Letter of Information (generic)

[This is a “generic” letter of information that provides information common across different experiments. Prior to participation, you would read and sign a letter of information specific to the study in which you are participating. The specific letter would contain additional details about the nature of the experiment, inclusion/exclusion criteria, compensation rate, duration of the experiment, etc.]

Introduction

[The purpose of the specific experiment you will be participating in will be explained.]

If you agree to participate in this study, you will undergo functional magnetic resonance imaging (fMRI) at the Robarts Research Institute. Functional MRI is a noninvasive brain imaging technique that uses the same machine that is used in MRI for patients. MRI uses a strong magnet and radio waves to make images of the brain. It does not involve x-rays or radiation. When a specific region of the brain is involved in processing information, there is an associated change in brain metabolism and blood flow to that region. These changes can be detected by the MRI scanner as changes in the image signal intensity. These changes are particularly prominent with stronger magnetic fields, which is why we use a 3 Tesla scanner.

Research Procedures

At the start of the study, you will be asked to complete a few prescreening tests including the Edinburgh Handedness Inventory. This questionnaire is used to help us determine whether you are left- or right-handed. Answering all questions in this inventory is required to confirm your eligibility for some of the study tasks. We will also briefly test your depth perception by asking you to tell us which of several visual stimuli appears closest to you. You may be also be asked to complete the Simulator Sickness Questionnaire to assess your susceptibility to motion sickness.

If you are eligible and agree to participate in this study, you will undergo functional magnetic resonance imaging (fMRI) at the Robarts Research Institute. Functional MRI is a noninvasive brain imaging technique that uses the same machine that is used in MRI for patients. MRI uses a strong magnet and radio waves to make images of the brain. It does not involve x-rays or radiation. When a specific region of the brain is involved in processing information, there is an associated change in brain metabolism and blood flow to that region. These changes can be detected by the MRI scanner as changes in the image signal intensity. These changes are particularly prominent with stronger magnetic fields, which is why we use 3 and 7 Tesla scanners. In comparison, most hospitals use a 1.5 Tesla or 3 Tesla scanner for clinical testing.

You will be scanned in either a 3- or a 7-Tesla scanner depending on the type of experiment you will be asked to perform. Most of the experiments in this study involve hand movements such as reaching or grasping. The area inside the 3-Tesla scanner is larger and better suited for these types of experiments. Therefore, most participants will undergo a 3-Tesla scan. We will scan participants at 7-Tesla only when we require scans to be conducted at higher resolution, as higher magnetic fields give us the ability to acquire more detailed images. The 7-Tesla experiments will only involve visual stimuli (no hand actions) as the space inside the scanner is smaller than in the 3-Tesla scanner. You will be informed at the beginning of the study about the type of testing and the scanner that will be used during your participation.

Because the MRI scanner uses a very strong magnet that will attract metal, we must be certain that you have no metal in or on your body when you go into the scanner. Prior to participating, you will be asked to fill out a screening checklist to evaluate whether you meet the eligibility criteria for participation in this fMRI study. These include precautions to ensure you have no metal in your body and, if you are female, that you are not pregnant or at risk of conceiving a child. You will also be asked to remove any metallic personal effects (jewelry, watch, hair clips, wallet) to be stored in a safe place while you are being scanned.

At the beginning of the session, you will first complete a few training trials outside the scanner to become familiar with the study tasks. You will then lie down on a table that slowly slides inside the long hollow tube at the centre of the MRI machine. The space within the large magnet is somewhat confined, although we have taken many steps to reduce any "claustrophobic" feelings. During the fMRI session, you will be asked to keep as still as possible, especially during periods lasting approximately five-ten minutes during which the magnet is beeping continuously. You will hear muffled banging and beeping noises throughout the scanner operation, but the hearing protection will reduce the sound level to an acceptable level. If you find the sound uncomfortably loud, notify the operator immediately.

You may also be asked to undergo an additional 12-minute scan to examine the white matter structure of your brain, known as diffusion tensor imaging. We may also record your heart rate, eye movements, and skin responses during the scans.

You will be in voice contact with the operator between scans (of approximately five-ten minutes apiece). You will also be given a squeeze ball to alert the operator during a scan. You may ask the operator to end the experiment at any time.

Voluntary Participation

Participation in this study is voluntary. You may refuse to participate, refuse to answer questions or withdraw from the study at any time with no effect on your academic or employment status. You should ask to stop the experiment if you feel uncomfortable or tired. You will have the right to withdraw your data at any point up until the data has been analyzed and prepared for publication. We may publish the study results in an open science forum, and it would be impossible to remove anonymized data from one participant at that point. None of the personal information will be shared in this way. All data collected will be de-identified and will not be traceable.

Compensation

You will receive $XX [the amount will be specified for the particular experiment at a rate typically around $25/hour]. If you do not complete the entire study or if you are found to meet the exclusionary criteria you will still be compensated for your time.

Benefits

There is no direct benefit to you from participating in this study. The results from this study may help us to better understand the brain regions underlying human vision and action.

Risks

There are no known biological risks associated with MR imaging. Some people cannot have an MRI because they have some type of metal in their body. For instance, if you have a heart pacemaker, artificial heart valves, metal implants such as metal ear implants, bullet pieces, chemotherapy or insulin pumps or any other metal such as metal clips or rings, they cannot have an MRI. During this test, you will lie in a small, closed area inside a large magnetic tube. Some people may get scared or anxious in small places (claustrophobic). An MRI may also cause possible anxiety for people due to the loud banging made by the machine and the confined space of the testing area. You will be given either ear plugs or specially designed headphones to help reduce the noise.

Confidentiality

Your contact and demographic information (name, email or telephone number, age, sex) collected for this study, will be stored in a secure, password-protected database (OurBrainsCAN) held at Western University. Only the researchers of this study and the BrainsCAN coordinator(s), who administers the database system, will have access to your identifiable information as stated above. The BrainsCAN coordinator will not need to review any of your information unless you have consented to be a part of the OurBrainsCAN registry. If you agree to be a part of the OurBrainsCAN registry and have indicated that the researchers of this study can enter your identifiable information, they will include the contact and demographic information collected for this study.

Following publication of results, the imaging data obtained through this study may be made openly available to other researchers. This is done in an effort to promote emerging best practices in neuroimaging for open science. None of your personal information will be shared in this way, and images will be modified to remove any information that could be used to produce an image of your face. You may opt out of this use of your data by checking the appropriate box at the end of this document.

Representatives of The University of Western Ontario Non-Medical Research Ethics Board may contact you or require access to your study-related records to monitor the conduct of the research.

If you would like to be contacted about future research studies for which you may be eligible, you can choose to have your identifiable information, as stated above, entered into “OurBrainsCAN: University of Western Ontario’s Cognitive Neuroscience Research Registry” by the researchers of this study OR alternatively you can be given the web address of OurBrainsCAN where you are able to enter your information. This is a secure database of potential participants for research at Western University, which aims to enrol 50,000 volunteers over a period of 5 years. The information in this database will be stored indefinitely. The records are used only for the purpose of recruiting research participants and will not be released to any third party. When you are invited to participate future research studies, you will be given a full description of what your involvement would entail. You are, of course, free to turn down any invitation. If, at any time, you decide that you do not want to be a part of this database, please contact ourbrainscan@uwo.ca to remove your information. 

Incidental Findings

The MRI experiments carried out for this study are performed solely for scientific purposes.  The data which is collected is not optimized to make clinical diagnoses, and the research team involved in these experiments are not trained to make medical evaluations.  Nevertheless, there is a small possibility that a potential abnormality might be observed – otherwise known as an incidental finding.  If this occurs, the participant will be notified of the issue by the principal investigator of the study who will assist them with their options for following up.

Consent form

You do not waive any legal rights by signing the consent form. You will be provided with a copy of this letter of information and the consent form.

Contact Information

If you require any further information regarding this research project or your participation in the study you may contact Professor Jody Culham, 519-661-3979, jculham <at> uwo <dot> ca

If you have any questions about your rights as a research participant or the conduct of the study you may contact:

The Office of Research Ethics
The University of Western Ontario
Phone: 519-661-3036
E-mail: ethics<at>uwo.ca

[If you wish to proceed with participation, you will be asked to sign and date a form indicating that you have read this letter and agree to participate.]