MAE is a smartphone sensing application developed by Research Science Consulting LLC (“RSC”) for research conducted by the Department of Orthopaedic Surgery at the University of Cincinnati College of Medicine. Its primary purpose is the collection of real-world behavioral data about users’ physical and mental well-being. The app is not used to diagnose or treat any medical condition.
This Privacy Policy details the information we may collect as a result of your use of any of our health research study Apps during participation in a Research Study. This Privacy Policy does not cover how we collect or use information associated with the use of our website or any other products and services that we offer. Those policies are described in our general privacy policy.
Informed Consent
To participate in a Research Study that uses the MAE smartphone App, you must sign an informed consent form. The consent form has been reviewed and approved in accordance with the policies and procedures of the University of Cincinnati’s Office of Research Human Research Protection Program. By signing the informed consent document in the App, you consent to the collection, use, and sharing of your information as described here in this Privacy Policy and as detailed in the Informed Consent. If there is a conflict between this Privacy Policy and the Informed Consent, the Informed Consent shall govern.
The use of the term “Research Team” refers to all individuals and entities that may have access to the data collected from the App as part of your participation a Research Study. The Informed Consent specifies who shall have access to your data and for what purpose.
Collection and Use of Information
Personal information is data that can be used to identify or contact a single person. Certain personal information and non-personal information, as described below, may be collected from or about you through the Apps or as part of a Research Study.
RSC and the Research Team members may share the information we collect through the App with each other and use it consistent with this Privacy Policy.
If you decide to participate in the Study, below are examples of the types of information that we may collect and how we may use it.
What information we collect
When you download the App and enroll in Research Study, below are examples of the categories of information (which may include some personal information) that may be collected from or about you through the App (“Study Data”). The specific categories of information that will be collected about you as part of a Study will be described in the Informed Consent.
- First and Last Name. Your first and last name are entered and recorded on the informed consent that you will sign before registering for the study. The consent form is stored separately from your “Study Data” which are anonymized.
- Health information, such as your height/weight, physical activity, mood, and sleep habits. This information may be collected through in-app surveys or other health surveys that you may be asked to complete.
- Sensor information. The App will collect information about your daily routine and behaviors through its sensors. The device may measure physical activity by using the built-in accelerometer in your phone as is typically done by many widely-used fitness apps. No one will have access to any location data about you in real time.
- Other information, if any, described in the Informed Consent.
All personal information will be separated from the rest of the data collected from you through the App and as part of the Research Study and replaced with a random code (“Coded Study Data”).
How will information about you be kept private and confidential?
Your Right to Data Confidentiality
Every effort will be made to maintain the confidentiality of your research records related to this study. Agents the University of Cincinnati, and the sponsoring organization (identified in the Informed Consent), designated Research Team personnel, the Institutional Review Board (IRB), and other regulatory authorities will be granted direct access to your original research records for verification of research study procedures or study data without violating your confidentiality, to the extent permitted by the applicable laws and regulations. By signing the informed consent, you are authorizing such access. The data from the study may be published; however, you will not be identified by name. Your identity will remain confidential unless disclosure is required by law.
Privacy Protection
Data collected via your smartphone or through computer surveys are stored on secure servers accessible to RSC and the Research Team using security procedures outlined below.
All data are anonymized and do not contain identifying information (i.e., your name or other personal information). All servers containing de-identified project data, including geographic data, are password-protected.
You have the option to turn your smartphone off at any time if you do not want activity information recorded. You may also delete the app from your smartphone if you no longer wish to participate in the study.
The only method of linking your anonymous data (records mentioned above) to your personal information is through a separate linking file that will be stored separately from your data in a locked location with restricted access. What this means is that there is no way for anyone to obtain your personal information from your smartphone data or other records. Only specific lab employees (designees) will have access to the file linking you to your anonymized study ID, but these designees will NOT have access to your study data. In this way, you will be anonymous to RSC and the Research Team and your data will NOT be available to the lab designees who have your personally identifiable information as a participant. The lab designees will only know that you are a participant. They may contact you to compensate you for your participation. These persons might also contact you to ensure your smartphone app is functioning properly, to remind you of other aspects of the study, or to invite you to participate in related studies.
What are your rights as a participant?
You may choose either to take part or not to take part in this research study. If you decide to take part, you may decide to leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to you.
The Research Team will tell you about new information that may affect your health, welfare, or willingness to stay in this study.
If you have questions about the study, you will have a chance to talk to a member of the Research Team. Do not sign this form unless you have had the chance to ask questions and have received satisfactory answers.
Nothing in this consent form waives any legal rights you may have nor does it release the investigator, the sponsor, the institution, or its agents from liability for negligence.
Children
Our App is not intended for children under the age of 18. Access to the App is restricted to participants who have received a user registration email and password. All potential participants are screened to meet the minimum age requirement (18 and older) approved for each Research Study by the University of Cincinnati’s Office of Research Human Research Protection Program.
Who do you contact if you have questions or problems?
If you have questions, concerns or complaints and/or suggestions about this research study or to report a research-related injury, please contact the contact person for the Research Team identified in the Informed Consent.
Please call the University of Cincinnati Medical Institutional Review Board at 513-558-5259 (Monday – Friday 8 am to 5 pm) if you:
- Think the research has hurt you.
- Have general questions about giving consent or your rights as a research participant in this research study.
- Have questions, concerns, or complaints and/or suggestions about the research.
- Cannot reach the research team or you want to talk to someone else.
To report complaints or concerns to an independent agency in an anonymous and confidential manner, please call the Research Compliance Hotline at 1-800-889-1547.