WHAT WILL HAPPEN IF YOUR SON TAKES PART IN THIS STUDY?
If you agree to allow your son to be in this study, and if he also agrees, the following will occur:
On the first day of the study, the coach will call a meeting of baseball team members in a high school classroom and your son will meet the people working on the project and learn about the project. He will fill out a survey that asks about his personal views and experiences with different tobacco products, including cigarettes, chew, snus, cigars, and e-cigarettes. The survey also will ask if your son has seen various advertisements either promoting or discouraging use of each of these tobacco products. Your son also will be asked to provide the name, phone number, and e-mail address of someone who would know how to contact him one year later for follow-up if we have trouble contacting him. These events will take place in a classroom at his school and should take a total of about 30 minutes.
At the time your son completes the survey, the study also will collect about 3 milliliters (less than 1 teaspoon) of saliva (spit) and about 30ml (about 6 teaspoons or 1 ounce) of urine from your son to analyze for nicotine fragments and carcinogens (cancer causing components in tobacco).
Your son will have the privacy of a bathroom stall to collect the urine sample. Samples will be labeled with bar codes of the study code number – your son’s name will not appear on the samples. The samples will not be used to test for recreational drugs or performance enhancing drugs. Only components of tobacco such as nicotine and cancer causing elements will be tested. It may take up to 30 minutes to collect saliva and urine from your son.
One year later, the baseball coach will call another team meeting in a high school classroom in which study athletes will complete another survey and provide saliva and urine samples under research staff supervision. The saliva and urine will be collected the same way as the first time. If your son is absent that day, or no longer attends the study high school, then he will be called to complete the survey over the phone, or online using a secure computer. Also at that time, the researcher will arrange collection of saliva and urine in person (collected the same way as the first time), or by mail for which the study would provide containers for mailing and cost of mailing. No more than 3 attempts will be made to contact your son to fill out the survey and to collect saliva and urine samples. The survey should take about 30 minutes for him to complete and will ask him about his personal views and experiences with different tobacco products, including cigarettes, chew, snus, cigars, and e-cigarettes. It also will ask him if he has seen various advertisements either promoting or discouraging use of each of these tobacco products. The saliva and urine collection could take about 30 minutes.
Each of the 2 surveys should take about 30 minutes to complete and each of the 2 saliva and urine collections should take about 30 minutes, for a total of 2 hours for the entire study.
Your son can stop being in the study at any time.
ARE THERE ANY RISKS OR DISCOMFORTS TO PARTICIPANTS?
It may be inconvenient to participate in this study due to the time it requires to fill out the surveys. Also, some of the questions may be uncomfortable to answer. If your son does not want to answer a question, for any reason, he does not have to.
ARE THERE ANY BENEFITS TO PARTICIPATING IN THIS STUDY?
There is no direct benefit to study participants. This study will be used to inform researchers and people interested in developing programs for teenagers on some of the reasons teenagers use tobacco.
WHAT ABOUT CONFIDENTIALITY?
Participation in the research may result in a loss of privacy. In this study, your son will be asked about tobacco and alcohol use. The researchers will keep information about your son as confidential as possible, but complete confidentiality cannot be guaranteed. On rare occasions, research records have been subpoenaed by court. However, your son’s survey answers will be handled as confidentially as possible. He will be assigned a code number at the beginning of the study. That study code will be used instead of his name on all research surveys and forms. Samples will be labeled with bar codes of the study code number – your son’s name will not appear on the samples. The researchers will enter the study information that he gives into a computer without his name on them. The researchers will keep all the original information under lock and key. Generally, only research staff will be able to see this information. The University of California staff may look at or copy research records to make sure the study is being run correctly. His family and friends will not know how he answered the questions. His name will not be used in any report or publication resulting from this study.
ARE THERE ANY COSTS TO PARTICIPANTS?
No. You will not be charged for participating in this study.
WILL HE BE PAID FOR PARTICIPATING IN THIS STUDY?
Your son will be given a $10 gift card for completing the survey, saliva and urine collection at the first visit. He will be given another $10 gift card for completing the survey, saliva and urine collection at the 1 year visit. He will receive these payments either in a gift card or deposited into an Amazon account, depending on what he prefers.
WHO DO WE CONTACT IF WE HAVE ANY QUESTIONS?
You should talk with the study project director or Dr. Margaret Walsh (415-476-9883) about this study and have all your questions answered.
If you have any comments or concerns about participation in this project, you should first talk with the research staff. If for some reason you do not wish to do this, you may contact the Committee on Human Research, which is concerned with the protection of volunteers in research projects. You may reach the committee office between 8:00 a.m. and 5:00 p.m. Monday through Friday by calling (415) 476-1814, or by writing: Committee on Human Research, Box 0962, University of California, San Francisco, San Francisco, CA 94143.
WHAT ARE YOUR CHOICES?
If you agree to allow your son to participate in this study, and if your son agrees, then he can be in this study. But, participation is completely voluntary.
If you decide to allow your son to be in the study now and you change your mind later, that’s okay too. You or your son will just have to tell the study staff as soon as you change your mind, and your son will be taken out of the study.