1. Study Details and Informed Consent

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Project Title: Knee-Spine Syndrome in Alpine Ski Instructors
Principal Investigator: Michael J. Decker, Ph.D.
DU IRB Protocol #: 689391-2

You are being asked to be in a research study. This form provides you with information about the study. A member of the research team will describe this study to you and answer all of your questions. Please read the information below and ask questions about anything you don’t understand before deciding whether or not to take part.

INVITATION TO PARTICIPATE IN A RESEARCH STUDY
You are invited to participate in a research study investigating the prevalence and development of knee and low back issues in alpine ski instructors.

You are being asked to be in this research study because you are employed as an alpine ski instructor that skis, snowboards or telemarks. The goals of this research are to determine the prevalence and development of knee and low back injuries in alpine ski instructors and investigate the effects of directional compression products and ski equipment on reducing the symptoms and injury risk of these issues.

DESCRIPTION OF SUBJECT INVOLVEMENT
If you agree to be part of the research study, you will be asked to complete 3 electronic questionnaires at the beginning, middle and end of the season requiring a total of approximately 45 minutes of your time. You will also be asked if you would like to participate in an intervention component of this study consisting of a form fitting, directional compression garment or a ski binding.

POSSIBLE RISKS AND DISCOMFORTS
The researchers have taken steps to minimize the risks of this study. Even so, you may still experience some risks related to your participation, even when the researchers are careful to avoid them. The study may include risks that are unknown at this time.

POSSIBLE BENEFITS OF THE STUDY
If you agree to take part in this study, there will be no direct benefit to you. However, information gathered in this study may provide detailed information on the development of knee and low back issues during alpine ski instruction to improve the understanding of injury risk and the effects of an intervention leading to injury risk reduction.

STUDY COMPENSATION
You will not receive any payment for being in the study. You will have the opportunity to purchase a pair of directional compression tights or ski bindings at a reduced price. This purchase is optional and is not required for your continued participation.

CONFIDENTIALITY, STORAGE AND FUTURE USE OF DATA
To keep your information safe, the researchers will keep data on a secured server. The files may be accessed only by authorized personnel on the research team. The researchers will retain the data for 10 years.

The data will be made available to other researchers for other studies following the completion of this research study and will not contain information that could identify you.

The results from the research may be shared at a meeting. The results from the research may be in published articles. Your individual identity will be kept private when information is presented or published.

WHO WILL SEE MY RESEARCH INFORMATION?
Although we will do everything we can to keep your records a secret, confidentiality cannot be guaranteed. Both the records that identify you and the consent form signed by you may be looked at by the Federal agencies that monitor human subject research and the Human Subject Research Committee.

All of these people are required to keep your identity confidential. Otherwise, records that identify you will be available only to people working on the study, unless you give permission for other people to see the records.
VOLUNTARY NATURE OF THE STUDY
Participating in this study is completely voluntary. Even if you decide to withdraw early, the information or data you provided will be destroyed. If there are any new findings during the study that may affect whether you want to continue to take part, you will be told about them.

CONTACT INFORMATION
The researcher carrying out this study is Michael J. Decker, Ph.D. You may ask any questions you have now. If you have questions later, you may call him at 512.788.1953 or call Bradley S. Davidson, Ph.D. at 303.871.2133.

If the researchers cannot be reached, or if you would like to talk to someone other than the researcher(s) about; (1) questions, concerns or complaints regarding this study, (2) research participant rights, (3) research-related injuries, or (4) other human subjects issues, you may contact the Chair of the Institutional Review Board for the Protection of Human Subjects, at 303-871-4015 or by emailing IRBChair@du.edu, or you may contact the Office for Research Compliance by emailing IRBAdmin@du.edu, calling 303-871-4050 or in writing (University of Denver, Office of Research and Sponsored Programs, 2199 S. University Blvd., Denver, CO 80208-2121).

AGREEMENT TO BE IN THIS STUDY
I have read this digital document about the study or it was read to me. I understand the possible risks and benefits of this study. I know that being in this study is voluntary. I choose to be in this study: I will get a copy of this consent form.

Please click the appropriate boxes:

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Is it OK to use your data for future research?

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Would you like a summary of the results of this study to be mailed to you?

If you would like to participate, please click on the appropriate box below and then type your name in the space provided. Clicking on either of the choices below and typing in your name represents your electronic signature and your decision to participate or not to participate in this study.

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Do you agree to participate?

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*Please type your full name.

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*Email Address

*Your name and email address will be replaced with a numeric number to make the information you provide in this third-party software program anonymous. Your information will not be accessible or provided to your employer or professional affiliations. Your email address will only be used by the research team to send emails pertinent to the objectives of this research study. If you do not wish to provide your name and email address please close your web browser and you will not be enrolled in this study.
 
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