Informed Consent: A Brief Primer

Informed consent is a process involving patient education and information shared between the provider performing the procedure and the patient having the procedure. Informed consent is not a signed form. The signed form is simply documentation proving that the consent discussion was done.

Informed consent establishes two major components: The patient's right of self-determination (no matter how bad the decision) and the physician's non-delegable responsibility, due to advanced training, knowledge and expertise to adequately communicate information to the patient through the informed consent process that would enable them to determine the course of treatment they choose to pursue.

While a statutory definition of informed consent has never been written into law, it is well understood within the medical and legal communities to mean that a patient “receive sufficient information to make a meaningful decision”regarding their own healthcare.

The consent process is the non-delegable duty of the physician. However, the expanding role of nurse practitioners and physician assistants allows them to obtain the patient's consent if they are performing the procedure as part of their standardized procedures or delegation of services agreement, respectively.

Who may give consent?

• Children (requires a parent or legal guardian)
• Teens (depends on the procedure)
• Adults (depends on their mental capacity)
• Seniors - (depends on their decision-making capacity)
• Couples (consent is never implied. Clarification is needed during the consent discussion)

The process involves communication between the patient and the physician or qualified provider that results in the patients signed agreement to undergo a specific medical treatment or procedure or to decline the proposed treatment or procedure (informed refusal).  With informed refusal, the provider must document that the patient, to the best of their knowledge, understood the consequences of declining treatment.

Included in this communication between the patient and physician or qualified provider are the following:

• The nature & purpose of the proposed treatment
• The risks & benefits of the proposed treatment
• The risks & benefits of alternative treatments
• The risks & benefits of declining the proposed treatment (informed refusal)

Consent forms should not be relied on to provide the above disclosures because they are not specific enough for each individual patient.  The risks and alternatives of a particular procedure vary from patient to patient depending on the patient's age, health and medical problems.

It is important that this process be thoroughly documented. This is where many physicians are taking the consent process to a new level.

Some are requiring patients take a T/F exam to determine the degree of patient understanding about the proposed treatment. The exam is scored and missed questions are reviewed and clarified with patient signature and date.

Some physicians also require a video of the procedure be viewed by patients who did not score 100%. Post video another test is given, scored and reviewed. This is also signed and dated by the patient and all of this becomes part of the patients medical record.

These steps pretty much eliminate the “You never told me…” or “If I had only known…” allegations often heard when there is less than an optimal treatment outcome. This also greatly enhances the physician’s ability to manage unrealistic patient expectations.

Linda Sue Mangels is senior risk management and patient safety specialist with the Cooperative of American Physicians.  This is one of a series of articles from CAP.