____________

Main Phone Number: (______)_____________________ Home Cell Work

Alternate Phone Number: (______)__________________ Home Cell Work

Email address: _____________________________________________________________

Which method(s) could we use to contact you? Email Mail

Name and phone number for friend or family member if your contact information changes: _________________________ _________________________ _______________________

Name Phone No. Relationship

Would you like to get the surveys in English or Spanish? English Spanish

To be completed by Research Study Staff:

Target respondent: Pregnant Postpartum Child

Target child’s First Name: _________________________________

Stopping point before WIC appointment: Screener Contact Card Survey Partial/Question No.____

Section 1 Completed

To be completed by WIC Site:

If Pregnant or Postpartum Survey: WIC ID number for mother: _________________________

If Child Survey: WIC ID number for child named above or infant if postpartum mother is not on WIC: ____________

Certified/recertified for WIC? YES NO

Thank you for taking part in our study.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0584-XXXX. The time required to complete this information collection is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

BB.1-1