INFORMED CONSENT FORM to Participate in Research, and AUTHORIZATION to Collect, Use, and Disclose Protected Health Information (PHI)

---

Title of this study: Assessment of Health in the Track and Field Master Athletic Cohort (TaFMAC-health): Establishing a Unique, International Resource for the Study of Healthy Ageing

Researchers: Principal Investigator: Dr. Sean Forbes, PhD, (352) 273-6111

Contact information for emergencies after hours or on weekends or holidays: Dr. Sean Forbes: (352) 222-8434

Other research staff:
Tanja Taivassalo, PhD, (352) 339-6666

You are being asked to participate in a research study.

Before you agree to take part in this study, Dr. Forbes or his representative will tell you:

Why the study is being done and what will happen to you if you take part in the study: The aim of this project is to contribute data to an international cohort study of track and field masters athletes (age 35 years and greater). Data collected in this study will be de-identified, transferred, and combined with a long term Track and Field Master Athletic Cohort (TaFMAC) project led by Dr. Rittweger at the Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany. The data collected will provide a valuable resource to address a wide range of scientific questions on sports participation, training regimes, and age-related changes in function and health status.

If you participate in this study, you will be asked to perform some standard health and physiological assessments. Also, we will ask for a saliva sample to measure genetic markers potentially related to injury risk and athletic profiles. During the week of the competition at Alachua County (March 23-30, 2025), we will do the following health and physiological assessments:

• Height, weight, hip-waist circumference
• Maximal exercise test on a treadmill with measurement of air breathed in and out
• Jump test on a force plate as a measure on leg strength, grip strength, gait speed
• Reaction time
• Index of cardiovascular health using a non-invasive device to measure the sticking of glucose (blood sugar) known as glycation in the skin
• Body composition with bioelectrical impedance, where a very weak, harmless electrical current goes through your body. Fat leads to electrical current that is slower than muscle tissue, and the method allows the determination of the composition of body fat and muscle tissue.
• MRI of leg muscles (in a subset of twenty subjects). The first twenty subjects who show interest in the MRI part of the study and are eligible (e.g., no contraindications to MRI) will perform this component of the study (see Addendum for consenting to this portion of the study).

How long you will be in the study:
After consenting, you will be in the study while answering some background questions and while completing the measurements during the competition. The total time to complete the questions and physical assessments is approximately 5 hours.

How many people will be in the study:
All those registering for the World Masters Athletics Indoor Championships in Alachua County (March 23-30, 2025) will be invited to participate. Since participation in this study is associated with extremely low risks for the participants, the sample size will be as large as operationally possible. We expect that 100 subjects will participate in the physiological assessments, and twenty of the subjects will undergo an MRI.

The possible foreseeable risks, discomforts, and benefits of this research:

Risks and discomforts

We expect that none of the methods and physical assessments performed will be of any greater risk than those experienced during the competition and training. For the maximal exercise testing, exercise can lead to some muscle fatigue and soreness in the days following the exercise. This is generally temporary and not harmful.

Under the conditions proposed for this project, MRI is not known to harm living systems. Magnetic resonance imaging (MRI) is a procedure that allows doctors to look inside the body by using a scanner that sends out a strong magnetic field and radio waves. This procedure is used routinely for medical care and is very safe for most people, but you will be monitored during the entire MRI scan in case any problems occur. The risks of MRI are:

• The MRI scanner contains a very strong magnet. Therefore, you may not be able to have the MRI if you have any type of metal implanted in your body, for example, any pacing device (such as a heart pacer), any metal in your eyes, or certain types of heart valves or brain aneurysm clips. Someone will ask you questions about this before you have the MRI.
• There is not much room inside the MRI scanner. You may be uncomfortable if you do not like to be in close spaces ("claustrophobia"). During the procedure, you will be able to talk with the MRI staff through a speaker system, and, in the event of an emergency, you can tell them to stop the scan.
• The MRI scanner produces a loud hammering noise, which has produced hearing loss in a very small number of patients. You will be given earplugs to reduce this risk.

Other possible risks to you may include:

• Researchers will take appropriate steps to protect any information they collect about you. However, there is a slight risk that information about you could be revealed inappropriately or accidentally. Depending on the nature of the information, such a release could upset or embarrass you, or possibly affect your insurability or employability. Sections below discuss what information about you will be collected, used, protected, and shared.
• This study may include risks that are unknown at this time.
• Participation in more than one research study or project may further increase the risks to you. If you are already enrolled in another research study, please inform one of the research team members listed above in this form or the person reviewing this consent with you before enrolling in this or any other research study or project.
• Throughout the study, the researchers will notify you of new information that may become available and might affect your decision to remain in the study.

This Research Study may also include risks that are unknown at this time.

Please note, participating in more than one research study or project may further increase the risks to you. If you are already enrolled in a research study, please inform one of the Research Team members listed above of this form or the person reviewing this consent with you before enrolling in this or any other research study or project.

During the study, the Research Team will notify you of new information that may become available and might affect your decision to remain in the study.

The University of Florida is required by law to protect your health information. Your health information will be stored in locked filing cabinets or on computer servers with secure passwords, or encrypted electronic storage devices, as required by University policy. However, there is a slight risk that information about you could be released inappropriately or accidentally. Depending on the type of information, a release could upset or embarrass you, or possibly affect your ability to get insurance or a job.

If you wish to discuss the information above or any discomforts you may experience, please ask questions now or call one of the Research Team members listed on page one of this form.

Potential Benefits

There are no direct benefits that you can expect to receive as a result of participating in this study. The potential benefit to others is through the knowledge gained from this study. This study may lead to better methods of monitoring aging and a better understanding of the most effective training methods to maintain fitness and health.

What will be done only because you are in this research study?

Since this study is part of a longitudinal project with data being collected over 10 years, the data collected in this study (World Masters Athletics, 2025) will be added to a banked resource. Therefore, your medical information, data, and contact information will be stored with the purpose of combining with future/past studies.
We wish to store your medical information/data we collect as part of your participation in this study and potentially use it in future research.

Many different kinds of research use medical information to answer new research questions. We will also store your contact information so that you may be contacted in the future regarding other research studies you might be interested in participating.

Your medical information and data will be kept in a secure location at the University of Florida and Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany. There is no direct benefit to you by allowing us to keep your medical information data. Although every effort will be made to keep your information confidential, there is a small risk that an unauthorized person may obtain your information. Therefore, there is a very slight risk that a test result could be linked to your identity and inadvertently disclosed to a third party.

The University of Florida will be allowed to collect, use and/or give out your data and medical information. They may give your data and medical information to other researchers whose research is approved by an Institutional Review Board (IRB). (An IRB is a group of people who are responsible for looking after the rights and welfare of people taking part in research.) They may also give your data and medical information to the study sponsor, the Food and Drug Administration, the Department of Health and Human Services, the Office of Human Research Protections, or other Government agencies. Your data and medical information may be shared with other research centers or private companies, in which case the University of Florida may charge the research center or private company a fee in order to recover the University of Florida’s costs of sharing your data and medical information. There is a risk that information received by these authorized persons or agencies could then be passed on to others beyond your authorization and not covered by the law.

A federal law, called the Genetic Information Nondiscrimination Act (GINA), makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. Be aware that this federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease being tested. Additional information can be obtained at http://irb.ufl.edu/gina.html or by calling 1-800-669-3362. If you think this law has been violated, it will be up to you to pursue any compensation from the offending insurance company and/or employer. In some states, such as Florida, upon your request, your DNA information will be made available to your physician.

Alternatives to being in the study:
You may freely choose to participate or not to participate in this study at any time. This study does not include any treatments, and your choice whether to participate will not affect your normal medical care. If you do not participate in this study, your medical care will continue as usual.

You may also refuse to authorize the use of your health information, but if you refuse, you may not be allowed to be in this research study. Your decision not to sign this Authorization will not affect any other treatment you may be eligible to receive.

How your study records will be maintained and who will have access:
All study documents are securely stored. The records for this study will be maintained and secured in locked cabinets within the Department of Physical Therapy. All electronic data related to this study will also be stored on a password protected, secure network. The principal investigators and study staff members will be the only ones to have access to both hard copy and electronic data. Hard copies of the informed consent forms and data records will be kept for a minimum of 5 years following completion of the study after which time the Principal Investigator will cross-shred and dispose of the documents.

If it will cost you anything to take part in this study:
The Sponsor will pay for all study related clinical services and certain routine clinical services that are required as part of your participation in this study. This may include some clinical services that you could have received if you were not in this study. All other non-study related clinical services will be billed to you or your insurance company as usual. For those services, you will be responsible for paying any deductible, co-insurance, co-payments, and for any non- covered or out-of-network services. Some insurance companies may not cover the cost of routine clinical services if they are associated with research studies. The principal investigator/study coordinator can help you work with UF Health to answer any financial questions you have about your participation in this study.

If you will be compensated for taking part in this study:
You will not be paid for participating in this study.

When or if you may be told about new findings which may affect your willingness to keep taking part in this study:
Although unlikely, if there are any new findings that may affect your willingness to keep taking part in the study after consenting, those findings will be shared immediately to the relevant participants (within 24 hours).

If you agree to participate in this study, you will be given a signed copy of this document.

You may contact Dr. Forbes at 352-273-6111 at any time if you have questions about the research or if you think that you have been hurt by the research.

You may contact the Institutional Review Board at the University of Florida Health Science Center at (352) 273-9600 if you have questions about your rights as a research subject or what to do if you are injured.

You may choose not to be in this study or you may quit being in the study at any time and there will be no penalty and no loss of any benefits you are entitled to. If you agree to participate in this study, Dr. Forbes will create, collect, and use private information about you and your health. This information is called protected health information or PHI. In order to do this, the Principal Investigator needs your authorization.

More specifically, the following information may be collected, used, and shared with others:

• The Research Team will collect demographic and medical history information, magnetic resonance images, and measures of functional abilities.
• The Research Team may collect this information from other healthcare providers, such as laboratories, which are a part of this research, as well as healthcare providers that are not part of this research (other doctors, hospitals or clinics). Other professionals at the University of Florida or Shands Hospital who provide study-related care, and the University of Florida Institutional Review Board (IRB), may also collect your health information.
• The Research Team listed above will use or share your health information as described below to carry out this research study.

This information will be stored in locked filing cabinets or in secure computer servers with security passwords.

Your PHI may be collected, used, and shared with others for the following study-related purpose(s):

• The Research Team will collect demographic and medical history information, physiological data, magnetic resonance images, and measures of functional abilities. The Research Team may collect this information from other healthcare providers, such as laboratories, which are a part of this research, as well as healthcare providers that are not part of this research (other doctors, hospitals or clinics). Other professionals at the University of Florida or Shands Hospital who provide study-related care, and the University of Florida Institutional Review Board (IRB), may also collect your health information.

Once this information is collected, it becomes part of the research record for this study. Only certain people have the legal right to collect, use and share your research records, and they will protect the privacy and security of these records to the extent the law allows. These people include:

• the study Principal Investigator, Dr. Forbes and research staff associated with this project,
• other professionals at the University of Florida or Shands Hospital that provide study-related treatment or procedures, and
• the University of Florida Institutional Review Board (IRB; an IRB is a group of people who are responsible for looking after the rights and welfare of people taking part in research).

Your PHI may be shared with:

• the study sponsor or their representatives;
• the United States or foreign governmental agencies who are responsible for overseeing research, such as the Food and Drug Administration, the Department of Health and Human Services, and the Office of Human Research Protections; and
• government agencies who are responsible for overseeing public health concerns, such as the Centers for Disease Control and federal, state and local health departments.

Otherwise, your research records will not be released without your permission unless required by law or a court order. It is possible that once this information is shared with authorized persons, it could be shared by the persons or agencies who receive it and it would no longer be protected by the federal medical privacy law.

Your PHI will be used and shared when needed with others until the end of the study.

If any identifiable information collected as part of this research, it is possible that your research information or data, with all personally identifiable information removed, could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you or your legally authorized representative.

If you have any questions now or at any time during this research study, please contact one of the research team members listed next to “Researchers” at the top of this form.

You are not required to sign this consent and authorization to allow researchers to collect, use, and share your PHI. Your refusal to sign will not affect your treatment, payment, enrollment, or eligibility for any benefits outside this research study. However, you cannot participate in this research unless you sign this consent and authorization.

You have the right to review and copy your protected health information. However, we can make this available only after the study is finished.

You can revoke your authorization at any time before, during, or after your participation in this study. If you revoke it, no new information will be collected about you, but information that was already collected may still be used and shared with others if the researchers have relied on it to complete the research. You can revoke your authorization by giving a written request with your signature on it to the Principal Investigator.

Signing this document means that the research study, including the above information, has been described to you orally and/or that you have read this document, and you voluntarily agree to take part.