PROJECT 3 – FAQs
Why is this study being done?
Drs. Margaret Walsh, Benjamin Chaffee, and others from the University of California San Francisco are conducting a study to better understand:
1. The beliefs and social influences among male high school baseball athletes that determine whether or not they decide to use conventional and new tobacco products
2. The impact of exposure to marketing and anti-tobacco messages on their perceptions of risk and benefits and on their actual exposure to nicotine and cancer causing chemicals in tobacco.
What events led up to this study?
The following 4 events laid the foundation for our study:
1. In 2005, the US Smokeless Tobacco Co. spent $250 million advertising and marketing traditional and new smokeless tobacco products (e.g., compressed tablets, strips, tooth-pick-like sticks, and Snus a form of moist snuff or dip modeled after a Swedish product). They were so successful that in 2006 and 2008, two major US cigarette companies (Reynolds America and Phillip Morris) purchased the US Smokeless Tobacco Co and began aggressively marketing smokeless tobacco products, such as Camel Orbs, Camel Strips, Camel Snus, and Marlboro Snus.
2. Beginning in 2004, several studies were published relating smokeless tobacco to pancreatic cancer.
- The first study, published in the Journal of Cancer Epidemiology, Biomarkers, & Prevention, concluded that adult males who used smokeless tobacco regularly had a 40% increased risk of pancreatic cancer than nonusers of tobacco.
- In 2005, a study published in the International Journal of Cancer also reported that smokeless tobacco use was significantly associated with pancreatic cancer.
- In 2007, a third study published in Lancet, a premier medical research journal, also found that smokeless tobacco users were significantly associated with increased risk of pancreatic cancer than never-users of any tobacco.
- Again in 2008, a study reported that NNAL, a biomarker for NNK a very potent cancer causing chemical, was found in the urine of smokeless tobacco users.
- Another study published in the Journal of Epidemiology Biomarkers, & Prevention in 2008, compared the NNAL concentration in the urine of adult male smokers with the NNAL concentration in the urine of adult male smokeless tobacco. Findings from that study indicated that the concentration of NNAL in the urine of exclusive smokeless tobacco users was significantly higher than the concentration of NNAL in the urine of exclusive smokers.
3. In 2009, Congress gave the FDA the power to regulate tobacco products and the marketing of these products. But when they began to make policy decisions about regulating these new products, they realized that there was not enough evidence about the new and emerging products like e-cigarettes, hookah, and the new smokeless tobacco products.
4. In 2010 the FDA put out a call to all research universities to apply to become a Center of Tobacco Regulatory Science to collect the needed evidence. They funded 12 centers nationally, and UCSF is one of the universities that the FDA funded.This study is being conducted in 40 high schools across the state of California and is funded by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Information from this study will help educators and health professionals better communicate with teenagers about tobacco use. Your son is being asked to participate in this study because he is a baseball student-athlete.
The current UCSF project is one of 5 projects in the UCSF Tobacco Center of Regulatory Science, and it is the only one that is addressing smokeless tobacco and other emerging tobacco products, like e-cigarettes, among high school baseball athletes. We chose high school baseball athletes because our prior work has shown that smokeless tobacco use is higher among high school baseball athletes than the mainstream high school male population.
To be eligible to participate in this study, one must be a member of the high school male baseball team, have parental consent to participate in the study, and must also assent to participate prior to the start of the study.
Is study participation voluntary?
Participation in this study is completely voluntary. If your son decides that he does not want to participate, he can stop at any time. Although research is voluntary, participation requires parental permission if the student is under 18 years of age. If a parent gives permission for the student to participate, but the student athlete does not want to participate, then he does not participate. Also, if he wants to participate, but his parents say no, then he does not participate.
About how many people will take part in this study?
About 800 high school baseball student-athletes will be in this study. On average, about 10-20 students are expected to be enrolled from each high school.
Where does the study take place?
The study researchers will make arrangements with the school and the baseball team to visit the high school to complete the study.
How much time will the study take?
The study takes about 1 hour from start to finish. It will take place on one day, either at the beginning or the end of baseball practice. One year later, all study procedures are repeated to see what has changed over time. That second follow-up visit also takes about 1 hour and takes place on a single day just before or after practice.
What risks are there to individuals who participate in the study?
It may be inconvenient to participate in this study due to the one-hour time it requires to collect our study data. Also, the survey questions ask about tobacco use and may be uncomfortable to answer for some individuals. If your son does not want to answer a question, for any reason, he does not have to answer the question.
What benefits are there to individuals who participate in the 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. However, all student athletes who participate in the study will receive a letter of recommendation from Dr. Walsh attesting to the student’s participation in community service and contributing to science.
What benefits are there to schools or teams who participate in this study?
The University of California will provide each study high school with a check for $150 for its baseball program as a token of appreciation for allowing the researchers to explain the study to student baseball athletes and to pass out parental consent forms at a baseball team meeting at the high school. The University also will provide the baseball program with another $150 for returning parental consent forms from 75% of all team members whether or not the parent granted or refused permission for their son’s participation. Finally, the University will provide the baseball program with another $150 for allowing researchers to return to conduct a 1-year follow-up visit.
Your son’s information collected as part of the study will be handled as confidentially as possible. He will be assigned a code number at the beginning of the study, and this will be used instead of his name on all information collected. The researchers will enter the study information he gives us into a computer without including his name. The researchers will keep all the original information under lock and key. Generally, only research staff will be able to see this information. University of California staff may look at or copy research records to make sure the study is being run correctly. Your family and friends will not know how he answered the questions. His name and the name of his school will never be used in any report or publication resulting from this study.
Our baseball league requires that all teams be 100% tobacco-free. will participating in this study jeopardize our membership in the league?
Participating in this study will not jeopardize your school’s membership in the league, because all information collected as part of the study including the names of schools participating in the study, is kept confidential.
Will parents and coaches know the results of the study?
Once the study is completed, we will prepare a report of our results for all the schools that were part of the study. However, this report will not include the names of any individuals or any schools that participated. No one, including parents, coaches, or school administrators will be given the results for any particular individual. This information is kept confidential. All results will be reported in aggregate. For example, we will report numbers such as the percentage of all student athletes in the entire study who answered that they ever tried tobacco, but we will never report the percentage of athletes who use tobacco at any particular school.
Will my son be paid for participating in this study?
Your son will be given a $10 gift card to Amazon.com for participating in the study at the time of the first visit. He will be given another $10 gift card at the 1 year visit.
Whom do I contact if I have any questions about the study?
You should talk with the study project director Elizabeth Couch (415) 476-9287, or Dr. Margaret Walsh (415) 476-9883, or Dr. Benjamin Chaffee (415) 476-9226 for any questions or concerns about this study.
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.
How will information resulting from this study be shared with the public?
We will publish our findings from the study in scientific journals and we will present our findings at scientific meetings. All findings will be presented in aggregate for all study participants that will contain no personal identifiers for individuals and schools that participated in the study.
What if a participant graduates, and moves from the area before the follow-up visit?
We will contact graduates and students who have moved out of the area via email to have them complete our 1-year follow-up survey online.
What if there are not any tobacco users on our team? Should we still participate?
Yes, we are just as interested in learning about tobacco non-users and their decision-making about whether or not to use tobacco. Most of the participants in our study will be non-users of tobacco.