The JHM IRBs have revised their policies for the conduct of research protocols involving imaging using Magnetic Resonance (MRI) to be consistent with The Johns Hopkins Hospital (JHH) policies for MRI clinical procedures.
The updated policy and consent form language options outlined below should be used for all research projects involving imaging in a MRI scanner. The revised consent form language is in bold. The document is modular and should be adapted to the specific imaging protocol. Paragraphs are labeled as follows: “P” paragraphs should be added to the procedures section of the consent form; “R” paragraphs should be added to the risks section. Additional language is provided for inclusion in those MRI protocols that include gadolinium contrast agents currently approved by the Food and Drug Administration (FDA), and for ECG monitoring. Please consult with the MRI department if you are unsure of what procedures will be required for your imaging protocol.
1. MRI Imaging Without Contrast
Prior Policy: JHH policy has been to ask women of childbearing potential the date of their last menstrual period:
(i) If less than 4 weeks, nothing further was done, and the procedure was performed.
(ii) If more than 4 weeks (i.e., pregnancy is possible), the patient was interviewed by a radiologist and signed a consent form for the procedure.
New JHMIRB Policy
As of April 2004, JHM IRBs will follow the JHH policy and instruct investigators submitting new or revised consent forms to the JHM IRB to add the consent form language provided below to all studies involving MRI scanning without contrast in the pregnancy risk section. 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.
B. Consent Language:
P1.1 As part of your participation in this research study, you will have an MRI exam (or Magnetic Resonance Spectroscopy (MRS). The MRI exam will take approximately _________ minutes. Prior to your exam, you will be asked to complete a standard questionnaire. The purpose of this questionnaire is to ensure that you are able to safely enter the MRI area.
(Choose a or b) :
(a) If you have a history of metal in your head or eyes, you will need an x-ray examination 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.
P1.2 To start your MRI test, you will lie on a padded table. (Please insert coil wording from section on coil designation). The coil is necessary to help the MRI machine take pictures. The table on which you are lying will be moved to the center of an MRI magnet, which looks like a long narrow tube. Even though the tube is open, some people feel confined in small places. If this bothers you, please notify the MRI staff. You may end your participation in this study at any time by telling the MRI staff. When MRI pictures are taken, or MRS is done, radio-signals and magnetic fields are used. When this happens, it is normal for the MRI machine to make loud, banging, and clicking noises. You will be asked to wear earplugs or headphones for your comfort during the exam.
For insertion into P1.2: Coil Designation:
- Head/Neck Coil: A Head/Neck Coil will be placed around your head, face, and neck
- Surface/Cardiac: A soft padded coil will be placed at the area where the pictures will be taken
- Breast Coil: You will be asked to place your breasts into a padded coil and pressure will be applied to your breasts (similar to a mammogram).
- Endorectal: An imaging device, similar to an endoscope, will be inserted by an MRI technologist into your rectum
- Endourethral: An imaging device, similar to a urine catheter, will be inserted by a physician or nurse into your urethra
- Endovascular: An imaging device will be inserted by a physician into your blood vessel using standard hospital and sterile techniques (similar to having an angiogram)
- Transesophogeal: An imaging device, similar to a bronchoscope, will be inserted by a physician through your nose and into your esophagus
P1.3 During the exam, the MRI staff is able to see and hear you. You will be able to hear the MRI staff. The MRI staff will be talking to you throughout your MRI exam and may issue simple instructions regarding holding your breath, maintaining position, etc. You will generally be requested to lie perfectly still throughout the exam.
R1.1 The effects of magnetic fields in an MRI scanner have been extensively studied, and there are no known significant risks with an MRI exam. You may, however, be bothered by feelings of confinement (claustrophobia), and by the noise made by the magnet during the procedure. You will be asked to wear earplugs or earphones while in the magnet. You may not participate in this study if you have a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices. It is important for you to advise the MRI staff if you have had brain surgery for a cerebral aneurysm, or if you have implanted medical or metallic devices, shrapnel, or other metal, such as metal in your eye.
R1.2 The following paragraph is added after R1.1 (if x-ray is included)
If you require an x-ray examination of your head and eyes, the total amount of radiation you will receive from the 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.
There are no known risks associated with having MRI imaging without contrast during pregnancy. There may be risks that are unknown.
Cost Section: ( if x-ray exam is included)
If you have an x-ray exam of your head and eyes because of a history of metal in your head and/or eyes, the cost of this x-ray exam:
(choose one of the following:)
(a) will be your responsibility. At your request, we will bill your health insurance company for the cost of this x-ray exam;
(b) will be covered by the sponsor of the study;
(c) will be covered by the study.
2. MRI Imaging with Any Contrast
Prior Policy: JHH Policy has been to ask women of childbearing potential the date of their last menstrual period:
(i) If less than 4 weeks, nothing further was done and the procedure was performed.
(ii) If more than 4 weeks (i.e., pregnancy is possible), the patient was interviewed by a Radiologist whose main goal was not to use contrast due to potential risk to the fetus. The Radiologist determined if contrast was needed for diagnostic images. If adequate images could be obtained without contrast, the contrast part might be postponed. If contrast was needed for diagnostic images, and the patient agreed to proceed after hearing the risks, a consent form was signed.
New JHMIRB Policy
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 of childbearing potential.
If the IRB determines that the use of contrast is justified and that women of childbearing potential 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. Radiologists in the MRI group can assist with this language.
B. Consent Language:
The following text is added after P1.3:
P1.4 At some point during your MRI exam the MRI staff will interrupt the scanning procedure in order to give a contrast agent. The agent is given through a needle placed (an IV) in your arm. The IV will be placed using standard hospital techniques.
The following paragraph is added after R1.1 or R1.2
R1.3 The contrast agent you will receive is FDA-approved and used routinely for MRI exams. It contains a material called gadolinium. The injection of contrast may cause discomfort, tingling or warmth in the lips, metallic taste in the mouth, tingling in the arm, nausea, or headache. These symptoms occur in less than 1% (less than 1 in 100) of people and 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.
Insertion of the needle (small plastic tube) to give you 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, which is the formation of too much connective tissue in the skin and internal organs throughout the body. People develop skin thickening that may prevent bending and extending joints, resulting in decreased movement of the joints. The skin changes can cause feelings of burning, itching and pain that can be severe. In addition, people may experience fibrosis that spreads to other parts of the body such as the diaphragm, muscles in the thigh and lower abdomen, and the lining of blood vessels in the lung. NSF/NFD is a serious progressive disease and can result in death.
If you have severe kidney failure and receive gadolinium, the risk of developing NSF/NFD is 1-5 % (up to 1 to 5 per 100 people). We may require a blood sample (about 1 tablespoon) to check your kidney function before you receive gadolinium contrast for your MRI.
Please notify a doctor, nurse or technologist if you are allergic to gadolinium, if you have any kidney problems, or if you experience any of these or other side effects. If you do not know if you have kidney problems or if you do not know if your kidney problems fall in the severe category, you can ask the principal investigator of your study to give you this information.
A physician will be available during the procedure to administer any necessary care if side effects do occur, and to determine when or if the injection of the gadolinium should be stopped.
MRI imaging is not known to cause risk to the developing fetus though 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.
Options Section: (if x-ray exam is included)
You may have a non-contrast MRI scan if the study allows this to be done. If possible, you should wait until after your pregnancy is completed before proceeding with the contrast-enhanced MRI imaging.
Use the same language provided in COST SECTION for MRI without contrast.
3. MRI Imagins with ECG Monitoring
The following text replaces P1.2:
P1.2a Once approved by the MRI staff, you will be placed on a padded table and positioned for your exam. You will be attached to an electrocardiogram (ECG) while you are in the magnet. The ECG permits the MRI to take pictures at the same time your heart is beating. It also allows the MRI staff to monitor your heart during the exam. (Please insert coil wording from section on coil designation). The coil is necessary to help the MRI system take pictures. The table on which you are lying will be moved to the center of an MRI magnet, which looks like a long narrow tube. Even though the tube is open, some people feel confined in small places. If this bothers you, please notify the MRI staff. You may end your participation in this study at any time by telling the MRI staff. When MRI pictures are taken or MRS (Magnetic Resonance Spectroscopy) is done, radio signals and magnetic fields are used. When this happens, it is normal for the MRI machine to make loud, banging, and clicking noises. You will be asked to wear earplugs or headphones for your comfort during the exam.