Consent Form For Crispus Attucks HS Screening


I, the undersigned, gives consent for the above named child to voluntarily participate in the Heart Screening and related research registry hosted by Simon’s Heart and the Screening Organization as described in this Informed Consent Form. I understand that the Heart Screening will include an electrocardiogram (ECG). My child may also have his/her blood pressure checked, have height and weight recorded, have a medical history form reviewed, and receive an echocardiogram (ECHO). The Heart Screening is not intended to serve as formal clearance for sports participation. Clearance for sports must be obtained from another medical provider. Data from the Heart Screening will be stored for future research to better understand the detection and treatment of heart conditions in children. Participation in the Heart Screening is voluntary. Choosing not to participate will not impact your usual clinical care from your own physician or health care provider.

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. My 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 my 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 used to look at the structure of my child’s heart. This test requires a small amount of gel to be placed on my child’s chest. The medical practitioner rubs a wand on my child’s chest to obtain the image of the heart. It is very similar 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 ECG and ECHO results are interpreted by licensed and qualified medical professionals. The Heart Screening is not performed for clinical purposes and I acknowledge that the Heart Screening does not establish a treatment relationship between my child, Simon’s Heart, the Screening Organization, or the licensed healthcare providers administering the Heart Screening for and on behalf of the Screening Organization.

Part Three: Your Responsibilities

I agree to complete a medical history form on behalf of my 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, I understand and agree that the information contained in my child’s medical history form is a very critical piece to the screening process. The information that I provide on the accompanying forms will be complete and correct to the best of my knowledge.

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

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

Part Four: HeartBytes and Medical Research

Simon’s Heart 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 Heart, for administrative purposes; the Screening Organization (if different) to facilitate the Heart Screening; PulseInfoframe, the architect of HeartBytes, to maintain the registry; and government authorities if mandated by applicable law.

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

By participating in the Heart Screening, I consent to having my child’s de-identified medical information obtained during the Heart Screening used and disclosed for research as described above. This means that my child’s ECG report, blood pressure results, height and weight measurements, and ECHO, if available, as well as any information provided in the medical history form (including family health history and other genetic information), may be shared with researchers after the data is de-identified. My child's identity will remain anonymous, and other personal identifiable information will be kept confidential.

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 robust 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. Additionally, as part of our continued efforts to improve our cardiovascular screenings and research, we may contact your child via email, SMS text or cell phone for follow up surveys. Their participation and/or response is completely voluntary.

You will not be informed about specific research studies that might be conducted using de-identified data about your child or of the results of such research studies. There is no direct financial or other benefit to you or your child from participating in the research registry, but your child’s participation may help to advance research regarding health conditions in children. There is no physical risk to you or your child from participating in the research registry, but research that uses health information can affect your or your child’s privacy. We will use reasonable efforts to protect all the information we collect and maintain, and we will only disclose de-identified information for research, but confidentiality cannot be guaranteed.

Heart Screening Informed Consent and WaiverYou will not be informed about specific research studies that might be conducted using de-identified data about your child or of the results of such research studies. There is no direct financial or other benefit to you or your child from participating in the research registry, but your child’s participation may help to advance research regarding health conditions in children. There is no physical risk to you or your child from participating in the research registry, but research that uses health information can affect your or your child’s privacy. We will use reasonable efforts to protect all the information we collect and maintain, and we will only disclose de-identified information for research, but confidentiality cannot be guaranteed.I acknowledge that I am not required to give my consent to these research uses and disclosures, and may withdraw this consent at any point in time, except I cannot withdraw my consent with respect to information that has already been disclosed. However, I acknowledge that if I withdraw or do not give my consent, my child will not be able to participate in the Heart Screening.

I hereby authorize Simon's Heart and the Screening Organization to collect, use and release my child's medical information for the research purposes identified above. I understand that all data shared for research purposes will be de-identified prior to disclosure. I understand that any other use or disclosure of my child’s medical information not described in this Consent and Waiver may require additional consent from me to the extent required by applicable law. I understand that some of the organizations listed above may not be required to protect medical information by applicable federal privacy law, including but not limited to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), if applicable.

Part Five: Media Release

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

Part Six: Release of Liability

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 my child to participate in the Heart Screening, I, on behalf of myself, my child(ren), spouse, heirs, executors, administrators and representatives, HEREBY RELEASE WAIVE AND DISCHARGE the Screening Organization and/or Simon’s Heart, 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 my child’s participation in this Heart Screening, whether as a result of negligence or otherwise.

Part Seven: Contact Information

If you are having a medical emergency, call 911 or go directly to an emergency room.

For Questions About:Person or OfficeContact Information
The StudyMain Investigator: Dr. David Shipon215 389 0607
Simons Heart424 E. Elm Street, Second Floor
Conshohocken, PA 19428

267-743-1400
If you need to contact someone other than the study personnel about a concern or your rights as a research subject Jefferson Center City

Institutional Review Board (Ethics Committee)
215-503-0203

215-503-8966

215-955-4239

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. There is no set time for destroying the information that will be collected for the registry. This Consent and Waiver does not expire for use of your child’s data unless you contact the study principal investigator and withdraw your permission.

By signing this form, you are indicating that you have had your questions answered, you agree to take part in the Heart Screening and research registry, and you are legally authorized to consent to your child’s participation. You are also agreeing to let Simon’s Heart use and share your child’s health information as explained above, including to disclose de-identified information for research. If you don’t agree to the collection, use and sharing of your child’s health information, your child cannot participate in the Heart Screening or the research registry.