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The consent form language options outlined in this document should be used for all research projects that include research imaging in an MRI scanner. Please consult with the MRI department if you are unsure of what procedures will be required for your imaging protocol.
Magnetic Resonance Imaging (MRI) scans create images of the body using a magnet and radio waves. While the procedure is much like a CT scan, there is no radiation involved in an MRI exam. The MRI exam(s) in this study will take about _____ minutes.
To be sure that it is safe for you to have an MRI exam, you will be asked to complete standard MRI screening questionnaires.
Since the MRI machine uses a strong magnet that will attract other metals, you may not take part in this study if you have a pacemaker, an implanted defibrillator, or certain other implanted electronic or metallic devices, shrapnel, or other metal.
Choose a or b:
(a) If you have a history of metal in your head or eyes, you will need an x-ray exam of your skull in order to find out if the MRI exam is safe for you.
(b) If you have a history of metal in your head or eyes, you cannot take part in this study.
Although the MRI machine is open at both ends, you may still feel confined (claustrophobic). If this bothers you, please tell the MRI staff. The MRI machine periodically makes loud banging noises. We will provide earplugs or headphones for you to wear during the MRI exam.
During the exam, you will be able to hear the MRI staff. They will be able to see and hear you.
If contrast will be used for the MRI exam, add the following language
At some point during the MRI exam, the scanning procedure will be interrupted to give you a contrast agent through a needle in your arm.
While no significant risks have been found from the use of MRI scans, you may be bothered by the MRI machine noise and by feelings of being closed in (claustrophobia).
If gadolinium contrast will be used for the MRI exam, add the following language:
The contrast agent you will receive is FDA-approved and used routinely for MRI exams. It contains a material called gadolinium.
- About 1 in 100 people may notice discomfort, tingling or warmth in the lips, metallic taste in the mouth, tingling in the arm, nausea, or headache. These symptoms go away quickly.
- There is a small risk of an allergic reaction to gadolinium. However, a severe allergic reaction occurs in less than one in 300,000 people.
- The placement of the needle (small plastic tube) to give you the gadolinium may cause minor pain, bruising and/or infection at the injection site.
People with severe kidney failure who receive gadolinium are at risk of developing Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). This disease causes fibrosis (the formation of too much connective tissue in the skin and internal organs). This is a serious disease, which can result in death.
You should notify the study team or MRI staff if:
- you are allergic to gadolinium
- you have kidney problems
If a screening skull x-ray is done, add the following radiation risk language:
If you require an x-ray examination of your head and eyes, the total amount of radiation you will receive from that x-ray examination is 0.01 rems. Radiation that occurs naturally (cosmic radiation, radon, etc.) causes whole body radiation exposures of about 0.3 rems per year. People who are exposed to radiation at their jobs are permitted to receive whole body exposure of 5 rems per year.
Use of investigational agent or an agent other than gadolinium:
If your research study involves the use of an investigational agent or an agent other than gadolinium, the Risks section must be specific to the agent being studied. This information can be found within the Sponsor’s Investigator’s Brochure or the package insert. Please consult with the MRI department if you are unsure of the contrast needs for the research.
PREGNANCY RISKS SECTION
If the MRI exam will NOT include a contrast agent, use the following language:
There are no known risks from MRI imaging without contrast during pregnancy. There may be risks that are currently unknown.
If the MRI exam WILL include a contrast agent, use the following language:
MRI imaging is not known to cause risk to the developing fetus. However, there may be risks that are not known at this time. MRI contrast is known to cross the placenta and subsequent risks to the developing fetus are not known. You may have an MRI scan without contrast if the study allows this. If possible, you should wait until after your pregnancy is completed before having contrast-enhanced MRI imaging.
JHMIRB policy for research MRIs in pregnant women
MRI Without Contrast
Pregnancy testing is not required and the radiologist investigator does not need to be involved on the day of the procedure. The MRI technologist will serve as the research study contact for the participant at the time of the MRI scanning procedure.
MRI With Contrast
If a research protocol requests contrast, the IRB will consider justification as to why contrast is needed and whether the protocol should or should not exclude women who are able to become pregnant. If the IRB finds that the use of contrast is justified and that women who are able to become pregnant should be allowed to participate, then the protocol must provide for a pregnancy test within a week prior to the MRI scan with contrast. If the pregnancy test is negative, then the study may proceed with appropriate consent language. If the pregnancy test is positive, the PI must discuss the risks and benefits with the participant and have her sign the appropriate consent forms (Hospital and research consent) depending on the contrast agent to be given.