MRI template language (also gadolinium)
Consent must be discussed and documented by a qualified member of the research team. The individual must certify that he or she has completed human subjects training and has been trained, and observed discussing consent. He or she must be supervised, as needed, during the consent procedure.
Sample Consent Form Language (please adapt as necessary for specific studies):
- Alternatives to participation (same for all MRIs)
This is not a treatment study. Information being collected is for research purposes only and is to learn more about __________, not about you. It is not necessary to participate in this research study to have an MRI, and the MRI done as part of this study is not the same as one done for medical purposes.
Study Procedures (same for all MRIs)
MRI (Magnetic Resonance Imaging). The MRI uses strong magnetic fields and radio waves to take pictures of your brain. MRI involves lying on a table that slides into a large magnet shaped like a cylinder. Before beginning the imaging procedure, we will determine that you do not have a pacemaker or any unsafe metallic implants such as an aneurysm clip or heart valve and certain tattoos, and you will be asked to remove any metal or magnetized objects (such as keys, chains, jewelry, retainers, medication patches, hairpins or credit cards). You will be asked to lie flat on your back in the MRI scanner for ______ minutes and to remain as still as possible. You will not feel anything, but you will hear a knocking, noise. This is a normal sound produced by the MRI scanner and does not indicate that anything is wrong.
Study risks must be described in relation to specific scanner and scanning procedures, for example, for 1.5T and 3T magnets.
While there have been no reports of any harmful long-term effects caused by 3T magnets or magnets of even higher strength, the long-term effects of being placed in a magnet of this strength are unknown. Also, although there are no known risks associated with pregnancy, we will not scan someone who is pregnant. If you are a female in your childbearing years, you will be asked to take a pregnancy test to ensure that you are not pregnant.
Some people have reported sensations during MRI scans with the 3T magnet, such as "tingling" or "twitching" (or, very rarely, a painful sensation), which are caused by changes in the magnetic field that can stimulate nerves in your body. With any MRI scan, on occasion, some people experience nervousness or discomfort due to the scanner's small space and the need to lie still. Except for pacemakers, some types of metallic implants, and medication patches, we are not aware of any other potentially dangerous interactions or hazards associated with the MRI scan. The MRI scanner also produces a loud noise; earplugs will be provided to reduce this discomfort. If you experience any discomfort and wish to stop the scan, you can tell the MRI technologist, and he or she will stop the scan immediately. In our experience, no one has had sensations from the MRI that did not stop when the scanning stopped.
Benefits regarding MRI
You are not expected to benefit from participation in this study.
Results of your MRI
While MRI scans are sometimes done for clinical purposes, the kind of MRI scan you will have as part of this study is for research purposes only. This means that the scans are not designed to provide clinical information that might be helpful to you or your doctor and they may not show problems that would normally be found in an MRI ordered to evaluate a specific medical problem. It is likely that the MRI scan will not have the quality of those done for clinical purposes.
For T1 weighted images:
However, within a month of the MRI, the scan will be read by a neuroradiologist for evidence of any obvious irregularities requiring your follow-up. You, or a physician whom you may designate, will be informed only when significant abnormalities are detected. If you wish, we can also inform you if there were no obvious findings. Given the nature of the scan, the absence of a finding does not mean that one is not present.
For T2 and T2-FLAIR images:
However, within a month of the MRI, your scan will be read by a neuroradiologist and information about the scan will be shared with you or a physician whom you may designate.
Confidentiality (re: MRI)
Depending on the location of scanning and interpretation, one of the following statements should be included:
The results of your MRI scan will be maintained in an electronically secure database at NYSPI or CUMC and accessible only to the members of the research team or,
The results of your MRI scan will be maintained on the clinical information system at Columbia University Medical Center and will be accessible to hospital clinicians.