This article is part of our ongoing California Defending Your Practice series. Get more information at ProAssurance.com/California.
“Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.” (AMA Code of Medical Ethics Opinion 2.1.1)
Except in an emergency, a physician must obtain informed consent from the patient or a legal decision-maker before performing certain procedures. Depending on state law, procedures requiring informed consent may include surgical and invasive procedures, administering certain medications or contrast agents that could have severe or unknown outcomes to the patient, entering a patient in a research trial, procedures involving medical students, and certain other circumstances. Failure to obtain a patient’s informed consent when required can result in a physician’s liability—even if a procedure or treatment is indicated and is otherwise performed non-negligently.
Difference between simple consent and informed consent:
- Simple consent may be implied and applies to common treatments or procedures with minimal or no risks.
- Informed consent applies when a proposed treatment is invasive or carries more risk. Informed means the patient is given the information a reasonable person would need to know in order to make a decision.
It is important to understand your own state-specific requirements in this area. Some states, including California, have statutes, regulations, or common law that specifically address informed consent. Since the landmark Cobbs v. Grant decision in 1972, California healthcare professionals in the state have had a legal obligation to ensure that their patients are fully informed about a proposed treatment.
According to the California Hospital Association, the physician who is performing the procedure is responsible for obtaining the patient’s consent. If a nonphysician will perform the procedure, the ordering physician is responsible for obtaining consent. In cases in which more than one doctor is involved, and the hospital policy does not specify, they can determine among themselves which provider will obtain the consent.
Informed Consent and Medical Liability Risk
In obtaining a patient’s or surrogate’s informed consent, the physician should: 1) assess the patient’s capacity to understand the treatment and make an informed decision; 2) discuss the diagnosis and the risks, benefits, and alternatives of the proposed treatment, including the risks, benefits, and alternatives of refusing treatment; 3) Confirm patient’s understanding and obtain informed consent or refusal; and 4) Thoroughly document the informed consent conversation and have patient sign consent form, if using. The process is designed to give patients the information necessary to make a voluntary and informed decision about a proposed treatment or procedure—even if that patient’s ultimate decision is not what the physician believes to be in the patient’s best interest. (see also: AMA Code of Medical Ethics Opinion 2.1.1)
Physicians may incur liability for consent issues even when their medical care otherwise met the standard of care. Although consent issues are not usually the central focus of malpractice claims, they often become important associated issues or secondary allegations. A lack of informed consent or an insufficient disclosure may not necessarily have a causal connection to medical injuries in a malpractice case, but those issues can discredit physicians at trial or during settlement discussions.
The physician ordering or providing the care, is responsible for obtaining the patient’s informed consent prior to the provision of the care. Physicians may not delegate to others the duty of informing patients about the treatment options, associated risks, and material information needed by patients to make an informed decision. Physicians may delegate to a nurse or office staff member the task of getting a consent form signed, but the physician is ultimately responsible for the consent process and should be available to answer any questions the patient has prior to scheduling, ordering, or carrying out the procedure. Meeting this responsibility is considered best practice from a patient safety and risk management perspective.
Informed Consent Exceptions
There are generally two exceptions to informed consent standards. There may be other state-specific exceptions, so providers should review their state’s guidelines:
- Emergency situations: In an emergency situation, if the patient does not have the capacity to make decisions, there is no legally designated decision-maker or representative available, and all reasonable efforts have been made to contact the legal representative, then a patient will be presumed to have consented to necessary medical treatment. This exception does not apply if the patient has already refused similar treatments in the past in writing (e.g., through an advance directive, durable power of attorney, or by signing a Do Not Resuscitate order).
- Therapeutic privilege: A very rare exception arises when a physician can prove that disclosure of medical information would cause the patient such serious psychological distress that disclosure is contraindicated.
Informed Refusal
After being appropriately informed of risks, benefits, and alternatives of a contemplated treatment, procedure, or high-risk medication, a patient (or their designated decision-making authority) has the right to refuse. Physicians should emphasize the importance of the treatment or procedure and the consequences of no treatment, and the patient should be made aware of the ramifications of his or her decision. However, if the patient understands the risks of no treatment and still chooses to refuse, the informed refusal decision must be respected, regardless of how detrimental the physician or healthcare team members think the decision is. If, after receiving information about risks and benefits, a patient refuses a treatment or procedure, the patient’s refusal should be documented in the medical record and the patient should be asked to sign a refusal of treatment form. The physician should also document the process related to the informed refusal (the main points of the discussions about risks, benefits, and consequences of declining treatment).
Documentation of Informed Consent
Documentation of the informed consent discussion is important. Having a patient sign a form is supportive evidence that the informed consent process took place. However, a signed form cannot replace the elements documented in a patient’s record summarizing the discussion and education provided in the informed consent process that took place. Additional notation in the patient’s record about the details of the informed consent discussion (e.g., questions answered, risks pointed out that were specific to that person, or educational elements reviewed) can be crucial in defending a lawsuit for an alleged failure to obtain the patient’s informed consent. Informed consent litigation often pits the memory of the patient against the documentation of the physician. A doctor’s best defense in these types of cases is the information contained in the medical record, including not only a consent form signed by the patient but a description of the content of the informed consent discussion in the progress notes. This type of evidence significantly reinforces the physician’s testimony.
Physician practices should develop informed consent forms that meet state and federal requirements. The consent form should include the same elements as the consent discussion and should be written in language that the patient can understand. The elements on the form should include disclosure of information that a reasonable person would regard as significant in deciding to accept or reject a recommended procedure, including the following:
- An explanation of the patient’s problem and proposed procedure
- Complications (e.g., bleeding, possibility of additional procedures)
- Severity (e.g., death, paralysis and loss of function)
- Incidence of risks (e.g., 1 in 1000 experience this complication), which helps the patient put the risk, including loss of life or limb, in perspective
- Information about common side effects (e.g., swelling or pain)
- Names of other physicians/clinicians who will be performing parts of the procedure, e.g. PA harvesting a leg vein for a CABG procedure
- An explanation of the benefits of the procedure
- A discussion of alternative treatments
- A statement that there are no guarantees that the procedure will be 100% successful
- Information about potential outcomes if treatment is refused
- Encouragement of the patient to ask questions
- Acknowledgment that the patient can withdraw consent
- The offer of a second opinion, if applicable
Documenting Consent Obtained Remotely
If the person having the legal authority to consent for the patient is not available to discuss informed consent in person, the physician must obtain consent remotely by telephone, email, or facsimile. The responsible physician must, to the extent possible, provide the legal representative with the information needed to obtain consent just as if that person were present.
Excluding emergency situations, prior to obtaining consent by remote means (including telehealth), it is important to have an established relationship with the patient. When obtaining consent remotely:
- Verify the authenticity of the person legally authorized to consent for the patient by asking questions regarding DOB, address, phone numbers, etc.
- Have a second responsible person witness the call.
- Follow standard consenting process discussing the risks, benefits, and alternatives with the person authorized to consent as if the discussion were in-person.
- Document in the patient’s medical record that consent was obtained remotely, who consented, who obtained the consent, and who witnessed it.
After the consent discussion, you may request that the person provide documentation of consent by email or fax. Have the person giving consent send a declarative statement of the consent, such as:
“I, [their name and relationship to the patient], have been informed by Dr. X of the risks, benefits, and alternatives associated with the proposed treatment and grant permission for Dr. X to provide medical treatment [or a specific procedure or treatment] to [me or Patient’s Name].”
Attach or scan a copy of the email or fax to the medical record. Whenever possible, original, signed consents should be obtained and filed or scanned into the medical record.
Barriers to the Informed Consent Process
Many factors, including a patient’s limited literacy skills, fear, sensory issues, level of intimidation, degree of modesty, or expectations regarding a specific outcome can diminish the patient’s ability to comprehend the consent process. Cultural and linguistic differences can also be barriers to a patient’s understanding. Since the informed consent process relies on discussion and education so that a patient can make an informed choice, it is a process that is heavily dependent on clear communication.
A study published in 2006 in the Journal of General Internal Medicine suggests various strategies for modifying the consent process for patients who may have problems understanding consent information. Specific modifications that were shown to reduce barriers and improve the consent process include:
- Using a more readable consent form (written with plain language, large font, short paragraphs, a lot of white space)
- Arranging for consent forms to be read to patients in their native languages
- Using an iterative “teach to goal” strategy (asking patients to answer questions to show their comprehension of material)
Risk Reduction Strategies
- Recognize that informed consent is a process, not a form. The consent form should never replace the discussion and education provided.
- Consider establishing a policy requiring consent within a certain period (e.g., 30 days) before the treatment.
- If no specific time policy is imposed by a facility, reassess the situation to ensure the underlying framework for the consent is still applicable by questioning the patient about changes to doctors, prescriptions, over-the-counter medication, hospital visits, or new treatments.
- Develop a policy and procedure for the informed consent process that ensures that patients’ rights are honored. Recognize that the office setting is the best place for the discussion to occur when providing the patient with information that allows the patient to make a meaningful medical care decision.
Education
- Use educational pamphlets, handouts, pictures, and pre-op and post-op instructions to help patients understand what they need to know in order to make an informed decision.
- Document in the patient’s record that the patient received these materials.
- Referencing educational materials could be used as reminders of the discussion or if the consent is challenged at a later date.
ProAssurance Resources
The following resources from ProAssurance Risk Management are available to assist in developing and using the informed consent process.