Informed Consent

ATTACHMENT 4

Focus Group Consent Form

Form Approved

OMB NO. 0920-XXXX

Exp. Date: xx/xx/xxxx

Focus Group Consent Form

Study Title: Communications Research for the Development of Messages and Materials about Cytomegalovirus (CMV) Infection and Prevention

Sponsor/Project Officer Centers for Disease Control and Prevention (Division of Birth Defects and Developmental Disabilities)

Please read this form carefully. If you decide to take part in this study by participating in this focus group, you must sign the end of this form.

Purpose of the Research Study

You are being asked to take part in this research study by participating in a focus group that will discuss issues surrounding congenital cytomegalovirus (CMV), a virus that can cause birth defects. The purpose of this study is to find the best ways to raise awareness about CMV and prevent the spread of the virus. The Centers for Disease Control and Prevention is sponsoring this study and Westat, a research firm, has been hired by CDC to help with this project. Your participation is voluntary.

Information About This Focus Group

A focus group is a small group of people who meet to answer questions and share their ideas and views about a topic. During this focus group, a person from Westat will ask the group questions and anyone can answer. You will be asked to participate in the focus group by answering the questions as honestly as possible. You may also choose not to answer a question for any reason.

The focus group will last about 1 and ½ hours. The focus group discussion will be audio- and video-taped and notes will be taken to record your responses. To protect your privacy, only first names will be used. About nine people will take part in the focus group and the groups will be observed by researchers from Westat and CDC.

Public reporting burden of this collection of information is estimated to average 15 minutes, 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 CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74,  Atlanta, Georgia 30333; ATTN:  PRA (0920-XXXX)

Confidentiality

Everything you say in the focus group will be kept secure to the extent provided by law. Your first name or other personal facts that would identify you will not be used when we discuss, or write about, this study. Your comments during the focus group will be audio- and video-taped only for use by our research team in developing a report. The audio and video files will be stored securely and only our research team will have access to them. The audio and video files will be destroyed at the end of the study.

Risks of the Study

There are no known risks of harm from taking part in this focus group. You may choose not to answer a question if you do not wish to.

Potential Benefits of Participating in the Study

You may receive no direct benefit from participating in this focus group. The results of this research will help to identify the best ways to raise awareness about CMV and how to prevent it.

Alternative to Participating in the Study

Since this focus group does not benefit you directly, you may choose not to take part.

Your Payment for Being in The Study

You will receive $X for your participation in the focus group. You will be paid at the end of the focus group session.

Getting Answers to Your Questions About the Study

If you have questions about this research, contact the Westat Project Director, Simani Price, at (301) 610-5536.

If you have questions or complaints about your rights as a research participant, contact Sharon Zack at the Westat Institutional Review Board at (301) 610-8828.

Voluntary Participation

Your participation is voluntary and you may withdraw your consent and your participation in this study at any time without penalty or loss of benefits to which you are otherwise entitled.

Statement of Consent

I have read this form and its contents were explained. I agree to be in this research study for the purposes listed above. All of my questions were answered to my satisfaction.

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Signature of Research Participant Date

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Printed Name of Research Participant