CAMRIS

CAMRIS Risk Language/Clauses


Introduction

In order to ensure safety and to communicate proper risk/benefit information to subjects who may consent to MRI research within CAMRIS, we require that certain risk information be included in each consent form. The required clauses are broken up into two categories: those studies that are using experimental sequences and/or coils, and those that are using standard sequences and/or coils.

If your MRI Protocol is using standard MRI sequences and coils, please place the following clauses in your consent form under a section titled “MRI Risks”

MRI Risks

Flying Objects: The known risks associated with this study are minimal. Implanted medical devices and metallic foreign fragments inside your body may pose a risk if you were to enter the MRI magnet room. Therefore, questions regarding medical and work history will be asked prior to your exam. The greatest risk is a magnetic object flying through the air toward the magnet and hitting you. To reduce this risk we require that all people involved with the study remove all magnetic metal from their clothing and all magnetic metal objects from their pockets. No magnetic metal objects are allowed to be brought into the magnet room at any time except by approved personnel. In addition, once you are in the magnet, the door to the room will be closed so that no one inadvertently walks into the room.

Magnetic Fields Health Risks Statement: There is no known health risk associated with exposure to magnetic fields during an MRI. There are minimal risks from the loud noise associated with the MRI scanner and from the discomfort of lying on a hard surface. We shall provide you with protective earplugs as necessary and make every attempt to ensure your comfort with blankets, etc. during your time in the scanner.

Pregnancy: Although there are no known risks related to MRI on pregnant women or a fetus, there is a possibility of yet undiscovered pregnancy related risks. Since there is no possible benefit from participating in this protocol for a pregnant woman, we will exclude pregnant women.

IMPORTANT NOTE: If you have an existing protocol that includes MRI scans that are conducted solely for research purposes and would like to move your existing protocol outside of EPIC, we recommend the following

  • Review your study design--
     
    • If your study includes multiple scan sessions and you currently have subjects’ active on study with future MRI appointments, you will need to continue ordering through PennChart. If you chose not to follow this route, you will need to re-consent your active subjects with the new clause: Revise your Informed Consent Form to include the following clause:
      The MRI performed under this protocol is not for medical purposes, and the images are not planned to be interpreted by a physician.
       
    • If your study includes one MRI scan session and your subjects are currently completed on study, you will need to consent all new subjects with the newly revised consent that includes the new clause:
      The MRI performed under this protocol is not for medical purposes, and the images are not planned to be interpreted by a physician.

Incidental Findings Clause: This MRI is not a clinical scan. It is possible that during the course of the research study, the research staff may notice an unexpected finding(s). Should this occur, the finding(s) will be considered by the appropriate personnel and the PI will inform you if necessary. These possible finding(s) may or may not be significant and may lead to anxiety about your condition and to further work-up by your physician.

Gadolinium Based Contrast Agents (GBCA) Risks (IF APPLICABLE)

 

Retention: Traces of gadolinium may remain in the body long-term after contrast administration. This risk increases with the number of administrations, but reviews to date have not identified adverse health effects from gadolinium retained in the brain or bodily tissues after MRI ([Gadolinium agents administered in this study are thought to minimize or eliminate this risk *]).
If you would like more information, please go to this link https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm or ask the study team for more information. 
*excluded for studies using linear GBCA.

IV Line Placement: Multiple needle-sticks may be necessary if a vein cannot be properly accessed and this will be carried out upon your permission.

IV Contrast Risks: Part of your MRI study will require the injection of a gadolinium contrast agent into your blood stream. There is a rare possibility that you could have an adverse reaction to the contrast agent such as rash, hives, itching, mild headache and nausea. You may also experience some minor discomfort and low risk of bleeding, infection and bruising associated with Intravenous catheter placement.

Pregnancy: Gadolinium-based IV contrast agents are not approved in pregnant women and therefore pregnant women will be excluded from this trial.

MRI Risks Clauses

The following language is required to be written into the ICF of all protocols that include experimental sequences and/or coils:

Research Risk Clause: Some of the pulse sequences and/or RF coils are not FDA approved but are considered to pose no more than minimal risk.

7T Clause (is using the 7T magnet)

While the FDA has not approved the use of 7.0T MRI scanners for diagnostic use, it does consider magnetic field strengths up to 8.0T to pose no more than minimal risk. No persistent adverse effects have been reported by facilities with magnetic field strengths at 7.0T.  However, some people have reported transient dizziness, nausea, or a metallic taste upon being moved into and out of the scanner.  These effects typically last less than 10 minutes, and can be minimized by reducing the speed at which the person is moved inside the magnet.

What is an MRI? What is a contrast agent?

CAMRIS has been asked how to properly describe an MRI and contrast for consent forms. We have suggested wording below you may find helpful and include in your consent form:

MRI (Magnetic Resonance Imaging)

A type of scan that uses radio waves to take detailed pictures. You will be asked to lie on an MRI table where the technologist will place a coil on the part of your body to be studied. You will be provided a blanket for comfort and earplugs since the MRI does make loud banging noises. You will still be able to hear some sound to ensure you can communicate with the technologist and can follow any direction given throughout the MRI scan. The technologist will slowly slide you into the MRI magnet where radio waves will be transmitted into you. Your body will give off radio waves which will be picked up by the coils and made into detailed pictures.

Contrast Agent

Note: Only needed if the study is an MRI with contrast

This study determines that you may need a contrast agent. During the MRI scan you will be given an intravenous injection of a contrast drug called gadolinium. Gadolinium is an FDA approved drug that brightens the images and provides more detail. Gadolinium is a routine drug given for many different types of MRI examinations during routine clinical care at the University of Pennsylvania MRI center.

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