Short Answer

Informed consent is an ongoing discussion between the provider and patient that helps the patient understand a proposed treatment or procedure, its potential risks and benefits, reasonable alternatives, and the potential consequences of non-treatment. When a patient refuses recommended care, providers should follow a similar informed refusal process by explaining the risks of refusal, discussing alternatives, and documenting the conversation and the patient’s decision in the medical record.

When do I need to obtain informed consent?

Informed consent discussions need to be held with patients (and documented) for any treatment or procedure that has the potential for significant risk. This results in the patient’s educated decision either to pursue or refuse certain treatments or procedures. It lets the patient know that complications can and do occur even in the absence of negligence, and that all treatments involve some element of risk. While persons other than the provider may perform administrative tasks, such as obtaining the patient’s signature on a form, handing out an educational pamphlet or showing a video, it is the provider’s responsibility to complete the actual consent process. Any doubts about the necessity of obtaining a special consent from the patient should be resolved in favor of obtaining consent.

What needs to be included in informed consent discussions with patients?

Where possible, it is desirable for the informed consent discussion to occur a sufficient period of time before the proposed treatment or procedure in order to allow the patient time to consider the information and ask questions. This also avoids any issue of pressure or duress. During the discussion, you should use language the patient can understand and avoid the use of medical jargon. A written informed consent document is highly recommended. Document the written consent, as well as the fact that a verbal informed consent discussion occurred between you and the patient.

The following information should be discussed with the patient and documented in the patient record:

• The nature of the patient’s illness, the diagnosis, the proposed treatment plan and the prognosis.
• A description of the recommended procedure or treatment and its purpose.
• The probable outcome, particularly if it is difficult to predict, and the patient’s expected post-procedure/treatment course.
• The most likely risks and side effects and the potential benefits, as well as the potential complications of the procedure or treatment.
• Reasonable alternative methods of treatment and non-treatment including the risks, benefits, complications and the prognosis associated with each alternative or with non-treatment.

How much information is adequate in an informed consent discussion?

Most states apply the “reasonable patient standard.” It focuses on what a patient would need to know in order to understand the decision he or she is being asked to make. A few states, Virginia for example, apply a “reasonable doctor standard.” This requires disclosure of the information a typical doctor would give about the treatment or procedure at issue.

The best approach to the question of how much information is enough is one that meets both your professional obligation to provide the best care and respects the patient as a person with the right to a voice in healthcare decisions. A provider need not disclose all of the risks or complications which may occur, but should discuss those risks most commonly associated with the procedure or treatment and which have a reasonable chance of occurring, as well as those risks which have a small chance of occurring but which have grave consequences.

Who can give consent?

Informed consent requires that a patient possess the requisite mental capacity to understand and weigh the positive and negative features of a proposed medical treatment and be able to voluntarily give or withhold consent after making an informed decision. If the issue of the patient’s capacity to consent is unclear, a psychiatric or other consultation may be helpful. If the patient is determined not to have the capacity to make decisions, someone else must be authorized to make medical decisions and give consent for the patient. It may be someone holding a durable Power of Attorney for Healthcare, a court appointed guardian or other person authorized under state or other applicable law to act on behalf of the patient in making healthcare decisions, such as the next of kin.

In most situations, parents can give informed consent for treatment of their minor children. However, some states allow minors to play a more active role in their medical care and treatment, including informed consent. Many states have specific laws that allow minors to consent, without parental knowledge or approval, to healthcare treatments related to substance abuse, mental health and sexual activity. Likewise, many states make various exceptions for “mature minors” and “emancipated minors.”
It is important to be familiar with your individual state laws regarding appropriate informed consent procedures for incompetent individuals or minors.

What do I need to do if a patient refuses a recommended treatment or procedure?

Patients have the right to refuse treatment. If a patient refuses a recommended plan of treatment, it is important that you undergo and document an “informed refusal” discussion with the patient. This process is basically the same as for informed consent discussions.

The patient’s refusal may be due to a lack of understanding of the recommended treatment or the patient’s inability to comply with the plan of treatment for one reason or another. For example, the patient may be a single parent who cannot afford to take off work for several weeks. Therefore, patient education is crucial. Provide the patient with specific, detailed information regarding the recommended treatment including the benefits and risks of the treatment and any risks connected with the failure to undergo the treatment. Additionally, discuss with the patient any alternative treatment possibilities and the risks and benefits of each. All discussions and educational efforts should be documented in the patient’s medical record along with the fact that the patient was made aware and understands the risks of non-compliance with the recommended plan of treatment.

Documenting refusal of care is particularly important where the patient refuses care because of monetary considerations such as lack of Medicare coverage. It is crucial in those instances that the provider document that the patient took into consideration factors independent of his or her bank account by additionally weighing the medical risks at issue.

Ultimately, the decision whether to undergo a certain treatment remains at all times with the patient, regardless of the patient’s reasons for refusal. If the patient exhibits knowledge of the proposed procedure and the risks of refusal and still refuses, it is recommended that the practitioner ask the patient to sign a “refusal of treatment” form. If the patient’s informed refusal creates an irreconcilable conflict with the standard of care, the practitioner may consider whether termination of the relationship is appropriate, subject to applicable legal and ethical requirements.

Key Takeaway

Informed consent is an ongoing discussion between the provider and patient that helps the patient understand a proposed treatment or procedure, its potential risks and benefits, reasonable alternatives, and the potential consequences of non-treatment. When a patient refuses recommended care, providers should follow a similar informed refusal process by explaining the risks of refusal, discussing alternatives, and documenting the conversation and the patient’s decision in the medical record. Ultimately, the decision whether to undergo a certain treatment remains at all times with the patient, regardless of the patient’s reasons for refusal.

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