What does participation look like?
Longitudinal studies involve observing the same variables repeatedly over long periods of time. Taking place over the course of three years, the CART Initiative is following four cohorts or groups of research participants, who share a defining characteristic (like age or geographical location). Observing the same subjects long-term allows for patterns, changes,and trends to be measured more accurately.
What does involvement look like? A research study, like CART, includes these steps:
During this phase, a person decides whether or not they'd like to participate in the study. If they're interested, they can contact a study coordinator to set-up a screening. Participation is voluntary.
Potential participants are screened to see if they meet the eligibility requirements.
Once screened, potential participants will sign a consent form in order to officially enroll in the study.
Once enrolled, participants are observed for the duration of the study and their data is collected. Participants can disenroll at any time.
How do researchers use the data?
Data collected throughout the CART study is analyzed by researchers to search for any patterns or trends related to day-to-day life activities. These include how often someone sleeps, how fast someone walks or how often they move around their home. Innovative algorithms translate data into meaningful information.
For the sake of privacy, data is de-identified. Participants are also not able to access the data that is collected about them.
We will take steps to keep your personal information confidential, but we cannot guarantee total privacy. You are responsible for the physical security of the study equipment in your home. If someone not involved in this research removes the hub computer from your home, they would potentially be able to access the sensor data from your home.
Some study tests are completed in an encrypted database called REDCap. The REDCap database is a password protected and maintained by the Oregon Clinical & Translational Research Institute (OCTRI) at Oregon Health and Science University (OHSU). A user profile based on your study ID number will be created for you, which will not contain your name or other identifying information. The database will collect your responses to questions, but will not contain any identifying information about you. By signing this informed consent, you give permission for this data to be maintained by OCTRI, which will be responsible for maintaining the security and confidentiality of the transferred data.
Some study surveys are completed using cloud software called Qualtrics. Qualtrics is password protected. Your full name, study ID number and email address will be stored on the Qualtrics server, in order to send you study surveys and to enable CART study staff to manage survey administration. The Qualtrics server will collect your responses to questions. By signing this informed consent, you give permission for this data to be stored on the Qualtrics servers and maintained by CART study staff, who will be responsible for maintaining the security and confidentiality of the transferred data.
We will create and collect health information about you as described in the Purpose and Procedures sections of this form. Health information is private and is protected under federal law and Oregon law. By agreeing to be in this study, you are giving permission (also called authorization) for us to use and disclose your health information as described in this form.
The investigators, study staff, and others at OHSU may use the information we collect and create about you in order to conduct and oversee this research study and store in a repository to conduct future research. We may release this information to others outside of OHSU who are involved in conducting or overseeing research, including:
- The funders of this study, and the funder’s representatives
- The National Institutes of Health
- The National Alzheimer’s Coordinating Center (NACC)
- The Office for Human Research Protections, a federal agency that oversees research involving humans
We will not release information about you to others not listed above, unless required or permitted by law. We will not use your name or your identity for publication or publicity purposes, unless we have your special permission. Information may be sent to the National Alzheimer's Coordinating Center (NACC) funded by the National Institute on Aging. The only piece of identifying information that will be shared is your age. Your identity will not be disclosed unless you give separate and specific consent for it.
To help us protect your privacy, this study and the National Alzheimer's Coordinating Center – NACC have obtained a Certificates of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).
A Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. However, if we learn about abuse of a child or elderly person or that you intend to harm yourself or someone else, or about certain communicable diseases, we will report that to the proper authorities.
When we send specimens or information outside of OHSU, they may no longer be protected under federal or Oregon law. In this case, your information could be used and re-released without your permission. Data from this study may be shared with other investigators for future research studies. All identifying information about you, except your age, will be removed before the information is released to any other investigators.
We may continue to use and disclose your information as described above indefinitely.