The Essential Elements of Informed Consent

Informed consent is a legal and ethical principle that supports disclosing important information to patients so they can understand proposed treatments and fully participate in their care. The basis of informed consent rests on the principle of autonomy, which recognizes an individual’s right to make decisions regarding his/her healthcare.

The thoroughness and complexity of the informed consent process will depend on the type of procedure or treatment involved. Minor procedures — such as the removal of a minor skin lesion or the filling of caries — may require only a simple discussion of risks. However, as procedures become more complex or have a greater degree of risk, the consent process should be more comprehensive.

Generally, a healthcare provider has a duty to disclose what a reasonable, prudent clinician in the medical or dental community would disclose to a patient. Although the information provided during informed consent should be tailored to each individual patient and their clinical condition, some basic elements include:

• The patient’s name
• The name of the hospital or healthcare practice
• The patient’s diagnosis
• The name and a description of the proposed procedure and an explanation of its purpose (information should be provided in both medical and layman’s terms)
• The names of all practitioners who will be involved in the procedure and the significant tasks of each
• A statement that the procedure was explained to the patient (or patient’s guardian)
• The name and signature of the person who explained the procedure to the patient (or patient’s guardian)
• The important risks and benefits of the procedure (e.g., common risks, risks/benefits that the patient might consider important, and risks/benefits that might affect the patient’s decision to accept or reject the recommendation)
• Alternatives to the proposed procedure, including doing nothing
• The estimated recovery time based on the procedure and the patient’s status as well as the importance of adhering to any recommended postprocedural therapies and follow-up appointments
• The patient’s signature memorializing understanding and providing consent
• The date and time consent is obtained
• A witness signature

In short, the healthcare provider should discuss details and risks that are relevant to, or necessary for, the patient’s ability to make informed decisions. Providers generally do not need to disclose remote risks, although many practitioners do advise patients of the risk of death or serious morbidity. This approach is particularly judicious if patients’ comorbid conditions or life situations make such information more urgent. For example, a surgeon will want to discuss and document in greater detail the risks of a knee procedure if the patient has a job that requires high mobility.

Additional elements of informed consent might be legally required and can vary by state. Healthcare providers should be aware of the laws and standards related to informed consent in the states in which they practice.

For more information about informed consent, see the following MedPro resources:

• Informed Consent for Medical/Surgical Procedures: So Much More Than a Form
• Guideline: Risk Management Strategies for Informed Consent
• Risk Resources: Informed Consent

Legal disclaimers