Human Subjects Protection Notes
To scan at CAMRI, approval from your home institution institutional review board (IRB) or committee for the protection of human subjects (CPHS) is required. When a protocol is submitted to the IRB, the IRB evaluates and reviews the procedures and risks as they relate to certain subject populations. The IRB may require additional items from what is listed below in order to provide approval; however, the language in this guide may assist you with protocol and consent form preparation when utilizing the CAMRI facility for procedures in research. Note that the sections referenced below are specific to the BCM IRB (BRAIN ESP) but may be applicable to others. Thanks to Lisa Wilde and Tiffany Sherrill for their assistance in preparing this template.
Section F2 (Procedures)
Please elaborate in order to specifically describe the procedures the subject(s) will be asked to do when in the scanner When subjects arrive for their study, they will follow standard research procedures for subject scanning at the Center for Advanced MRI (CAMRI) and be verbally questioned to ensure that they have no implanted or other metal and other metal that is not implanted (e.g., non-removable piercings), metal-containing tattoos, as well as devices such as insulin and other types of pumps. This is to ensure that the subjects are screened for those items which could pose a health risk during MRI scanning. While in the MRI scanner, subjects will be presented with a safety screening form.
Section H (Risks)
There are no known risks to functional and structural scans. Because the scans are relatively loud, subjects will be provided with hearing protection to prevent damage to their hearing. Some subjects may experience claustrophobia. Any subject who is uncomfortable for any reason will have their concern addressed- for example: including removal from the scanner, being provided a blanket or adjusting position. Before the scanning begins, subjects will complete a questionnaire to screen for any conditions that could make the scanning dangerous. Subjects will be screened for things such as 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. Any subject with such a condition will not be allowed to participate in the experiment. There are no known risks from this type of imaging without contrast during pregnancy; however, there may be risks that are currently unknown. Therefore, pregnant women will not be allowed to undergo the scanning.
Include if applicable
Subjects remain in contact with the study staff or scanner technician via microphone and visual monitoring through a window
Section S (Attachments)
Attach to the protocol the CAMRI Pre-Screening and Screening forms available on the CAMRI website.
Procedures section (Qc)
Please edit to specifically describe the procedures the subject(s) will be asked to do when in the scanner. This study uses imaging to look at the brain. Magnetic resonance imaging is a type of brain scan that uses magnetic fields and radio waves to make an image of changes in blood flow in your brain while you do certain tasks. In order to make sure the procedure will be safe, you will be asked to fill out a screening form before starting the study. It is important that you tell the researchers in this study if you have any history of: - Metal fragments in your eyes or face. - Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlea implants or nerve stimulators. - Surgery on the blood vessels of your brain or the valves of the heart - Claustrophobia (fear of enclosed places) - Body piercing or tattoos You will be given instructions outside the scanner about the scanning. Next you will be asked to lie still on the patient table and your head will be placed in a specially-designed head holder. Your head will be cushioned by a firm foam pillow. The table will then slide into the enclosed space of the scanner. The scanning session will take (put in length of time) minutes to complete once you are in the scanner. (Note: if more than one session will be needed be sure this is stated—e.g., two sessions in the scanner for 20 minutes each.) You will be encouraged to hold as still as possible, and to let the investigators know if you are uncomfortable in any way as soon as possible after the imaging session begins. The front of the head-holder will be open, which lets you look through a special mirror and see pictures presented to you on a projection screen near your feet. Sounds may also be presented to you using specially designed headphones. You will be asked to hold your head as still as possible and (insert applicable language specific to the protocol). The MRI scanner makes loud banging noises while taking a measurement, so either ear plugs or specially designed headphones will be used to reduce the noise. The earplugs or headphones should not get in the way of communicating with the researchers. Use if applicable: The researchers will be in communication with you through an intercom system to tell you how the study is going.
Potential Risks and Discomforts section (Qe)
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, you cannot have an MRI. Some people are scared or anxious in small places (claustrophobic). The MRI scanner makes loud banging noises while taking a measurement, so either ear plugs or specially designed headphones will be used to reduce the noise. Current experience shows that there are no risks or adverse effects from the magnetic fields used in MRI; any risks that do exist are similar to those of talking on a cell-phone.
Potential Risks and Discomforts section (Qe)
A. If a neuroradiologist will review the MRI scans collected as part of your protocol because you have arranged this on your own, please insert the following paragraph in your consent form: A physician who specializes in brain MRI (a neuroradiologist) will review the structural images of your brain and notify you of any abnormalities or incidental findings that are found. However, because this is a research study and not a clinical exam, we may not examine all parts of your brain or search for all types of abnormalities. B. Otherwise, insert the following paragraph in your consent form: A physician will not review the structural images of your brain. Because this is a research study and not a clinical exam, we will not examine your brain for abnormalities.