Cobb v. Grant was one of the first California cases to establish two informed consent 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 the patient to determine the course of treatment he or she chooses.
While a statutory definition of informed consent has never been written into California 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 his or her own health care.
Who may obtain consent?
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: Generally, by a parent or legal guardian
- Teens: Depends on the procedure, so please get further guidance when in doubt
- Adults: Depends on their mental capacity
- Seniors: Depends on their decision making capacity
- Couples: Consent is not implied; clarification is needed during the consent discussion
What is an informed consent?
Informed consent is a process and not a signed form. The process involves communication between the patient and the physician or qualified provider that results in the patient’s 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 his or her knowledge, understood the consequences of declining treatment.
Included in this communication between the patient and physician or qualified provider are the following:
- The nature and purpose of the proposed treatment
- The risks and benefits of the proposed and alternative treatments
- The risks and 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.
What to document?
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 require a video of the procedure be viewed by patients who did not score 100 percent. 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 patient’s medical record.
These steps pretty much eliminate the “You never told me…” or “If I had only known…” allegations often heard when there are less than optimal treatment outcomes. This also greatly enhances the physician’s ability to manage unrealistic patient expectations.
Author Linda Sue Mangels is a Senior Risk Management & Patient Safety Specialist for the Cooperative of American Physicians, Inc.
If you have questions about this article, please contact us. This information should not be considered legal advice applicable to a specific situation. Legal guidance for individual matters should be obtained from a retained attorney.