The 5 Elements of Informed Consent

The 5 Elements of Informed Consent

The 5 Elements of Informed Consent

  • Competence: A legal term for the capacity to make a rational choice. A physician can make a judgment about an individual's competence. Factors include the following:

    • ability to comprehend medical information and consequences of decisions

    • ability to communicate decisions

    • one's age: Competence is presumed in healthcare decisions at age 18 years. Emancipated minors can make some or all of their own healthcare decisions.

  • Amount and accuracy of information:

    • inheritance of condition and patient-specific risks

    • potential benefits, risks, and limitation of all management options

    • available alternatives

    • for patients seeking cancer predisposition genetic testing, the National Cancer Institute (2004) provides guidance about the

  • Patient understanding: This is perhaps the most challenging aspect of informed consent; it is the responsibility of the healthcare provider to identify and attempt to overcome such barriers as the following:

    • fear or denial
    • illness
    • undereducation or reduced cognitive ability
    • cultural considerations
    • unscientific beliefs, family myths
    • language barriers
  • Voluntariness: The patient has to make a personal decision without coercion. He or she cannot simply yield to the suggestion of a family member, healthcare provider, or any other individual.

  • Authorization: The patient should actively agree to a course of action and that decision should be documented.

(Adapted from Schmerler, 1998)