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 calfflexibility 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 evaluatedby 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 thatwill test the range of motion, strength, sensation and reflexes in your legs as well as your ability to perform functional and balance activities.
  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, 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.

  • 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.

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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