General Information

Informed consent must be obtained for all interventional procedures. The steps of the procedure should be explained to the patient using lay terms as well as special considerations for the procedure when appropriate. Indication/benefits, risks, potential complications and alternatives for the procedure should be discussed. For Spanish speaking patients, a Spanish consent form must be used and the consent obtained through an official interpreter.

All consents require a witness and should ideally be obtained from a person that witnessed the consent and conversation about the procedure. For inpatients, once the signed consent form is obtained, the paper copy should be placed in the designated bin by the board in the VIR main hallway. After obtaining written informed consent, the provider obtaining consent needs to place an attestation into epic. This can be part of the inpatient consult note or as a separate note.

General Procedure Consents

In general, all interventional procedures carry risk of bleeding, infection, and pain. Damage to surrounding structures is also a risk, depending on where the target lesion is located. There is also always a possibility that the procedure will fail to yield the diagnostic or therapeutic benefits expected. Please refer to the subsequent section for specific risk associated with each procedure.

Special Considerations

In addition to the above, there are several additional things that may need to be included in the informed consent discussion.

Contrast-induced nephropathy (CIN) and contrast allergic reaction should be discussed if iodinated contrast will be used. Alternatively, negative contrast such as CO2 (carbon dioxide) could be considered and discussed with the VIR attending. It is especially important to prevent CIN in patients with Diabetes Mellitus, Multiple Myeloma and borderline kidney function (Creatinine > 1.5). Hydration and reduction in the amount of iodine contrast should be discussed with the VIR Fellow/Attending and discussed with the patient. Special attention should be paid to patients with history of cardiac failure. End-stage renal disease (ESRD) patients with chronically elevated creatinine do not need hydration protocol.

For complex cases that may require extended fluoroscopy, the patient should be made aware of the small possibility of radiation exposure complications (see appendix for cutaneous injury threshold doses).

Informed Consent Checklist

A checklist has been devised that may be helpful to ensure that a complete informed consent discussion is had. Below is an example of a checklist that may be useful to follow:

Reference:

• Ripley et al. JVIR 2015; 26(11):1639-46.