Know your baseline health data without medical insurance – join in this study

In knowing what is normal and not normal in many of our bodily functions, fluids and other biometrics, we can find health cures from health data generated from these biometrics. Today, an organization is set to study these health data.
Biometrics is the measurement and statistical analysis of people’s physical and behavioral characteristics.
Learn about your health, participate in this study and email Connie to be your health coach at motherhealth@gmail.com

Why I am joining?

why.JPG

In the future, together we can make money from our health data if we join forces to store our data together. For now, we have no funding as individual health consumers but we can participate in this study and learn about our health.
Connie’s Note: We cannot review/copy our health data after it is given to the Baseline team. Find a way to know your health data before it is given to the Baseline team to effect wellness and do a personalized monitoring of your health data.
Tip: Create a separate google email account. Data privacy is maintained from transit to storage. When your health data is shared anywhere to any organization or person, the following will be replaced with codes: name, email address, and street address.
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Informed consent

https://baseline.google.com/enroll/consent

PARTICIPANT INFORMATION AND CONSENT INFORMATION SHEET

TITLE: THE BASELINE STUDY
PROTOCOL NO.: 2017-BL-001
WIRB® Protocol #20170163
Baseline Profile Consent
SPONSOR: Baseline Study LLC
STUDY-RELATED PHONE NUMBER(S): The Baseline Call Center
1-855-5-BASELINE (1-855-522-7354)

A person who takes part in a research study is called a participant. In this consent form, “you” always refers to the participant.

SUMMARY

You are being asked to decide if you want to create a Baseline Profile, which is not only a key step in applying to the Project Baseline but also will be used by the Baseline Team, including Verily, to conduct research on human health. This consent form is designed to provide you with the information you need to decide if you want to create a Baseline Profile. Part of this information is the description of how the Baseline Team will use the information in your Baseline Profile. For example, the Baseline Team will use your Baseline Profile to determine if you are eligible for the Baseline study.

Creating a Baseline Profile is completely voluntary. An unlimited number of people can create a Baseline Profile. Eligible individuals who create a Baseline Profile will become part of a registry of individuals that are interested in participating in future research on human health. As such, information in your Baseline Profile may also be used by the Baseline Team to contact you, including to provide you with opportunities to test various tools and technologies and contribute additional information for research.

By signing this form, you confirm that you are eligible to create a Baseline Profile. Your Baseline Profile has no expiration. If you create a Baseline Profile and are selected to come onsite for the Baseline study, you will be asked to sign another consent form. If you create a Baseline Profile but are not selected to come onsite for an in-person visit, you will not be paid and will have the opportunity to withdraw your Baseline Profile at any time.

Please read this form carefully. You should take your time to decide whether or not you want to create a Baseline Profile. Do not sign this consent form until all of your questions have been answered by the information on this website. You can also call the Baseline Call Center at 1-855-5-BASELINE (1-855-522-7354) between 8am and 11pm Eastern Time, Monday through Friday, and 10am to 7pm Eastern Time, on Saturday, with any questions. Signing this form is equivalent to signing a paper consent form.

PURPOSE

What is my Baseline Profile?Your Baseline Profile is a collection of information about you and your health, including your name and your health history. Your Baseline Profile will be used to:

  • Decide if you are eligible for the Baseline Study and/or future studies
  • Register you for Project Baseline
  • Conduct research on health and disease
  • Create new tools and technologies relating to health and disease
  • Contact you to provide additional health information
  • Contact you with updates about the current Baseline study and additional ways you can contribute

Your Baseline Profile will continue to be used for these purposes even if you are not eligible for the Baseline study.

PROCEDURES

Am I eligible to create a Baseline Profile?You can create a Baseline Profile if you are:

  • 18 years of age or older
  • A U.S. resident
  • Able to speak and read English or Spanish
  • Not working on Project Baseline, including the Baseline study
  • Willing and able to provide your health information, including your health records and insurance claims data
  • Willing and able to sign this form

By signing this form, you are telling us that you meet the requirements above.

What will happen if I choose to create a Baseline Profile?If you choose to create a Baseline Profile, here is what will happen next:

  • You will log into an existing Google Account or create a new Google Account. To create your Baseline Profile, you will be asked to log into an existing Google Account (for example, your existing Gmail account) or create a new Google Account at https://accounts.google.com/signin. If you decide to create a new Google Account, you will need to provide your name and birthdate. You will then create a username and password for your new Google Account. Whether or not you log into an existing Google Account or create a new Google Account, you will need to use this account going forward for study activities. For example, if you sign this form, we will send a copy of it to you at this Google Account.
  • You will log into the Baseline Web Portal and respond to surveys. Once you have a Google Account, you will use this Google Account to log into an online portal, called the “Baseline Web Portal”. In the Baseline Web Portal, you will be asked to complete a series of surveys. The surveys will ask about things such as your health and lifestyle, if you smoke and other habits, and your medical history. We will also ask you for your name, phone number, email address, and mailing address so we can contact you in the future. Women will also be asked questions about their reproductive history. These surveys should take less than 30 minutes to complete.
  • The Baseline Team will let you know if you qualify for the Baseline study. Based on the answers you provide in these surveys, the Baseline Team will use a computer system to determine if you qualify for the Baseline study. The Baseline study is a study to collect health information. Researchers and other health professionals will use the information to study and develop new insights, tools and technologies to improve health.

What if I qualify for the Baseline study?If you qualify for the Baseline study, we will do our best to contact you as soon as possible using the information in your Baseline Profile.

To participate in the Baseline study you will need to go to one of the study sites for a site visit. We will let you know which study site is closest to where you live. During your onsite visit, you will review a separate consent form (“Onsite Consent”) relating to the Baseline study, where you will learn more information about the activities in the Baseline study. Participation in the Baseline study is completely voluntary. If you review the Onsite Consent and agree to participate in the Baseline study, you will be asked to perform certain activities including, but not limited to, giving samples (such as blood, saliva and tears), using devices (such as a wrist-worn sensor), undergoing assessments (such as physical exams and x-rays), and giving additional health information on an ongoing basis through the Baseline Web Portal and Baseline mobile app (“Baseline Mobile App”). Your participation in the Baseline study is expected to last for at least four years, but may be extended or stopped in advance of that date by the Baseline Team.

Before the site visit, the Baseline Team may need to access and review your health record to confirm the information you provided in your Baseline Profile or access additional information. A health records release form is provided after this form. This health records release form allows the Baseline Team to collect your medical information from many sources and include it in the Baseline Database. This could include hospital records and blood test results.

What if I do not qualify for the Baseline study? What if I qualify for the Baseline study and decide not to participate?The information in your Baseline Profile will be used for research. See more information in the “INFORMATION USE AND SHARING” section below.

Even if you are not selected or choose not to participate in the Baseline study, you can still contribute to research on health and disease. Here’s how:

  • Participate in future studies. Project Baseline is starting with the Baseline study, but hopes to have many efforts relating to health and disease. If there are new studies, we will use your Baseline Profile to determine if you may be eligible. Verily may contact you via the Baseline Web Portal or other contact information that you provide in your Baseline Profile to tell you more about these future efforts.
  • Provide ongoing information and updates about your health and disease. You may be asked to provide additional information about your health. For example, this could be additional surveys about your health, lifestyle, or family history. This information will be used for purposes consistent with this form including to develop new information, tools and technologies to improve health. Some of this information can be provided electronically via the Baseline Web Portal without going to a study site.
  • Test out new technologies and tools. You may be asked to test out new technologies and tools. For example, Verily is currently developing the Baseline Mobile App that will be used in the Baseline study. In the future, people who are not in the Baseline Study may be invited to download the Baseline Mobile App. In the Baseline Mobile App, you will be able to contribute to health research virtually (through surveys, for example), test out new technologies and communicate with the Baseline Team. Downloading the Baseline Mobile App will be optional.
    • The Baseline Mobile App may also include technologies that collect information relating to your use and interaction with your mobile device. This includes information like how and when you use your mobile device, how and when you communicate with others, your location and speed of movement, how often you make calls and send text messages, and smartphone actions like how often you use certain apps or websites. After you install the Baseline Mobile App, you will be notified before this information is collected and you will have the option to turn off this data collection but remain in the study.
  • Stay current with updates, reminders, and study communications. You may receive updates on research and activities relating to the Baseline study and other studies.

If you would like not to receive these communications, please let us know by calling the Baseline Call Center at 1-855-5-BASELINE (1-855-522-7354) between 8am and 11pm Eastern Time, Monday through Friday, and 10am to 7pm Eastern Time, on Saturday.

If you are not selected for the Baseline study, you can withdraw your Baseline Profile at any time.

RISKS AND DISCOMFORTS

When you agree to create a Baseline Profile, you provide Verily and the Baseline Team with access to your name, address, health information, and other potentially sensitive information. We do our best to protect your privacy and the security of your information, but there is a risk that someone could get unauthorized access to the information stored about you. Additional information regarding the privacy and security of your data can be found in the “CONFIDENTIALITY” section below.

Your Baseline Profile poses no known physical risks to you as you will not receive any treatment or therapy. If you are accepted into the Baseline study, there are additional risks and discomforts that will be provided in the Onsite Consent.

NEW INFORMATION

If new information is made available to the Baseline Team that might change your decision to create a Baseline Profile or provide information, the Baseline Team will try to make sure you are told about the information. Should this occur, you may need to sign a new consent form to continue as a participant.

BENEFITS

It is not anticipated that you will receive any benefits from creating a Baseline Profile. In the future, research resulting from the information in your Baseline Profile could benefit other individuals by learning more about health and disease.

If you are accepted into the Baseline study, the Onsite Consent will provide information on the additional benefits of being in the Baseline study.

COSTS

There are no costs to you if you create a Baseline Profile. Depending on your mobile phone plan, you could incur charges such as receiving study text messages and data charges for accessing the Baseline Web Portal and Baseline Mobile App.

PAYMENT FOR PARTICIPATION

You will not be paid for creating a Baseline Profile, or for the Baseline Team’s use of the information that is in your Baseline Profile.

If you are accepted into the Baseline study, the Onsite Consent will provide information on compensation for participation in the Baseline study.

It is possible that some of the research done through the Baseline study or using the Baseline Profile information could lead to the development of new tests, drugs, or other commercial products. Baseline Study LLC and other organizations may also make money by allowing health-related organization to use the stored, anonymous information for research. In this case, you will not share in any revenues or profits, or receive any financial compensation.

ALTERNATIVE TREATMENT

This is not a treatment study. Your only alternative to creating a Baseline Profile is not to create a Baseline Profile.

INFORMATION USE AND SHARING

What information may be used and given to others?By signing this consent, you are allowing the Baseline Team to keep all of the information you provide in a database, called the Baseline Database. This consent has no expiration. Your information will be stored for possible use in the future, whether or not you qualify for the Baseline study. The Baseline Team will be responsible for making sure the information is stored safely and used only for uses listed in this form.

If you qualify for the Baseline study, the information in your Baseline Profile will be shared with the Baseline Team and your study site so they can schedule and prepare for your site visit.

Verily is helping to build and run some of the technology and systems associated with your Baseline Profile. This includes the Baseline Web Portal, the Baseline Mobile App, and the Baseline Database, among other technologies. As such, Verily, and organizations that it hires to support the operations of the Baseline study, will also have access to information in your Baseline Profile. Additional information regarding the privacy and security of your data can be found in the “CONFIDENTIALITY” section below.

The information you provide will be used for research by the Baseline Team including Verily, Duke University School of Medicine, Stanford Medicine, and Google. In the future, the Baseline Team may be expanded to include additional research organizations and sponsors.

In the future, the Baseline Team may allow the data to be used by researchers outside of the Baseline Team. If this happens, the Baseline Team will not include direct identifiers (name, street address, phone number, and email address). This means that before the Baseline Team gives anyone your information, these direct identifiers will be removed and replaced with a code number.

What if I decide not to give permission to use and share my health information for research purposes?If you do not give permission, then you will not be able to create a Baseline Profile or join the Baseline study.

May I review or copy my information?No, you may not review or copy your information after it is provided to the Baseline Team. However, you may be given access to the results of certain surveys and, in the future, be able to review the research that results from information in your Baseline Profile and the Baseline Study.

May I withdraw or revoke (cancel) my permission?You may withdraw your permission to collect new information at any time. You do this by calling the Baseline Call Center at 1-855-5-BASELINE (1-855-522-7354) between 8am and 11pm Eastern Time, Monday through Friday, and 10am to 7pm Eastern Time on Saturday. When you withdraw your consent, no new health information will be gathered about you after that date.

If you are not selected or choose not to participate in the Baseline Study and withdraw your consent, your Baseline Profile will be archived in de-identified form. No additional information will be collected from you and you will not be contacted for participation in future studies.

CONFIDENTIALITY

As mentioned above, Verily is helping to build and run some of the technology and systems used to develop your Baseline Profile and to conduct the Baseline study. Verily will keep your health information on secure Google and third party systems with many layers of protection. Here are just a few of the steps Verily will take to protect your information:

  • Keep all Baseline study information in a secure place with many layers of protection.
  • Limit and keep track of access to these materials to make sure they are safe. This includes limiting the number of employees who have access to the data and monitoring their access.
  • Before your information is provided to qualified researchers from third-party organizations outside of the Baseline Team, Verily will arrange to remove your direct identifiers (name, street address, phone number, and email address) and replace these with a code number. Qualified researchers outside of the Baseline Team who study your information will be required to sign an agreement that they will not try to find out who you are. They must also promise to keep the materials secure.
  • Use your information for the activities consistent with this consent form.

While Google provides computing, analytics, and data handling power, Google will not use the information you provide in your Baseline Profile for advertising. All your information will be stored in a secure, encrypted database with restricted access.

Officials from the Baseline Team or its designees, qualified Institutional Review Boards, or other regulatory bodies or agencies, such as the FDA, may review your information to make sure things are being done ethically and in a way that is consistent with this form.

VOLUNTARY PARTICIPATION AND WITHDRAWAL

Your creation of a Baseline Profile is voluntary. Your Baseline Profile has no expiration. You can withdraw your Baseline Profile at any time, although the information already provided will be kept by the Baseline Team in de-identified form.

You may decide not to participate or to withdraw at any time. Your decision to not participate or to withdraw will not result in any penalty or loss of benefits to which you are entitled. If you decide to withdraw participation after signing the informed consent, call the Baseline Call Center at 1-855-5-BASELINE (1-855-522-7354) between 8am and 11pm Eastern Time, Monday through Friday, and 10am to 7pm Eastern Time, on Saturday.

Your participation may be stopped at any time by the Baseline Team without your consent for any reason. This may include:

  • If the Investigator or his/her delegate believes it is in your best interest, such as for safety or administrative purposes
  • If you do not consent to continue participating in the study after being told of changes in the research that may affect you
  • If you engage in misconduct, disassemble, or violate the terms of use of the technology involved
  • If you are uncooperative or not compliant with study requirements

SOURCE OF FUNDING FOR THE STUDY

The Baseline study is being funded by Baseline Study LLC. Verily is the managing member of Baseline Study LLC. In the future, Baseline Study LLC may be expanded to include additional sponsors who support the overall mission to improve human health. It is possible that some of the research done using information in your Baseline Profile or using Baseline study information could lead to the development of new tests, drugs, or other commercial products. Baseline Study LLC, Verily, and other organizations may also make money by allowing health-related organizations to use the stored information for research. In this case, your direct identifiers (name, street address, phone number, and email address) will be removed and replaced with a code number. You will not share in any revenues or profits, or receive any financial compensation.

QUESTIONS

Contact the Baseline Call Center at 1-855-5-BASELINE (1-855-522-7354) between 8am and 11pm Eastern Time, Monday through Friday, and 10am to 7pm Eastern Time, on Saturday for any of the following reasons:

  • If you have any questions about your Baseline Profile
  • If you have questions, concerns or complaints about the research
  • If at any time you feel you have had a research-related issue

If you have questions about your rights as a research participant or if you have questions, concerns or complaints about the research, you may contact:

      Western Institutional Review Board® (WIRB®)
      1019 39th Avenue SE Suite 120
      Puyallup, Washington 98374-2115
      Telephone: 1-800-562-4789 or 360-252-2500
      E-mail: Help@wirb.com

WIRB is a group of professionals who independently review research to ensure that it is ethical and safe for participants.

WIRB will not be able to answer some study-specific questions, such as questions about appointment times. However, you may contact WIRB if the research staff cannot be reached or if you wish to talk to someone other than the research staff.

Do not sign this form unless you have had a chance to ask questions you may have and have gotten satisfactory answers.

A description of this clinical trial will be available on https://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

CONSENT

I have read this consent form (or it has been read to me). All my questions about creating my Baseline Profile have been answered. I freely consent to create a Baseline Profile.

By signing this consent form, I have not given up any of my legal rights, and I certify that I am at least eighteen (18) years old and a resident of the United States.

VIEW PRINT-FRIENDLY VERSION

2 thoughts on “Know your baseline health data without medical insurance – join in this study

  1. Pingback: Know your baseline health data without medical insurance – join in this study | Senior care and Disease Prediction

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