NYU Langone Health is committed to protecting the privacy and confidentiality of your health information. We are asking for your permission to use and to disclose your health information in connection with a study using the NYU Langone Concussion Tracker app.
You have the right not to give us this permission; however, you will then not be able to participate in this study.
If you do not give this permission, your treatment outside of this study, payment for your healthcare, and your healthcare benefits will not be affected.
What information about me may be used or shared with others?
The following information may be used or shared in connection with this research:
- location services data collected during a daily six-minute walking test
- Apple HealthKit data, potentially including heart rate data, as measured by Apple Watch® throughout the study
- all information collected during the study
Why is my information being used?
Your de-identified information will be used by the research team and others involved in the study to conduct and oversee the study.
Who may use and share information about me?
The following people may use, share, or receive your information for this research study:
- the principal investigator, study coordinators, other members of the research team, and personnel responsible for the support or oversight of the study
- the study sponsor: NYU School of Medicine
- governmental agencies responsible for research oversight (e.g., the U.S. Food and Drug Administration, or FDA)
Your de-identified information may be re-disclosed or used for other purposes if the person who receives your information is not required by law to protect the privacy of the information.
For how long may my information be used or shared?
Your permission to use or share your personal health information for this study will never expire, unless you withdraw it.
Can I change my mind and withdraw permission to use or share my information?
Yes, you may withdraw or take back your permission to use and share your health information at any time. If you withdraw your permission, we will not be able to take back information that has already been used or shared with others.
To withdraw your permission, send a written notice to the principal investigator of the study, Dr. Laura Balcer, at 240 East 38th Street, 20th Floor, New York, NY 10016. You also need to withdraw from the study from within the app. If you withdraw your permission, you will not be able to stay in this study.
Optional Permission for Future Use
NYU Langone would also like to store, use, and share your de-identified health information from this study in research databases or registries for future research conducted by NYU Langone or its research partners. You may still participate in this study even if you do not give us this additional permission.
NYU Langone will continue to protect the confidentiality and privacy of this information as required by law and our institutional polices. If you give this additional permission, you will continue to have the rights described in this form. You have the right to take back this additional permission at any time.
How does the NYU Langone Health IRB protect me?
The Institutional Review Board (IRB) reviews all human research studies—including this study. The IRB follows federal government rules and guidelines designed to protect the rights and welfare of the people taking part in research studies. The IRB also reviews research to make sure the risks for all studies are as small as possible.
NYU School of Medicine’s IRB office number is 212-263-4110. NYU School of Medicine’s IRB is made up of doctors, nurses, non-scientists, and people from the community.
How can I get more information about the study?
If you have questions, concerns, or complaints regarding your participation in this research study, or if you have any questions about your rights as a research subject, please call the principal investigator at 646-501-9269.