HIDDEN: Stores the date and time the participant enrolled or survey was last updated
Now M-D-Y H:M:S
HIDDEN: Mirror Master Timestamp for Long Covid Surveys
HIDDEN: PDF of consent with LAR signature
Are you 18 to 80 years old?
* must provide value
Yes
No
Are you 13 to 17 years old?
* must provide value
Yes
No
Thank you for your interest. You are not eligible to participate in this research study, since you must be between 13 and 80 years of age in order to participate.
If you have any questions, please feel free to email the research coordinators at wearables_validation@stanford.edu . Please close this page.
Are you currently pregnant, or is there a chance you may be pregnant?
* must provide value
Yes
No
Thank you for your interest. You are not eligible to participate in this research study.
We currently do not have enough information on how pregnancy affects the COVID-19 alert system.
If you have any questions, please feel free to email the research coordinators at wearables_validation@stanford.edu . Please close this page.
Do you have any known cardiac conditions?
* must provide value
Yes
No
e.g. coronary artery disease, myocardial infarction, brady- or tachyarrhytmia, cardiomyopathy, or implanted cardiac device or pacemaker
Thank you for your interest. You are not eligible to participate in this research study.
We currently do not have enough information on how cardiac conditions affect the COVID-19 alert system.
If you have any questions, please feel free to email the research coordinators at wearables_validation@stanford.edu . Please close this page.
Do you currently own a wearable device?
* must provide value
Yes
No
Wearable Health Tracker e.g. Fitbit, Apple Watch, Whoop, Oura Ring...
Thank you for your interest. You are not eligible for our study at this time.
If you have any questions, please feel free to email the research coordinators at wearables_validation@stanford.edu . Please close this page.
Are you willing to share wearable device data for research?
* must provide value
Yes
No
Thank you for your interest. You are not eligible to participate in this research study, since you must be willing to share wearable wearable device data to participate.If you have any questions, please feel free to email the research coordinators at wearables_validation@stanford.edu . Please close this page.
Thank you, you are eligible for the study... If you are between 13-17 years old please have a parent or guardian help you complete the next section
STUDY TITLE:
VALIDATING ALGORITHMS FROM WEARABLES DATA TO PREDICT ONSET AND PROGRESSION OF RESPIRATORY INFECTION INCLUDING COVID-19
SUMMARY OF THE STUDY We are asking you to consider being in this research study, and your participation is completely voluntary. The purpose of this study is to understand if wearable devices can be used to track infectious diseases like COVID-19. Your participation will take 5-10 hours over a period of 5 years total. We will ask you to download our mobile app and share your wearables data. The app may send you an alert and ask you to report symptoms or circumstances back to us. Some people will also be asked to collect nasal swabs samples and blood samples from a finger prick. The risks of participating in this study are minimal and may include: a possible loss of confidentiality; skin reaction to the bands supplied with the wearable devices; pain and/or inflammation at the site of the finger prick. We cannot and do not guarantee or promise that you will receive any benefits from this study. The alternative is not to participate in the study. I am an adult participant in this study.
I am the parent or guardian granting permission for a child in this study (the use of "you" refers to "your child" or "your ward.")
Consent PURPOSE OF RESEARCH You are invited to participate in a research study to evaluate the use of algorithms from wearables data to predict onset and progression of respiratory infection.
We are trying to establish if data collected from wearable devices (eg Fitbit, Apple Watch, Oura Ring, Garmin and others) can be used to predict the onset of an infectious disease such as COVID-19 before the symptoms start. Depending on your device, we will collect data such as step count, body movement, electrical changes in the skin related to stress (galvanic skin response, GSR), skin temperature, your location (global positioning system, GPS), the amount of oxygen in your blood, blood pressure, sleep quality, heart rate and heart rate variability.
In a previous study, we developed an algorithm that can correlate changes in physiological parameters (such as heart rate) with onset of infectious disease(s). We hope that this algorithm can be used to warn people that they are getting sick, even before any symptoms start. The purpose of this study is to test this algorithm. We will do this by sending participants an alert when we detect a change in their physiological parameter(s). After receiving the alert, participants will be asked to report circumstances back to the research team. This will help us to understand whether the algorithm is detecting the onset of infection(s), or if there is another reason for the physiological change (eg heart rate change because of watching a scary movie, stress, medications).
We are asking about 10,200 participants to be part of this study at Stanford University.
Active participation will take approximately 5-10 hours total over the course of up to 5 years.
WHO CAN BE ENROLLED IN THE STUDY?
To be eligible for this study, you must:
Own a wearable device that measures heart rate; Be 13 - 80 years of age; Do not have any known cardiac conditions (e.g. coronary artery disease or history of myocardial infarction, brady- or tachyarrhythmias, valvular disease, cardiomyopathy, etc) or cardiac devices (e.g. implanted cardiac monitor, pacemakers, defibrillators, etc). Not be pregnant. VOLUNTARY PARTICIPATION
Your participation in this study is entirely voluntary. If you decide not to participate it will not have any negative effect on you or your medical care. You can decide to participate now but withdraw your consent later and stop being in the study without any loss of benefits or medical care to which you are entitled.
WHAT WILL YOU ASK ME TO DO? Taking part in the study will involve:
1- Downloading an app, developed by the Snyder lab at Stanford University, that will allow us to collect the data from your wearable device;
2- Telling us about your symptoms and circumstances using the app when asked;
3- We will ask some participants (see below description of the study groups) to collect some samples at home.
There will be two groups of participants that will receive different instructions. You can choose which group you would like to be part of.
Group A (200 people - for US residents only) - reporting symptoms and collecting samples:
We will mail you a kit to collect samples at home We may ask you to take a baseline sample when you enroll When you receive an alert on the app, we will ask you to report your symptoms and circumstances via the app for the next several days to weeks, when prompted; take a microsample (a drop of blood from a finger prick) and nasal swabs sample at home several times over the next several weeks, when prompted. Group B (10,000 people) - reporting symptoms but not collecting samples:
• When you receive an alert on the app, we will ask you to report your symptoms and circumstances via the app for the next several days to weeks, when prompted.
We will ask everyone to report their health status at least once per month using the app.
We will ask you to continuously wear your device and share the data collected by the device with the study team. The devices will be worn or used every day, for up to 24 hours per day, up to 24 months. You will be able to remove the devices for part of each day as needed and when you feel comfortable doing so. The study-related app that we will ask you to download will give us access to your wearable device data remotely. You will receive instructions via email on how to properly install the app and how to sync it to your wearable device(s) app, so it can securely collect your data. If you are using a Fitbit device, Stanford will have access to data about your activity (including steps distance, calories burned, and active minutes), heart rate, location, nutrition, sleep, weight, heart rate variability (HRV), Fitbit cardio fitness score, off wrist time, and sedentary time. We will analyze data from your wearable device with the symptoms and circumstances you report to us. We will also gather your health information by asking you directly or by looking at your electronic medical record if you agree (see section below). You have the right to refuse to answer particular questions. If you are participating in other Stanford research study(ies), we will ask for your permission to obtain and analyze research data collected from that research study if that study allows for the sharing of your research data.
YOUR MEDICAL INFORMATION If you agree, we would like to collect medical history and medial information regarding COVID-19 infection and/or other infectious diseases including test results and diagnoses. We will either ask your permission to access your electronic medical record and/or ask you to share these records with us. Please note that you might also need to agree to a separate medical release form before sharing your records. This may vary by the clinic/hospital where you are receiving your medical care. If you are not sure whether or not you want to give this study permission to access your medical records, please talk to your physician about it first.
ALERTING When our algorithm detects a change in your heart rate or other physiological parameters, you will receive an alert via a push notification from the study app. You will be asked to report circumstances back to us. This will help us to track if you are getting sick, or whether there might be other reasons for the change in the physiological parameter. Some examples of other reasons for change in physiological parameters are: watching a scary movie, high level of stress, change in medication, intense and prolonged physical activity, etc. Please note that this alert is for research purposes only. We can't promise to monitor or notify you about medically significant issues, but it is possible that in some cases we might contact you if we believe there is something worth following up.
There is a chance that you will receive an alert when there is no change detected in your physiological parameters. This is part of validating of our algorithm. The alert will look the same to you, so we want you to follow the same procedure, according to the group you are in.
SAMPLING (Group A only) You will receive by mail a kit containing all the supplies together with the instructions for you to follow to collect blood microsamples and nasal swabs samples. You can collect the samples at home and safely store them in your fridge using the bags we will give you. We expect you to mail the samples back on a weekly basis. We will give you the shipping materials and shipping instructions. We would like to collect samples at the following times. We will send you reminders via the app:
Soon after you enroll you will collect one microsample When you receive an alert (within 24 hours) you will collect one microsample and one nasal swabs sample; we will provide you with instructions on how to collect the samples. 3 days, 1 week, 2 weeks and 4 weeks after the alert you will collect a microsample and nasal swabs sample (4 times total over the course of 4 weeks); 12 weeks after the alert you will collect one microsample. If you report any symptoms you will be asked to restart this timeline schedule. For example, if you develop a sore throat on day 10 after the alert, we will ask you to collect samples on that day, then 3 days, 1 week, 2 weeks and 4 weeks after that. We will send you reminders via the app. Preferably the microsamples should be collected in the morning after fasting for 10 hours. Every time you collect microsamples, please complete a short online survey to tell us the day and time of samples collection and the barcode number of the microsampling device. All the data collected in this study will be stored in a secure online database and can only be accessed by study staff.
WHAT TEST WILL YOU DO ON MY SAMPLES? We will perform a series of test, including but not limited to:
C-reactive protein (CRP), a protein that indicates the level of inflammation in your body; Testing for several different types of respiratory infections including COVID-19, that can indicate if you have an active infection; Antibodies for COVID-19 or other infections, that can indicate you might have been expose to the COVID-19 virus or other virus in the past. Any of your samples used in research may result in new products, tests or discoveries. In some instances, these may have potential commercial value and may be developed and owned by the Investigators, Stanford University and/or others. However, donors of samples do not retain any property rights to the materials. Therefore, you would not share in any financial benefits from these products, tests or discoveries.
DATA RELEASE The data we collect for the study may be used for research use purposes, for example making the algorithms publicly available, or sharing research data in databases that can be accessed by the public. Any information that is shared publicly will be de-identified and no personal identifiers (such as name, date of birth, address, etc.) will be shared.
Identifiers might be removed from samples and data and the de-identified samples and data could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you. Upon your request, we can provide you a visual representation of some data collected from the wearable devices combined with your self-reported data about sickness and symptoms. You are welcome to express interest by emailing us at wearables_validation@stanford.edu. Please note that this representation of data is a summary of the data collected over a certain period of time with no interpretation of results, and it must be considered for research use only.
If you are in the Group A, we may inform you of any research results we learn from your samples. Results from the nasal swabs regarding active COVID-19 infection (meaning you have the virus at the time of the sampling) will be available to you from the Labcorp website. You will need to create an account on their website. You should receive the COVID-19 results within 2-3 days from the day you collect and ship the samples. There is no cost for you for this test, including the shipment. Please note that we are obligated to share positive coronavirus test results with the public health department of the county in which you live. On the microsamples, we might perform COVID-19 and other infections antibodies test. This test helps to determine if a person may have been infected with the virus that causes COVID-19. The test looks for the presence of antibodies, which are specific proteins made in response to infections. Antibodies are detected in the blood of people who are tested after infection; they show an immune response to the infection. Microsampling to test the presence of other infection disease antibodies will be for research only and you will not receive the results from the test.
PARTICIPANT RESPONSIBILITIES As a participant, your responsibilities include:
Follow the instructions of the Protocol Director and study staff. Collect samples as instructed. Complete surveys about your symptoms and circumstances when prompted. Ask questions as you think of them. Tell the Protocol Director or research staff if you change your mind about participating in the study. WITHDRAWAL FROM STUDY If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time. If you withdraw from the study, we will continue using data collected from you, your health information and samples unless you tell us not to. It is possible that some samples and data may not be able to be withdrawn after the study has started. The Protocol Director may also withdraw you from the study without your consent for one or more of the following reasons:
Failure to follow the instructions of the Protocol Director and study staff. Unanticipated circumstances. POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions. There could be a possible skin reaction to the bands supplied with the wearable devices. The finger prick may cause discomfort, pain and/or inflammation at the site of the finger prick. Although we will make every effort to keep your information confidential, there is a theoretical risk of a privacy breach as there is for every research study.
POTENTIAL BENEFITS Reasonably expected benefits include:
Contribution to understanding and tracking COVID-19 infection. We cannot and do not guarantee or promise that you will receive any benefits from this study.
ALTERNATIVES The alternative is not to participate in the study.
PARTICIPANT'S RIGHTS You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director. You will be told of any important new information that is learned during the course of this research study which might affect your condition or your willingness to continue participation in this study.
CONFIDENTIALITY The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified. Patient information may be provided to federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.
FINANCIAL CONSIDERATIONS You will not be paid to participate in this research study. There is no cost to you for participating in this study. The National Institute of Health (NIH) is providing financial support and/or material for this study.
COMPENSATION for Research-Related Injury All forms of medical diagnosis and treatment - whether routine or experimental - involve some risk of injury. In spite of all precautions, you might develop medical complications from participating in this study. If such complications arise, the Protocol Director and the research study staff will assist you in obtaining appropriate medical treatment. In the event that you have an injury or illness that is directly caused by your participation in this study, reimbursement for all related costs of care first will be sought from your insurer, managed care plan, or other benefits program. You will be responsible for any associated co-payments or deductibles as required by your insurance. If costs of care related to such an injury are not covered by your insurer, managed care plan or other benefits program, you may be responsible for these costs. If you are unable to pay for such costs, the Protocol Director will assist you in applying for supplemental benefits and explain how to apply for patient financial assistance from the hospital. You do not waive any liability rights for personal injury by signing this form.
CONTACT INFORMATION Questions, Concerns, or Complaints: if you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, you should contact the research coordinator Alessandra Celli at alessandra.celli@stanford.edu. You should also contact the protocol director Michael Snyder at mpsnyder@stanford.edu at any time if you feel you have been hurt by being a part of this study.
Independent Contact: If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at (650)-723-5244 or toll free at 1-866-680-2906. You can also write to the Stanford IRB, Stanford University, 1705 El Camino Real, Palo Alto, CA 94306.
EXPERIMENTAL SUBJECT'S BILL OF RIGHTS As a research participant you have the following rights. These rights include but are not limited to the participant's right to:
be informed of the nature and purpose of the experiment; be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized; be given a description of any attendant discomforts and risks reasonably to be expected; be given an explanation of any benefits to the subject reasonably to be expected, if applicable; be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits; be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise; be given an opportunity to ask questions concerning the experiment or the procedures involved; be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision. CERTIFICATE OF CONFIDENTIALITY This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.
FOR EUROPEAN UNION RESIDENTS ONLY As described elsewhere in this informed consent form, during the study, data pertaining to your participation in the study will be generated and recorded. In addition, we will collect from you your personal data and sensitive personal data, including health-related data. We refer to all such data as "Your Study Data," which will be specifically regulated in the EU/EEA under the General Data Protection Regulation (the "GDPR"). Your Study Data may be processed or used for the following purposes, which we refer to, collectively, as "Data Processing":
to carry out the study; to confirm the accuracy of the study; to monitor that the study complies with applicable laws as well as best practices developed by the research community; to make required reports to domestic and foreign regulatory agencies and government officials who have a duty to monitor and oversee studies like this one; and, to comply with legal and regulatory requirements, including requirements that data from this study, without information that could directly identify you, be made available to other researchers not affiliated with the study sponsor or with the study team. It is possible, for example, that as part of efforts to make research data more widely available to researchers, regulatory authorities in some countries may require that Your Study Data, without information that could directly identify you, be made publicly available on the internet or in other ways. The following entities and organizations may engage in Data Processing of Your Study Data:
the study team; the Office for Human Research Protections in the U.S. Department of Health and Human Services; the ethics committee or institutional review board that approved this study; and domestic and foreign regulatory agencies and government officials who have a duty to monitor or oversee studies like this one. We may conduct the study in the United States or in other countries where the laws do not protect your privacy to the same extent as the laws in your country of residence. In addition, we may disclose Your Study Data for Data Processing to entities and individuals located in the United States or in other countries where the laws do not protect your privacy to the same extent as the laws in your country of residence. However, all reasonable steps will be taken to protect your privacy in accordance with the applicable data protection laws.
YOUR RIGHTS AND DATA RETURN
The GDPR gives you certain rights with regard to Your Study Data. You have the right to request access to, rectification of, or erasure of, Your Study Data. You also have the right to object to or restrict our Data Processing of Your Study Data. Finally, you have a right to request that we move, copy or transfer Your Study Data to another organization. In order to make any such requests, please contact the Principal Investigator Dr. Michael Snyder at mpsnyder@stanford.edu or +1 650-736-8099 and/or the study coordinator Alessandra Celli at alessandra.celli@stanford.edu or +1 650-725-4185. There is no limit on the length of time we will keep Your Study Data for this research because it may be analyzed for many years. We will also retain your Study Data to comply with our legal and regulatory requirements. We will keep it as long as it is useful, unless you decide you no longer want to take part. You are allowing access to this information indefinitely as long as you do not withdraw your consent. You may withdraw your consent at any time. If you withdraw your consent, this will not affect the lawfulness or our collecting, use and sharing of Your Study Data up to the point in time that you withdraw your consent. Even if you withdraw your consent, we may still use Your Study Data that has been anonymized so that the data no longer identifies you. In addition, we may use and share Your Study Data that has been pseudonymized (by removal of your name and certain other identifiers so that the data does not directly identify you) as permitted by applicable law for purposes of: (a) public health (e.g., ensuring high standards quality and safety of health care and/or of medicinal products or medical devices), (b) scientific or historical research or statistical analysis as permitted by applicable European Union or European Union Member State laws and (c) archiving in the public interest. Further, we will maintain Your Study Data in fully identifiable form if required by law. You consent to the collection, use and transfer of Your Study Data, which includes health and other sensitive personal data, for the purpose of carrying out the research study and know that you can withdraw your consent at any time, and we will stop processing your personal data, except as described above.
Please read the consent carefully before continuing.
Do you agree with the terms of the study?
* must provide value
I've read the attached document and I AGREE with the terms of the study.
I've read the attached document and I DO NOT AGREE with the terms of the study.
Thank you for your interest. You are not eligible to participate in this research study.If you have any questions, please feel free to email the research coordinators at wearables_validation@stanford.edu . Please close this page.
Please enter your signature for consent
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Signing your name means you agree to be in this study and that you will receive a copy of this signed and dated consent form.
Signature of Legally Authorized Representative (LAR)
(e.g., parent, guardian or conservator)
* must provide value
Print name of Legally Authorized Representative (LAR)
(e.g., parent, guardian or conservator)
* must provide value
LAR’s Authority to Act for Participant
(e.g., parent, guardian or conservator)
* must provide value
HIDDEN: Name of Person Obtaining Consent
HIDDEN: Signature of Person Obtaining Consent
HIDDEN: Date of Person Validating Consent
Today M-D-Y
HIPAA Authorization HIPAA Authorization: Please read it carefully before continuing.
Authorization To Use Your Health Information For Research Purposes Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it. What is the purpose of this research study and how will my health information be utilized in the study? The purpose of this study to evaluate the use of algorithms from wearables data to predict onset and progression of respiratory infection. We are trying to establish if data collected from wearable devices can be used to predict the onset of an infectious disease such as COVID-19 before the symptoms start. All data will be stored securely on RedCap or Stanford Medicine Box. Data from your blood microsamples and nasal swabs samples will be considered in the context of the study participant population to determine if different types of biological responses exist, and if so, how we might predict the response of an individual. You will also be asked to complete a survey about your symptoms, share if you have a COVID-19 test and the results of the test, as well as other medical information that are relevant to infectious diseases.
Do I have to sign this authorization form? You do not have to sign this authorization form. But if you do not, you will not be able to participate in this research study. Signing the form is not a condition for receiving any medical care outside the study. If I sign, can I revoke it or withdraw from the research later? If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to: Dr. Michael Snyder (mpsnyder@stanford.edu ).
What Personal Information Will Be Obtained, Used or Disclosed? Data collected during the study consists of, but is not limited to, your name, date of birth, phone number, email address, postal address, gender, ethnicity, other demographic information, medical record number, answers to questionnaires, wearable device serial number (if available), test results and other diagnosis, treatment, or physiologic information from your medical record. Additionally (for Fitbit owners only), we will collect Fitbit I.D.’s: the Fitbit Heart Rate Variability data comes with the Fitbit ID, so we need the Fitbit IDs (that will be stored in Stanford secure database Redcap) to map participants’ Heart Rate Variability data set to each individual.
Who May Use or Disclose the Information? The following parties are authorized to use and/or disclose your health information in connection with this research study:
The Protocol Director Dr. Michael Snyder The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary Research Staff Who May Receive or Use the Information? The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:
The Office for Human Research Protections in the U.S; Department of Health and Human Services; The Food and Drug Administration (FDA); The National Institute of Health (NIH); Labcorp; The local health officer where you reside. Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.
When will my authorization expire? Your authorization for the use and/or disclosure of your health information will end on December 31, 2030 or when the research project ends, whichever is earlier.
Please read the HIPAA authorization carefully before continuing.
Do you authorize the use of your health information for research purposes?
* must provide value
I've read the attached document and I AGREE with the terms of the study.
I've read the attached document and I DO NOT AGREE with the terms of the study.
Thank you for your interest. You are not eligible to participate in this research study.If you have any questions, please feel free to email the research coordinators at stanford_covid19_wearables@stanford.edu. Please close this page.
Please enter your signature for HIPAA authorization
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Please print name of Adult Participant for HIPAA authorization
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Please enter signature of Legally Authorized Representative (LAR) for HIPAA authorization
(e.g., parent, guardian)
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Please print name of Legally Authorized Representative (LAR) for HIPAA authorization
(e.g., parent, guardian)
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Assent - To be completed by child Please have the child carefully read and complete the assent form below
STUDY TITLE: VALIDATING ALGORITHMS FROM WEARABLES DATA TO PREDICT ONSET AND PROGRESSION OF RESPIRATORY INFECTION INCLUDING COVID-19
1. WHAT WILL HAPPEN TO ME IN THIS STUDY?
This study is trying to understand if the information from a smart watch (like Apple watch, Fitbit, etc.) can be used to guess and track when people are getting sick from diseases like the coronavirus, COVID-19.
To participate in this study, you must already own a smartwatch like a Fitbit, Apple Watch, Garmin, etc. and a smartphone as well. Your watch must collect information such as the number of steps that you take during the day, your heart rate (the number of times your heart beats per minute), the quality of your sleep (if you wear the watch while sleeping), etc.
If you decide to be in this study, we will ask you to wear your smartwatch on your wrist as much as possible and ask you to install in your phone a study app (called MyPHD) that will collect the information that we need for the study. This app will also ask you sometimes to tell us how you feeling. This will ask if you are experiencing things like fever, headaches, or cough or if you have been doing other things such as watching a scary movie or exercising.
2. Can anything bad happen to me?
We do not think that anything bad can happen to you if you decide to be in this study. If wearing the watch is bothering you, please tell your parents and do not wear it anymore if you don’t want to.
3. Can anything good happen to me?
Being in this study will not help you, but it might help other people because we will learn things that could help treat people who are sick with COVID-19.
4. Do I have other choices?
You do not have to be in this study if you do not want to. It is completely up to you.
5. Will anyone know I am in the study?
Your participation in this study will be kept secret from most people, but some researchers at the Stanford University will know who you are.
6. What happens if I get hurt?
Your parents (or legal guardians) have the information about what to do if you are hurt during this study. Please it is important that you tell them if you get hurt because of this study at any point.
7. Who can I talk to about the study?
If this form is confusing to you or has words you do not understand, please ask your parents or us to explain it better.
If you have any questions about the study or any problems later, you or your parents can contact the Protocol Director, Michael Snyder. You can call him at (650) 736-8099 or email him at mpsnyder@stanford.edu.
If you have questions about the study but want to talk to someone else who is not a part of the study, you can call the Stanford Institutional Review Board (IRB) at (650)-723-5244 or toll free at 1-866-680-2906.
8. What if I do not want to do this?
You do not have to be in this study if you do not want to. No one will be upset or angry with you. If you start this study and change your mind later, you can stop. You can stop any time without getting in trouble. Just let your parents or guardian and Dr. Snyder and his team know.
If you agree to be in this study, please sign here: Signature of Child
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Printed name of Child
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If you have read the forms attached and have decided to participate in this project, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled. The alternative is not to participate. You have the right to refuse to answer particular questions.
Have you had a confirmed or suspected case of COVID-19?
* must provide value
Yes
No
How was your case of COVID-19 confirmed or suspected?
* must provide value
Confirmed - PCR test (e.g. nasal/throat swab, saliva)
Confirmed - Antibody test (e.g. blood draw)
Confirmed - Other test
Suspected - Self-assessment (e.g. close contact/symptomatic)
Suspected - Doctor diagnosis (but not tested)
I believe I had COVID-19 but PCR test was negative
I believe I had COVID-19 but antibody test was negative
Approximate date of COVID-19 symptom onset?
* must provide value
Today M-D-Y
Date sample collected for COVID-19 test?
* must provide value
Today M-D-Y Ideally the first test that was positive if multiple tests performed
Would you like to provide additional details about your COVID-19 confirmed or suspected status?
Are you at a higher risk of exposure to COVID-19 for any of these reasons?
Check all that apply, or select other and fill in reason
When your illness started were you at a higher risk of exposure to COVID-19 for any of these reasons?
Check all that apply, or select other and fill in reason
Please let us know how you may have had higher exposure to COVID-19?
Have you received a vaccination for COVID-19?
Yes
No
When did you first receive your vaccination for COVID-19?
Today M-D-Y M-D-Y
Verification emails addresses must match! Please make sure the Email Address and Verify Email fields match!
Date of Consent *must provide value
First Name *must provide value Last Name *must provide value Email Address *must provide value Verify Email (Please enter the same email address again)
*must provide value
Phone Number
*must provide value What operating system runs on your phone?
*must provide value What types of wearable device are you using?
*must provide value Mailing Address
Street:
City: *must provide value
State / Province: *must provide value
Country:
*must provide value
Zip Code / Postal Code: *must provide value
Date of Birth
*must provide value Sex assigned at birth (Biological Sex)
*must provide value Race / Ethnicity
*must provide value Height
Feet:
Inches:
--- OR ---
Meters:
Centimeters:
Weight in Pounds (lbs) Please indicate if we can collect your electronic medical records *must provide value How did you hear about this study? Are you willing to be recontacted for future studies? *must provide value
Verification emails addresses must match! Please make sure the 'Email Address' and 'Verify Email' fields match!
Please let us know what other type of wearable wearable device you use?
Are you a nursing home resident?
Yes
No
Do you have a history of any of the following conditions? Please select all that apply.
Are you currently taking any medications routinely?
Yes
No
Including hormone therapy
Please list any medications you are currently taking
Please provide further details about ear, nose, or throat disease or condition
Please provide further details of cardiovascular disease or conditions
Please provide further details about respiratory or lung disease or condition
Please provide further details about gastrointestinal or digestive system disease or condition
Please provide further details about genitourinary disease or condition
Please provide further details about skin disease or condition
Please provide further details about neurological disease or condition
Please provide further details about psychiatric disease or condition
Please provide further details about endocrine disease or condition (other than diabetes)
Please provide further details about muscular or skeletal disease or condition
Please provide further details about blood or lymphatic disease or condition
Please provide further details about allergy or immune system disease or condition
Please provide further details about any other disease or condition not covered above
Date of Consent
* must provide value
Today M-D-Y
First Name
* must provide value
Last Name
* must provide value
Email
* must provide value
Verify Email
* must provide value
Phone Number
* must provide value
Phone System
* must provide value
I have an iPhone, so iOS
I have an Android phone
What type of wearable device?
* must provide value
Address City
* must provide value
Address State / Province
* must provide value
Address Zip Code / Postal Code
* must provide value
If you do not have one or this does not apply please enter 0
Address Country
* must provide value
Date of Birth
* must provide value
Today M-D-Y
Male
Female
Intersex
Other / Decline to answer
Race/Ethnicity
* must provide value
2 feet 3 feet 4 feet 5 feet 6 feet 7 feet 8 feet
0 meter 1 meter 2 meters
0 inches 1 inch 2 inches 3 inches 4 inches 5 inches 6 inches 7 inches 8 inches 9 inches 10 inches 11 inches
Recontact
* must provide value
Yes
No
Medical Record Share
* must provide value
Yes
No
Click to view consent
Do you live in the United States or Canada?
* must provide value
Yes
No
Thank you for your interest. You are not eligible to participate in this research study, unfortunately we can only accept US participants at the moment.
If you have any questions, please feel free to email the research coordinators at wearables_validation@stanford.edu . Please close this page.
You may be eligible to receive a wearable device from our study team. Please continue answering the following screening questions if interested.
If you have any questions or concerns please reach out to covid19_fitbit_study@stanford.edu
Have you been diagnosed with COVID-19?
* must provide value
Yes
No
Were you referred to this study by UCLA Healthcare or a UCLA affiliate?
Yes
No
Are you at higher risk of exposure to COVID-19 through your occupation or lifestyle (e.g. healthcare or frontline worker, student attending classes)?
* must provide value
Yes
No
Are you a:
* must provide value
Healthcare worker
Frontline worker
In-person teacher
Student attending in-person classes
None of the above
Other
Thank You - You are eligible to participate... We appreciate your interest in Stanford University's study to find out how wearable devices can track infectious diseases like COVID-19. This study is being conducted by the laboratory of Dr. Michael Snyder, PhD.
It should take you approximately 5 minutes to complete enrollment in this study.
Next steps: 1. Read the consent materials 2. Sign our e-consent form
Study Overview We are trying to establish if data collected from wearable devices can be used to predict the onset of an infectious disease such as COVID-19 before the actual symptoms start. We will collect data such as heart rate, skin temperature, blood oxygen saturation etc.
We will want you to: 1. Wear your device continuously 2. Register in the MyPHD smartphone app to upload wearable data 3. Regularly fill out surveys in the MyPHD app
Data We ask you to install and register the MyPHD app on your smartphone device to allow secure transfer of data from your wearable device to Stanford.
Additionally, if you agree, we would like to collect medical record information from you. We will either ask your permission to access your electronic medical record and/or ask you to share these records with us.
Other Information Time Involvement: Your participation will take up to 24 months and you will be asked to wear the device continuously, with breaks as needed. The daily survey can be filled out online or via the app, and will take 1-2 mins per day.
Risks and Benefits: There might be some loss of confidentiality for the data collected by the wearable devices. We cannot and do not guarantee or promise that you will receive any benefits from this study.
Payments: You will receive no payment for your participation.
Cost: There is no cost to you for participating in this study.
Contact Information Questions: If you have any questions, concerns or complaints about this research, its procedures, risks and benefits, contact us at wearables_validation@stanford.edu
Independent Contact: If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at 650-723-2480 or toll free at 1-866-680-2906. You can also write to the Stanford IRB, Stanford University, 1705 El Camino Real, Palo Alto, CA 94306.
Consent Agreements [Attachment not found] Thank you, you are eligible... Please read and complete the consent below
Consent STUDY TITLE: VALIDATING ALGORITHMS FROM WEARABLES DATA TO PREDICT ONSET AND PROGRESSION OF RESPIRATORY INFECTION INCLUDING COVID-19 - FITBIT
SUMMARY OF STUDY We are asking you to consider being in this research study, and your participation is completely voluntary. The purpose of this study is to understand if wearable devices can be used to track infectious diseases like COVID-19. Your participation will take 3-5 hours over a period of 2 years total. We will ask you to download our mobile app and share your wearables data. The app may send you an alert and ask you to report symptoms or circumstances back to us. If some participants wish, they can undergo additional optional sampling where they will be asked to collect nasal swabs samples and blood samples from a finger prick. The risks of participating in this study are minimal and may include: a possible loss of confidentiality; skin reaction to the bands supplied with the wearable devices; pain and/or inflammation at the site of the finger prick. We cannot and do not guarantee or promise that you will receive any benefits from this study. The alternative is not to participate in the study. PURPOSE OF RESEARCH You are invited to participate in a research study to evaluate the use of algorithms from wearables data to predict onset and progression of respiratory infection.
We are trying to establish if data collected from wearable devices like the Fitbit smartwatch, can be used to predict the onset of an infectious disease such as COVID-19 before the symptoms start. Depending on your device, we will collect data such as steps, distance, calories burned, and active minutes), heart rate, location, nutrition, sleep, weight, heart rate variability (HRV), Fitbit cardio fitness score, off-wrist time, and sedentary time.
In a previous study, we developed an algorithm that can correlate changes in physiological parameters (such as heart rate) with onset of infectious disease(s). We hope that this algorithm can be used to help detect the onset of sickness or disease, even before any symptoms start. The purpose of this study is to test this algorithm. We will do this by sending participants an alert when we detect a change in their physiological parameter(s). After receiving the alert, participants will be asked to report circumstances back to the research team. This will help us to understand whether the algorithm is detecting the onset of infection(s), or if there is another reason for the physiological change (eg heart rate change because of watching a scary movie, stress, medications).
Please note that the study device (algorithm used with wearable device data and MyPHD app) is not FDA approved for the use under this study.
We are asking about 500 participants to be part of this study at Stanford University.
Active participation will take approximately 3-5 hours total over the course of up to 2 years.
WHO CAN BE ENROLLED IN THE STUDY? To be eligible for this study, you must:
Be 18 - 70 years of age; Do not have any known cardiac conditions (e.g. coronary artery disease or history of myocardial infarction, brady- or tachyarrhythmias, valvular disease, cardiomyopathy, etc) or cardiac devices (e.g. implanted cardiac monitor, pacemakers, defibrillators, etc). Not be pregnant. Are at high risk of exposure to COVID-19 because of contact with positive individuals (e.g. healthcare workers, frontline workers, student attending on-campus classes, etc.) VOLUNTARY PARTICIPATION Your participation in this study is entirely voluntary. If you decide not to participate it will not have any negative effect on you or your medical care. You can decide to participate now but withdraw your consent later and stop being in the study without any loss of benefits or medical care to which you are entitled.
WHAT WILL YOU ASK ME TO DO? Taking part in the study will involve:
Downloading an app, MyPHD, developed by the Snyder lab at Stanford University, that will allow us to collect the data from the wearable device; Telling us about your symptoms and circumstances using the app when asked; If some participants wish, they will be asked to provide additional optional sampling to collect at home (see below description for optional sampling). Reporting symptoms but not collecting samples:
When you receive an alert on the app, we will ask you to report your symptoms and circumstances via the app for the next several days to weeks, when prompted. Optional Sampling– reporting symptoms and collecting samples:
We will mail you a kit to collect samples at home We may ask you to take a baseline sample when you enroll When you receive an alert on the app, we will ask you to report your symptoms and circumstances via the app for the next several days to weeks, when prompted, and take a microsample (a drop of blood from a finger prick) and nasal swabs sample at home several times over the next several weeks, when prompted. Additionally:
We will ask everyone to report their health status at least once per month using the app.
We will ask you to continuously wear the Fitbit device and share the data collected by the device with the study team. The devices will be worn or used every day, for up to 24 hours per day, up to 24 months. You will be able to remove the devices for part of each day as needed and when you feel comfortable doing so.
The study-related app, MyPHD, that we will ask you to download will give us access to your Fitbit wearable device data remotely. You will receive instructions via email on how to properly install the app and how to sync it to your Fitbit smartwatch that we will provide, so it can securely collect your data.
In order to use the provided Fitbit device, you will have to create an account on the Fitbit website and agree with the Fitbit’s Privacy Policy and Terms of Service, which are separate from this research consent form. Fitbit’s Privacy Policy describes how Fitbit collects, uses, shares, and protects your data. Fitbit may also have access to device identifiers so they may be able to identify that you are a participant in this research. For more information about the information that Fitbit may have access to, refer to Fitbit’s Privacy Policy. By agreeing to the Fitbit’s Privacy Policy and Terms of Service, you give Fitbit the right to use Fitbit information so they can provide, improve, and develop their services. In addition, it is important to read Fitbit’s Terms of Service because it includes information about your legal rights when using Fitbit’s products that may differ from your rights as a participant in this study. You can always exercise your right to access your personal information and to understand how Fitbit collects, uses, and discloses the information to other third parties by logging into your Fitbit account and using your account settings.
Stanford will have access to data about your activity (including steps distance, calories burned, and active minutes), heart rate, location, nutrition, sleep, weight, heart rate variability (HRV), Fitbit cardio fitness score, off wrist time, and sedentary time.
We will analyze data from your wearable device with the symptoms and circumstances you report to us. We will also gather your health information by asking you directly or by looking at your electronic medical record if you agree (see section below). You have the right to refuse to answer particular questions.
If you are participating in other Stanford research study(ies), we will ask for your permission to obtain and analyze research data collected from that research study if that study allows for the sharing of your research data.
YOUR MEDICAL INFORMATION If you agree, we would like to collect medical history and medical information regarding COVID-19 infection and/or other infectious diseases including test results and diagnoses. We will either ask your permission to access your electronic medical record and/or ask you to share these records with us. Please note that you might also need to agree to a separate medical release form before sharing your records. This may vary by the clinic/hospital where you are receiving your medical care. If you are not sure whether or not you want to give this study permission to access your medical records, please talk to your physician about it first.
ALERTING When our algorithm detects a change in your heart rate or other physiological parameters, you will receive an alert via a push notification from the study app. You will be asked to report circumstances back to us. This will help us to track if you are getting sick, or whether there might be other reasons for the change in the physiological parameter. Some examples of other reasons for change in physiological parameters are: watching a scary movie, high level of stress, change in medication, intense and prolonged physical activity, etc. Please note that this alert is for research purposes only. We can’t promise to monitor or notify you about medically significant issues, but it is possible that in some cases we might contact you if we believe there is something worth following up.
OPTIONAL SAMPLING If you wish to provide additional optional samples, you will receive by mail a kit containing all the supplies together with the instructions for you to follow to collect blood microsamples and nasal swabs samples. You can collect the samples at home and safely store them in your fridge using the bags we will give you. We expect you to mail the samples back on a weekly basis. We will give you the shipping materials and shipping instructions.
We would like to collect samples at the following times. We will send you reminders via the app:
Soon after you enroll you will collect one microsample When you receive an alert (within 24 hours) you will collect one microsample and one nasal swabs sample. We will provide you with instructions on how to collect the samples. 3 days, 1 week, 2 weeks and 4 weeks after the alert you will collect a microsample and nasal swabs sample (4 times total over the course of 4 weeks) 12 weeks after the alert you will collect one microsample. If you report any symptoms you will be asked to restart this timeline schedule. For example, if you develop a sore throat on day 10 after the alert, we will ask you to collect samples on that day, then 3 days, 1 week, 2 weeks and 4 weeks after that. We will send you reminders via the app.
Preferably the microsamples should be collected in the morning after fasting for 10 hours. Every time you collect microsamples, please complete a short online survey to tell us the day and time of samples collection and the barcode number of the microsampling device. All the data collected in this study will be stored in a secure online database and can only be accessed by study staff.
WHAT TEST WILL YOU DO ON MY SAMPLES?
We will perform a series of test, including but not limited to:
C-reactive protein (CRP), a protein that indicates the level of inflammation in your body; Testing for several different types of respiratory infections including COVID-19, that can indicate if you have an active infection; this test will be prescribed by a licensed health care provided through a company called LetsGetChecked (see below for more details). Antibodies for COVID-19 or other infections, that can indicate you might have been exposed to the COVID-19 virus or other virus in the past. Any of your samples used in research may result in new products, tests or discoveries. In some instances, these may have potential commercial value and may be developed and owned by the Investigators, Stanford University and/or others. However, donors of samples do not retain any property rights to the materials. Therefore, you would not share in any financial benefits from these products, tests or discoveries.
DATA RELEASE The data we collect for the study may be used for research use purposes, for example making the algorithms publicly available, or sharing research data in databases that can be accessed by the public. Any information that is shared publicly will be de-identified and no personal identifiers (such as name, date of birth, address, etc.) will be shared.
Identifiers might be removed from samples and data and the de-identified samples and data could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you. Research using private information and/or specimens is an important way to try to understand human disease. You are being given this information because the investigators want to save private information and/or specimens for future research.
Your information and specimens will be stored with a code number that is linked to your name and other identifiers.
Fitbit will have access to the information you entered to create your account, and the information as covered in the Fitbit Privacy Policy and Terms of Service.
Stanford will protect your data in accordance with this consent and authorization form. In addition, if you agree to create a Fitbit account and provide information to Fitbit, your Fitbit data collected as part of this study will be shared with the researchers with your permission via the MyPHD app. It is important for you to read Fitbit’s Privacy Policy which describes how Fitbit collects, protects, uses, and shares your information.
Upon your request, we can provide you a visual representation of some data collected from the wearable devices combined with your self-reported data about sickness and symptoms. You are welcome to express interest by emailing us at covid19_fitbit_study@stanford.edu. Please note that this representation of data is a summary of the data collected over a certain period of time with no interpretation of results, and it must be considered for research use only.
If you wish to provide us with additional optional samples, we may inform you of any research results we learn from your samples. Results from the nasal swabs regarding active COVID-19 infection (meaning you have the virus at the time of the sampling) will be available to you from the LetsGetChecked website. You will need to create an account on their website by entering your name, email address, address, phone number, date of birth, sex, ethnicity, COVID-19 symptoms and other health conditions. You will need to agree to their Terms of Use and Privacy Policy when you set up your account, which is separate from this consent form and this research study. You should receive the COVID-19 results within 2-3 days from the day you collect and ship the samples. There is no cost for you for this test, including the shipment.
Please note that we are obligated to share positive coronavirus test results with the public health department of the county in which you live. The COVID-19 results will then be transferred from the LetsGetChecked company to the Stanford research team using a secure file transfer protocol, a HIPAA compliant system which will ensure a high level of security.
On the microsamples, we might perform COVID-19 and other infections antibodies test. This test helps to determine if a person may have been infected with the virus that causes COVID-19. The test looks for the presence of antibodies, which are specific proteins made in response to infections. Antibodies are detected in the blood of people who are tested after infection; they show an immune response to the infection. Microsampling to test the presence of other infection disease antibodies will be for research only and you will not receive the results from the test.
PARTICIPANT RESPONSIBILITIES As a participant, your responsibilities include:
Follow the instructions of the Protocol Director and study staff. Collect samples as instructed. Complete surveys about your symptoms and circumstances when prompted. Ask questions as you think of them. Tell the Protocol Director or research staff if you change your mind about participating in the study. WITHDRAWAL FROM STUDY If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time.
If you withdraw from the study, we will continue using data collected from you, your health information and samples unless you tell us not to. It is possible that some samples and data may not be able to be withdrawn after the study has started.
The Protocol Director may also withdraw you from the study without your consent for one or more of the following reasons:
Failure to follow the instructions of the Protocol Director and study staff. Unanticipated circumstances. POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions.
There could be a possible skin reaction to the bands supplied with the wearable devices. The finger prick may cause discomfort, pain and/or inflammation at the site of the finger prick.
Although we will make every effort to keep your information confidential, there is a theoretical risk of a privacy breach as there is for every research study.
POTENTIAL BENEFITS Reasonably expected benefits include: Contribution to understanding and tracking COVID-19 infection.
We cannot and do not guarantee or promise that you will receive any benefits from this study.
ALTERNATIVES The alternative is not to participate in the study.
PARTICIPANT’S RIGHTS You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director.
You will be told of any important new information that is learned during the course of this research study which might affect your condition or your willingness to continue participation in this study.
CONFIDENTIALITY The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified. Patient information may be provided to federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.
FINANCIAL CONSIDERATIONS You will not be paid to participate in this research study. There is no cost to you for participating in this study. The National Institute of Health (NIH) is providing financial support and/or material for this study. COMPENSATION for Research-Related Injury All forms of medical diagnosis and treatment – whether routine or experimental – involve some risk of injury. In spite of all precautions, you might develop medical complications from participating in this study. If such complications arise, the Protocol Director and the research study staff will assist you in obtaining appropriate medical treatment. In the event that you have an injury or illness that is directly caused by your participation in this study, reimbursement for all related costs of care first will be sought from your insurer, managed care plan, or other benefits program. You will be responsible for any associated co-payments or deductibles as required by your insurance.
If costs of care related to such an injury are not covered by your insurer, managed care plan or other benefits program, you may be responsible for these costs. If you are unable to pay for such costs, the Protocol Director will assist you in applying for supplemental benefits and explain how to apply for patient financial assistance from the hospital.
You do not waive any liability rights for personal injury by signing this form.
CONTACT INFORMATION Questions, Concerns, or Complaints: if you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, you should contact the research coordinator Arshdeep Chauhan at arshdeep.chauhan@stanford.edu. You should also contact the protocol director Michael Snyder at mpsnyder@stanford.edu at any time if you feel you have been hurt by being a part of this study.
Independent Contact: If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at (650)-723-5244 or toll free at 1-866-680-2906. You can also write to the Stanford IRB, Stanford University, 1705 El Camino Real, Palo Alto, CA 94306.
EXPERIMENTAL SUBJECT’S BILL OF RIGHTS As a research participant you have the following rights. These rights include but are not limited to the participant's right to:
be informed of the nature and purpose of the experiment; be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized; be given a description of any attendant discomforts and risks reasonably to be expected; be given an explanation of any benefits to the subject reasonably to be expected, if applicable; be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits; be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise; be given an opportunity to ask questions concerning the experiment or the procedures involved; be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice; be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision. be given a copy of the signed and dated consent form. CERTIFICATE OF CONFIDENTIALITY This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.
PLEASE PRINT A COPY OF THIS CONSENT FORM TO KEEP FOR YOUR RECORDS. Consent Form PDF: Click on this PDF link to download the complete consent form.
HIPAA Authorization Authorization To Use Your Health Information For Research Purposes
Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it.
What is the purpose of this research study and how will my health information be utilized in the study?
The purpose of this study to evaluate the use of algorithms from wearables data to predict onset and progression of respiratory infection. We are trying to establish if data collected from wearable devices can be used to predict the onset of an infectious disease such as COVID-19 before the symptoms start.
All data will be stored securely on RedCap or Stanford Medicine Box. Data from your blood microsamples and nasal swabs samples will be considered in the context of the study participant population to determine if different types of biological responses exist, and if so, how we might predict the response of an individual.
You will also be asked to complete a survey about your symptoms, share if you have a COVID-19 test and the results of the test, as well as other medical information that are relevant to infectious diseases.
Do I have to sign this authorization form?
You do not have to sign this authorization form. But if you do not, you will not be able to participate in this research study. Signing the form is not a condition for receiving any medical care outside the study.
If I sign, can I revoke it or withdraw from the research later?
If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to: Dr. Michael Snyder (mpsnyder@stanford.edu).
What Personal Information Will Be Obtained, Used or Disclosed?
Data collected during the study consists of, but is not limited to, your name, date of birth, phone number, email address, postal address, gender, ethnicity, other demographic information, medical record number, answers to questionnaires, wearable device serial number (if available), test results and other diagnosis, treatment, or physiologic information from your medical record. If you are in Arm A, to do COVID-19 testing LetsGetChecked will collect your name, email address, address, phone number, date of birth, sex, ethnicity, COVID-19 symptoms and other health conditions.
Who May Use or Disclose the Information?
The following parties are authorized to use and/or disclose your health information in connection with this research study:
The Protocol Director Dr. Michael Snyder The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary Research Staff Who May Receive or Use the Information?
The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:
The Office for Human Research Protections in the U.S; Department of Health and Human Services; The Food and Drug Administration (FDA); The National Institute of Health (NIH); LetsGetChecked; The local health officer where you reside. Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.
When will my authorization expire?
Your authorization for the use and/or disclosure of your health information will end on December 31, 2030 or when the research project ends, whichever is earlier.
PLEASE PRINT A COPY OF THIS FORM TO KEEP FOR YOUR RECORDS.
HIPAA Authorization PDF: Click on this PDF to download the document describing how your health information will be used or disclosed in this study. Please read it carefully before continuing.
Did you join the study through association with:
None of these
MCI OneHealth Healthcare Network
East Carolina University (ECU) Healthcare
ECU Patient
ECU Healthcare Provider (including Dental Hygienist, Student, Resident)
ECU Staff