What type of data does this application collect?
The SPACES application will collect geographic information (GI) tracking information as well as survey responses. The app will collect continuous geolocation data in the background during participation in the study. Participants will also provide specific geolocation information (i.e., addresses) in response to questions.
Where will this data be transmitted to?
The data will be stored online using the Amazon Web Services (AWS) cloud computing platform. AWS provides secure data encryption and the option for multi-factor authentication and is designed and managed in alignment with security best practices and IT security standards. Access to the server will be limited to investigators and cloud administrators and will be monitored with user activity logs. In addition, data stored online will not have identifying information of the participants included. The data is not stored on the individual devices. Once downloaded, digital data will be stored on a password-protected desktop computer in a locked research office.
What happens to the information collected for the research?
Data from this study will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). NDA is a large database where deidentified study data from many NIH studies are stored and managed.
During and after the study, the study researchers will send deidentified study data about your health and behavior to the NDA. Other researchers across the world can then request your deidentified study data for different research projects. Every researcher (and the institution to which they belong) who requests your deidentified study data must promise to keep your data safe and promise not to try to learn your identity. Experts at the NIH who know how to keep your data safe will review each request carefully to reduce risks to your privacy. Sharing your study data does have some risks, although these risks are rare. Your study data could be accidentally shared with an unauthorized person who may attempt to learn your identity. The study researchers will make every attempt to protect your identity.
You may not benefit directly from allowing your study data to be shared with NDA. The study data provided to NDA may help researchers around the world learn more about brain science and how to help others who have problems with brain science. NIMH will also report to Congress and on its website about the different studies using NDA data. You will not be contacted directly about the study data you contributed to NDA.
You may decide now or later that you do not want your study data to be added to NDA. You can still participate in this research study even if you decide that you do not want your data to be added to NDA. If you know now that you do not want your data in NDA, please tell the study researcher before leaving today. If you decide any time after today that you do not want your data to be added to NDA, call or email the study staff who conducted this study, and they will tell NDA to stop sharing your study data. Once your data is part of NDA, the study researchers cannot take back the study data that was shared before they were notified that you changed your mind. If you would like more information about NDA, it is available on-line at http://nda.nih.gov.
Efforts will be made to limit the use and disclosure of your personal information, including research study and medical or education records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the Institutional Review Board (“IRB”) and other representatives of this organization. Your participation is voluntary and your privacy will be maintained. Confidentiality will only be broken in rare circumstances when the information that you report suggests an immediate and identifiable danger to yourself or another person. Although the results of this study will be published, your name/identity will not be revealed in any publication.
Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research team principal investigator Dr. Jennifer Read, who can be reached by email at email@example.com or by phone at 716-645-0193. You may also contact the research participant advocate at 716-888-4845 or firstname.lastname@example.org.
This research has been reviewed and approved by an Institutional Review Board (“IRB”). An IRB is a committee that provides ethical and regulatory oversight of research that involves human subjects. You may talk to them at (716) 888-4888 or email email@example.com if:
• You have questions about your rights as a participant in this research
• Your questions, concerns, or complaints are not being answered by the research team.
• You cannot reach the research team.
• You want to talk to someone besides the research team.
• You want to get information or provide input about this research.