• CONSENT

  • I have read and understand the information in this informed consent document. I have had an opportunity to ask questions and all of my questions have been answered to my satisfaction. I voluntarily agree to participate in this study until I decide otherwise. I do not give up any of my legal rights by signing and dating this consent document. I will receive a copy of this signed and dated consent document.

  • Powered by Jotform SignClear
  •  - -
  • Powered by Jotform SignClear
  •  - -
  • AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION

  • If you decide to be in this study, the study investigator and study staff will use and share health data about you to conduct the study. Health data may include:

    • Your name
    • Address
    • Phone number
    • Date of birth
    • Medical history
    • Information from your study visits
    • Your electroencephalography (EEG) data collected by the study device(s)
    • Your accelerometry data collected by the study device(s)
    • Your PSG data collected at the University of California, San Francisco (if applicable)

    Health data may come from your study records or from existing records kept by your doctor or other health care workers. 


    For this study, the study staff may share health data about you with authorized users. Authorized users may include:

    • Representatives of Attune Neurosciences, Inc. 
    • Representatives of Advarra IRB (an Institutional Review Board that reviews this study).
    • The Food and Drug Administration (FDA) and other US federal and state agencies.
    • Government agencies to whom certain diseases (like HIV, hepatitis, and STDs) must be reported.
    • Governmental agencies of other countries.
    • Outside individuals and companies, such as laboratories and data storage companies, that work with the researchers and sponsor and need to access your information to conduct this study.
    • Other research investigators and medical centers participating in this research, if applicable. 
    • A data safety monitoring board which oversees this research, if applicable.
    • Your health data will be used to conduct and oversee the research.


    Once your health data has been shared with authorized users, it may no longer be protected by federal privacy law and could possibly be used or disclosed in ways other than those listed here. 


    Your permission to use and share health data about you will end in 50 years unless you revoke it (take it back) sooner. 


    You may revoke (take back) your permission to use and share health data about you at any time by writing to the study investigator at the address listed on the first page of this form. If you do this, you will not be able to stay in this study. No new health data that identifies you will be gathered after your written request is received. However, health data about you that has already been gathered may still be used and given to others as described in this form. 


    Your right to access your health data in the study records will be suspended during the study to keep from changing the study results. When the study is over, you can access your study health data.


    If you decide not to sign and date this form, you will not be able to take part in the study.

  • STATEMENT OF AUTHORIZATION

  • I have read this form and its contents were explained. My questions have been answered. I voluntarily agree to allow study staff to collect, use and share my health data as specified in this form. I will receive a signed and dated copy of this form for my records. I am not giving up any of my legal rights by signing and dating this form.

  • Powered by Jotform SignClear
  • Should be Empty: