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Appendix D – Consent Form for Westat Formative Research Study

INTRODUCTION

Thank you for agreeing to help us out today. My name is ________ and I work for (Westat, a survey research company here in Rockville.) Let me tell you what this is about. We are asking women to help us try-out one or more interview sessions from an upcoming study, The National Children’s Study, sponsored by the National Institute of Child Health and Human Development (NICHD). The NICHD has asked (Westat) to try-out a few of their survey instruments and the procedures for the study. The best way for us to do that is to have you and other people complete the survey questions with us. Today, we’re just going to focus on one of the interviews planned for that study. Depending on your situation, you might also be able to participate in a few really short interviews (over the phone/on the computer) in a few months or so.

 

Ultimately, the survey you’re going to try out for us today will be done in people’s homes. A National Children’s Study data collector will knock on people’s doors and ask to complete the interview. All the households in the sample for the National Children’s Study will receive in the mail the same letter and brochure you’ve seen that explains a little bit about the study and letting them know a study representative will visit them to ask them to do this interview. For today, I’d like you to imagine that situation – that we’re in your home and I’ve just asked you to complete the short survey on this computer.

Do you have any questions so far?

Before we get started there are a few other things I should mention.  This is a research project, and your participation is voluntary.  If you prefer not to answer any question, just tell me and I’ll go on to the next one.  It’s also okay if you change your mind after starting and would rather not participate.

 

All your answers, everything you say, will be kept confidential. We will not use your name in any reports. The interview will take about 15 minutes and you will receive $50 as a thank-you for your help.  We will destroy the electronic record of your responses and any identifying information when the project ends.

Your thoughts will help us improve the survey before the sponsor begins collecting any data.  I am not testing you, I am testing the questionnaire. Don’t worry about hurting my feelings if you criticize any of the questions. I didn’t write them--my goal is to work with you to make them better. Does that sound okay? Okay, let’s begin. 

CONSENT FORM

(Westat) is conducting research for the National Institute of Child Health and Human Development. The purpose of this interview is to try-out some survey questions about pregnancy, and trying to conceive. Your opinions are important and will assist in the development of the questionnaire.

• The interview today will be audio taped and the interviewer may take some notes. In addition, project researchers may be observing the interview.

• The interview should take about 15 minutes.

• Your participation is completely voluntary. You may stop at any time, and you do not have to answer any questions you do not wish to answer.

• All information obtained from this study will be treated as confidential and will only be seen by people authorized to work on this project. The report summarizing the findings will not contain any names or identifying information. We will destroy the electronic record of your responses and any other identifying information when the project ends.

• You will receive $50 in cash for completing the session.

If you agree to participate in this interview, please sign the following statement:

I have read this consent form and understand the proposed project.

I consent to participate in this study and to have this interview audio-taped.

Signature Date

Printed Name

Public reporting burden for this collection of information is estimated to average 0.25 hours (15 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. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0590). Do not return the completed form to this address.