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Informed Consent: Substance and Signature

Thursday, July 30, 2020

True informed consent is a process of managing a patient’s expectations; it is not just a signature on a document. Achieving an accurate diagnosis requires the patient to provide accurate information to the physician. The physician must then provide sufficient information to the patient so that he or she can make a reasonable and informed decision regarding a comprehensive plan for medical or surgical treatment. This physician responsibility cannot be delegated.

Informed consent cannot eliminate malpractice claims, but an established rapport between the patient and the physician based on robust exchanges of information can prevent patient disappointment from ripening into a claim.

Avoid medical jargon. Define and explain medical words and concepts using simple pictures and analogies.

Identify any uncertainty and risk involved with a specific treatment plan, including the probability factors, if possible. Discuss reasonable assumptions the patient may make about the treatment plan.

Encourage questions. Questions provide a better understanding of the patient’s comprehension of the information and facilitate the dialogue between the patient and the physician.

Documentation is another key component of the informed consent process that cannot be entirely delegated to a nurse or another member of the healthcare team. If the doctor-patient discussion proceeds successfully and the patient requests treatment, the doctor is required in some jurisdictions to write a note in the patient’s record.

The consent form must be signed and dated by the patient

Consent forms should also include statements to be signed by the patient and the physician. The patient attests that he or she understands the information in the treatment agreement. The physician attests that he or she has answered all questions fully and believes that the patient/legal representative fully understands the information. These statements help defend against any claim that the patient did not understand the information.

The informed consent process for same-day surgery patients may occur in the physician’s office before scheduling the procedure. That will allow the patient time to think about the information, ask questions, and make an informed decision.

Hospitalized patients must be informed as far in advance of the procedure as practicable. If the patient is incompetent or otherwise cannot consent, the physician is legally bound to obtain informed consent from the incompetent patient’s authorized representative, except in an emergency.

Every physician should develop his or her own style and system for the informed consent process, making it easier to avoid omissions.

Do not speed through the process. Give the patient and the family time to absorb and comprehend the information.

Assess the patient’s level of understanding just before documenting the process. This will increase the likelihood that you will be able to manage the patient’s expectations effectively.


Robert Morton, CPHRM, CPPS, Assistant Vice President, Department of Patient Safety and Risk Management

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.