The Office of Research Ethics – Human Participants Review Sub-Committee has established some required wording to be included on Consent forms for MRI projects.
The following language must be included verbatim in the consent forms for all studies using the York MRI Facility
What Is Involved in the Study?
Your participation will involve measuring the anatomy and activity of your brain using magnetic resonance imaging (MRI). MRI scanners image your brain using radio waves and very strong magnetic fields. You will be asked to fill out a safety screening form to assess whether it is safe for you to enter the MR room. It is important that you provide us with an accurate and up-to-date medical history, and when unsure to ask clarifying questions so that we can proceed safely. You will then be asked to remove any metallic objects you may be carrying (for example, wallets, watches, earrings or piercings) and possibly to change clothing into a gown that we will provide (if deemed necessary because of large zippers etc.). You will be required to lie completely still on the patient bed that will slide into the bore of the MRI scanner. You will be able to communicate with us at all times via a built-in intercom. You will be holding an emergency bulb that you can squeeze at any time to let us know you want to come out of the MRI scanner.
This is Not a Clinical Evaluation
The images of your brain collected in this study are not intended to reveal any disease state, in part because this MRI protocol is not designed for clinical diagnosis. Thus, your brain images will not be routinely examined by a clinical radiologist. The personnel at the MRI Research Facility are not qualified to medically evaluate your images. However, if in the course of collecting images of your brain we have any concerns, we may show your scans to a clinical radiologist, who may suggest that you obtain further diagnostic tests.
At the investigator’s discretion, you may view your brain images and receive digital copies of them. However, you should be aware that brain structures within the normal population are highly variable, and that it is difficult to draw any conclusions from your images; you should be aware of the potential distress or discomfort that may occur by viewing your own images. Do not rely on this research MRI to detect or screen for brain abnormalities.
What Are the Risks of the Study?
Metal: The MRI scanner produces a constant strong magnetic field, which may cause any metal implants and/or clips within your body to shift position. The magnetic field may also cause any implanted medical devices to malfunction. Thus, if you have any implanted metal, clips or devices, it is hazardous to your health to participate in this study. Please provide us with as much information as you can, for example if you had surgery in the past, so that we may decide whether it is safe for you to be a subject. Metallic objects brought into the MRI environment can become hazardous projectiles. Metal earrings, body piercings, and necklaces must be removed prior to the study.
Pregnancy: Exposure to MRI scanning might be harmful to a pregnant female or an unborn child. Although there are no established guidelines at this time about MR and pregnancy, you should be informed that there is a possibility of a yet undiscovered pregnancy related risk. If you know or suspect you may be pregnant or if you do not want to expose yourself to this risk, we recommend that you do not participate in this study.
Inner ear damage: MRI scanning produces loud noises that can cause damage to the inner ear if appropriate sound protection is not used. Earplugs and/or headphones will be provided to protect your ears.
Claustrophobia: When you are inside the MRI scanner, the MRI scanner surrounds your body and your head will also be positioned inside a close-fitting scanning coil. If you feel anxious in confined spaces you may not want to participate. If you decide to participate and begin to feel claustrophobic later, you will be able to tell us via the intercom and we will discontinue the study immediately.
Burns: In rare cases, contact with the MRI transmitting and receiving coil, conductive materials such as wires or other metallic objects, or skin-to-skin contact that forms conductive loops may result in excessive heating and burns during the experiment. The operators of the MRI scanner will take steps, such as using foam pads when necessary, to minimize this risk. Tattoos with metallic inks can also potentially cause burns. Any heating or burning sensations during a scan in progress should be reported to the operators immediately and we will discontinue the scan.
Besides the risks listed above, there are no other known risks from the magnetic field or radio waves at this time. Although functional MRI scanning has been used for more than 15 years, long-term effects are unknown. If new findings about the risks of the MRI technique become available within a year of your participation, we will let you know about them.
What about Confidentiality?
All information obtained during the study will be held in strict confidence to the fullest extent possible by law. In no case will your personal information be shared with any other individuals or groups without your expressed written consent. Your brain images will be stored on secured computer servers and will be archived indefinitely. The experimental data acquired in this study may, in an anonymized form that cannot be connected to you, be used for teaching purposes, be presented at meetings, published, shared with other scientific researchers or used in future studies. Your name or other identifying information will not be used in any publication or teaching materials without your specific permission.
Privacy: Personal information in connection with this form is collected under the authority of The York University Act, 1965 and will be used for educational, administrative and statistical purposes. If you have any questions about the collection, use and disclosure of personal information by York University, please contact: Title, Address, Telephone Number, (Email).
