Letter of Information (generic)
[Contact information for the investigator will be provided.]
[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.
At the beginning of the session, you will 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. The session will last up to two hours, during which you must keep as still as possible, especially during periods lasting approximately five minutes during which the magnet is beeping continuously. You will hear a 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.
[The details of the specific experiment and the expectations for your participation will be explained.
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 (jewellery, watch, hair clips, wallet) to be stored in a safe place while you are being scanned.
You will be in voice contact with the operator between scans (of approximately five 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.
You will be compensated $25 per hour for your time, parking and the inconveniences associated with participating in the study.
The Food & Drug Administration (USA) has indicated that for clinical diagnosis an ‘insignificant’ risk is associated with human MRI exposure at the intensities used in this project. Current Canadian guidelines follow the USA guidelines. Although very rare, injury and deaths have occurred in MRI units from unsecured metal objects being drawn at high speeds into the magnet or from internal body metal fragments of which the subject was unaware or had not informed MRI staff. To minimize this latter possibility it is essential that you complete a screening questionnaire. Other remote but potential risks involve tissue burns and temporary hearing loss from the loud noise inside the magnet. The latter can be avoided with ear protection that also allows continuous communication between you and the staff during the study.
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.
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, claustrophobic or tired. You have no obligation to participate in concurrent or future studies.
Participant Exclusion Criteria
If you have any history of head or eye injury involving metal fragments, if you have ever worked in a metal shop or been a soldier, if you have some type of implanted electrical device (such as a cardiac pacemaker), if you have severe heart disease (including susceptibility to arrhythmias), if you are wearing metal braces on your teeth, or [for women] if you could be pregnant, or have an intrauterine device, you should not have an MRI scan.
Any information obtained from this study will be kept confidential. Any data resulting from your participation will be identified only by case number, without any reference to your name or personal information. The data will be stored on a secure computer in a locked room. Both the computer and the room will be accessible only to the experimenters. After completion of the experiment, data will be archived on storage disks and stored in a locked room for five years, after which they will be destroyed.
Estimate of participant’s time and number of participants
Each experiment will last approximately two hours. Each experiment within the project will involve [to be specified] subjects. The entire research project will involve approximately [to be specified] subjects.
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.
If you would like to receive a copy of the overall results of the study, please print your name and address on a blank piece of paper and give it to the experimenter.
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
[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.]