UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Study Title: Predictors of Outcomes in MBSR Participants from Teacher Factors (PrOMPT-F) - Student consent
This is a research study about the benefits that people may get from Mindfulness Based Stress Reduction (MBSR) and how teacher factors affect participant outcomes. The study is being led by Fredrick Hecht, MD from the UCSF Osher Center for Integrative Medicine and by Judson Brewer, MD, PhD from the University of Massachusetts Center for Mindfulness (CFM).
Research studies include only people who choose to take part. Please take your time to make your decision about participating, and discuss your decision with your family or friends if you wish. If you have any questions, you may ask the researchers.
You are being asked to participate in this study because you are at least 18 years old and have enrolled in a MBSR class that will be led by a teacher who is participating in this study, and who will be videotaped teaching your mindfulness course as part of this study.
Why is this study being done?
The purpose of this study is to learn about teacher factors that affect MBSR outcomes.
This study is paid for by a grant from the National Institutes of Health: National Center for Complementary and Integrative Health (NCCIH).
How many people will take part in this study?
Overall, about 200 MBSR participants and 19 MBSR teachers will take part in this study.
What will happen if I take part in this research study?
First you will view a video about the study to confirm that you are eligible and interested to participate.
If you agree to participate in this study, the following procedures will occur:
- You will attend the MBSR course as already planned.
- You will complete questionnaires online 3 times: before your MBSR course begins, soon after your MBSR course ends, and two months later. The questionnaires will ask about your reasons for enrolling in MBSR, your health history, stress, mood, emotions, your mindfulness practice and your attendance and experience in the MBSR class. Weekly during the 8-week MBSR class, you will be asked to provide information about the number of minutes you meditated each day, and whether you attended class. We will ask you to provide contact information so that we can reach you by phone, text, mail or email to remind you to complete study questionnaires.
- You may be contacted for a 15-30 minute phone interview to share more in-depth about your MBSR experience.
- Your teacher has agreed to participate in the study and have her/his teaching filmed, so your MBSR class will be video recorded. The video camera will be aimed at your teacher, so your face should not be recorded, but your voice and that of other participants may be recorded.
- Location: Study participation will involve completing questionnaires online. If you prefer, you may schedule an in-person visit at UCSF or UMass CFM to complete the enrollment and questionnaires online. No in-person visits will be required for the study. You will attend the MBSR classes as already planned.
How long will I be in the study?
You will be in the study for approximately 5 months, and will spend a total of about 3 hours completing study assessments.
Can I stop being in the study?
Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away if you wish to stop being in the study.
Also, the study researcher may stop you from taking part in this study at any time if he or she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.
What side effects or risks can I expect from being in the study?
You may feel uncomfortable answering some of the items on the online questionnaires, but you are free to decline to answer any questions you do not wish to answer or stop participating at any time.
Completing questionnaires is the only step involved in participating in this study, so there should not be other risks. If you have more questions about risks, ask one of the researchers.
Are there benefits to taking part in the study?
There will be no direct benefit to you from participating in this study. However, the information that you provide may help health professionals better understand/learn more about factors that influence how much people benefit from MBSR.
What other choices do I have if I do not take part in this study?
You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you. Your MBSR course will be the same whether or not you choose to enroll in this study.
Will information about me be kept private?
We will do our best to make sure that the personal information gathered for this study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.
Organizations that may look at and/or copy your research records for research, quality assurance, and data analysis include:
- The University of California
- National Institutes of Health
Research records will be kept as confidentially as possible. All data collected will be coded with a study number (no names will be used). Questionnaire responses are confidential and will not be shared with people outside the study. Every reasonable effort will be made to keep your records confidential. All paper data forms will be stored in a locked file cabinet only accessible to the study team. All electronic data will be stored on computers with extra steps taken to protect privacy in ways that meet the requirements of the federal Health Insurance Portability and Accountability Act for personal health information. This includes using secure servers with access restricted to a limited number of study staff who must enter password identification to access data.
What are the costs of taking part in this study?
You will not be charged for any of the study procedures.
Will I be paid for taking part in this study?
If you complete the entire study, you be paid $75—$25 for completing each of the three online surveys, i.e. at baseline, after MBSR ends, and two months later. You will be paid by Amazon e-gift card after you complete the online surveys at baseline, 2 months, and 4 months.
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.
Who can answer my questions about the study?
You can talk to the researcher(s) about any questions, concerns, or complaints you have about this study. Contact the researcher(s): At UCSF, Dr. Frederick Hecht at 415-353-9743 or the Dr. Patty Moran at 415-353-9745; At UMass CFM: Dr. Judd Brewer 508-856-1632. You can ask your questions now or later, any time you like.
If you wish to ask questions about the study or your rights as a research participant to someone other than the researchers or if you wish to voice any problems or concerns you may have about the study, please call the UCSF Institutional Review Board at 415-476-1814.
CONSENT
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PARTICIPATION IN RESEARCH IS VOLUNTARY. I have the right to decline to be in this study, or to withdraw from it at any point without penalty or loss of benefits to which I am otherwise entitled.