EXAMPLE: Parental Consent Form
Belmont University Institutional Review Board
CONSENT TO PARTICIPATE IN RESEARCH
The Effects of Backpack Carrying Method on Gait Kinetics
Parent Consent Form
We invite your child to participate in a research study conducted at the University School of Nashville by Amy Student, George Student, and Casey Student, students in the physical therapy program at Belmont University. Susan Faculty Member is the Belmont University faculty advisor for this study. Your child’s 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 your child may participate.
PURPOSE OF THE STUDY The purpose of this study is to determine if the methods that students use to carry their backpacks make any difference in the way they walk. To participate in this study your child must be in the seventh or eighth grade at the University School of Nashville, have no history of a heart condition, lung condition, known musculoskeletal disorder (problem of the bones, joints, or muscles), and have had no injury within the last three months that could affect their ability to carry a loaded backpack and walk safely.
DURATION AND LOCATION Your child’s participation in this study will last for approximately one hour during one normal school day. Their participation will occur during normal school hours. This study will be conducted at University School of Nashville. No academic classes will be missed for participation in this study
PROCEDURE If you allow your child to participate in this study, we would ask them to do the following things:
1. Be weighed both with and without your backpack.
2. Complete a survey, in which we will ask your child some general questions such as:
“How do you usually carry your backpack?”
Page 1 of 5 EXAMPLE: Parental Consent Form
“Do you ever have any pain from carrying your backpack?”
3. Walk across a mat which contains sensors that record information about how your child walks. They will be asked to walk in four different ways:
a. Walk with no backpack
b. Walk with a backpack worn properly containing 15% of their body weight
c. Walk with a backpack slung low containing 15% of their body weight
d. Walk with a backpack on one shoulder containing 15% of their body weight.
The order in which they will be asked to do these things will be random in for research purposes.
POTENTIAL RISKS AND DISCOMFORTS Risks involved in this study include the possibility of muscle soreness from lifting and carrying the weighted backpack. There is also the possibility of tripping and falling while carrying the weighted backpack. To reduce the likelihood of either soreness or falling, we will only ask your child to carry 15% of their body weight, which is the maximum carrying weight recommended by the American Physical Therapy Association (APTA). Your child will not be asked to carry any more than 30 pounds regardless of their body weight. We will also insure that there is a clear path around the mat to prevent tripping. We will also be asking your child how they feel numerous times through out the procedure. If at any time they feel uncomfortable, they are free to rest or to stop participating in the study.
ANTICIPATED BENEFITS TO SUBJECTS You or your child will receive no direct benefit from their participation in this study, but their participation may help health care providers better understand the effects of different backpack carrying methods on how students walk. This could play a role in developing safety recommendations for backpack carrying methods.
ALTERNATIVES TO PARTICIPATION You have the right to refuse permission for your child to participate in this study. You may also choose to withdraw your child 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),
Page 2 of 5 EXAMPLE: Parental Consent Form
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 child’s identity. If photographs, videos, or audio-tape recordings of your child will be used for educational purposes, their identity will be protected or disguised.
Your child’s 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 Participation in this research is voluntary. If you do not allow your child to participate, that will not affect your relationship with University School of Nashville or with Belmont University. If you allow your child participate, you are free to withdraw your consent and discontinue their participation at any time without prejudice.
WITHDRAWAL OF PARTICIPATION BY THE INVESTIGATOR The investigator may withdraw your child from participating in this research if circumstances arise which warrant doing so. If your child experiences any of the following side effects (back pain or neck pain) or if they become ill during the research, they may have to drop out, even if they would like to continue. The investigator will make the decision and let your child know if it is not possible for them 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
Page 3 of 5 EXAMPLE: Parental Consent Form
In the event of a research related injury or if your child experiences an adverse reaction, please immediately contact Dr. Beverly Schneller, Associate Provost for Academic Affairs, 615 460-5630 and one of the investigators listed below. If you have any questions about the research, please feel free to contact Susan Faculty Member at 460-6713.
RIGHTS OF RESEARCH SUBJECTS You may withdraw your consent at any time and discontinue your child’s participation without penalty. You are not waiving any legal claims, rights or remedies because of your child’s participation in this research study. If you have questions regarding your child’s rights as a research subject, you may contact you may contact Dr. Beverly Schneller, Associate Provost for Academic Affairs, 615 460-5630.
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 PARENT OF RESEARCH SUBJECT 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 Parent Name of Child ______Signature ofParent 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 (same as subject’s)
SIGNATURE OF INVESTIGATOR
Page 4 of 5 EXAMPLE: Parental Consent Form
______Signature of Investigator Date (same as subject's)
Page 5 of 5