SAMPLE INFORMED CONSENT FORM – LIST FORMAT
[Customize information (specific to your study) in italics]
UNIVERSITY OF TENNESSEE AT CHATTANOOGA
[PROTOCOL TITLE: THE EFFECTS OF CRYOTHERAPY ON ANKLE STRENGTH] Please read this consent document carefully before you decide to participate in this study. Purpose of the research study:
The purpose of this study is to [examine the effects of cold therapy on ankle strength].
What you will be asked to do in the study:
Following a brief [5] minute [warm-up on a stationary bicycle], you will be asked to [volunteer to perform several stretching exercises. You will then be asked to sit on a kinetic testing device with your dominant ankle and lower leg securely fastened to the footplate attachment. You will be given a series of warm-up repetitions to familiarize yourself with the appropriate ankle motion to be tested. Following the warm-up you will be asked to perform 3 tests with your dominant ankle only. A total of 4 ankle motions will be tested at two different test speeds (slow and fast). The speed is controlled by the computer in the kinetic testing device. Following the test you will be asked to place your dominant ankle in a whirlpool tub filled with ice and cold water for 10 minutes. At the conclusion of the procedure you will again be tested for ankle strength using the identical procedure described above.] At the conclusion of the test session, you will be asked to [perform a series of stretches].
Time required:
[1 hour]
Risks and Benefits:
The risks of the study are [describe the risks]. The potential benefits of the study include [describe the benefits or We do not anticipate that you will benefit directly by participating in this experiment]. If you are younger than 18 [or have any cold allergies], you will be excluded from the study.
Incentive or Compensation:
There is no extra credit or other incentive for participating; therefore, you will not be adversely affected in any way if you choose not to participate.
Confidentiality:
Your identity will be kept confidential to the extent provided by law. Your information will be assigned a code number. The list connecting your name to this number will be kept in a locked file in the faculty supervisor's office. When the study is completed and
the data have been analyzed, the list will be destroyed. Your name will not be used in any report or publication.
Voluntary participation:
Your participation in this study is completely voluntary. Should you elect to discontinue participation, any information already collected will be discarded. There is no penalty or loss of benefit for choosing not to participate.
Right to withdraw from the study:
You have the right to withdraw from the study at any time without consequence or penalty.
Whom to contact if you have questions about the study:
Dr. Jane Doe (address, telephone number, and email). If this is a student project, include contact information for the student researcher and faculty advisor.
If you have any questions about your rights as a subject/participant in this research, or if you feel you have been placed at risk, you may contact Dr. Amy Doolittle, Chair of the UTC Institutional Review Board at (423) 425-5563. This research protocol has been approved by the UTC Institutional Review Board. Additional contact information is available at www.utc.edu/irb.
Agreement:
If you wish to participate in this study, please sign the form below. A signature will indicate agreement to participate.
Participant’s Name: (Print)
Signature (Date)