You are being shown this message because you have shown interest in our study about cognitive function (the way you think). The purpose of the study is to look at cognitive function in youth in their daily lives using a smartphone application. In order to determine if you are eligible for this research study we need to ask you a few questions. This is called an online screen. The screen is for research purposes and could last about 3 minutes. We will ask you questions about your child’s health and ask you for your contact information.

The National Institute of Diabetes and Digestive and Kidney Diseases and the Washington University Institute for Clinical and Translational Sciences KL2 Program are funding this study.

A risk of participating in this screen is that confidential information about you may be accidentally disclosed. You will not benefit from participating in the online screen. We will keep the information you provide confidential by storing your information on a secure, password-protected platform. Any report or article that we write will not include information that can directly identify you. However, federal regulatory agencies and Washington University, including the Washington University Institutional Review Board (a committee that reviews and approves research studies) and the Human Research Protection Office may inspect and copy records pertaining to this research activity.

Your participation in this screen is completely voluntary. You may choose not to take part at all. If you decide to participate in the screen you may stop participating at any time. Any data that was collected as part of this screen will remain as part of the study records and cannot be removed. If you decide not to take part in the screen, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you otherwise qualify. If, after completing this screen, you are eligible for the research study you will be asked at a later date to sign a separate consent form that includes more detailed information about the study.

Your answers to the screening questions will create Protected Health Information (PHI) that identifies you. Your health information is protected by law under HIPAA (the Health Insurance Portability and Accountability Act). Because of this law, you will need to give the research team permission to use and share your PHI from the online screen for this research

When possible, the research team will make sure information cannot be linked to you. Once information doesn’t identify you, it may be used and shared for other purposes not discussed during this online screen.

The information collected today during the online screen may be seen by people making sure the research is being done right. This may be people at Washington University, and government representatives, (including the Office for Human Research Protections and the Food and Drug Administration). BuildClinical may have access to your identifiable information for recruitment purposes.

• If you agree, you are giving permission for us to use of your PHI for this research, and your permission will not expire.
• If you do not agree to allow us to use your PHI it will not affect your treatment or the care given by your health provider, insurance payments or enrollment in any health plans, or any benefits to which you are entitled. However, it will not be possible for you to take part in the phone screen for this study.
• Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA.
• If you change your mind and do not want the research team use or share your information, you will need to provide a written letter to the research team cancelling your permission. Please contact the Human Research Protection Office for more information on how to revoke your authorization or contact the research team to request the withdrawal letter.  If you do this, the research team may only use and share information already collected for the study. You will not be allowed to continue to participate in the study.

• If you have questions or concerns about your privacy and the use of your protected health information, please contact the University’s Privacy Officer at 866-747-4975.

We encourage you to ask questions.  If you have any questions about the research study itself, please contact: Dr. Mary Katherine Ray at m.ray@wustl.edu. If you have questions, concerns, or complaints about your rights as a research participant, please contact the Human Research Protection Office at 1-(800)-438-0445 or email hrpo@wustl.edu.   General information about being a research participant can be found on the Human Research Protection Office web site, hrpo.wustl.edu.  To offer input about your experiences as a research participant or to speak to someone other than the research staff, call the Human Research Protection Office at the number above.