APPENDIX B Informed Consent

University of North Carolina-Chapel Hill Consent to Participate in a Research Study Adult Participants

Social Behavioral Form

________________________________________________________________________ IRB Study # 07-1935__________________

Consent Form Version Date: _01/17/08_________

Title of Study: An Analysis of a Dual-Task Paradigm for the Assessment of Sports-Related Concussion

Principal Investigator: Luke Ross, ATC

UNC-Chapel Hill Department: Exercise and Sport Science UNC-Chapel Hill Phone number: 962-1787

Email Address: [email protected]

Faculty Advisor: Kevin M. Guskiewicz, PhD, ATC Funding Source: N/A

Study Contact telephone number: (773) 844-1247 Study Contact email: [email protected]

_________________________________________________________________ What are some general things you should know about research studies?

You are being asked to take part in a research study. To join the study is voluntary.

You may refuse to join, or you may withdraw your consent to be in the study, for any reason, without penalty.

Research studies are designed to obtain new knowledge. This new information may help people in the future. You may not receive any direct benefit from being in the research study. There also may be risks to being in research studies.

Details about this study are discussed below. It is important that you understand this information so that you can make an informed choice about being in this research study. You will be given a copy of this consent form. You 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 the effects of a doing more than one thing at a time on reaction time and balance in healthy subjects. This study will examine the

feasibility of the use of the above mentioned task in the assessment of concussion in order to more accurately reproduce the demands of sport. Also, this study will examine if doing more

How many people will take part in this study?

If you are in the healthy group and decide to be in this study, you will be one of approximately 30 people in this research study.

If you are in the injured group, you will be one of approximately 15 subjects in this research study.

How long will your part in this study last?

If you are in the healthy group, you will be asked to complete two 45 minute test sessions. The first test session will occur after your recruitment into the study and the second session will occur exactly 14 days following the first. At the completion of the second 45 minute session, your involvement in the study will be complete.

If you are in the injured group, you will be asked to complete one 45 minute test session when you are no longer experiencing the symptoms of concussion and have returned to “normal performance” on the standard measures we use to assess concussion. These measures include a graded symptom checklist, the Automated Neuropsychological Assessment Metrics, and the Sensory Organization Test.

What will happen if you take part in the study?

If you are in the healthy group, you will complete two 45 minute test sessions occurring exactly 14 days apart. Testing will include the Procedural Reaction Time (PRT) module of the Automated Neuropsychological Assessment Metrics (ANAM) which will assess your reaction time and take approximately 5 minutes. The Sensory Organization Test (SOT)- Neurocom® International Inc.which will assess your balance will take approximately 20 minutes. The Balance Error Scoring System (BESS) which will also assess balance will take approximately 20 minutes. A dual-task assessment will also be completed. This assessment will involve you completing the reaction time task in combination with each of the

previously described balance tasks.

If you are in the injured group, you will be asked to complete one 45 minute test session when you are no longer experiencing the symptoms of concussion and have returned to “normal performance” on the standard measures we use to assess concussion. The test protocol for that session will be identical to that described above for the healthy group. What are the possible benefits from being in this study?

You will receive no direct benefits from taking part in this study.

What are the possible risks or discomforts involved from being in this study? There may be a risk of falling during balance testing as well as other uncommon or previously unknown risk. There will be a spotter present during your balance testing to ensure that you do not fall, as well as the researcher being present during the rest of the test session to ensure your safety in case complications arise. If you feel uncomfortable, please let the researcher know and your testing can be terminated.

How will your privacy be protected?

Measures will be taken to ensure the privacy of each participant is protected. All electronic data will be stored on an external hard drive which will require a specific user name and password to access. This external hard drive will be kept in a secure cabinet under lock and key. All copies of hard data files will be stored in locked file cabinets. Personal names will not be stored on the electronic data files. A unique master ID number will be used to link data records to individuals. Only members of the research team will have access to the list of master ID’s and names. This master list will be stored in a locked cabinet separate from the data files. This information will be destroyed upon completion of the study. Additionally, names of participants will not appear on reports or publications. Participants will not be identified in any report or publication about this study. 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. In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies for purposes such as quality control or safety.

Video recordings of the dual-task BESS will be stored in a locked filing cabinet in the Sports Medicine Research Lab for the duration of the study. Although your face will be visible, the file names for the videos will be de-identified and only two members of the research team will have access to these videos. The videos will be erased and destroyed following completion of the study.

What will happen if you are injured by this research?

All research involves a chance that something bad might happen to you. This may include the risk of personal injury. In spite of all safety measures, as mentioned there may be a risk of falling during balance testing as well as other uncommon or previously unknown risk. This risk may occur as balance testing involves moving surfaces and uncommon body positioning. There will be a spotter present during your balance testing to ensure that you do not fall, as well as the researcher being present during the rest of the test session to ensure your safety in case complications arise. If such problems occur, the researchers will help you get medical care, but any costs for the medical care will be billed to you and/or your insurance company. The University of North Carolina at Chapel Hill has not set aside funds to pay you for any such reactions or injuries, or for the related medical care. However, by signing this form, you do not give up any of your legal rights.

Will you receive anything for being in this study? You will not receive anything for taking part in this study. Will it cost you anything to be in this study?

offered or receive any special consideration if you take part in this research.

If you are in the injured group, the information obtained in this study will not influence your participation in your sport. Return to play decisions will continue to be made by your team physician and will not be influenced by the information gathered in this study.

What if you have questions about this study?

You 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 have questions about your rights as a research participant?

All research on human volunteers is reviewed by a committee that works to protect your rights and welfare. If you have questions or concerns about your rights as a research subject you may contact, anonymously if you wish, the Institutional Review Board at 919-966-3113 or by email to [email protected].

- - - Participant’s Agreement:

I have read the information provided above. I have asked all the questions I have at this time. I voluntarily agree to participate in this research study.

_________________________________________ _________________

Signature of Research Participant Date

_________________________________________ Printed Name of Research Participant

_________________________________________ _________________

Signature of Person Obtaining Consent Date

_________________________________________ Printed Name of Person Obtaining Consent

APPENDIX C