What is Informed Consent?

Informed consent lets patients make good choices about their own care, and failure to obtain it can be medical malpractice.

Informed consent is the process by which fully-informed patients can make the best choices about their healthcare. It originates from the legal and ethical right a patient has to direct what happens to their own body, and from the ethical duty of the physician to involve the patient in their care. A health care professional's failure to obtain informed consent from a patient can amount to medical malpractice. Read on to learn more.

What are the elements of informed consent?

The most important goal of informed consent is to give the patient an opportunity to be an educated participant in his or her health care decisions. It is generally accepted that complete informed consent includes a discussion of the following elements:

  • the nature of the decision/procedure
  • reasonable alternatives to the proposed procedure 
  • the relevant risks, benefits, and uncertainties related to each alternative
  • assessment of patient understanding, and 
  • the acceptance of the procedure/decision by the patient. 

In order for the patient's consent to be valid, he or she must be considered competent to make the decision at hand, and consent must be voluntary. It is easy for coercive situations to arise in medicine. Patients often feel powerless and vulnerable. To lessen this, the physician can make clear to the patient that they are participating in a decision, not merely signing a form. With this understanding, the informed consent process should be seen as an invitation to participate in the health care decision-making discussion and process.

The physician is also generally obligated to provide a recommendation and share her reasoning process with the patient. Comprehension on the part of the patient is equally as important as the information provided. Consequently, the discussion should be carried on in layperson's terms and the patient's understanding should be assessed along the way.

Basic consent entails letting the patient know what the health care provider would like to do, and asking them if that will be all right. Basic consent is appropriate, for example, when drawing blood. Decisions that merit this sort of basic informed consent process require a low-level of patient involvement because there is a high-level of community consensus.

How much information is considered "adequate"?

How do you know when a care provider has said enough about a certain decision? Most of the literature and law in this area suggest one of three approaches:

Reasonable physician standard: What would a typical physician say about this decision or procedure? This standard allows the physician to determine what information is appropriate to disclose. However, it is probably not enough, since most research in this area shows that the typical physician tells the patient very little. This standard is also generally considered inconsistent with the goals of informed consent as the focus is on the physician rather than on what the patient needs to know.

Reasonable patient standard: What would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a patient would need to know in order to understand the decision at hand.

Subjective standard: What would this patient need to know and understand in order to make an informed decision? This standard is the most challenging to incorporate into practice, since it requires tailoring particular information to a particular patient. Most states have legislation or legal cases that determine the required standard for informed consent.

What sorts of procedures or decisions require informed consent?

Most health care institutions have policies that state which health interventions require a signed consent form. For example, surgery, anesthesia, and other invasive procedures are usually in this category. These signed forms are really the culmination of a dialogue required to foster the patient's informed participation in the clinical decision.

For a wide range of decisions, written consent is neither required or needed, but some meaningful discussion is needed. For instance, a man contemplating having a prostate-specific antigen screen for prostate cancer should know the relevant arguments for and against this screening test, discussed in layman's terms.

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