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Introduction:

What is Informed Consent?

Informed consent is the process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention [AMA 1998]. For both ethical and legal reasons, patients must be given enough information to be fully informed before deciding to undergo a major treatment, and this informed consent must be documented in writing.

Although this process of patient-physician communication involves much more than getting a patient to sign a written consent form (See below: “Informed Consent: It’s Not About the Form”), it is the very formality and finality of that signed document that for practical purposes distinguishes full informed consent from the routine patient education that occurs in nearly every clinical encounter. In most institutions, this more formal process requiring a signature is reserved for surgery, anesthesia, and other invasive or complex medical or radiologic procedures. Laws vary from state to state about exactly when and how formal informed consent must be provided but, national standards exist as well.

Note that formal informed consent is usually not required for more common and generally less risky treatments, tests, and medications. The patient’s consent to these more common interactions and therapies is generally “implied.” And for some very basic procedures—like a whole blood draw—a “basic consent” process involving a simple description and request for verbal approval may be adequate. On the other end of the extreme, the informed consent process for patients volunteering for clinical research is much more complex, involving special Institutional Review Boards and close monitoring. [CFR Title 45 1991]

Why this guide?
This publication focuses on ways to improve full informed consent—both the process and the written forms—as it is employed in everyday (i.e., NOT research) patient care settings. We understand that there are many challenges to the informed consent process in every day practice and we hope this guide can improve the dialogue among various professionals who have the responsibility to improve patients’ understanding of the complexities of their care. We see this guide as a place to start and a mechanism to improve this important dialogue. As you and your organization work to improve your consent process, it is important to ensure that your health care organization remains within both the spirit and the letter of your state laws and institutional policies related to informed consent. We understand all those setting out to improve their informed consent practices to work closely with their own legal counsels and risk managers.

Developed with a grant from the Robert Wood Johnson Foundation

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