Participants

There are some risks in undergoing an MRI:

• The magnetic effect of the MRI on implanted devices. The MRI could cause any metal in your body to heat up. This is because the MRI machine uses strong magnets in order to collect the scans. Every effort will be made to eliminate this risk, by asking you ahead of time about any devices or injuries from metal objects, and not running the test if you have anything in your body that will be affected by the machine.
• The brain MRI is a magnetic resonance imaging procedure to take images of your brain. This MRI procedure will have you lie on your back on a narrow table that will be moved into a circular tube. You will not be able to see outside of the tube. There will be repetitive thumping noises as the MRI scans your brain. It will take approximately 45 minutes to complete the scans.

These discomforts will be mitigated in the following ways:

• Headphones and ear plugs will be worn for ear protection.
• Tingling sensations sometimes occur in the arms, but these can usually be prevented by keeping the hands apart.
• The technician will maintain visual and verbal contact with you throughout the MRI scanning sessions.
• As an extra precaution, you will be given an “emergency” button to be used if you wish to end the procedure.
• It is important to understand that participation in the MRI scans will require travel outside your home. The MRI facilities and CLSA staff will follow the required protocols for working safely during the pandemic.

You will be asked to repeat this data collection in two years.

As with all studies that collect personal information, there is a remote possibility that third parties such as an insurance company or employer could access the information you have provided without permission of the CLSA. Many levels of safeguards have been put in place to reduce this risk.

All identifiable information will be kept in a secure database with a unique study number at McMaster University and will only be used to contact you. The information that you provide for us, without your name or contact information, will be stored in a secure database at McMaster University. Data collected by interviewers are transferred to the McMaster database over secure, encrypted connections.

All CLSA staff will sign an agreement to protect your privacy and confidentiality.

The CLSA Memory Study data will not be available to other researchers through our general study data access processes. Any requests to access the CLSA Memory Study data will need to be submitted to and approved by the CLSA Memory Study principal investigators. Researchers using data from the CLSA Memory Study will not be provided with any identifying information.

Records identifying you as a participant in the CLSA Memory Study will be kept confidential and, to the extent permitted by the applicable laws, will not be disclosed or made publicly available, except as described in this document. If required, direct authorized representatives of the following organizations may look at your original identifiable data to check that the information collected for the study is correct and follow proper laws and guidelines:

The research ethics boards oversee the ethical conduct of this study in each province.

The CLSA Memory Study will take approximately two years to complete, and the results should be known in approximately three years.

There are no known medical risks to wearing mobility trackers. There are some minor discomforts you may have from using these devices. First, there is the general feeling of being aware that you are wearing these devices while you go about your usual activities. The level of discomfort, however, should be small and hopefully go away as you get used to having them on. You may find that the bands and adhesives on the thigh ActiGraph may cause skin irritation. There is also a slight chance that you may feel as if you are being watched due to being tracked by the GPS device in the TicWatch.

The data collected on all of the trackers and their applications are de-identified (meaning the data are connected to an ID number, not to your name or any other personal identifying information). This means that if a tracker is lost or an unauthorized person tries to access the data, they will not be able to connect the data or tracker back to you. Further, data are protected by encryption that cannot be accessed without having credentials. These credentials are only known to key CLSA staff. No identifiable information will be shared with anyone outside of our established CLSA protocols. The data from this part of the study are kept, like all CLSA data, on secure servers located at McMaster University.

There are no known medical risks to wearing sleep trackers. There are some minor discomforts you may have from the wrist ActiGraph. This discomfort is similar to wearing a watch. You may experience some minor disturbance of your usual sleep on the nights that you are wearing the Muse headband. You may find that the bands on the Muse headband may cause skin irritation.

The data collected are de-identified (meaning it is connected to an ID number, not to your name or any other personal identifying information). No identifiable information will be shared with anyone outside of our established CLSA protocols. The data from this part of the study are kept, like all CLSA data, on secure servers located at McMaster University. The stool samples will be stored in freezers located at McMaster University.

The stool sample you provide will be stored for future research. No tests will be run on the sample at the time of collection, and no individual results will be provided from the research performed in the future.

There are no known medical risks to completing stool sample collection.

There are no known medical risks to completing the stool sample collection and memory tests.

There are some risks in undergoing an MRI: The magnetic effect of the MRI on implanted devices. The MRI could cause any metal in your body to heat up. This is because the MRI machine uses strong magnets in order to collect the scans. Every effort will be made to eliminate this risk, by asking you ahead of time about any devices or injuries from metal objects, and not running the test if you have anything in your body that will be affected by the machine.

The stool sample you provide will be stored for future research. No tests will be run on the sample at the time of collection, and no individual results will be provided from the research performed in the future.

The additional memory tests are collected for research purposes only. No results from these tests will be provided to you.

The MRI scan being done is designed to answer research questions, not to examine your brain medically. This MRI scan is not a substitute for one that a doctor may order for a specific reason. This research MRI may not show problems that would be picked up by a medical MRI scan. However, if we believe that we have found a medical problem in your MRI scan, we will contact you and with your permission, contact your family physician or help in getting the right medical follow-up for you. No information generated in this study will become part of your health records. However, if the study detects an abnormality in your MRI scan and further follow-up is required, then this information may become part of your health records.