The University of Arizona Consent to Participate in Research
Study Title: Mobile Application for Guided Imagery to Address Smoking, Diet and Physical Activity (Stage 6) Principal Investigator: Judith Gordon, PhD Sponsor: National Cancer Institute
This is a consent form for research participation. It contains important information about this study and what to expect if you decide to participate. Please consider the information carefully. Feel free to discuss the study with your friends and family and to ask questions before making your decision whether or not to participate.
1. Why is this study being done? The purpose of this study is to develop a mobile phone application (app) for women who are concerned about gaining weight as they quit smoking. The app will use guided imagery for increasing physical activity and assist women in tobacco cessation and healthy eating. Guided imagery is a form of mind-body therapy that involves controlled visualization of specific mental images, and overlaps with mindfulness meditation.
2. How many people will take part in this study? Seventy people will complete all study activities. When seventy people have completed the study, we will close enrollment. All those who have enrolled but have not completed the study will receive an email indicating they are no longer study participants.
3. What will happen if I take part in this study? Should you choose to take part in this study, you will be asked to install and use the application (app) on your Android phone for up to 12 weeks. On the first day of the study, you will be asked to complete a questionnaire on your mobile phone or your personal computer that will ask information about you, such as your history of tobacco use, your diet and exercise practices, and your concerns about gaining weight. Then, you will be asked to use the app for up to 12 weeks. During this time, the app will automatically collect information on your use, and you may be prompted to send the research team information about your tobacco use, diet, and exercise practices via your mobile phone. At the end of the study period, we will ask you to complete a questionnaire that will also collect information on how satisfied you were with using the app.
4. How long will I be in the study? Your active participation in this study will be for a minimum of 2 hours over a period of up to 12 weeks.
5. Can I stop being in the study? Your participation is voluntary. You may refuse to participate in this study. If you decide to take part in the study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your usual benefits. Your decision will not affect your future relationship with The University of Arizona. If you are a student or employee at the University of Arizona, your decision will not affect your grades or employment status.
6. What risks, side effects or discomforts can I expect from being in the study? We do not expect that you will experience any risks, side effects, or discomfort as a result of being in this study.
7. What benefits can I expect from being in the study? The greatest benefit that you can expect from this study is that you may quit smoking. In addition, your contribution to the development of this app may result in helping another smoker quit using tobacco.
8. What other choices do I have if I do not take part in the study? You may choose not to participate without penalty or loss of benefits to which you are otherwise entitled.
9. Will my study-related information be kept confidential? Efforts will be made to keep your study-related information confidential. However, there may be circumstances where this information must be released. For example, personal information regarding your participation in this study may be disclosed if required by state law. Also, your records may be reviewed by the following groups (as applicable to the research): -Office for Human Research Protections or other federal, state, or international regulatory agencies -The University of Arizona Institutional Review Board or Office of Responsible Research Practices -The sponsor supporting the study, their agents or study monitors
10. What are the costs of taking part in this study? Other than your time, there are no additional costs for taking part in this study.
11. Will I be paid for taking part in this study? You will receive $50.00 (a gift card or check) in compensation for participating in this study. By law, payments to subjects may be considered taxable income.
12. What happens if I am injured because I took part in this study? If you suffer an injury from participating in this study, you should seek treatment. The University of Arizona has no funds set aside for the payment of treatment expenses for this study.
13. What are my rights if I take part in this study? If you choose to participate in the study, you may discontinue participation at any time without penalty or loss of benefits. By signing this form, you do not give up any personal legal rights you may have as a participant in this study. You will be provided with any new information that develops during the course of the research that may affect your decision whether or not to continue participation in the study. You may refuse to participate in this study without penalty or loss of benefits to which you are otherwise entitled. An Institutional Review Board responsible for human subjects research at The University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.
14. Who can answer my questions about the study?
For questions, concerns, or complaints about the study you may contact Dr. Judith Gordon 520-626-6452 or firstname.lastname@example.org.
For questions about your rights as a participant in this study or to discuss other study-related concerns or complaints with someone who is not part of the research team, you may contact the Human Subjects Protection Program at 520-626-6721 or online at http://orcr.arizona.edu/hspp.
If you are injured as a result of participating in this study or for questions about a study-related injury, you may contact Dr. Judith Gordon, Principal Investigator, at 520-626-6452 or email@example.com.Signing the consent form
I have read (or someone has read to me) this form, and I am aware that I am being asked to participate in a research study. I have had the opportunity to ask questions and have had them answered to my satisfaction. I voluntarily agree to participate in this study.
I am not giving up any legal rights by signing this form. I will be given a copy of this form.