Parental/Guardian Permission for a Child to Participate in Research
IRB Study #: 05-0018
Consent Form Version Date: March 24, 2023
Title of Project: National Center for Catastrophic Sport Injury Research
Principal Investigator: Kristen Kucera, MSPH, PhD, ATC
UNC-Chapel Hill Department: Exercise and Sport Science
Mailing Address: 209 Fetzer Hall, CB#8700, Chapel Hill, NC 27599
UNC-Chapel Hill Phone Number: 919-843-8357
Email Address: firstname.lastname@example.org
Co-Investigators: Robert C. Cantu, MD; Douglas J. Casa, PhD, ATC; Jonathan Drezner, MD; Johna Register-Mihalik, PhD, ATC
What are some general things you should know about research studies?
You are being asked to participate in a research study and allow your child to take part in the same study. Research studies are designed to obtain new knowledge and this new information may help people in the future. They may or may not benefit your child, and there may also be risks.
It is important for you to know that your family’s participation in this study is voluntary. You may refuse to give consent, or you may withdraw your consent for any reason and at any time.
A copy of this consent form is enclosed for you to keep for your records. You and your child should ask the researchers named above, or staff members who may assist them, any questions you have about this study at any time.
What is the purpose of this study?
The purpose of this research study is to learn about catastrophic deaths, disability, and/or serious sports-related injuries and illnesses among middle school, high school and collegiate athletes, and semi-professional and professional athletes in order to help make sports safer for the participants. You and your child are being asked to participate in this study because we have received information indicating that your child sustained a catastrophic injury during a sporting activity.
How many people will take part in this study?
Approximately 150 athletes sustain a catastrophic sports injury each year. We are inviting athletes, family members, school and, team officials and medical providers to provide information about the nature of the injuries and the circumstances surrounding the injury event.
What will happen if your family takes part in this study?
If you and your child agree to participate, we will:
1) Ask you and/or your child to participate in a 30-45 minute telephone interview consisting of questions about your child’s age, height, weight, playing experience, previous injury experience, the circumstances of the injury event, the type of injuries, and subsequent medical treatment provided. Participation by you and your child is voluntary so if there is a question or questions that you do not want to answer, that is not a problem—just tell the interviewer to go on to the next question. Similarly, your child may skip any question.
2) We will also ask your child’s school staff members (athletic trainers, athletic directors, coaches, and/or other school staff) to participate in a similar interview.
3) For certain injuries we may also ask to interview your child’s personal physician and the medical personnel who treated their injuries. We may request radiological images (x-rays, MRIs, CT scans) and/or other medical information such as medical records about your child’s injury or information regarding treatment provided.
4) We may also request other personal items of scientific relevance to the injury, for example video recordings of the injury, football helmets for head/neck injuries or clothing for exertional heat stroke. These items will be evaluated and archived.
5) We may also contact you again if more information is needed. We will not contact your child without contacting you first.
6) This is an ongoing study that has been active at UNC-CH since 1982-1983. We anticipate that the project will continue indefinitely. All files will be kept and stored securely. Consent can be withdrawn for any reason and at any time, but must be done so in writing to the principal investigator on the top of this form.
What are the possible risks or discomforts involved from being in this study?
Although extremely rare, there are some potential risks involved with this study. There is the possibility that you and/or your child may experience emotional distress when asked questions about the injury. Any problems or concerns should be reported to the researchers, who have been trained to provide assistance to aid in management of emotional distress.
What are the possible benefits involved in being in this project?
There are no direct benefits expected for you or your child from being in this study. However, we hope your contribution will help us learn more about preventing injuries and making sports safer for future athletes.
How will your privacy and that of your child’s be protected?
All information that you and your child tell us will be kept confidential, as will any information obtained from related interviews with school officials or medical personnel, and medical records. For instance, no information from one interview participant will be shared with another. Names of individuals, schools or teams will never be identified in any report or publication about this study. Interview forms and other paper records will be in stored in locked offices and access will be limited to the research team. Electronic data are stored on secure computers. Access is limited to study staff using individual passwords. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information.
Will you or your child receive anything for being in this study?
You or your child will not receive any compensation for taking part in this study.
Will it cost you anything for you or your child to be in this study?
There will be no costs to you or your child for participating in this study.
What if you or your child has questions about this study?
You and your child have the right to ask, and have answered, any questions you may have about this research. If you have questions or concerns, you should contact the researchers listed on the first page of this form.
What if you or your child has questions about your child’s rights as a research participant?
All research on human volunteers is reviewed by a committee that works to protect your child’s rights and welfare. If you or your child has questions or concerns about your child’s rights as a research subject, you may contact (anonymously if you wish) the Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu.
Funding Sources: This research is funded by the National Collegiate Athletic Association (NCAA), National Federation of State High School Associations (NFHS), American Football Coaches Association (AFCA), National Athletic Trainers' Association (NATA), National Operating Committee on Standards for Athletic Equipment (NOCSAE), and American Medical Society for Sports Medicine (AMSSM). This means that the research team is being paid by the sponsors for doing the study. In addition, a family member of Johna Register-Mihalik, a co-investigator on this study, has received money from NOCSAE for work that is not part of this study. These activities may include consulting, service on advisory boards, giving speeches, or writing reports.