Informed Consent: Substance and Signature

For decades, consent documents protected physicians against any legal recourse a dissatisfied patient might pursue. Times have changed. Modern medicine requires a more complex and complete acknowledgment of both the patient’s and the physician’s rights and responsibilities to each other.

True informed consent is a process of managing a patient’s expectations; it is not just a signature on a document. Achieving an accurate diagnosis requires the patient to provide accurate information to the physician. The physician must then provide sufficient information to the patient so that a reasonable and informed decision regarding a treatment plan can be made.

A successful exchange of information between the doctor and the patient accomplishes two things. First, when the physician explains diagnoses, treatments, expected outcomes, and potential risks to the patient it demonstrates that the physician recognizes the patient’s rights and will remain responsive to them. Second, it shifts the decision-making responsibility from the physician alone to a mutual responsibility of both physician and patient. Informed consent should protect and inform both the patient and the doctor.

Litigation often results from a discrepancy between the patient’s expectations and the outcome of treatment. Informed consent cannot completely eliminate malpractice claims, but an established rapport between the patient and a physician based on solid exchanges of information can prevent patient disappointment from ripening into a claim. The informed-consent process is not limited to surgical procedures, but is also appropriate for comprehensive medical treatment plans.

Physician-Patient Dialogue

When discussing diagnoses, treatment plans, risks, and expected outcomes with the patient, use medically correct wording and names, but avoid medical terminology. If there are alternative treatment options, discuss them in detail. Also, outline the recovery process with the expected short- and long-term impact on the patient.

Identify any uncertainty and risk involved with a specific treatment plan, including the probability factors, if possible. Discuss reasonable assumptions the patient may make about the treatment plan. Whenever possible, you should supply reading materials and the consent form document for the patient to take home and discuss with his or her significant other. Encourage questions; this provides the physician with a better understanding of the patient’s comprehension of the information, and it facilitates the dialogue between the patient and the physician. Where time permits, physicians may want to consider scheduling a second visit with the patient to review the consent form and assure patient comprehension of the proposed treatment and expectations—especially with elective surgery procedures.

Documentation

Documentation is a key component of the informed-consent process that cannot be fully delegated to a nurse or other clinic personnel. If the doctor-patient discussion proceeds successfully and the patient requests treatment, then a note in the patient’s record written by the doctor is required. The consent document must include the patient’s name, doctor’s name, diagnosis, proposed treatment plan, alternatives, potential risks, complications, and benefits.

Physicians who use an informed-consent document can protect themselves to some extent by including a statement to the effect that information listed on the form covers only that information that applies generally, and that the physician has personally discussed specific factors with the patient. The consent document must be signed and dated by the patient (or the patient’s legal guardian or representative). Many consent forms also require a physician signature.

The Doctors Company offers a variety of sample consent forms in the Patient Safety/Risk Management section of our Web site at www.thedoctors.com. The information in the consent forms is for reference purposes only. It is a general guideline and not a statement of standard of care and should be edited and amended to reflect the policy requirements of the physician’s practice site(s) and the legal requirements of the individual state(s). The consent forms include a statement to be signed by the patient and the physician that all pertinent information was understood and the patient attests to the fact that all of his or her questions were satisfactorily answered. This statement helps avoid any claim that the patient did not understand the information.

Informed Consent in Special Situations

The informed-consent process for same-day surgery patients may occur in the physician’s office before scheduling the procedure. That will allow the patient time to think through the information, ask questions, and make an informed decision. Hospitalized patients must be informed as well in advance of the procedure as practicable. In an emergency, the physician must contact a legally authorized relative to obtain an informed consent, if time permits. If the nature of the emergency does not permit time to contact a legally authorized relative or guardian, consent is implied. Consent may be waived under emergent conditions that threaten life, limb, eyes, and the central nervous system. If the patient is incompetent, or otherwise cannot consent, the physician is legally bound to obtain informed consent from the incompetent patient’s authorized relative or guardian, except in an emergency. This type of consent should be very well documented in the medical record.

Additional Tips and Suggestions

• Obtaining consent from the patient after administration of a sedative or sleep-inducing medication is not recommended. However, when there is a change in the patient’s condition that requires a change in treatment, consent may be secured from the patient. The facts and conditions surrounding the need for the revised consent are to be thoroughly documented in the medical record.
• Additions or corrections to the consent form must be dated, timed, and signed by the person making the additions or corrections.
• Any member of the health care team may sign as a witness to the patient’s signature, although this serves only to verify that it was the patient who signed the form. The witness does not obtain consent or verify patient competency to give consent.
• A patient’s questions or obvious lack of understanding of the procedure should be referred to the attending physician as soon as possible.
• Translate consent forms to the most common non-English language that you encounter in your practice, and verify that the form is translated correctly.

Patient Safety Measures

Every physician should develop his or her own style and system for the informed-consent process. Developing your own process will make it easier to avoid omissions, and—more importantly—it will ensure consistency of application.

Do not speed through the process. Give the patient and the family time to absorb and comprehend the information. Preprinted materials are extremely helpful for patient understanding and will serve as a trigger for other questions.

Assessing the patient’s level of understanding is the step just before documenting the process. Be sure your patient fully comprehends what will occur in the surgical procedure or when he or she complies with the proposed medical plan. One way of doing this is to ask the patient to repeat back to you his or her understanding of the information you have communicated. This will increase the likelihood that the physician will be able to effectively manage the patient’s expectations.

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