Statement on Conflict of Interest - University of Mary ...



UNIVERSITY OF MARY HARDIN-BAYLORSchool of Exercise & Sport ScienceTitle of Investigation: Body Composition Characteristics and Knee Injury Prevalence of NCAA Division III Sports AthletesPrincipal Investigator:Lem Taylor, PhD, FACSM, FISSNProfessor and Director of Human Performance Lab, School of Exercise & Sport Science, University of Mary Hardin-BaylorStudy Coordinators:Stacie Urbina, MSedAssistant Director of Human Performance Lab, University of Mary Hardin-BaylorCo-investigators:Colin Wilborn, PhD, FNSCA, FISSN, CSCS*DExecutive Dean, Mayborn College of Health Sciences, Professor, Physical Therapy, University of Mary Hardin-BaylorAbbie E. Smith-Ryan, PhD, CSCS*D, FACSM, FNSCA, FISSNAssociate Professor, Director of Applied Physiology Laboratory, and Co-Director of Human Performance Center, Department of Exercise and Sport Science, University of North Carolina, Chapel Hill Javier Zaragoza, BSHPL Graduate Assistant, University of Mary Hardin-BaylorChristine HarrisonHPL Lab Assistant, University of Mary Hardin-BaylorCamden WilsonHPL Lab Assistant, University of Mary Hardin-BaylorJessica PratherHPL Lab Assistant, University of Mary Hardin-BaylorPurpose of the Study:The purpose of the study is to characterize body composition differences and injury rates of division III male and female sports athletes (soccer, volleyball, basketball, baseball, softball, golf, and tennis) at three separate time points (up to six for golf and tennis) using dual-energy x-ray absorptiometry (DEXA) and bioelectrical impedance analysis (InBody BIA). What is my involvement for participating in this study?I will be asked to fill out medical history and sign an informed consent statement. The testing sessions will span the length of your competitive sport season. I will come into the HPL to complete the testing sessions. The estimated time for the testing sessions will be about 30-60 minutes. The total time testing will be approximately 1.5 to 3 hours over the course of the study.Inclusion Criteria Participants will be male or female between the ages of 18-30 years; Subject is an active member of an UMHB athletics team (minus football);Subject has provided written and dated informed consent to participate in the study;Subject is willing and able to comply with the protocol;Subject is apparently healthy and free from disease, as determined by a health history questionnaire;Subject Exclusion Criteria Subject is not a currently active member of an UMHB athletics team;Subject may be pregnant, are pregnant, are trying to become pregnant, or are breastfeeding;Subject reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study;TestingI will be one of the healthy male and female active sports athletes between the ages of 18-30 to participate in this study. During my first appointment, I will have the study explained to me both verbally and in writing. If I agree to the guidelines, I will fill out a medical history questionnaire and sign an informed consent statement that complies with the University of Mary Hardin-Baylor. I will also begin to fill out other questionnaires for the study and receive two scans telling me my fat and muscle percentages (DEXA and InBody). I will be required to come to the lab to participate in two other testing sessions. Both testing sessions will include questionnaires, DEXA scans, and InBody scans. All my testing sessions will be scheduled and an email will be sent before every testing session with instructions for me to follow.Risks and BenefitsI will be exposed to an x-ray dose similar to about 3 hours of natural background radiation. I will be exposed to both low and high frequency (5, 50, and 500 kHz) currents sent through my entire body while performing each InBody test. If I have a pacemaker or other electronic medical devices, I should not perform the InBody. As a participant in this study my benefits of participation will include getting free body composition and bone mineral density assessments at multiple time points throughout the athletic season.Alternative TreatmentsThis is not a medical treatment. Therefore, if medical treatment is needed, I must continue to obtain treatment for any medical problem I might have from my personal physician.Costs and PaymentsNo academic credit will be given for participating in this study. Upon completion, participants will be given a free HPL t-shirt. ConfidentialityData will be stored in a locked file cabinet for at least 3 years. Electronic data will be stored without identifiers on a password-protected computer. Right to WithdrawalI understand that I am not required to participate in this study and I am free to withdraw from the study at any time. Further, that my decision to withdraw from the study will not affect my care at this institution or cause a loss of benefits to which I might be otherwise entitled. Compensation for Illness or InjuryI understand that if I am injured as a direct result of taking part in this study, I should consult my personal physician to obtain treatment. I understand that the cost associated with the care and treatment of such injury will be the responsibility of me or my insurance carrier. In some cases, insurers may not reimburse claims submitted for a research-related injury resulting from medical procedures or treatments performed as part of a research study. I understand that the University of Mary Hardin-Baylor will not be accountable for illness or injury acquired during this study. However, I may be referred to my personal physician if any clinically significant medical/psychological findings are observed during this study.Statement on Conflict of Interest I understand that researchers involved in collecting data in this study have no financial or personal interest in the outcome of results or sponsors. Voluntary ConsentI certify that I have read this consent form or it has been read to me and that I understand the contents and that any questions that I have pertaining to the research have been, or will be answered by Lem Taylor, PhD (Professor, School of Exercise and Sports Science, Human Performance Lab, UMHB Box 8010, 900 College Street, University of Mary Hardin-Baylor, phone: 254-295-4895, ltaylor@umhb.edu) or one of the research associates. My signature below means that I am at least 18 years of age and that I freely agree to participate in this investigation. I understand that I will be given a copy of this consent form for my records. If I have any questions regarding my rights as a research subject in this study I may contact Dr. Aaron Baggett, Chair of Institutional Review Board (phone: 254-295-4553, abaggett@umhb.edu at UMHB.Date Subject’s Signature I certify that I have explained to the above individual the nature and purpose of the potential benefits and possible risks associated with participation in this study. I have answered any questions that have been raised and have witnessed the above signature. I have explained the above to the volunteer on the date stated on this consent form.Date Investigator's Signature ................
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