Research Consent Document
Research Consent Document
Full Consent Document
One of Restafy’s missions is to make and support meaningful scientific and other health discoveries by enabling its customers to participate directly in research. Specifically, Restafy Research refers to research aimed at publication in peer-reviewed journals and research funded by the federal government (such as the National Institutes of Health – NIH), and other private and public institutions. The Restafy Research study aims to:
- Discover sleep factors behind problems, conditions, diseases, and traits
- Uncover connections among problems, conditions, diseases, and traits and sleep
- Learn about seasonal, evolving, and other sleep issues
- Understand how people react to their personal sleep information
For further details on Restafy’s other uses of personal information, see our Privacy Statement.
Restafy seeks your voluntary participation in Restafy Research.
This document explains:
- What you are agreeing to if you consent
- How you can participate
- How your data will be used
- How we protect your data and keep it private
- The benefits and risks of participation
- Your options and how to withdraw
- Who to contact if you have questions
1. What am I agreeing to if I consent?
Giving consent by selecting the appropriate option on the Sleep Assessment means that you agree to let Restafy researchers use your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information for Restafy Research, as described above. “Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information” refers to:
- Your Home Sleep Test Kit data
- Information you enter into surveys, forms and other features labeled with the Restafy Research name or logo
- Data you authorize us to import for research (if we request health information, we will ask you to review a separate Authorization form)
- Your age, sex, height, weight, and ethnicity
Sleep Assessment includes any information you submitted prior to giving consent. Your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information does not include identifying Registration Information you provided when you purchased the Sleep Profile Basic service, Sleep Profile Plus Service, or created an account (such as name, address, email address, user ID, password, or credit card information).
2. How do I participate?
Participation consists of (1) allowing Restafy researchers to use your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information for Restafy Research and (2) entering data about yourself into Restafy Research features on the Restafy website. These features include surveys, individual questions, and other features where you enter information. If you do not feel comfortable providing a piece of information, you may choose not to answer that question. You may choose to take all, some, or none of the surveys.
The Restafy Research study is open-ended: new surveys and features may be added on a continuing basis. If new surveys or features are added, you may receive an email update or see an announcement when you sign in to your account. We might invite you to participate in a specific study if your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information matches the area of interest.
For your participation, monetary, cash equivalents such as gift certificates or discounts on future Restafy service purchases, or charitable donations (up to a value of $30 per half hour of expected time) may be provided as compensation for your time.
Your participation in the Restafy Research study is completely voluntary.
3. How will my data be used in Restafy Research?
Your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information may be used to discover links between sleep data, traits, diseases, lifestyle, behaviors and other characteristics; to study seasonal, evolving, and other sleep issues; or to assess how people respond to personal sleep wellness information. Discoveries made as a result of this research could be used to understand the basic causes of sleep issues, develop drugs or other treatments and/or preventive measures, or predict a person’s risk of sleep issues. The topics to be studied span a wide range of traits and conditions, from common to rare. The topics include issues such as insomnia, sleep apnea, PLM, REM behavior, sleepwalking, bruxism, and narcolepsy. Some of these studies may be sponsored by or conducted on behalf of third parties, such as non-profit foundations, academic institutions, or pharmaceutical companies.
This study may cover potentially sensitive topics such as prescription or illicit drug use or other risky behaviors. When Restafy conducts studies on such sensitive topics, you will be provided additional information to help you decide whether you want to participate in research on these topics.
4. How do you keep my data protected and private (whether or not I consent)?
Restafy’s Privacy Statement outlines how the company protects your privacy while conducting business, such as providing our services to you. Restafy uses a range of physical, technical, and administrative procedures to protect the privacy of your personal information, including your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information and your survey responses.
If you agree to this Consent Document, Restafy can use your information in additional ways. Specifically, Restafy researchers can use your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information for research that will be published in scientific journals, health publications, and other media or that is sponsored by the National Institutes of Health and certain other organizations.
Just as Restafy aims to minimize the chances of a privacy breach while conducting its business, Restafy researchers aim to minimize the chances of a privacy breach while conducting research. Here are the main ways we do that:
- The Restafy researchers who conduct the statistical analyses do not have access to Registration Information (name, address, email address, user ID, password, or credit card) of customers
- Restafy researchers who interact with research participants and conduct interviews have access to names and contact information of participants, but only to very limited Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information and other personal information
- To minimize the chance that an external person can determine that any particular customer is part of a study, Restafy researchers either
- publish only data pooled across multiple customers or
- publish only very limited, non-identifying information of a single individual
- All Restafy employees are trained on how to work with human research participants. In addition, all Restafy researchers are trained on how to conduct research responsibly.
5. What are the benefits and risks of participation?
One of Restafy’s missions is to make meaningful scientific and other sleep health discoveries by enabling its customers to participate directly in sleep research. If Restafy publishes study results in peer-reviewed journals, there may be an indirect benefit to you as scientific and other sleep health knowledge increases and/or new drugs or tests are developed.
You may also have the opportunity to acquire one or more of the following, in return for some level of participation in the research:
- Comparison of your personal survey responses to those of all responders, additional information about sleep, sleep research or the Restafy study, and/or preliminary research findings
- There may be additional benefits to participation that are currently unforeseeable.
Based on the results of this study, Restafy may develop intellectual property, including but not limited to patents, copyrights, and trademarks, and/or Restafy may commercialize products or services, directly or indirectly. In such cases, you will not receive any compensation.
There are some potential risks to participating in the Restafy Research study, as described below.
- Some survey questions or data comparisons may make you or your family members uncomfortable.
- Your Sleep Assessment, Home Sleep Test Kit Information, Sleep Profile Information, survey responses, and/or personally identifying information may be stolen in the event of a security breach. In the event of such a breach, if your data are associated with your identity, they may be made public or released to insurance companies, which could have a negative effect on your ability to obtain insurance coverage. In addition, if you or a family member has sleep data linked to your name or your family member’s name in a public database, someone who has access to your Restafy Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information might be able to link that data to your name or your family member’s name through the publicly available sleep data. Although Restafy cannot provide a 100% guarantee that your data will be safe, Restafy has strong policies and procedures in place to minimize the possibility of a breach.
- When Restafy researchers publish results from this ongoing study, they may include your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information but only as part of a summary across enough people to minimize the chance that your personal information will be exposed. Identification of your individual-level data from those summaries would be extremely difficult, but it is possible that a third party that has obtained some of your sleep data could compare that partial data to the published results and infer some of your other personal information.
- As with any online service, if you disclose your account password to others, they may be able to access your account and your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information.
- There may be additional risks to participation that are currently unforeseeable.
None of the surveys or other procedures used by the researchers in the Restafy Research study is invasive or experimental. The procedures involved do not involve more than the minimal risks described above.
6. Do I have any alternatives? Can I withdraw from this study?
Your alternative is not to participate in the Restafy Research study. If you choose not to give consent for Restafy Research, your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information may still be used for other purposes, as described in our Privacy Statement. If you do give consent to participate in this study, you may choose not to take Restafy Research surveys or use other Restafy Research features.
At any time, you may choose to change your consent status to either take part in Restafy Research or to withdraw all or some of your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information from Restafy Research. Your consent status is located in the Restafy “My Account” page (if you experience problems changing your consent status, write to email@example.com. If you withdraw all or some of your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information, Restafy will prevent that information from being used in new Restafy Research initiated after 30 days from receipt of your request (it may take up to 30 days to withdraw your information after you withdraw your consent). Any research on your data that has been performed or published prior to this date will not be reversed, undone, or withdrawn.
Choosing not to give consent or withdrawing from Restafy Research will not affect your access to your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information or to the Restafy Service.
You may also discontinue participation by closing your Restafy account, as described in the Terms of Service. Requests for account closure must be made in writing to Restafy’s business address or via Customer Care.
In addition, the Restafy Research study may be terminated without your consent. In the following cases, Restafy will maintain your Sleep Assessment, Home Sleep Test Kit Information, and Sleep Profile Information according to the terms of our Privacy Statement.
- Transfer of ownership. If Restafy undergoes a business transition such as an acquisition or merger, the Restafy Research study may be terminated. In such case, your information would remain subject to the promises made in any pre-existing Privacy Statement.
- Termination of service. Restafy may terminate your access to the Restafy Service for any of the five reasons described in the Terms of Service. If your access to the Restafy Service is terminated for any of these reasons, your participation in the Restafy Research study may also be terminated.
7. Who do I contact if I have questions?
If you have general questions and need help with Restafy’s service, please contact:
- Restafy Customer Care
- 1-402-447-3700 (8:00 AM-4:30 PM, central time)
If you have any questions or concerns about the Restafy Research study, if you suffer a research-related injury, or if you have a question about subjects’ rights, please contact the following:
- Restafy Privacy
- Email: firstname.lastname@example.org