Attachment D1 Consumer Informed Consent

ATTACHMENT D1:

INFORMED CONSENT FORM FOR HEALTH CARE CONSUMERS

Informed Consent Form for Health Care Consumers

Health Care Study
Focus Group Consent Form
(Reading Grade Level 7.9 Assessed Using Flesch-Kincaid)

Introduction and Purpose

You have been asked to be in this focus group as part of our research study on preventive health, or what you can do to prevent yourself from growing ill. The purpose of the group is to discuss what you do to take care of your health and your experiences with preventive health care. RTI International, a nonprofit company, is doing this project. The Centers for Disease Control and Prevention (CDC) is the sponsor. Neither company works for or supports the tobacco industry in any way.

Procedures

This research involves a focus group discussion that will last about 2 hours. We will ask you questions about your beliefs about your health and preventive health care, including screening for certain diseases. You may choose not to answer any question for any reason.

We plan to audiotape the session. Only study staff will be able to use the audiotapes. The audiotapes are to make sure the notes that we take are correct. The audiotapes will be destroyed after we write up our notes. Your names will be taken out of the notes.

Risk/Discomforts

We do not expect any risks to you from being in this focus group. However, issues discussed could make you feel uncomfortable. You can stop being in the focus group at any time. It is possible, but unlikely, that you may know someone in the group. We will ask everyone in the group to not talk about who is in the group or what is said in the group, but we cannot be sure that this information will be kept private. Please do not tell anyone about who is in the group or what you talk about today.

Benefits

You will get no direct benefit from being part of this study. But helping to carry out this research will tell us a lot about what people like yourself believe and do to take care of their health. We will use this information to make recommendations for future research and educational materials. These activities and materials could be of future benefit to you or someone you know.

Privacy

We will keep the records in locked files, and only study staff will be allowed to look at them. The information from the focus groups will be combined for analysis. Your name and other facts that might point to you will not appear when we present this study or publish its results. What we talk about will be kept private to the extent allowable by law. To protect your privacy, we will keep the records under a code number rather than by name.

Payment

For participating in the focus group, we will give you $75.

Right to Refuse or Withdraw

It is your choice to join this focus group. You can refuse to talk about any topic. You can leave the group at any time, for any reason, and you will still be paid the $75 for your time and to cover any costs that you may experience as a result of being in the study such as transportation or child care.

People to Contact

If you have questions about the focus group, you can call or e-mail David Driscoll at 1-800-334-8571, extension 6565, driscoll@rti.org. If you have any questions or concerns about your rights as a research participant or feel that you have been harmed, you can call Dr. Wendy Visscher, Director of RTI’s Office of Research Protection, toll-free at 1-866-214-2043. You may also contact CDC’s Acting Deputy Associate Director for Science at 1-800-584-8814 and leave a message with your name, phone number, and refer to CDC protocol # 5119, and someone will call you back.

Your Consent

We have given you a copy of the consent form. When you sign below, it shows that you agree to be part of the study. If there is any part of this form that is not clear to you, be sure to ask questions about it. Do not sign until you get answers to all of your questions.

If you choose to join the focus group, sign your name on the line below.

Participant Signature Date

Print Name

After the focus group, we may have some more questions for you. We may want to speak with you at a later date and time in a one-on-one telephone interview. This interview would last about an hour. It would occur no later than one month after the focus group and would be scheduled at a time that is convenient for you. As a thank you for your time, we would give you an extra $25.

□ I decline.

□ I am interested. (Please sign and print your name and telephone number below if you check this box.)

Participant Signature Date

Print Name

Telephone Number

The best time to reach me at this number: Day Evening Either