Informed Consent Document
One of Striiv's missions for the Scout HR program is to make meaningful discoveries by enabling our users to voluntarily participate in our research project. The research project aims to:
- Discover heart rhythm factors behind diseases and traits
- Understand how people react to their heart related data
This Informed Consent gives you information to help you decide if you would like to participate in the research project to be performed by Striiv, Inc. (“Striiv”), its affiliated companies and its partners, including each of their respective websites, mobile applications and services (“Striiv,” "us," "we," or “our”). We believe in being transparent and want you to understand this consent form, so if you have any questions, please contact us using the information below and feel free to discuss your participation with anyone you choose in order to better understand this research project, your options, and whether or not to participate.
Please read this Consent Form carefully; you should print out a copy and keep it somewhere safe. A copy of it is also available on our website at www.striiv.com/pages/scout-hr-consent
1. What is the research project?
The Scout HR Research Project collects, preserves, and analyzes PPG (Photoplethysmography) sensor data, accelerometer data, surveys, and other information (collectively, “Data”) from our users in order to conduct research to better understand heart-related and health-related diseases and traits (the “Project”). Researchers hope that the Project will be an invaluable tool for a wide range of scholars interested in cardiology, arrhythmias, population health issues, medicine, and other findings that may benefit future generations.
The Informed Consent explains:
- What Data will be collected;
- How the Data will be used;
- How you can take part in the Project;
- What the costs are and if will you receive compensation;
- What is your alternative to participating;
- What the benefits are of participating;
- What the risks are, if any, to participating;
- What will happen to the heart rate data;
- How we will protect the Data;
- Could your participation end without your consent;
- How you can withdraw from the Project;
- What happens if you or your family member work for Striiv;
- Whether the researchers work for Striiv; and,
- Additional information to help you make an informed decision as to whether or not to participate in the Project.
2. What data will be collected?
The Project will collect data (as defined above) consisting of health, heart rate, and activity information. “Health Data” is health-related information provided by you (if you choose to fill out the User Survey and you agree by accepting the Informed Consent) such as responses to medical conditions, diseases, personal traits, and other information you either upload or provide consent for us to gather. “Heart Rate Data” is your heart rhythm patterns that are discovered when we process the PPG sensor data on the device. Your heart rhythm is a marker for your health and can be used to discover heart related conditions and diseases. The variance in your heart rate can determine if you suffer from any arrhythmias or if your heart is beating at a steady rhythm. “Activity Data” is your step and sleep data that is obtained when we process the accelerometer data that is on the device. Your step and sleep data reflects your walking behavior and sleep patterns. These patterns can give you insights into your current activity level.
Each time an individual study is undertaken with a third party researcher or anytime the results of the Project or an individual study are to be published, Information that traditionally permits identification of specific individuals, such as your name, is removed from the Data. This is done to minimize the possibility that any individual participant can be identified from the Data by any researcher or other individual.
3. How will the Data be used?
For each study that involves a third party researcher, your data (minus any information that permits identification of specific individuals, such as your name) will be combined with data about others (minus any information that permits identification of specific individuals, such as their names). In addition, whenever the results of the Project or an individual study are to be published, only data (minus information that permits identification of specific individuals, such their names,) will be available or published.
Discoveries made as a result of this Project could be used in the study of cardiology, arrhythmias, population health issues, medicine (for example, to identify health risks, drug responses, drug adherence, etc.) and other topics.
Data will also be used to make connections between activity level, health and other traits.
4. How do you take part in the Project?
You have already decided to wear a Scout HR device to get information about your heart and activity data from Striiv. The researchers want to know if you will allow the information obtained from this sample to be combined with other people’s results for research.
To participate in this research project, you will be asked to accept this Informed Consent on this website; accepting the Informed Consent will allow us to use the Data you provide (directly, or by providing consent for us to collect) for the Project. You will also need to read and accept the Scout HR Terms & Conditions (as well as the Terms & Conditions of any other of our websites for which you register).
If we or a third party wants to conduct a study (1) on topics unrelated to the Project, or (2) using information beyond what is described in this Informed Consent, we will re-contact you to seek your specific approval. In addition, we may contact you to ask you to complete a questionnaire or to ask you if you are willing to be interviewed about the Project or other matters.
5. What are the costs and will you receive compensation?
You will be responsible for the cost of wearing a data collection device and having your data analyzed by sending it in, just like you would be if you decide not to participate in the Project.
There is no financial cost to you for allowing the information from this analysis to be used in the Project. All we ask is that you have your wearable data analyzed and agree to have your Data used for the Project; this will take the same amount of time and effort as having your wearable data analyzed by Striiv even if you are not participating in the Project.
You will not get paid for being in this Project. The sample(s) you share with us for this Project might benefit researchers and others in the future. We will own the results of the Project and any subsequent publication of the results. If any commercial product is developed as a result of the Project, there will be no financial benefit to you.
6. What is my alternative to participating?
This project does not involve treatment for any condition and you will receive your results from Striiv regardless of your participation. Your alternative is not to be in the study.
7. What are the benefits of participating?
Participating in this Project will not benefit you directly. This Project is intended to assist us and other researchers to better understand the human heart and the technology to collect data on the functioning of the heart, so the more Data contributed to the Project, the better the potential results could be.
It is not anticipated that any of the Project results will have significance to any individual participant, and Research Project results will not be communicated by Striiv to you, regardless of whether you participate in the Project.
8. Are there any risks to participating?
Your test results may reveal information about you, and the physical risks for wearing a wearable device include, but are not limited to, allergic reactions to the wristband or device. While the Data that may be shared (through publication or with another entity) in the context of each of the studies under this Project will not contain information that permits identification of you, such as your name people may develop ways in the future that would allow someone to re-engineer the otherwise de-identified data. We do and will continue to work hard to ensure that this does not happen. There may also be additional risks to participation that are currently unforeseeable.
9. What will happen to the data?
Your data will be sent to a processing center in the United States. Your data will not be labeled with your name or other directly identifying information. Your data will have a code instead. The list that matches the code with your name and information will be stored separately from your sample.
Your data will be kept indefinitely unless you ask the researchers to delete it.
10. How will we protect the Data you provide?
Data obtained from this research will be stored electronically in the United States. We use a range of physical, technical, and administrative procedures to protect the privacy of the Data. For example, we restrict access to our data center and databases by using industry standard protocols, such as passwords and pass cards, encrypted Internet connections to the Striiv website, and all Striiv Internet computer servers have firewall protections in place. As Data is shared between and among us, it will be protected by encryption. Additionally, when we collaborate with external third parties as part of the Project, these parties will only have access to pooled information from which information that traditionally permits identification of specific individuals, such as name, has been removed. We will never purposely release Data along with direct identifiers (such as your name, phone number, and the like) without asking for and receiving your explicit authorization to do so, except as required by law, and your identity will not be disclosed by us in any publication related to or arising out of the Project without your permission. The Data used in the Project will be segregated from other information and only specifically authorized individuals will have access to this Data.
Be aware that records including Data (such as health and other Information as described above) will be shared and copied as needed for the Project.
11. Could your participation end without your consent?
Yes. We may terminate the Project in our discretion without your consent. We will protect the Data even after the Project is terminated or the data you provide is no longer in use.
12. How do you withdraw from this Project?
Participation in this Project is purely voluntary. You can decide not to be in this Project and, at any time, you may choose to withdraw some or all of the Data you provided by sending a request to email@example.com. There will be no penalty to you, and you will continue to be able to use our websites and services as before. We will cease using the Data you provided for the Project and any future studies promptly after receipt of your request. Due to the removal of information that traditionally permits identification of you, such as your name and birth date, any research using the Data that has already begun, studies that have been performed completely, and any study results or findings that have been published prior to this date cannot be reversed, undone, or withdrawn.
13. What if you or your family member work for Striiv?
Employees and their family members do not have to participate in this Project. No one should influence or pressure you to participate in the Project. An employee or his/her family member’s decision to participate in the Project, or to withdraw from the Project at any time, will not affect the employee’s job or job benefits.
14. Do the researchers work for Striiv?
Some of the researchers involved in this study are employees of Striiv and some are third party researchers. Some of the researchers who are employees of Striiv also have a significant amount of stock or other ownership in Striiv. If you have concerns about this employment and stock ownership, ask for more information via the contact information listed below.
15. Further Information
If you have general questions and need help with Scout HR's service, please contact:
If you have any questions or concerns about the Scout HR Research study, if you suffer a research-related injury, or if you have a question about subjects' rights, please contact us at
- Email: firstname.lastname@example.org