Jefferson Office of Human Research

Informed Consent OHR-8

Version Date - FOR OHR USE: 5/22/20

Department: Jefferson Clinical Research Institute (JCRI)

Principal Investigator: David M. Shipon MD

Study Title: HeartBytes Registry

Lay Title: HeartBytes Registry

Please note, this form is being used both for adults and for children and their parents or guardians. If you are reading this form as a parent or guardian, please note that this form is about the child who may take part in this study.

General Information Section

Informed Consent

You or your child are being asked to take part in a medical screening and research study. Research is different from standard medical care, and is done to learn something new.

Please read on to find out:

• The purpose of this medical screening and research.
• How this medical screening and research are different from standard medical care.
• The procedures involved.
• The risks.
• The possible benefits.
• The alternatives to taking part in this research.

Use this information to decide if you want you or your child to take part in this research. This process is called informed consent. If you would like to discuss this study with the research personnel, please contact Simon's Heart or the Main Investigator. There is contact information listed later in this form.

Voluntary Participation

You or your child do not have to take part in this research. It is your choice whether or not you want you or your child to take part. If you choose not to take part or choose to stop taking part at any time, there will be no penalty or loss of benefits that you or your child would normally get.

Purpose

The purpose of the HeartBytes Registry is to provide standardized, de-identified data to qualified researchers for use in future academic and clinical research projects that may lead to a better understanding of the detection and treatment of heart conditions in children.

The purpose of the Heart Screening is to contribute to the HeartBytes Registry. The screening also provides you with information about your or your child's heart and health through the collection of medical history information, electrocardiogram and/or echocardiogram exams, blood pressure measurements, weight and height, and heart sounds. The information learned in the screening can provide you with some awareness about your or your child's cardiac risk factors.

How this Research is Different from Standard Medical Care

The Heart Screening is not performed for clinical purposes and the Heart Screening does not establish a treatment relationship between you and/or your child, Simon's Heart, the Screening Organization, or the licensed healthcare providers administering the Heart Screening for and on behalf of the Screening Organization.

The Heart Screening is not intended to serve as formal clearance for sports participation. Clearance for sports must be obtained from another medical provider. Participation in the Heart Screening is voluntary. Choosing not to participate will not impact your or your child's usual clinical care from your own physician or health care provider.

Following the Heart Screening, you may receive information about you or your child's heart. The information you receive from the Heart Screening may reflect only the condition of your or your child's heart on the day of the screening. Results from the screening do not constitute a conclusive diagnosis of you or your child's heart health or physical condition, and is not intended to serve as a replacement for treatment and checkups with your or your child's primary care physician or other provider.

You can continue to monitor your or your child's heart and become familiar with the warning signs and symptoms of sudden cardiac arrest. You may wish to provide and discuss any abnormal results with your or your child's physician as soon as possible and/or follow up with a pediatric cardiologist.

Number of Participants

There is no maximum number of participants in the screening or the research. The Heart Screening and the HeartBytes Registry are ongoing.

Duration

You or your child will participate in the research for during completion of the health questionnaire and during on the day of the Heart Screening.

Procedures and Risks

It is important that you know the procedures and risks involved in this research. These will be included in detail later in this form. Review the information carefully when making your decision to take part in this research.

Possible Benefits

The Heart Screening provides the potential benefit of learning more about your or your child's heart health.

Alternatives to Taking Part in this Research

The alternative to being in this screening and registry is to not take part.

Costs

There are no costs for participating in the Heart Screening or HeartBytes Registry.

Payment

There is no payment for taking part in this study. If this research or the information or specimens you or your child provide result in commercial profit, you or your child will not receive any money from that profit.

Ending Study Early

There are a number of reasons you may decide or be asked to stop the study early (example: medical issues). You or your child may also have to stop the study early even if you do not want to. You and the research personnel will discuss the reason if this becomes necessary.

New Information

New information may come out during the course of Heart Screenings and the HeartBytes Registry. You will be provided with the results of your child's heart screening, but you will not be provided with the results of the future research projects that use data from the HeartBytes registry.

Detailed Information Section

Procedures

During the Heart Screening, you or your child will have different procedures, tests and/or evaluations which are described below. Please note that additional tests and procedures may be needed to check on your health condition.

Before attending the screening, you will be asked to complete a medical history form for yourself or on behalf of your child which will be reviewed by the medical team performing the Heart Screening. This questionnaire includes questions about your or your child's physical activity, sport participation, nutrition habits, diagnosis history, medications, COVID-19 history, heart health symptoms and history of care, as well as family history of illness and heart conditions.

The Heart Screening is administered by health professionals, which may include cardiologists, pediatricians, family doctors, technicians and nurses. You or your child will also have his/her blood pressure checked, have height and weight recorded, have a medical history form reviewed, and receive an echocardiogram (ECHO) and an electrocardiogram (ECG). The ECG and ECHO results are interpreted by licensed and qualified medical professionals.

An ECG is a non-invasive test that measures the electrical activity of the heart and can detect certain heart abnormalities leading to sudden cardiac death. You or 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 or your child's heart.

An ECHO 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 your or your child's heart. This test requires a small amount of gel to be placed on your or your child's chest. The medical practitioner rubs a wand on your or your child's chest to obtain the image of the heart. It is very similar to a pregnancy sonogram.

You or 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 and access to the HeartBytes Registry.

By participating in the Heart Screening, your or your child's de-identified medical information obtained during the Heart Screening used and disclosed for research as described above. This means that your or your 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. You or your child's identity will remain anonymous, and other personal identifiable information will be kept confidential.

Risks

Taking part in this screening involves certain risks. There may also be risks that are not known at this time. If you have any medical issues during this screening, call the appropriate number in the contacts section of this form.

Risks of electrocardiogram (ECG):

There is some risk with the electrocardiogram participation. An ECG is a non-invasive test. You or your child will have twelve electrodes placed on your or your child's chest, arms and legs. These are attached with adhesive stickers to the skin. The adhesive may or may not cause some skin irritation or have potential for an allergic reaction.

Risks of HeartBytes Registry:

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.

Costs

There are no costs for participating in the Heart Screening or HeartBytes Registry. It is free to attend a Heart Screening.

Research-Related Injury

There is a possibility that you could have research-related injury, which is an illness or an injury that is directly caused by a screening procedure. If you have a research-related injury, we will offer you reasonable and necessary care to treat injuries directly resulting from taking part in this research. Neither Jefferson nor the study will pay for costs associated with treatment of research-related injury or illness. These costs may be billed to your insurance. In addition, you will be responsible for any deductibles and co-payments required under your health plan and for any claims ultimately denied by your health plan. There are no plans for Jefferson to pay you or give you other compensation for the injury. If you think you have been injured as a result of taking part in this research study, tell the research personnel as soon as possible. Please see the contact information in this consent form.

Privacy and Confidentiality: HIPAA Authorization

Information will be collected about your or your child for this study. The information will be seen by the people involved with this research. Steps will be taken to protect your or your child's identity. But the information collected about you can never be 100% secure.

HIPAA (Health Insurance Portability and Accountability Act) - This is the law that protects your or your child's personal health information.

To do this study, we need to collect, use, and share your or your child's personal health information. This form will explain why the information is being collected, what information will be collected, and who will have access to it. By signing, you are giving us permission to use your or your child's information as described in this form.

We are committed to respecting your or your child's privacy and to keeping your or your child's personal health information confidential. Your and your child's personal health information includes the information in your or your child's health care records and information that can identify you or your child. For example, personal information may include your name, address, phone number, social security number, and medical information. The personal health information that may be collected, used, and shared for this research includes:

• Information from your or your child's medical history
• Demographic information such as name, gender, birth date, ethnicity, and health care providers
• Physical examinations, procedures, tests, labs, your or your child's medical conditions, and medications your or your child uses
• Information collected about any research related injury
• Information about mental health and other sensitive information
• Photographs, video, and/or audio taken of you or your child during the Heart Screening may be collected. Simon's Heart and the Screening Organization may use this information for the purposes of marketing Simon's Heart or the Heart Screening, but the information will not be used to identify you or your child.
• Email address will be collected and may be added to Simon's Heart and the Screening Organization's email list. The email address will be used to contact you to provide updates related to the screening you or your child has registered for and about Simon's Heart and the Screening Organization's future events and endeavors.

Your personal information will be used by and shared with the following:

• Personnel at Thomas Jefferson University and its affiliates for the purpose of this research
• Screening personnel at Simon's Heart and screening organizations
• Personnel at Pulse Infoframe, the company that maintains the HeartBytres Registry database, who may need to see identifiable information in the course of performing their respective functions to the registry, including to perform routine and maintenance tasks as needed
• Personnel at INFINITT North America, the company that maintains the ECG and ECHO database for Simon's Heart
• Personnel at DataMed, the company that donated the ECG translation software, and Amps LLC , who donated the ECG conversion services
• Institutional Review Boards (ethics committees that review research) including the Thomas Jefferson University IRB
• Others as required by law

When your or your child's personal information is provided to some of the people listed, it may no longer be protected under the HIPAA privacy law. You can see your health care records at any time. However, generally you will not be able to see your study records or the study results until the study is completed. After providing consent to participate in the study, a blank copy of this consent form will be emailed to you for your records.

This authorization does not have an expiration date. Please inform the screening personnel if you want to end your participation in the screening and permission to collect information. Please note that anything already collected will still be used and you may not be able to continue in this study.

The information from this study may be published in scientific journals or presented at scientific meetings, but you will not be personally identified.

Your private information, with the identifiers removed, could be used for future research studies or distributed to other researchers for future research studies without your additional permission.

Contacts

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

Signatures

Patient/Subject: By signing this form, you are agreeing that:

• You were given the opportunity to read this form.
• All of the information in this form was discussed with you by an investigator or other research personnel to your satisfaction.
• All your questions have been answered to your satisfaction.
• You were not pressured and you voluntarily agree to take part in this research.