OMB No. 0910-0796
Exp. 06/30/18
Consent to Participate in Focus Group
Qualitative Study on Acute Nicotine Toxicity Warnings for E-Liquids
You are being asked to participate in a research study. Before you decide if you want to take part in this study, you need to read this Informed Consent form so that you understand what the study is about and what you will be asked to do. This form also tells you who can be in the study, the risks and benefits of the study, how we will protect your information, and who you can call if you have questions. Please ask the researcher to explain anything you don’t understand before you make your decision. You will receive a copy of this consent form for your records.
This research study is being conducted by RTI International for the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP). The purpose of today’s focus group is to get opinions and knowledge of e-cigarettes and nicotine exposure. You are one of approximately 144 participants who will take part in this study.
If you agree to participate, you will be asked to participate in a focus group discussion with about 11 other people and answer some questions about labels that might be used on future e-cigarettes and e-cigarette packaging. You will also be asked to fill out a worksheet about these labels. Tonight’s discussion will be audio-recorded but not video-recorded. We will use the tapes to prepare a transcript of each group’s discussion; however, your name will not be associated with your responses in any reports. At the completion of this study, the audio recordings will be destroyed. Additionally, other staff members will be viewing tonight’s discussion in person (behind a one-way mirror) or remotely (via video-streaming).
Your participation in this study will take no longer than 60 minutes.
There are minimal psychological, social, or legal risks to participating in this study. You will be asked to share your attitudes and opinions in a group setting. Tonight’s discussion topics are minimally sensitive in nature because they include tobacco use. Your participation is voluntary, and you can choose not to answer any of the questions. You can also stop being in the focus group at any time without penalty. If the moderator believes that it would be best for you or the rest of the group, they may ask you to leave the group. You will still be compensated. As with all research there is a chance that confidentiality of the information we collect from you could be breached. We will take steps to minimize this risk.
There are no direct benefits to you from participating in this study. Your opinions will help us improve our understanding of how people think about and use tobacco products.
You will receive $40 for your participation. This will be given to you at the end of the focus group session. You have the right to terminate your participation at any point, without penalty. If you must leave or are asked to leave for any reason before the conclusion of the session, you will receive the full incentive amount.
We will create transcripts of tonight’s discussion. To help protect your privacy, only your first name will be used during the group discussion and your identity will never be linked to what you say during the discussion. Any forms for the project that have your name or anything that could identify you will be kept in a locked file cabinet. Except for this consent form, these forms will be destroyed once the focus group ends. Upon completion of the study, we are required to store these transcripts for at least three years. Transcripts will be stored securely on a password-protected computer. Information from this study may be published in professional journals or presented at scientific conferences, but your confidentiality will be respected and no names will be used in any report or presentation.
The Institutional Review Board (IRB) at RTI International has reviewed this research. An IRB is a group of people who are responsible for assuring that the rights of participants in research are protected. The IRB may review the records of your participation in this research to assure that proper procedures were followed.
Your Rights
Your decision to take part in this research study is completely voluntary. You can refuse any part of the study and you can stop participating at any time. You can refuse to answer any question. If you decide to participate and later change your mind, you will not be contacted again or asked for further information.
Your Questions You may ask questions or express concerns about this consent form, the study, your rights as a research subject, or report problems (e.g. any research –related injuries) at any time before, during or after the study. You may contact the research team through the Principal Investigator of the study, Jennifer Alexander of RTI at 301-770-8219. If you have concerns about how you are treated in the study, you may contact RTI’s Office of Research Protection toll-free at 1-866-214-2043.
YOU WILL BE GIVEN A COPY OF THIS CONSENT FORM TO KEEP.
Your signature below indicates that you have read the information provided above, have received answers to any questions you may have, and have freely decided to participate in this research. By agreeing to participate in this research, you are not giving up any of your legal rights.
______________ ___________________________________ _ Date Signature of Participant
____________________________________ __
Printed Name of Participant
Paperwork Reduction Act Statement: 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. The public reporting burden for this information collection has been estimated to average 10 minutes per response to complete the Adult Consent (the time estimated to read, review, and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to [email protected].
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| File Type | application/msword |
| File Title | RESEARCH TRIANGLE INSTITUTE |
| Author | Anh Nguyen Zarndt |
| Last Modified By | SYSTEM |
| File Modified | 2018-01-11 |
| File Created | 2018-01-11 |