Information You may be eligible to take part in a research study. This form gives you important information about the study.
Please take time to review this information carefully. You should talk to the researchers about the study and ask them any questions you have. You may also wish to talk to others (for example, your friends, family, or a doctor) about your participation in this study. If you decide to take part in the study, you will be asked to accept the terms and conditions. Before you sign, be sure you understand what the study is about, including the risks and possible benefits to you.
The researchers hope to learn how well this real-time mobile app will be used by persons who download it on their personal smartphone or tablet and if they will respond to questionnaires that are periodically sent to them. This app will ask a series of questions regarding the treatment performed on your tooth and the pain that you are experiencing following treatment. Notifications are sent to your personal smart device over a three-month period following the treatment. The study is designed to gather information on whether a subject will actually respond to the questionnaires when they are sent. It is hoped that this app will help prompt you to report any pain or problems you may be having with your tooth after treatment and to contact the clinic, if needed, for additional care.
Confidentiality: How will your records be kept confidential? Information we learn about you in this study will be handled in a confidential manner, within the limits of the law. If we publish the results of the study in a scientific journal or book, we will not identify you. The Institutional Review Board and other groups that have the responsibility of monitoring research may want to see study records, which identify you as a subject in this study.
Research policies require that private information about you be protected and this is especially true for your health information. However, the law sometimes allows or requires others to see your information. The information given below describes how your privacy and the confidentiality of your research records will be protected in this study.
What is Protected Health Information (PHI)? Protected Health Information is information about a person's health that includes information that would make it possible to figure out whose it is. According to the law, you have the right to decide who can see your protected health information. If you choose to take part in this study, you will be giving your permission to the investigators and the research study staff (individuals carrying out the study) to see and use your health information for this research study. In carrying out this research, the health information we will see and use about you will include your name, gender and date of birth.
Once you have registered in the mobile app using your name, gender, and date of birth, the app will assign your information a unique code that will be attached to your survey answers from that point forward. Because you will create your own password to enter the mobile app, no one will have access to the survey answers you provide.
How will your PHI be shared? Because this is a research study, we will be unable keep your PHI completely confidential. We may share your health information with people and groups involved in overseeing this research study including: The company Quacito, LLC that made the smartphone application for the study. The members of the local research team. The Institutional Review Board and the Compliance Office of the University of Texas Health Science Center at San Antonio, and other groups that oversee how research studies are carried out. The Research offices at the University of Texas Health Science Center at San Antonio.
If you decide to participate in this study, you will be giving your permission for the groups named above, to collect, use and share your health information. If you choose not to let these groups collect, use and share your health information as explained above, you will not be able to participate in the research study.
How will your PHI be protected? In an effort to protect your privacy, the study staff will use code numbers instead of your name, to identify your health information you have entered into the application downloaded on your personal smart device. Initials and numbers will be used on any photocopies of your study records, and other study materials containing health information that are sent outside of UT Dental for review. If the results of this study are reported in medical journals or at meetings, you will not be identified.
Do you have to allow the use of your health information? You do not have to allow (authorize) the researchers and other groups to see and share your health information. If you choose not to let the researchers and other groups use your health information, there will be no penalties but you will not be allowed to participate in the study. After you enroll in this study, you may ask the researchers to stop using your health information at any time. However, you need to say this in writing and send your letter to:
Dr. Sukhpreet SandhuIf you tell the researchers to stop using your health information, your participation in the study will end and the study staff will stop collecting new health information from you and about you for this study. However, the study staff will continue to use the health information collected up to the time they receive your letter asking them to stop.
Can you ask to see the PHI that is collected about you for this study? The federal rules say that you can see the health information that we collect about you and use in this study. Contact the study staff if you have a need to review your PHI collected for this study. However, the PHI that we have collected on you is the information that you have entered on the application, which you downloaded on your smart device.
How long will your PHI be used? By signing this form, you agree to let us use and disclose your health information for purposes of the study until the end of the study. This permission to use your personal health information expires when the research ends for all enrolled subjects, and all required study monitoring is over.
Contact Information: Who can you contact if you have questions, concerns, comments or complaints? If you have questions now, feel free to ask us. If you have additional questions, concerns, comments or complaints later or you wish to report a problem, which may be related to this study please contact:
Primary contact: Dr. Sukhpreet Sandhu, Department of Endodontics, 7703 Floyd Curl Drive San Antonio, TX 78229
Endodontic Clinic Phone: 210-450-3636
The University of Texas Health Science Center committee that reviews research on human subjects (Institutional Review Board) will answer any questions about your rights as a research subject, and take any concerns, comments or complaints you may wish to offer. You can contact the IRB by calling 210-567-8250, or by mail to IRB, UTHSCSA, Mail Code 7830, 7703 Floyd Curl Drive, San Antonio, TX 78229-3900