Proceed to the next page to complete the Patient Subject Information & Consent Form
SUMMARY: You are being asked to be in a research study. The purpose of this consent form is to help you decide if you want to be in the research study. You should not join this research study until all of your questions are answered. Things to know before deciding to take part in a research study:
If you take part in this research study, you will be given a copy of this signed and dated consent form.
PURPOSE OF THE STUDY: The Heart Sense Structural Heart Disease Disparities Project is a research study being conducted in Baton Rouge, Louisiana and 12 surrounding parishes. The purpose of the study is to screen for heart problems, primarily aortic valve problems. The study will also examine the impact of race, sex, insurance payor, and socio-economic status on prevalence, incidence and mode of treatment patients found to have structural heart disease. A total number of 3,000-5,000 subjects will be enrolled in a period of 12-24 months.
PROCEDURES: We are asking patients over 60 years old without known heart disease to participate in this research study. If you agree to participate in this study, you will first be asked to sign a consent form. The study coordinator will then ask you to fill out a personal information sheet and health history questionnaire. This will contain questions regarding your income, education, race, insurance, etc. It will also ask you questions about your current activity level and previous symptoms or conditions you have been diagnosed with.
Once you agree to participate, an Electrocardiogram and Echocardiogram will be performed by the study coordinator.
An Electrocardiogram(EKG) is a test that measures the electrical signals in your heart. You will be seated. The procedure requires a small sensor to be placed on your chest. The procedure will be painless. It will involve placing a small device on your chest to record your heart sounds and your heart rhythm.
An Echocardiogram is a test that uses ultrasound to show how your heart muscle and valves are working. We use a probe to perform an ultrasound on your heart. This procedure will also be painless.
If you allow, your primary care doctors will be contacted with the results of the Electrocardiogram and Echocardiogram. The study doctor may suggest you see a heart specialist if a significant problem is detected. The study doctor may follow up with you by phone call approximately one year after you have completed the screening visit. The study doctor will ask you questions regarding your care-surgery, medication, etc. or other details from the heart specialist you saw for the problem.
RISKS AND DISCOMFORTS: While there are no physical risks from the testing, there is the risk of a possible loss of your health information. We are very careful not to lose your health information, and we use special codes and passwords so that your name is never kept with study information, but there is still a very small risk that your privacy could be violated or your private health information lost.
BENEFITS: For some, the study may not have a direct benefit, but for others, the study may be beneficial in providing you with information regarding an unknown cardiac condition you may have. The study doctor may identify a need for you to be referred to a heart team to manage the condition. The results of this studymay help other people, who are not enrolled in this study with heart conditions, in the future.
COSTS: The screening tests that are done for the study will not be billed to you or your insurance company. There is no cost for you to enroll in the study. If you are referred to a heart doctor, those costs will be standard of medical care cost and your insurance will be billed by the doctor who provides you with care.
ALTERNATIVES TO PARTICIPATION IN THE STUDY: The alternative is not to participate. If you choose not to participate, your medical care will continue as if this study does not exist.
PAYMENT FOR PARTICIPATION: You will not receive any payment/compensation for being in the study.
CONFIDENTIALITY: Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality, but we will share no protected health information or your name with anyone.
By signing this form, you are giving permission for the Baton Rouge General Medical Center to make records available to the Baton Rouge General Medical Center (IRB) and Dr. Antoine Keller; all of whom must maintain confidentiality.
If we publish or present the information we learn from this study, you will not be identified by name or in any other way.
DATA AND INFORMATION SHARING: Certain information will be collected from you (we call this “Study Data”). Study Data will be used to conduct the study and will be encrypted, transmitted, maintained, and stored securely by Heart Sense.
In this study, you will be de-identified at the time of enrollment and assigned an alpha-numerical identifier (“Unique ID”) to coincide with your Study Data. Heart Sense study staff will maintain a Master File that contains your Subject ID with your corresponding personally identifiable information (PII) (full name, date of birth, etc). The Master File with your PII will be encrypted and stored securely with access limited to only the Heart Sense study staff. Your private information and your medical record may be shared with the Institutional Review Board
(IRB) that reviewed this research. Study Data may also be provided to public, regulatory, or government authorities, including law enforcement, when required by law, legal process, or litigation. The study Data will be kept as long as necessary for the use cases described in this consent. No PII will be used in connection with your Study Data.
The de-identified Study Data collected as part of this study includes:
The Study Data from the electronic stethoscopes and echocardiographic probes will be transmitted to an application on a study Apple iPad or iPhone using Bluetooth®. The study coordinator will save the recording under your Unique ID only. No personal information is recorded in the application. After the coordinator saves the recording, the data will be automatically transmitted over the secure Wi-Fi to a secure, HIPAA-compliant, cloud-based database server and managed by the study sponsor.
The demographic and clinical data listed above are collected and shared with the study sponsor in order to perform proper analysis of the heart sound data we are collecting. After your study session is completed, the coordinator will look at your medical record to record this information onto an electronic data form under yourassigned Subject ID. No personal information is recorded on the data form. The electronic data form will be completed while connected to secure Wi-Fi and automatically saved to a secure server and managed by the study sponsor.
The study sponsor, Heart Sense, may use the de-identified Study Data and share it with its partner companies or with national and international regulatory agencies to help answer the study question, to develop future studies on this product, or for research related to this study. Organizations that may review, share, or use your de-identified Study Data for research, quality assurance, and data analysis include:
We may publish results from this research or present results at scientific meetings. However, your name and other personal information will not be used.
By signing this consent form, you agree to allow the study sponsor Heart Sense to collaborate (under appropriate contractual obligations), to collect, use, store, process, analyze, and disclose (“use and disclose”) your de-identified information for the development, design, approval (including regulatory approval), production,publication, and/or support of Eko and/or Butterfly Network products, technologies, and services. Eko and/or
Butterfly Network may combine your de-identified information with data from other health studies for these same purposes. Only select employees of Eko and/or Butterfly will have access to this de-identified information and no protected personal information will be shared.
Data collected in this research will be used for future research or distributed to another investigator for future research without your consent, but it will be de-identified.
When the study is finished, a de-identified electronic copy of the recordings will be stored indefinitely for research purposes, but no information from the electronic stethoscopes will enter your medical record. The Heart Sense study coordinator may fill out an electronic study form with questions about your medical historyand demographic information and will provide this to Eko and/or Butterfly Network. The coordinator will also send your echocardiogram data and, if available, our 12-lead ECG data to Eko and/or Butterfly Network. This will help them analyze the recordings to know if the algorithm is accurate or not. None of your personally identifiable information (name, address, email, medical record number, birth date, etc.) will be sent to the study sponsor at any point. All data will be de-identified first.
The electronic stethoscopes and echocardiography probes used in this study are approved by the FDA and used by doctors all over the world, but the heart sound analysis algorithms are still under development. Therefore, no results from the recordings will be provided to you, nor used to make clinical care decisions.
VOLUNTARY PARTICIPATION AND WITHDRAWAL: Your participation in this study is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled.
SOURCE OF FUNDING FOR THE STUDY: The sponsor, Heart Sense, will be providing funding for this research study.
QUESTIONS: Contact Dr. V. Antoine Keller at (225) 955-9324 for any questions related to the study. If you have questions about your rights as a research subject or if you have questions, concerns or complaints about the research, you may contact:
Baton Rouge General Medical CenterInstitutional Review Board (IRB)3600 Florida BoulevardBaton Rouge, LA 70808Telephone: 1-225-387-7112E-mail: email@example.com
Baton Rouge General Medical Center IRB is a group of people who independently review research for research subject rights and protection.
Baton Rouge General Medical Center IRB will not be able to answer some study-specific questions, such as questions about appointment times. However, you may contact the IRB if the research staff cannot be reached or if you wish to talk to someone other than the research staff. Do not sign this consent form unlessyou have had a chance to ask questions and have gotten satisfactory answers.
If you agree to be in this study, you will receive a signed and dated copy of this consent form for your records.
CONSENT: I understand and have read this consent form (or it has been read to me). All my questions about the study and my part in it have been answered. I consent to be in this research study. I will be given a copy of the signed consent form.
By signing this consent form, I have not given up any of my legal rights.
Federal regulations give you certain rights related to your health information. These include the right to know who will receive the information and how it will be used. The study doctor must obtain your authorization (permission) to use or release any health information that might identify you. During the course of the study, the study doctor will collect health information about you, which will be used to learn about the safety and effectiveness of the study drug. This will include information that identifies you. You must give your authorization (permission) before the study doctor can use or share your health information with others. This section will describe how your health information will be collected, used, and disclosed and describes your rights, including the right to see your health information.
DEFINITION OF HEALTH INFORMATIONYour health information includes your medical records such as your medical records made by any doctor, hospital, or another healthcare provider not part of the study. It also includes information about you collected during the study. This information may include the dates or results of different tests or examinations. The study doctor may need this information to watch, review and report on the safety of the study drug.
Some of the information that may identify you include:
Specifically, I request and authorize any part of my health information relevant to the research project, identified above and in the informed consent document, to be used and/or disclosed to the Principal Investigator above or his/her designee, in connection with the research project.
I specifically authorize the use and disclosure of the following Protected Health Information.
I understand that copies of the records indicated above may be:
I understand that by signing this form, I will allow Baton Rouge General Medical Center and its researchers to use and disclose my health information in connection with the attached informed consent and for the purpose of the research that is described in the informed consent. For example, the researchers may need the information to verify that I am eligible to participate in the study, or to monitor the results, including expected or unexpected side effects or outcomes. Other Baton Rouge General Medical Center and government officials, safety monitors, and study sponsors may need the information to ensure that the study is conducted properly. Also, I understand that my health information may be disclosed to insurance companies or others responsible for my medical bills to secure payment.
I understand that any privacy rights not specifically mentioned in this Authorization are contained in the Notice of Privacy Practices that I received, or will receive, from the Principal Investigator or at the facility that I attend.
I understand that I may revoke this authorization at any time, except to the extent that Baton Rouge General Medical Center has already relied on the authorization, by sending or transmitting of a facsimile, a written notice to the contact person listed in the attached informed consent document(s).
I understand that if my information has already been included in a research database or registry as described in the attached informed consent document(s), Baton Rouge General Medical Center considers itself to have relied on it and therefore, my information will not be removed from those repositories.
Unless otherwise revoked, I understand that this authorization:
☒ Will expire upon the destruction of study records.
I understand that if I do not sign this form, I will not be able to participate in the above research study or receive the study related interventions, but that Baton Rouge General Medical Center cannot withhold treatment.
While the research study is in progress, my right to access any research records or results that are maintained by the facility may be suspended until the research study is over. If my access is denied, I understand that it will be reinstated at the end of the research study.
I understand that the information disclosed by this authorization may be subject to additional disclosure by the recipient and no longer be protected by the Health Insurance Portability and Accountability Act. The Baton Rouge General Medical Center facility, its employees, officers, and physicians are hereby released from any legal responsibility or liability for disclosure of the above information to the extent indicated and authorized herein.