Informed consent for Infusions of Biologics

A common question I get asked by nurses is… I need to obtained an  informed consent from a patient who is receiving infusions of biologic agents such as  Remicade (Infliximab)?

An informed consent, according to the American Medical Association (AMA), is the communication process between a patient and his or her physician that results in the patient’s agreement to undergo a particular medical procedure or treatment. The concept of informed consent is rooted in medical ethics and codified as legal principle – it is based on the assertion that a competent person has the right to determine what is done to him or her.1

With surgical and other invasive procedures, there is no question that an informed consent must be obtained. But what about FDA approved prescription medications such as parenteral biologics?   We all know that patients are entitled to informed decisions about their healthcare, but there is little to no guidance on the topic of informed consent for biologic infusions.

My simple answer is to always discuss with your risk managers and/or legal counsel the need for a written informed consent. Many practices only require a general consent for treatment when the patient is admitted for service while others obtain a general consent for treatment and have a separate consent form for infusions.

It is important to remember that the primary goal of the informed consent process is to convey significant safety information so the patient can decide whether or not to undergo medical treatment. Sources of information include the product manufacturer, product or package labeling, medication guides, continuing medical education, information from colleagues, journal articles, and personal experience. Once the physician has a foundation of knowledge, the next step is to effectively convey that information to the patient.

After a patient has been seen by the physician prescribing the infusion, it is my understanding that a nurse may obtain the patient’s signature on a consent form. In such an instance, the nurse is not being asked to provide the information necessary for the patient to grant informed consent. Rather, the nurse is merely acting as a witness to the patient’s identity and to the patient’s signature on the form. When a nurse is present at the time a patient signs a consent form, it is a good opportunity to assess the patient’s level of understanding and determine whether the patient wishes to speak further with the physician.2


1. Informed Consent: American Medical Association.
2. Can a Nurse Witness a Surgical Consent Form Before the Anesthetist Has Seen the Patient? article by Jane C. Rothrock, DNSc, MSN, BSN, CNOR, FAAN. posted on Medscape 9/21/2004.