University of North Carolina at Chapel Hill
Information about a Research Study
Adult Participants
Consent Form Version Date: September 2015
IRB Study # 06-0469
Title of Study: Measuring Outcomes of Mindfulness-based Stress and Pain Management
Program
Principal Investigator: Susan Gaylord
Principal Investigator Department: Physical Medicine And Rehabilitation
Principal Investigator Phone number: (919) 966-8586
Principal Investigator Email Address: gaylords@med.unc.edu
_________________________________________________________________
What are some general things you should know about research studies?
You are being asked to take part in a research study. To join the study is voluntary.
You may refuse to join, or you may withdraw your consent to be in the study, for any reason,
without penalty.
Research studies are designed to obtain new knowledge. This new information may help people
in the future. You may not receive any direct benefit from being in the research study. There
also may be risks to being in research studies.
Details about this study are discussed below. It is important that you understand this information
so that you can make an informed choice about being in this research study.
You will be given a copy of this consent form. You should ask the researchers named above, or
staff members who may assist them, any questions you have about this study at any time.
What is the purpose of this study?
We want to better understand how the UNC Mindfulness-based Stress and Pain Management
(MSPM) Program can help people deal with life’s challenges. We will use to learn more about
how MSPM helps people. This study is being conducted to prepare for a larger study that will be
conducted in the future.
You are being asked to be in the study because you signed up for the MSPM program.
How many people will take part in this study?
There will be approximately 725 people in this research study.
How long will your part in this study last?
The pre- and post-program questionnaires will take 30 minutes to fill out. We will ask you to fill
them out once at the beginning of the program and once at the end. You will be sent a link to
complete the questionnaires online using a secure website. If you prefer, paper copies can be
provided to you. You will also be asked to complete online questionnaires every other week.
These questionnaires will be sent to you at weeks 2, 4, and 6 of the program, and will take
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between 10 and 15 minutes to fill out. You can stop participating at any time you wish.
What will happen if you take part in the study?
After the orientation session, you will fill out the questionnaires. Then, in the week following
your first mindfulness class and for every two weeks thereafter (weeks 2, 4, and 6) on a day that
will be designated to you by your mindfulness instructor, you will practice a 15-minute session
of mindful breathing and then immediately afterward log in to a secure, online system. You will
fill out several questionnaires online, asking about your experience in meditation that day, as
well as your thoughts and feelings over the past week. It will take approximately 10 to 15
minutes to complete the questionnaires online for each session. After the end of the last class,
you will be given a link to the follow-up questionnaires or paper copies of the questionnaires to
complete. You do not have to answer any questions that you do not wish to answer, for any
reason.
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. Your participation is
important, and will increase science’s understanding of the interrelationships between
mindfulness, stress, and coping styles. A secondary gain of the research is the potential for
improvements in the UNC MSPM Program, based on the information obtained. You may not
benefit personally from being in this research study. However, at the end of the study, you will
have the option of receiving personalized feedback about how your scores may have changed as
a result of the MSPM program.
What are the possible risks or discomforts involved from being in this study?
We do not think you will experience any discomfort or risk from your participation. Because
some of the items in the questionnaires ask about emotional distress, you may find some of the
questions mildly disturbing. Please remember that your participation is voluntary and you can
choose to skip any questions.
There may be uncommon or previously unknown risks. You should report any problems to the
researcher.
What if we learn about new findings or information during the study?
You will be given any new information gained during the course of the study that might affect
your willingness to continue your participation.
How will your privacy be protected? When you choose to participate in the study, we will
keep your filled-out questionnaires strictly confidential. We will not include any identifying
information on the questionnaire itself but will assign a subject number to each set of
questionnaires that we can use later to identify you. The research staff will keep a listing
assigning a subject number to each of you who have agreed to participate in the study on a
secured, password-protected School of Medicine computer. All the rest of the questionnaire data
will be kept in a locked office in a locked data cabinet or in another location on the server. The
only identifier on the survey data will be the subject number. After the study is complete, we
will destroy the data file containing the subject number identifier.
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Participants will not be identified in any report or publication about this study. Although every
effort will be made to keep research records private, there may be times when federal or state law
requires the disclosure of such records, including personal information. This is very unlikely,
but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect
the privacy of personal information. In some cases, your information in this research study could
be reviewed by representatives of the University, research sponsors, or government agencies for
purposes such as quality control or safety.
What if you want to stop before your part in the study is complete?
You can withdraw from this study at any time, without penalty. The investigators also have the
right to stop your participation at any time. This could be because you have had an unexpected
reaction, or have failed to follow instructions, or because the entire study has been stopped.
Will you receive anything for being in this study?
You will receive a $25 gift card for taking part in this study to compensate you for your
time. You will have the opportunity to review your scores with our research staff.
Will it cost you anything to be in this study?
It will not cost you anything to be in this study.
What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research. If
you have questions about the study (including payments), complaints, concerns, or if a researchrelated injury occurs, you should contact the researchers listed on the first page of this form.
What if you have questions about your rights as a research participant?
All research on human volunteers is reviewed by a committee that works to protect your rights
and welfare. If you have questions or concerns about your rights as a research subject, or if you
would like to obtain information or offer input, you may contact the Institutional Review Board
at 919-966-3113 or by email to IRB_subjects@unc.edu.
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University of North Carolina at Chapel Hill
Information about a Research Study
Adult Participants
Consent Form Version Date: September 2015
IRB Study # 06-0469
Title of Study: Measuring Outcomes of Mindfulness-based Stress and Pain Management
Program
Principal Investigator: Susan Gaylord
Principal Investigator Department: Physical Medicine And Rehabilitation
Principal Investigator Phone number: (919) 966-8586
Principal Investigator Email Address: gaylords@med.unc.edu
_________________________________________________________________
Participant’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I
voluntarily agree to participate in this research study.
______________________________________________________ ____________________
Signature of Research Participant
Date
______________________________________________________
Printed Name of Research Participant
______________________________________________________ ____________________
Signature of Research Team Member Obtaining Consent
Date
______________________________________________________
Printed Name of Research Team Member Obtaining Consent
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