Consent Form

O MB Control Number: 0925-0663
Expiration Date: 11/30/2015

Consent for Cognitive Interviewing -
Population Assessment of Tobacco and Health (PATH) Study

You are being asked to take part in a research study conducted by the National Institutes of Health (NIH) in partnership with the Food and Drug Administration (FDA). Both the NIH and the FDA are part of the U.S. Federal Government. This study is to help us test materials to be used in a study about tobacco use and health in the U.S. population. The findings from talking to you will help us evaluate whether the materials are understandable and the questions make sense.

Before we conduct interviews on health and behavior, we review the interview materials with the help of people like you. It is important that the materials are clear and that everyone understands the information the same way. If you agree to take part in this, we will ask you to read and answer a series of questions. Then we will ask you what you were thinking as you read them and how you came up with your answers. Our purpose is not to collect information about you. Instead, we will test the material to be used in a later study.

The interview will last about one hour. When it’s over, you will receive $40 in cash to thank you for your time.

Your participation in this study is voluntary. You may choose not to answer any question, and you can stop this interview at any time.

Researchers from the NIH and FDA may be observing this interview and may hear your comments about the survey questions and materials.

There are no known risks to you for taking part in this interview. All the data we collect will be kept private. Your name will never be linked to your answers to the questions nor will it appear in any written reports or publications. There are also no direct benefits to you for taking part in this interview, but your answers will help us provide useful information that may lead to improved health policies.

With your permission, I will audio-record the interview. The recording allows us to more carefully study how well the questions are working. The recording and all study materials that identify you will be destroyed within three months after this study is completed.

If you have any questions about this study, contact Jocelyn Newsome at 301-212-3734. If you have questions about your rights and welfare as a research participant, please call the Westat Human Subjects Protections office at 1-888-920-7631. Please leave a message with your full name, the name of the research study (PATH Testing) that you are calling about, and a phone number beginning with the area code. Someone will return your call as soon as possible.

I have read the information above and:

• I agree to participate in the interview.

• I agree to have my interview audio-recorded.

Signature: _____________________________________

Print Name: ____________________________________

Date: _______________________________________

Name of Researcher: _________­­­­___________________

Public reporting burden for this collection of information is estimated to average 4 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 (0925-0663). Do not return the completed form to this address.