Consent Form For Cumberland Valley Heart Screening Screening - Oct 28, 2017


You, the undersigned, give consent for your child to voluntarily participate in the Heart Screening hosted by The Peyton Walker Foundation and the Screening Organization as described in this Informed Consent Form. You understand that the Heart Screening will include a few tests. Your child will receive an electrocardiogram (ECG), have his/her blood pressure checked, have height and weight recorded, have a medical history form reviewed, and if required, based on findings, receive an echocardiogram (ECHO). The screening process should take less than one hour. The Heart Screening is not intended to serve as formal clearance for sports participation. Clearance for sports must be obtained from your child's physician.

Part One: Definitions

An electrocardiogram is a non-invasive test that measures the electrical activity of the heart and can detect certain heart abnormalities leading to sudden cardiac death. Your child will have twelve stickers (electrodes) placed on his/her chest, arms and legs. These stickers are connected to wires and the wires are connected to the ECG machine. It will read the electrical activity of your child's heart.

An echocardiogram is a non-invasive test that uses sound waves to create a moving picture of the heart that can detect heart abnormalities. This test is only used if the medical team wants to take a closer look at your child's heart. This test requires a small amount of gel to be placed on your child's chest. The medical practicioner rubs a wand on your child's chest to obtain an image of hte heart. It is very sinmilar to a pregnancy sonogram.

Part Two: About the Screening

The Heart Screening is administered by health professionals, which may include cardiologists, pediatricians, family doctors, technicians and nurses. The results from the ECG and ECHO are interpreted by licensed and qualified medical professionals. You acknowledge that the Heart Screening does not establish a treatment relationship between your child and Simon's Fund or the licensed healthcare providers administering the Heart Screening for and on behalf of the Screening Organization.

Part Three: Your Responsibilities

You agree to complete a medical history form on behalf of your child which will be reviewed by the medical team performing the Heart Screening. Many of the conditions that lead to sudden cardiac arrest and death are genetic and have warning signs. Therefore, You acknowledge and agree that the information contained in your child's medical history form is a very critical piece to the screening process. The information that You provide on the accompanying forms will be complete and correct to the best of your knowledge.

Prior to leaving the Heart Screening, You will receive information about your child's heart, including ECG and ECHO results. You understand and acknowledge that your child's heart is growing, and that his/her heart is changing too. As such, You acknowledge that the information You receive from the Heart Screening reflects the condition of your child's heart today. It does not constitute a conclusive diagnosis of your child's heart health or physical condition, and is not intended to serve as a replacement for treatment and checkups with your child's primary care physician or other provider.

You will continue to monitor your child's heart and become familiar with the warning signs and symptoms of sudden cardiac arrest. You acknowledge and agree that it is your duty to provide and discuss any abnormal results with your child's physician as soon as possible and/or follow up with a pediatric cardiologist.

Part Four: Medical Research and HeartBytes Registry Participation

Simon's Fund created and operates HeartBytes, a digital youth cardiac registry of seemingly healthy kids that streamlines the heart screening process, and collects data gathered during the Heart Screenings. The data collected may include medical history, ECG and/or ECHO exams, blood pressure measurement, weight and height, and heart sounds. This data is kept confidential and protected. The following entities may have access to your child's data: Simon's Fund, for administrative purposes, Thomas Jefferson University Office of Human Research and the investigators named on this consent form, the Screening Organization to facilitate the Heart Screening, and Pulse InfoFrame, the architect of HeartBytes, to maintain the registry.

Your child's data may also be reviewed by researchers, but only after the data is de-identified (made anonyous). Researchers must submit their proposals to an independant medical review team for approval.

By participating in the Heart Screening, You consent to having your child's medical information that is obtained during the Heart Screening, used and disclosed anonymously for research as described above. Your child's identity will remain anonymous, and other identifiable personal informaton will be kept confidential. You understand that the research will not directly benefit yoru child but may help children in the future. You understand that the biggest potential risk to your child is the risk of accidental loss of confidentiality, but that careful computer security is in place to prevent this. Your alternative is to not have your child participate in the heart screening and HeartBytes.

There are no costs to you should your child's de-identified data be included in a future research project. However, in an effort to make this registry robuts and useful, we may send you a follow up survey. Your completion of this survey is completely voluntary. Your cooperation is greatly appreciated and will greatly help the cause.

You acknowledge that you are not required to give your consent to these research uses and disclosures, and may withdraw this consent at any point in time up until the Heart Screening is performed. However, you acknowledge that if you withdraw or do not give your consent, your child will not be able to participate in the Heart Screening. There is no penalty or cost if your child does not participate or you withdraw your consent.

You hereby authorize Simon's Fund and the Screening Organization to collect, use and release your child's medical information for the research purposes identified above. You understand that any other use or disclosure of your child's medical information not described in this Consent and Waiver may require additional consent from you to the extent required by applicable law. You understand that your child's de-identified medical information may be subject to re-disclosure by researchers and no longer protected by applicable laws governing this Consent and Waiver, including but not limited to the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), if applicable. For questions about your child's rights as a research participant, call the Thomas Jefferson University Institutional Review Board at 215-503-8966.

Part Five: Confidentiality

Federal regulations require that certain information about individuals be kept confidential. This information is called "protected health information" (PHI). PHI includes information that identifies an individual personally such as name, address and social security number, or any medical or mental health record, or test result, that may have this sort of information on it. Even though HeartBytes is not required to adhere to the federal privacy law (i.e., HIPAA), we are applying HIPAA requirements in order to protect your child's health information to the best of our ability.

The following individuals or entities may have access to your child's PHI and will protect it: investigators listed on this consent form, Thomas Jefferson University's Office of Human Research and Institutional Review Board (IRB) and HeartBytes.

The following information will be provided to HeartBytes and other entities noted above:

Study data for analysis: medical and family history information provided by parent or guardian prior to the Heart Screening.
Demographic data: first name, last name, address, date of birth, gender and race.
Other: blood pressure, height, weight, heart sounds, EKG and/or Echo, as collected at the Heart Screening.

There is no expiration date for the use of your child's PHI.

The information from this study may be published in scientific journals or presented at scientific meetings but no one will be personally identified in these publications and presentations.

Part Six: Media Release

You grant Simon's Fund and the Screening Organization permission to use any photographs, video and/or audio taken of your child during the Heart Screening for the purpose of fulfilling its mission — to raise awareness about sudden cardiac arrest and death in children. You understand that Simon's Fund and the Screening Organization will not use the identity of your child — only his/her image. You acknowledge and understand that all media, including photographs, videos and recordings are the property of Simon's Fund or the Screening Organization. You also grant Simon's Fund permission to add you to its email list, which will be used to provide you with updates related to this screening and about the organization's future endeavors. You understand that You can opt out at any time from the emails.

Part Seven: Release of Liability

You understand and acknowledge that this Heart Screening is being provided free of charge by the Screening Organization. The Screening Organization organizes volunteer medical professionals and lay people to administer the Heart Screening and is not intended as treatment or provision of health care. In order for your child to participate in the Heart Screening, You, on behalf of yourself, your child(ren), spouse, heirs, executors, administrators and representatives, HEREBY RELEASE WAIVE AND DISCHARGE the Screening Organization and/or Simon's Fund, the independent health care personnel and volunteers who are conducting or participating in this Heart Screening, the school, the school district, and any vendors, sponsors, their officers, directors, employees, agents, volunteers, and representatives, from and against any and all claims, demands, damages, and other losses or liability, including but not limited to personal injury, illness or death arising out of or related to your child's participation in this Heart Screening, whether as a result of negligence or otherwise. The above statement does not apply to use of your child's data for research purposes and you are not giving up your child's rights in regard to research.

By typing your name, you acknowledge that you have carefully read and understand this Consent and Waiver, have had the opportunity to ask any questions and have them answered, and hereby consent to your child's participation in the Heart Screening, and use and disclosure of information, as set forth in this Consent and Waiver. You hereby acknowledge receipt of a copy of this Consent and Waiver. This Consent and Waiver does not expire.