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The University of Arizona Consent to Participate in Research

The University of Arizona Consent to Participate in Research

Study Title: The Impact of Long Haul Travel on Each Player’s Adaptability, With The Aim of Optimizing Individual Player Recovery Short Term, And for Future Long Haul Trips With Tailored Strategies
Principal Investigator: Forrest Baker

This is a consent form for research participation. It contains important information about this study and what to expect if you decide to participate. Please consider the information carefully. Feel free to discuss the study with your friends and family and to ask questions before making your decision whether or not to participate.

Key Information:
The purpose of this study is to identify players not adapting well to the long haul travel schedule, and upon return to the USA display evidence of poor recovery. Evidenced through biomarker data (changes in inflammation, oxidative stress, immune function and anabolic drive), and cognitive performance via a psychomotor vigilance test (PVT). Monitoring the player’s biochemistry and mental performance, individual players can be targeted with specific strategies in order to optimize pre-season preparations on return from long-haul travel.
If you agree to take part in this study you will be required to fast overnight (8 to 12 hours) twice, provide two blood samples, and complete a PVT test every day for 14 days. Your time commitment will be about 3 hours over entire study.

Although there will be no direct health benefit for you, the data we get from this study may lead to a better understanding of how long-haul travel may effect an athlete’s biochemistry and mental performance, leading to specific recovery strategies. Your risks in this study are minor, and include those associated with drawing blood (including occasional bleeding and local pain).

There are no alternative ways of being involved in this study other than to decline participation.

Why is this study being done?
Eastward long-haul travel has been associated with increased fatigue in athletes with the degree of fatigue and duration varying between individuals. Long-haul travel has been shown to disrupt circadian rhythm, increase the risk of illness, and disrupt the bodies homeostasis. Determining the amount of disruption in elite athletes after long-haul travel could be essential for athlete management, in individualization of training, sleep, and recovery. The monitoring of oxidative stress may provide a biochemical insight to amount of disruption to homeostasis. Long haul travel (west to east) has been shown to increase oxidative “damage” and decrease measures of antioxidant “defense;” notwithstanding the impact of pollution in such studies. To date no studies have experimentally examined the impact of travel and jet lag on redox homeostasis, biochemistry, and mental performance in athletes.

What will happen if I take part in this study?

Visit 1: Pre Trip Venous Blood Draw

Participants will be scheduled to visit the training between 08:00 and 10:00. A member of staff will ask the participant to questionnaire to determine if he/she adhered to the pre-testing guidelines (8-12h fast, no vigorous physical activity). Subjects will have their blood collected from the antecubital vein by a trained phlebotomist (approx. 55 mL).

Visit 2: Post Trip Venous Blood Draw

Participants will be scheduled to visit the training between 08:00 and 10:00. A member of staff will ask the participant to questionnaire to determine if he/she adhered to the pre-testing guidelines (8-12h fast, no vigorous physical activity). Subjects will have their blood collected from the antecubital vein by a trained phlebotomist (approx. 55 mL).

PVT Testing (Time commitment: 45 minutes)

Participants will also be asked to complete a cognitive performance test via a psychomotor vigilance test (PVT). Each player will need to download the Orreco PVT app with their phone in flight mode /do not disturb mode. This will reduce the chance of distractions on phone from incoming messages and notifications to ensure a more accurate test result. The PVT should only take 3 minutes/day. The players will be asked to complete the PVT 3 consecutive days prior to trip, every day (8 days) during the drip, and 3 consecutive days after returning.

How long will I be in the study?
The total time commitment for this study is 3 hours over two visits to the laboratory.

How many people will take part in this study?
Up to 20 healthy volunteers (age 18-44 years) will be recruited to participate in this study.

Can I stop being in the study?
Your participation is voluntary. You may refuse to participate in this study. If you decide to take part in the study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you. Your decision will not affect your future relationship with The University of Arizona. If you are a student or employee at The University of Arizona, your decision will not affect your grades or employment status. If, at any point you wish to discontinue participation in the study, let a member of the research staff know, and they will take steps to remove you from the study as quickly as is safe. Either of the principle investigators may remove you from your involvement in the study based on results of the initial health screening or indicators along the way that this study may pose a risk to your health. Additionally, if you do not follow the study instructions, (i.e. fasting prior to blood draws, coming to appointments), you may be removed from the study.

What risks or benefits can I expect from being in the study?
The risks of venipuncture are very minimal. They may include occasional bleeding, local pain, bruising, and very rarely, infection. Every precaution to minimize these minor risks will be implemented. The venipuncture will only be performed by a trained phlebotomist or physician to ensure your safety. If you suffer an injury from participating in this study, you should seek treatment. The University of Arizona has no funds set aside for the payment of treatment expenses for this study. You will not benefit directly from this study. However, the data we get from this study may lead to a better understanding of how long-haul travel may effect an athlete’s biochemistry and mental performance, leading to specific recovery strategies.

Will my study-related information be kept confidential?
We will take all reasonable precautions to ensure that your study-related information remains confidential. Only the two principal investigators will have access to your identifying information. Each of them has received CITI training on subject confidentiality. One copy of this signed consent form and the results of your health screening will be secured in a locked cabinet in the principle investigator’s private office. These documents will be destroyed after six years. Your blood samples will be completely de-identified prior to any processing or analysis. Upon your enrollment in the study, you will be given a unique study number. Your blood samples and all resulting data will be identified only by the study ID number. The code matching your information with the ID number will be secured in a locked cabinet in the principle investigator’s private office and destroyed after one year. If the analysis of this data results in publication, your personal information will not be part of the analysis or publication. You may request a copy of any publication resulting from this study. Your records may be reviewed by The University of Arizona Institutional Review Board.

What are the costs of taking part in this study?
There are no monetary costs to taking part of this study. You will invest about three hours in appointments and PVT tests.

Will I be paid for taking part in this study?
No compensation will be given for participation in this research study.

Will my data or specimens be stored for future research?
Any remaining de-identified blood samples may be cryo-preserved and stored in the Simpson laboratory for future study related to exercise and PBMC mobilization. The samples will not be shared with other institutions or sold to pharmaceutical companies or for commercial profit. These samples will not be used for whole genome sequencing.

Who can answer my questions about the study?
For questions, concerns, or complaints about the study you may contact Forrest Baker at flbaker@email.arizona.edu or Dr. Richard Simpson at rjsimpson@email.arizona.edu.

For questions about your rights as a participant in this study or to discuss other study-related concerns or complaints with someone who is not part of the research team. If you are injured as a result of participating in this study or for questions about a study-related injury, you may contact the Human Subjects Protection Program at 520-626-6721, vpr-irb@email.arizona.edu or online at http://rgw.arizona.edu/compliance/human-subjects-protection-program.

An Institutional Review Board responsible for human subjects research at The University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.

Signing the consent form
I have read (or someone has read to me) this form, and I am aware that I am being asked to participate in a research study. I have had the opportunity to ask questions and have had them answered to my satisfaction. I voluntarily agree to participate in this study.

I am not giving up any legal rights by signing this form. I will be given a copy of this form to sign.