The Fundamental 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. At minimum, this includes:
- The patient’s diagnosis
- The name of the proposed procedure (information should be provided in both medical and layman’s terms)
- A description and explanation of the proposed procedure and its purpose
- The names of all practitioners who will be involved in the procedure and the significant tasks of each
- Important risks and benefits (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 no action
In short, the healthcare provider should discuss details and risks that are material or necessary to the patient’s informed decision-making. Remote risks generally do not need to be disclosed, 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 (such as the patient’s signature) 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 MedPro Group’s Risk Management Strategies for Informed Consent guideline and Risk Resources: Informed Consent.
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