Question

Informed consent is an essential aspect of study design. Discuss the factors required to meet the standards for informed consent.

Answer 1

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.