1. About the Electrocardiogram ("ECG") Screening

An ECG screening (also commonly referred to as an EKG) is a test that measures the electrical activity of the heart to help identify an individual’s risk for heart conditions and some causes of sudden cardiac death. ECG screenings performed by Who We Play For (“WWPF”) involve (i) an ECG screening and (ii) a medical history form.

2. Consent to Participate and Acknowledgments

To receive an ECG screening, you must read and sign this Consent Form and Release of Liability (“Consent and Release”). If you are a minor, your parent or legal guardian must read and sign this Consent and Release. By signing below, you (or you and your parent or legal guardian if you are a minor) agree to the following:

---- I have carefully read this Consent and Release, I understand this Consent and Release, and I have had the opportunity to ask any questions; and

---- I voluntarily consent and elect to have representatives and volunteers perform an ECG screening; and

---- I understand that ECG screenings are noninvasive, painless tests and have no major risks. I voluntarily assume all risks associated with the ECG screening. I understand that the ECG screening will only screen for abnormalities in my heart and that it is not a complete medical exam or diagnosis. I understand that abnormal test results do not officially represent or imply that I have a heart condition. I understand that no warranty or guarantee has been made to me about the results of the screening. I understand that this screening will not diagnose all causes of sudden cardiac death. I acknowledge that the information I receive from the ECG screening reflects the condition of my heart at the time of the ECG screening. This ECG screening does not constitute a conclusive diagnosis of my heart health or physical condition; and is not intended to serve as a replacement for treatment and checkups with a primary care physician or other provider. I acknowledge the limitations of an ECG screening and that sudden cardiac death or other cardiac events may still occur, despite this screening. I understand that this ECG screening does not establish a treatment or provider relationship with anyone who administers the screening, interprets the ECG, or communicates the results. I recognize and acknowledge that I am solely responsible for taking any appropriate follow-up action related to the ECG screening results. I understand that follow-up care and treatment is not a part of this ECG screening program; and

---- I have the authority to sign this Consent and Release because either (i) I am an adult that is participating in the screening or (ii) I am the parent or legal guardian of a participant.

3. ECG Screening Results, Communication, and Confidentiality

The board-certified or board-eligible cardiologist that reads and interprets the ECG screening will place the participant into one of three categories: (i) low risk; (ii) follow-up required; or (iii) higher risk. You (or you and your parent or legal guardian if you are a minor) hereby acknowledge that if the ECG is categorized as “follow-up required” or “higher risk,” then you will be responsible for seeking follow-up care and additional testing (e.g., an echocardiogram) before further athletic activities. In certain counties and schools, you may be required to undergo additional testing prior to being allowed to resume participation with organized sports teams. You (or you and your parent or legal guardian if you are a minor) acknowledge, understand, and accept the following:

---- WWPF personnel, contractors, and volunteers (the “WWPF Team”) may disclose your screening results to individuals that oversee your involvement in athletics; and

---- The WWPF Team may contact me about the ECG screening and results. The participant’s screening results and medical history or health information may be used and disclosed by the WWPF Team for diagnostic purposes, follow-ups, aggregated statistical purposes, medical research, and research and development purposes. The information collected from any ECG screening event may be published in scientific journals or presented at scientific meetings in an aggregated way so long as you are not personally identified; and

---- The WWPF Team will follow all applicable state and federal laws and regulations, including any applicable sections of the Health Insurance Portability and Accountability Act (HIPAA) and the Family and Education Rights and Privacy Act (FERPA). This authorization may be revoked by submitting a written notice to WWPF at info@whoweplayfor.org

4. Research

Researchers at the University of Washington are interested in the real-world outcomes of large-scale electrocardiogram ("ECG") screening of secondary-school athletes implemented under Florida’s secondary-school cardiac-screening requirement, using the screening program operated by Who We Play For (WWPF). Their goal is to learn how well large-scale ECG screening works and what happens to athletes whose ECG is abnormal. If you are interested in participating in research, please review the study below.

5. Waiver & Release of Claims and Liability

By signing this Consent and Release and in exchange for a no or low-cost screening, you (or you and your parent or legal guardian if you are a minor) hereby agree to waive any and all claims, liabilities, or damages against the following parties: (i) the WWPF Team or its employees, directors, officers, representatives, sponsors, trustees, partners, consultants, and its contractors including all interpreting cardiologists; (ii) if applicable, the School Board that oversees the school district in which the ECG screening took place, including the local School Board’s employees and agents; and (iii) if applicable, the school, university, college, or business in which the ECG screening took place, including their employees and agents (collectively, the “Indemnified Parties”). You (or you and your parent or legal guardian if you are a minor) further agree to indemnify, release, and hold harmless the Indemnified Parties from and against any and all claims, liabilities, damages, costs, and expenses arising out of or connected to the performance, interpretation, and/or communication of the results of this ECG screening.

6. Acknowledgment

You (or you and your parent or legal guardian if you are a minor) certify that you have read this form or have had it explained to you in a language you can understand and that you have been encouraged to ask any questions about the screening process, benefits, limitations, and risks.

Note: If you would like to “pay it forward” and donate to cover the cost for a student in financial need, please include the donation with your payment or reach out to WWPF at the screening event or at whoweplayfor.org – thank you!

UNIVERSITY OF WASHINGTON
Consent or Parental Permission for Children Participation in Research
Who We Play For (WWPF) - Florida Electrocardiogram (ECG) Screening Outcomes Study

 
University of Washington Researchers:
Jonathan Drezner, MD – (206) 598-3294

Who We Play For (WWPF) Researchers:
Stephen Chelko, PhD – (850) 644-2215

The American Medical Society for Sports Medicine (AMSSM) Collaborative Research Network (CRN) Researchers, housed at the University of Wisconsin-Madison:
Stephanie Kliethermes, PhD – (608) 262-7800

Oregon Health and Science University Researchers:
Bradley Petek, MD 

 

What is this study about?

We are conducting this study because we are studying the results of heart screenings with an electrocardiogram (ECG) of student-athletes in Florida. Our goal is to learn how well large-scale ECG screening works and what happens to athletes whose ECG is abnormal. The purpose of this form is to provide you (≥ 18 years old) or as a parent/guardian of a prospective research study participant (if child is under 18 years old) information that may affect your decision as to whether or not to participate or let your child participate in this research study. For the purposes of this form “you” will refer to adult participants or parent/guardians of minor participants (<18 years old). If you decide to be involved in this study, this form will be used to record your permission.

What will you be asked to do?

If you agree, you give permission for ECG screening information from the Who We Play For (WWPF) screening event to be used for this research. That information includes an ECG image, the screening result, and basic information such as age, sex, race/ethnicity, height, weight, sport, home zip code, and school. 

Heart doctors will review abnormal ECGs as part of the study. For athletes whose screen is abnormal, the research team will request related medical records from the athlete’s doctors to learn about the evaluation, testing results and care that followed, and the final diagnosis. We will collect information like age and race/ethnicity, diagnostic testing, and any heart condition that is diagnosed. If an abnormal screening ECG result is found through the WWPF screening event, the research team will contact you in follow-up to learn if and where additional cardiology care was obtained. There is no additional time commitment or other requirement beyond what is necessary for the WWPF ECG screening. 

What are the risks involved in this study?

There are no foreseeable risks to participating in this study.

What are the possible benefits of this study?

There is no direct benefit from participating in this study; however, participation in this research study may benefit other people in the future by helping us learn more about future care and treatment options for student-athletes in Florida.

Why might you want, or not want, to participate?

Taking part in this research is your choice. Whether or not you agree to the research, you will still receive the ECG screening through WWPF. Your decision will not change anything about the screening, the result, or any follow-up care received.

Information collected for this study is used for research purposes only. The research team’s re-review of ECGs is not a medical diagnosis and will not be sent to you or your child. The actual screening result and any recommended follow-up will come from WWPF’s screening program, not from this research study. Participating in this study does not impact in any way the medical care you or your child would receive from a heart specialist if you or your child’s ECG is determined to be abnormal by the WWPF program.

Do you or your child have to participate?

No, participation in this study is voluntary. You may decline permission to participate or withdraw from participation at any time.  Withdrawal or refusing to participate will not affect you or your child’s status in any way with WWPF. You can agree to be in the study now and change your mind later without any penalty.  

How will your privacy and confidentiality be protected if you participate in this research study?

Your privacy and the confidentiality of the data will be protected. The study data will be private, meaning names or any other information that links to you will be removed from the data, and then combined with similar data from other athletes. All data is stored in a secured database approved by the University of Washington with access limited to only approved study researchers.

If it becomes necessary for the Institutional Review Board to review the study records, information that can be linked to you or your child will be protected to the extent permitted by law. Research records will not be released without your consent unless required by law or a court order. De-identified data resulting from your participation may be made available to other researchers in the future for research purposes not detailed within this consent form. In these cases, the data will contain no identifying information that could associate it with you or with your child’s participation in the study.

Using your data in future research

The information that we obtain from you for this study might be used for future studies. We will remove anything that might identify you from the information. The de-identified information would then be used for future research studies or given to another investigator without getting additional permission from you. It is also possible that in the future we may want to use or share with you information about other related studies that you would be eligible for. If we do, a review board will decide whether we need to get additional permission from you.

Other information about this study

Being in this study is voluntary. This means that you can refuse to sign up. It also means that if you do sign up, you can decide to stop being in the study at any time without penalty. You can skip any questions that you prefer not to answer. If you withdraw, the team will stop collecting new information, but information already collected may still be used. Declining or withdrawing will not affect your screening or any benefits you are otherwise entitled to.

A copy of this form and HIPAA Authorization form will be emailed to you at an email address that you provide. It will be a “PDF” document. Most computers already have PDF viewer software installed, which will allow you to open, read, or print the consent form or HIPAA Authorization form. The email we send you will include a link to PDF viewer software (such as Adobe Acrobat Reader) in case your computer doesn’t already have it. If you would prefer to receive a paper copy of the consent form or HIPAA Authorization form at no cost to you, please contact the researcher(s) listed in this consent form.

What can you do if you want more information?

Contact the study team. We are here to help you understand the study. Please ask us any questions you may have, even about things that are not in this document. It is our responsibility to give you the information you need to make a decision and to give you time to think about whether you want to sign up. Prior, during or after your participation you can contact the lead researcher Dr. Jonathan Drezner at 206-598-3294 or send an email to jdrezner@uw.edu for any questions or if you feel that you have been harmed. This study has been reviewed and approved by The University of Washington Institutional Review Board and the study number is STUDY00026061.

Talk to someone else. If you want to talk about the study with someone who is not part of the study team, talk about your rights as a research participant, or to report problems or complaints about the study, contact the UW Human Subjects Division. 

Study Team

Dr. Jonathan Drezner (Principal investigator at the University of Washington)
206-598-3294
jdrezner@uw.edu

Laurel Thur, MS (research coordinator at University of Washington)
lathur@uw.edu
UW Human Subjects Division
(206) 543-0098 or call collect at (206) 221-5940

hsdinfo@uw.edu
24-hour emergency telephone number:
(206) 598-6190

 

HIPAA Authorization

 

Research Title: Who We Play For (WWPF) - Florida Electrocardiogram (ECG) Screening Outcomes Study

Lead researcher: Jonathan Drezner, MD

Institution of lead researcher: University of Washington

A. Purpose of this form

The purpose of this form is to give your permission to the research team to obtain and use your or your child’s patient information. Your or your child’s patient information will be used to do the research named above.

State and federal privacy laws protect patient information. These laws say that, in most cases, your health care provider can release identifiable patient information, or protected health information (PHI) to the research team only if you give permission by signing this form.

You do not have to sign this permission form. If you do not, you will not be allowed to join the research study. Your decision not to sign this permission will not affect any other treatment, health care, enrollment in health plans or eligibility for benefits.

B. The patient information that will be obtained and used

“Patient information” means the health information in your or your child’s medical or other healthcare records. It also includes information in you or your child’s records that can identify them. For example, it can include name, address, phone number, birthdate, and medical record number.

1. Location of patient information

By signing this form, you are giving permission to WWPF and your or your child’s medical provider to disclose patient information for this research. A list of hospitals and cardiologists will be made available, the most common locations for follow-up are listed below:

1. AdventHealth for Children

2. Arnold Palmer Hospital for Children

3. Nemours Children’s Hospital

4. Nicklaus Children’s Hospital

5. Joe DiMaggio Children’s Hospital

6. Johns Hopkins All Children’s Hospital

7. Wolfson Children’s Hospital

8. UF Health Shands Children’s Hospital

9. Golisano Children’s Hospital of Southwest Florida

10. Holtz Children’s Hospital

11. St. Joseph’s Children’s Hospital 

12. Tampa General Hospital 

13. Children’s Cardiology Clinic 

14. Kidz Medical

15. Pediatric Associates

2. Patient information that will be released for research use

This permission is for the health care provided during the following time period:

From the time of the cardiac screening from Who We Play For (WWPF) until the end of the participation in this research study.

The specific information that will be released and used for this research is described below: 

Hospital records and discharge summary
Clinic records and office notes 
Radiology records
Medical history / treatment
Consultations
Cardiology testing (like echocardiography, cardiac MRI, ECG monitoring, or stress testing)
Radiology images (like X-rays, ultrasound, MRI, or CT scans)
Laboratory / diagnostic tests
ECG report and tracing 
EEG report
Pathology reports
Operative report (about an operation)
Pathology specimen(s) and/or slide(s)
Diagnostic imaging report

C. How the patient information will be used

Who may receive your child’s patient information
Only the research study team will have access to your or your child’s records.

Why your child’s patient information will be used and/or given to others
To do the research
To study the results, and
To see if the research was done right
Storing PHI in a data repository

The use of PHI for the current research and potential future studies is outlined in the Who We Play For (WWPF) - Florida Electrocardiogram (ECG) Screening Outcomes Study consent.

If the results of this study are made public, information that identifies you or your child will not be used. 

The researcher will use you or your child’s patient information only in the ways that are described in the research consent form that you sign and as described in this HIPAA Authorization.  

You can ask questions about what the research team will do with your or your child’s information and how they will protect it.

The privacy laws do not always require the receiver of your information to keep your information confidential.  After your information has been given to others, there is a risk that it could be shared without your permission.    

You have the right to obtain your or your child’s patient information in their healthcare record. The study procedures do not include a plan to share the research results, though you may be able to request them through the Washington State Public Records request system after the study is done. 

D. Expiration 

This permission for the researchers to obtain your or your child’s patient information:   

Ends when the research ends, and any required monitoring of the study is finished.

E. Canceling your permission

You may change your mind at any time. To take back your permission, you must send your written request to:

Jonathan Drezner, MD
University of Washington
Sports Medicine Center
Box 354060
3800 Montlake Blvd NE
Seattle, WA  98195

If you take back your permission, the research team may still keep and use any patient information that they already have. But they can’t obtain more health information for this research unless it is required by a federal agency that is monitoring the research.

If you take back your permission, you or your child will need to leave the research study. Changing your mind will not affect any other treatment, payment, health care, enrollment in health plans or eligibility for benefits.  

F. Giving permission

I have read this HIPAA Authorization form describing how my patient information or my child’s patient information will be used. If I have any questions, I can contact the research study team (206) 598-3294. I agree with the use of my or my child’s patient information for this research.