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Study # 11PS387
Roanoke College
Informed Consent Statement
Prophylactic Bracing: Tracking changes in postural control over time
You are invited to participate in a research study. The general purpose of the study is two-fold. First, it will try to determine if the use of prophylactic ankle braces impair one’s postural control over the period of six weeks. Second, it will determine the length of time necessary for a person to recover fully from any postural impairment incurred during the bracing period
Information
You will be asked to participate in a series of balance testsand to wear an ankle brace during cardiovascular training and workoutsover a period of six weeks. Data collection will take place before you begin wearing the brace, each week during the bracing period and then one to four weeks after you stop wearing the brace.
For data collection, you will be asked to stand on the force platform in a 1)double footed stance; 2)single footed right leg stance; 3)single footed left leg stance; 4)tandem stance with dominant foot forward and 5)tandem stance with non-dominant foot forward. Each stance will be recorded for 20 seconds while you are barefoot. You will be asked to keep your eyes open and closed and to look straight ahead with your hands down at your sides trying to keep as still as possible. You will complete this process 8 – 10 times throughout the entire study. Collection of this data will take place in the Health and Human Performance Lab at Roanoke College.
In addition you will also complete the Balance Error Scoring System (BESS), a field based balance test. Here you will perform the first three conditions stated about on both a firm and foam surface. You will be asked to close your eyes and keep your hands on your hips. Based on a set of rules you will either gain or lose points during each of your 20 second trials. The total number of points gained throughout all six trials will add to be your BESS score.
Time required by you will be about 30min-1 hour for each data collection day. It is also asked of you to wear the ankle brace during any cardiovascular training for 1.5-2 hours a day for six days a week for six weeks.
Approximately 10 subjects are required for the study.
Risks
The only risk associated with the study is a potential slight decrease in postural control over time. It is possible that after you wear the brace for a prolonged period of time that the muscles and ligaments surrounding the ankle joint become dependent on the brace. If this does show to be true, then it is possible that you may experience slight instability in the ankle when not wearing the brace.
Emergency Medical Treatment
In the unlikely event of physical injury resulting from the laboratory testing, first-aid treatment will be provided at no cost to you. A trained first-aid and CPR certified provider will be present and, if needed, emergency personnel will be called upon to respond. Be certain that you immediately notify the researcher if you are injured. If you require additional medical treatment you will be responsible for the cost. No other compensation will be provided if you are injured in this research, and financial responsibility for any injuries that occur during the study will fall directly on the subject. Further, it is required that each participant be covered under a medical insurance policy.
Benefits
It should be understood that the study may not benefit you directly but you may benefit from the information regarding injury prevention revealed from the study
Confidentiality
Your name will be used during the study to help with scheduling and data collection purposes. Following the study, all names and associations with the study will be changed. Each subject will be denoted by a number or letter for confidentiality in reports and computer-based files.
Contacts
If you have questions at any time about the study or the procedures, you may contact the researcher, Jane Doe, atRoanoke CollegeStevens Hall 205, 540-375-0000, and .
If you feel you have not been treated according to the descriptions in this form, or your rights as a participant in research have been violated during the course of this project, you may contact the office for the Institutional Review Board, Roanoke College, Admin 204A, 221 College Lane, Salem, Virginia 24153, 540-375-5249, by e-mail at .
Participation
Your participation in this study is voluntary; you may refuse to participate without penalty. If you decide to participate, you may withdraw from the study at any time without penalty and without loss of benefits,with exception to the personalized exercise program, to which you are otherwise entitled. If you withdraw from the study before data collection is completed your data will be returned to you or destroyed.
Consent
I have read this form and received a copy of it. I have had all my questions answered to my satisfaction. I agree to take part in this study.
Subject's signature______Date______
I agree to allow my child, ______, to take part in this study.
Parent's signature______Date______
Consent form date: 1/04/11
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