Informed Consent Revisited: What is Expected of Providers

Published on: July 29, 2019

Informed consent has generated many articles, legal opinions and court decisions, yet it is still a misunderstood topic. Failure to obtain informed consent is a common allegation in medical malpractice cases involving surgery, invasive diagnostic studies and even medications. In some cases, defendants are absolved of negligence, but are held liable for not adequately disclosing the material risks of treatment which prevented the patient from giving an informed consent.

Many physicians think informed consent is something they give to patients (“I consented the patient.”). In fact, doctors provide information, but obtain consent from their patients by having a full discussion before proceeding with treatment. For patient consent to be “informed,” the discussion must include the following:

The expected outcome and potential benefit of the proposed procedure, treatment, or medication
The material risks associated with the treatment
The reasonable alternatives
Answers to any questions from the patient

MIEC recommends that providers protect themselves from liability by developing a consistent policy for educating patients, and for obtaining, as well as documenting, patients’ informed consent.

Why We Have Consent Laws

In 1914, New York State Supreme Court Justice Nathan Cardozo said, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.” Every state’s courts recognize this principle. Issues such as what a patient needs to know to give an informed consent, who must provide the information, and how to document that informed consent was obtained are determined by state law and standards of practice in each medical specialty.

Benefits of Informed Consent

There are numerous benefits to educating patients about their care and obtaining full informed consent, including:

Informed patients make better healthcare decisions
Informed patients are more compliant with medical advice and recover faster
Informed consent discussions increase patients’ confidence in their physicians and strengthen physician-patient relationships
Informed consent discussions deter non-meritorious claims that result from unrealistic expectations or misunderstandings
Informed patients are less likely to sue in the setting of a medical error or adverse event

Documenting the Informed Consent Discussion

As discussed later in this article, having a patient sign a comprehensive, accurate consent form is recommended as an important part of the informed consent process. However, an essential part of this process is a dedicated verbal discussion between the physician and patient which includes the following elements:

Discussion of risks, benefits, alternatives
Opportunity for the patient to ask questions and have them answered
Patient expression of their desire to proceed

Ideally, a patient will sign a consent form following this discussion- however, it is also important for the provider to document in the record when the informed consent discussion occurred.

Defense attorneys have opined that a signed consent form is less likely to be questioned in litigation if it is backed up by a physician’s handwritten or dictated note that verifies that informed consent was obtained. They recommend that physicians document the consent discussion with a note such as: “I advised patient of the purpose, benefits and significant risks of this procedure, including but not limited to bleeding, infection, [damage to adjacent structures or organs] [other specific, common risks]. I also discussed alternative treatments and their risks, and the risks of non-treatment. I answered patient’s questions. (S)he expresses understanding of the risks of the procedure and gives his/her informed consent.”

Providers should document the informed consent discussion in the same note as the visit when the discussion occurred; this may be in the office progress note, or the hospital admission H&P. Physicians should take care not to document informed consent in operative or procedure reports, which are often dictated following a surgery or a procedure and may lack credibility in the setting of an adverse event or claim.

Consent Forms

Written informed consent, in the form of a signed patient consent form, is used widely and in some cases is required for certain procedures or facilities. For cases in which a standardized consent form is not required, providers need to decide whether one should be use, and the best format to employ.

MIEC recommends the use of consent forms, in addition to documentation of informed consent discussions, as redundant documentation that full informed consent has taken place prior to any surgery, or any treatment/medication that is associated with a significant risk or side effect. The format of a consent form should be tailored to the procedure or treatment. Providers may wish to develop specialized consent forms for a particular surgery/treatment or type of treatment, and these can be incorporated with patient educational content or used in conjunction with educational aids (as discussed further below).

For minor in-office procedures, physicians are encouraged to develop a generic consent form for patients to sign when the procedure is discussed. Include statements on the form for the patient to initial such as: “Dr. (name) has explained to my satisfaction the purpose, benefits and alternatives to this procedure, the significant risks, and the consequences of not having the procedure. The doctor answered my questions about the procedure. I wish to proceed.”

Patient Education Materials

It takes time for a physician to explain why a patient needs surgery, what the surgery will entail, alternatives, and the potential risks; it also takes time to listen to and answer the patient’s questions. Using written materials and audiovisual aids to supplement (but not replace) the in-person informed consent discussion facilitates the process and reduces the amount of time physicians must spend explaining procedures and answering questions. In most instances, written information is essential for patient education, as many patients cannot remember most of what the doctor told them after they heard the words, “You’re going to need surgery.” A handout that describes the procedure in plain language and summarizes the key points of the doctor’s oral discussion gives the patient another opportunity to review the choices before deciding. Equally important, patients can take written material home to educate and inform a spouse or other family members. Documentation that written information was dispensed strengthens the doctor’s position in a professional liability case in which the patient does not remember preoperative discussions. A number of vendors market informed consent videotapes, computerized consent education programs, shared decision-making resources and other materials that reduce the amount of time the physician must spend explaining and reiterating.

Informed Refusal

Similar to informed consent, physicians should document a patient’s informed refusal of surgery, diagnostic studies, treatment or referral to another physician, to the extent that the patient’s decision may expose them to the risk of a poor outcome. In general, a brief note would suffice- such as, “Patient refuses test [or procedure]; explained risks and consequences of not having treatment [surgery; referral] and degree of urgency; patient expresses understanding of risks and does not wish to proceed.”

Implied Consent for Minor Procedures

Even though a patient may not sign a document or verbalize consent for a medical procedure, a patient’s conduct will imply consent in some instances. The patient’s acquiescence to medical procedures is evidence of consent. For example, the patient may hold out an arm to allow blood to be drawn without ever articulating consent, but consent to the blood test can reasonably be inferred from the patient’s conduct. Implied consent is a legal recognition of the reliance on nonverbal communication in simple situations. Consent may not be implied, however, where a medical procedure is complex or not commonly understood by a lay person.

Emergencies

The law generally assumes that a patient who is in extremis and unable to communicate would nonetheless desire that appropriate medical assistance be rendered. Unless it is known that the patient does not desire treatment, or unless the patient is able to communicate his or her conscious refusal, one may render aid or care to prevent illness, serious injury, or loss of life in an emergency. The emergency doctrine is a form of implied consent. However, implied consent in this circumstance lasts only for as long as the emergency, and formal consent must be obtained for procedures performed after an emergency has passed.

When Consent is Withheld for Religious Reasons

When a competent adult refuses treatment for religious or other reasons, there is little that a physician can do. The patient’s decision cannot be ignored if the patient has made an informed decision, no matter how unwise. Courts usually respect the wishes of a competent adult to refuse treatment. A court may order medical treatment in very limited circumstances, such as for a mother where the wellbeing of an infant would be in jeopardy. Problems arise, however, if the patient is incompetent or of questionable competence, or is a minor whose parents refuse to consent to medical treatment despite serious medical consequences. If the adverse consequences to the patient are sufficiently grave, the physician may try to obtain consent by asking the family to convince the patient to consent to needed medical care. When persuasion fails, a court may order needed medical treatment directly or through a temporary guardianship.

State-Specific Laws:

While this article addresses informed consent generally, the specific requirements of informed consent are generally governed by state law. Discussions of informed consent laws for the four states in which MIEC insures can be found here:

Alaska

California

Hawaii

Idaho

Frequently-Asked Questions

Does getting the patient’s signature on a consent form suffice?

Not always. A consent form is not the same as informed consent, and the signed consent form is not a substitute for a conversation. Even in states in which a signed consent form is regarded as evidence that the pa-tient did give informed consent (i.e., prima facie evidence), malpractice defense attorneys have considerable difficulty refuting a plaintiff’s claim that he or she signed a consent form but did not understand its contents. Plaintiffs’ attorneys are aware that some patients are informed of risks and see a consent form for the first time just prior to surgery. Plaintiffs have successfully argued in court that they were unable to make informed choices minutes before being taken to the operating room. Others have claimed in litigation that even though they had questions or did not fully understand a proposed procedure, they signed the hospital’s consent form “under duress,” when told that unless they signed, the procedure would be canceled or rescheduled.

Who is responsible for obtaining a patient’s informed consent?

In most jurisdictions, obtaining consent is the obligation of the physician who will perform a procedure. (State law may allow consent to be obtained by another physician who is able to perform the procedure and is familiar with the benefits and risks, but who may not perform the procedure on the subject patient. This is a common practice among anesthesiologists and radiologists.) Courts have recognized that, with respect to a specific patient, only a qualified physician can determine if a procedure is indicated and explain the risks for that patient. Nonphysicians, including nurses and medical assistants, can help educate patients in a general way about a procedure and answer basic questions but the physician must “fine tune” this information, based on a specific patient’s medical condition and history.

How much information does a patient need to give an informed consent?

This varies, but in general, physicians are required to tell patients the nature and purpose of a procedure or other recommended treatment, the “significant” or “material” risks, alternative treatments and their benefits and risks, including no treatment, and the expected outcome. “Significant” or “material risks” are those that involve potentially serious temporary or permanent injury or disability. For major surgery, significant risks may include death, paralysis, hemorrhage and infection. Certain procedures involve additional specific risks. For example, a significant potential risk of abdominal surgery is injury to adjacent tissues and organs. The failure of a procedure to resolve a medical condition, or the need to redo a surgery are significant risks of some neurological, ophthalmological and cardiothoracic surgeries. The more elective a procedure, the more physicians are obligated to disclose the risks and less risky alternatives. State laws generally embrace a “reasonable person standard,” a “reputable physician standard,” or both, for determining how much information a person needs to know for his or her consent to be an informed one. Under a “reasonable person standard,” physicians must disclose what a reasonable person in the patient’s situation would need to know in order to make an informed decision. Under the “reputable physician standard,” a doctor must disclose to patients what other reputable physicians who perform the same procedure ordinarily disclose to their pa-tients. Both standards must be met in some states. Another guideline for what to disclose is subjective: if the patient was your [the physician’s] spouse or child, how much information would you and the patient want to have before consenting to the procedure?

Doesn’t telling patients about the risks of surgery frighten them away from needed treatment?

Studies show more patients decline surgery because of a lack of information than because they were told the risks of necessary surgery. In some states, the so-called “therapeutic privilege” permits a physician to withhold a discussion of potential serious risks if the physician has good reason to believe that disclosure would be so upsetting that the patient would not be able to make a rational decision. Physicians should use this therapeutic privilege judiciously. When a patient’s emotional or physical condition makes the doctor reluctant to disclose significant risks, the discussion can take place with a spouse or other close relatives. If the patient has no available family, the physician might ask a colleague to evaluate the patient and concur that it would be prudent to not discuss the potential risks.

Do risks have to be disclosed if the patient does not want to know?

Patients can decline an informed consent discussion, a decision the physician should document. If the surgery is elective or if nonsurgical alternatives are possible, the physician should encourage the patient to listen to the choices and their risks. Prudent physicians often decline to do elective surgery if a patient is unwilling to be informed about potential risks, adverse outcomes or failure of the surgery. Such patients usually have unrealistic expectations.

California and other states have an “informed refusal” doctrine. This doctrine holds that competent adult patients have a right to refuse treatment, surgery, tests or referrals, even if they could suffer severe consequences as a result. Informed refusal requires physicians to disclose material information that a patient needs to make an informed decision.

To help a patient understand, the physician should explain the likely, known consequences of not having a surgery, test, medication or referral. A patient who declines treatment for cancer can be told the probable result of foregoing treatment. There is less certainty about what to tell a patient who refuses a test or X-ray the doctor needs to make a diagnosis. In such cases, the physician should explain why the test is needed and what problems could remain unidentified and untreated if the test is not done. How much to disclose depends on what a reasonable person in the patient’s position would regard as significant.

MIEC’s Recommendations

Understand your state’s informed consent laws from the state-specific supplements in this article, or obtain advice directly from MIEC’s PSRM team.

Ask colleagues in your specialty what they disclose to patients about specific procedures; physicians in group practices should adopt their colleagues’ best practices around informed consent, and maintain consistency across the practice.

Use plain language to explain medical procedures to patients. The law does not require physicians to give patients a mini-course in medicine or to disclose every problem that could occur, but they should use layperson’s language and avoid complex medical terminology when describing care.

Encourage patients to ask questions. Consider asking the patient to invite a spouse or other relative to join in the informed consent discussion. Don’t be offended if a patient seeks a second opinion about the surgery or tests you recommend. Third-party payors often require second opinions; support for your recommendation is a plus.

Train your staff to assist you to educate patients and families generally about treatment or surgery. Use written materials, models, audiovisual aids, or shared decision-making resources to supplement discussions. Document educational efforts.

Ask the patients to sign a consent form at the conclusion of an informed consent discussion, even if the hospital has its own. Sign the form yourself and provide the patient with a copy.

Document a summary of your informed consent discussions in your office chart and in the hospital admitting history and physical report (not in the operative report); include the name and relationship of others who were present, and the name of foreign or sign language interpreters who participated in your discussions with the patient.

Do not wait until the last minute to discuss a surgery or procedure in order to obtain a patient’s informed consent. In order to make good decisions about their care and to provide proper informed consent, patients must be given adequate time to consider alternatives and not be unduly pressured to make a decision.

Don’t delegate the task of obtaining a patient’s informed consent to your staff or to hospital staff. Although these individuals can help educate patients in a general way about a planned surgery or procedure, a physician should explain to individual patients why they need surgery, what the risks are, and feasible alternatives for that patient.

Don’t confuse “informed consent” with “consent form.” In most jurisdictions, a signed con-sent form carries obligation to inform a patient of the material risks of a surgery or procedure, as discussed in this newsletter.

Don’t provide any guarantees, make exaggerated claims or minimize risks of a procedure. Patients should understand that problems can occur under the best of circumstances and in the most skilled hands. Refer to the literature and consider your own experience when responding to questions about the historical success of a surgical procedure.

Contact our Claims Specialists