EXAMPLE: Informed Consent Form
Belmont University Institutional Review Board
Consent to Participate in Research
Comparison of the effects of Prostretch and runner’s stretch on the extensibility of
the plantar flexor muscles
Adult Consent Form
We invite you to participate in a research study conducted at the University School of
Nashville by Amy Student, George Student, and Casey Students, students in the physical
therapy program at Belmont University. Susan Faculty Member is the Belmont
University faculty advisor for this study. Your participation in this study is voluntary.
You should read the information below, and ask questions about anything you do not
understand before deciding whether or not to participate.

PURPOSE OF THE STUDY
Past research demonstrates that slow, gradual stretching helps increase muscle flexibility and
range of motion at the joint, as well as decrease the risk of injury, fatigue, and muscle soreness.
Calf muscle stretching and mobility is receiving increased attention as it relates to normal
walking and running. The study compares the effectiveness of a new device called the Prostretch
versus a traditional runner’s stretch in increasing calf flexibility and range of motion. Prostretch
is a rocker bottom device that allows you to stretch the ankle muscles by slowly rocking the foot
back and forth (see photo on flyer). Effectiveness will be evaluated by the ability of the ankles to
flex and rotate (dorsiflexion). Evaluation is done with a non-invasive device that looks somewhat
like a slide ruler and measures the degree of rotation and range of motion.

DURATION AND LOCATION
Your participation in this study will last for approximately one hour during one day. This
study will be conducted at Orthopedics Lab in School of Physical Therapy at Belmont
University.

PROCEDURE
If you volunteer to participate in this study, we would ask you to do the following things:
1.
Come to the lab wearing athletic shoes and comfortable clothing.
2.
Read this consent form and ask any questions. Sign the consent form if you desire to
participate.
3.
Complete a health history form.
4.
Undergo a non-invasive screening that will test the range of motion, strength,
sensation and reflexes in your legs as well as your ability to perform functional and
balance activities.
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EXAMPLE: Informed Consent Form
5.
If you are chosen to participate, you will be randomly assigned to one of three activity
groups --Prostretch, runners stretch, and a control group. The investigators who
measure your ankles throughout the study will not see you perform the stretches and
will not know which activity group you are in.
6.
Regardless of your activity group, a researcher will draw two non-permanent lines on
each of your ankles and lower legs that will be used as guidelines to measure ankle
range of motion before and after stretching. Your starting or baseline ankle
dorsiflexion will be measured in both ankles.
7.
You will then be asked to perform two assigned stretches (one on each ankle) without
performing the same stretch twice.
8.
If you are assigned the runners stretch, you will stand facing a wall while placing one
foot behind the other foot with the rear foot flat on the floor keeping the heel in
contact with the floor. You will then lean toward the wall to stretch the calf muscles.
9.
If you are assigned the Prostretch stretch, you will place one foot on the rocker and
the other on the floor and slowly rock the foot on the Prostretch back and forth while
an investigator stands next to you to help prevent you from falling if you lose your
balance.
10.
If you are in the control group, you will perform no stretch.
11.
Your ankle dorsiflexion will be measured in both ankles again.

POTENTIAL RISKS AND DISCOMFORTS
Risks involved in this study include the possibility of muscle soreness and fatigue. If you are
assigned use the Prostretch device, there is a chance of falling off of the device. To minimize this
risk, one of the investigator’s will stand next to you to watch you and support you if you lose
your balance. To reduce the likelihood of muscle injury, please notify anyone of us if you have
pain or discomfort during or after stretching. We will also be asking you how you feel several
times throughout the procedure. If at any time you feel uncomfortable, you are free to rest or to
stop participating in the study.

ANTICIPATED BENEFITS TO SUBJECTS
There are no direct benefits to you but you may gain insight into the benefits of stretching prior
to exercise.

ALTERNATIVES TO PARTICIPATION
All students have the right to choose not to participate in this study. You may also choose to
withdraw at any time from the study.

MEDICAL CARE FOR RESEARCH RELATED INJURY
In the event of an injury resulting from the research procedures, no form of compensation
(i.e., payment) is available from Belmont University. Medical treatment may be provided
at your own expense; or at the expense of your health care insurer (e.g., Medicare,
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EXAMPLE: Informed Consent Form
Medicaid, BC/BS), which may or may not provide coverage. If you have questions, you
should contact your insurer.

CONFIDENTIALITY
When the results of the research are published or discussed in conferences, no
information will be included that would reveal your identity. If photographs, videos, or
audio-tape recordings of you will be used for educational purposes, your identity will be
protected or disguised.
Your information will be kept confidential and secure by locking forms in a file box. All
subjects will be identified by a code number. The list of code numbers with the subject
names will be kept in a separate lock box in a different location. All data entered into
computers will be password protected. This information will be stored for three years and
then destroyed.

PARTICIPATION AND WITHDRAWAL
Your participation in this research is voluntary. If you choose not to participate, that will
not affect your relationship with Belmont University. If you decide to participate, you are
free to withdraw your consent and discontinue participation at any time without
prejudice.

WITHDRAWAL OF PARTICIPATION BY THE INVESTIGATOR
The investigator may withdraw you from participating in this research if circumstances
arise which warrant doing so. If you experience any pain or if you become ill during the
research, you may have to drop out, even if you would like to continue. The investigator
will make the decision and let you know if it is not possible for you to continue. The
decision may be made either to protect your health and safety, or because it is part of the
research plan that people who develop certain conditions may not continue to participate.

NEW FINDINGS
During the course of the study, you will be informed of any significant new findings
(either good or bad), such as changes in the risks or benefits resulting from participation
in the research or new alternatives to participation, that might cause you to change your
mind about continuing in the study. If new information is provided to you, your consent
to continue participating in this study will be re-obtained.

IDENTIFICATION OF INVESTIGATORS
In the event of a research related injury or if you experience an adverse reaction, please
immediately contact one of the investigators listed below. If you have any questions
about the research, please feel free to contact Susan Faculty Member at 460-1234.
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EXAMPLE: Informed Consent Form

RIGHTS OF RESEARCH SUBJECTS
You may withdraw your consent at any time and discontinue participation without
penalty. You are not waiving any legal claims, rights or remedies because of your
participation in this research study. If you have questions regarding your rights as a
research subject, you may contact you may contact Micaela Brown, Compliance
Coordinator, Belmont University IRB, 208 Lila Bunch Library, Belmont University,
37212, 615-460-6960.

OFFER TO ANSWER QUESTIONS
If you have any questions about this study, you may call Amy Student at 615-460-3241.
If a research related injury occurs, you should call Susan Faculty Member at 460-1234.
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EXAMPLE: Informed Consent Form
SIGNATURE OF RESEARCH SUBJECT
[Suggested text]:
I have read the information provided above. I have been given an opportunity to ask
questions and all of my questions have been answered to my satisfaction. I have been
given a copy of this form.
________________________________________
Name of Subject
_______________________________________ ______________
Signature of Subject
Date
Address
SIGNATURE OF WITNESS
My signature as witness certifies that the subject signed this consent form in my presence
as his/her voluntary act and deed.
________________________________________
Name of Witness
_______________________________ _____________________________
Signature of Witness
Date
SIGNATURE OF INVESTIGATOR
________________________
Signature of Investigator
_
_____________________________
Date
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