Sample and Standard IRB Application Materials

Note: Forms for Partners IRB applications can be downloaded from the Partners Human Research Committee website.

MRI STUDIES

Nonionizing Radiation Forms: 1.5T, 3T, 7T

Sample MR Screening Form (to be used for ALL human MRI studies) Download MSWord

Sample fMRI Consent Form Download MSWord

Consent Form Verbage Regarding Research vs. Diagnostic Use of MRI data Download MSWord

The Partners IRB has suggested that Martinos Center MRI study consent forms include the following text:

The MRI scan being done is designed to answer research questions, not examine your brain medically. This MRI scan is not a substitute for one a doctor would order. It 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 ask a doctor who is trained in the reading of MRI scans, a radiologist, to help us review the scan.  If the radiologist thinks that there may be an abnormality in your MRI scan, we will contact you and will help you get medical follow-up for the problem.  If you have a primary care doctor, we can contact your doctor, with your permission, and help him or her get the right follow-up for you.  No information generated in this study will become part of a hospital record routinely.   However, if the study detects an abnormality in your MRI scan, then this information may become part of the MGH hospital record.  It is possible that you could be unnecessarily worried if a problem were suspected, but not actually found.

 

MEG STUDIES

Research Related Use of Medical Devices form for MEG (MEG_5-device.doc) Download MSWord

Research Related Use of Medical Devices form for MEG (page 2) Download MSWord

This text is to be attached to MEG_5-device.doc (above):

Biomedical Engineering
MGH Biomedical Engineering has inspected the machine (reference protocol # 2000-P-002117, E. Halgren, PI). The manufacturer will inspect the machine yearly and provide the test data to Biomedical Engineering for review.

Methods
MEG/EEG data will be acquired simultaneously in a magnetically and electrically shielded chamber equipped with adjustable lighting, interphone and videocamera. MEG signals are recorded from the entire head using a Neuromag Vectorview system ($D NeuroImaging, San Diego, California). The subject sits or lies with his/her head inside the helmet-shaped lower end of the dewar containing the sensors. Magnetic fields are recorded at 102 sites each consisting of 2 planar gradiometers and one magnetometer. Signals are recorded continuously, with a typical sampling rate of 601 Hz and are minimally filtered (typically 0.1 to 200 Hz). 32 to 128 channels of EEG can be acquired simultaneously from non-magnetic scalp electrodes (impedance < 3Kohm) embedded in a net, including EOG (electrooculogram). MEG and EEG techniques yield complementary information, as they are sensitive to different biophysical properties.

The position of each of the electrodes in addition to fiduciary points such as the nose, nasion and preauricular points will be digitized with a 3Space Isotrak II system, to permit the subsequent precise co-registration with MRI images. The position of the head in the dewar is determined by digitizing the positions of five small ‘HPI’ coils that are attached to the head and are subsequently recorded by the MEG sensors for co-registration. Under development is a method for continuous measurement of the HPI coils during MEG/EEG measurements to permit continuous localization of the head and thus correction for reasonable levels of movement within the same long recording session. Supplemental electrodes are placed in the inferior temporal and sub-ocular regions to better sample basal temporal and frontal activity, where the electrocap does not apply sufficient pressure. EEG is recorded with respect to a reference at the tip of the nose. All data are stored on a RAID storage system with terabytes of online storage, and are available over a high-bandwidth local network to the analysis computers (Beowulf compute cluster, linux, SGI, HP, and Sun workstations).

 

Sample Consent for Verbage for MEG Download MSWord

PROCEDURES
During the MEG measurement, you will be sitting in a magnetically shielded room with your head supported against the helmet shaped bottom of the magnetometer, holding 306 superconducting sensors. Before the measurements, 4–5 small coils will be taped on your skin and a digitizer will be used to measure the location of these coils with respect to specific points on your head. Small currents will be passed through the coils once you are in the instrument; this will allow us to position each coil with respect to the sensors and to align the MEG and MRI coordinate systems. The sensors will record your brain activity while you are performing different tasks. For example, you may look at pictures shown on a screen or you may feel tactile stimuli on your palm/fingers. You may be asked to make judgements about the stimuli by pressing buttons on a handheld response device. You will be asked to sit still during the entire measurement since movements will interfere with getting accurate data.

RISKS
There are no known or foreseeable risks or side effects associated with conventional MEG recordings. However, you may become uncomfortable from having to sit still throughout these recordings.

 

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