Developing Tobacco and Nicotine Related Biomarkers
You are being asked to take part in a research study.
Before you agree to take part, someone will explain to you:
- The purpose of the research
- What you will need to do if you choose to take part
- This study is VOLUNTARY - you do not have to participate if you do not want to
- You can agree to take part and change your mind later
- Your decision to participate or not will not be held against you
- You can ask all the questions you want before deciding to participate or not
Why is this study being done?
The purpose of this study is to create a bank of biological samples (saliva, oral cells, urine) from people who use different tobacco and nicotine products. These samples will be used by researchers to identify potential biomarkers (changes in the body) related to tobacco and nicotine exposure. The goal is to find out if some biomarkers are specific to certain types of tobacco or nicotine use, and if certain biomarkers can be used to understand or predict different health conditions that may arise from tobacco or nicotine use.
How long will I be in the study and what will I have to do?
You will be in this study for less than 30 minutes. If you choose to participate you will be asked to do the following things:
- Rinse your mouth with water
- Provide Saliva - spit in a tube (~1 mL)
- Brush your teeth *no eating, drinking, or using tobacco/nicotine products after brushing*
- Take a Carbon Monoxide (CO) breath test
- Fill out Questionnaires (demographics, tobacco/nicotine/alcohol/ use history)
- Provide Saliva - spit into a tube (~3-5 mL)
- Provide Oral Cells - swish a salty solution from cheek to cheek for 30 seconds and spit rinse into a tube
- Provide Buccal Cells - brush inside of each cheek 30 times with soft brush
- **Optional** - Provide urine sample
- Receive $25 cash or gift card for participation
What are the risks and benefits to being in this study?
There are no risks or benefits to being in this study.
What will be done with the data and samples collected?
No identifying information will be collected about you. The information and samples you provide will be coded and provided to researchers to investigate tobacco and nicotine related biomarkers. NO genetic analysis will be done on these samples. If you withdraw from the study, samples and data already collected may not be removed from the study database.
Who can I talk to about this study?
For questions about the research study or other concerns, contact the study team:
| Researchers Name: Stephen Hecht, PhD | Study Staff: Laura Maertens, PhD |
| Phone: (612) 624-7604 | Phone: (612) 626-8654 |
| Email: hecht002@umn.edu | Email: maert006@umn.edu |
This research has been reviewed and approved by an Institutional Review Board (IRB) within the Human Research Protections Program (HRPP). To share feedback privately with the HRPP about your research experience, call the Research Participants' Advocate Line at 612-625-1650 (Toll Free: 1-888-224-8636) or go to z.umn.edu/participants. You are encouraged to contact the HRPP if:
- Your questions, concerns, or complaints are not being answered by the research team
- You cannot reach the research team
- You want to talk to someone besides the research team
- You have questions about your rights as a research participant
- You want to get information or provide input about this research
You will be given a copy of this information to keep for your records.
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