Informed Consent: Substance and Signature

For decades, consent documents have helped protect healthcare practitioners against the claims of dissatisfied patients. Times have changed, however, and a more complex and complete acknowledgment of both the patient’s and the practitioner’s rights and responsibilities to each other is required.

True informed consent is a process of managing a patient’s expectations through shared decision making; it is not just a signature on a document. The patient provides accurate information to the healthcare practitioner to obtain the correct diagnosis, and the practitioner communicates sufficient information for the patient to be able to make a reasonable and informed decision regarding a comprehensive plan for medical, surgical, or dental treatment.

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

The process of reaching a shared decision and obtaining consent to proceed is the responsibility of the practitioner performing the test, procedure, or treatment or ordering the medication, and it cannot be delegated to another member of the healthcare team. The statutes governing advanced practice clinicians are currently being revised in many states. If an advanced practice clinician is responsible for performing the test, procedure, or treatment, consult the law in your jurisdiction regarding how the applicable statutes may affect the consent process.

Practitioner-Patient Dialogue

Litigation often results from discrepancies between the patient’s expectations and treatment outcomes. Informed consent cannot eliminate professional liability claims; however, an established rapport between the patient and the healthcare practitioner based on robust information exchanges can prevent patient disappointment from ripening into a claim.

Avoid using clinical terminology when discussing diagnoses, treatment plans, risks, and expected outcomes with the patient. Define and explain clinical words and concepts using simple pictures and analogies. If alternative treatment options, particularly nonsurgical, are available, discuss them in detail. Outline the anticipated recovery process and the expected short- and long-term effects 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. Supply reading materials and consent documents for the patient to take home and discuss with family members whenever possible.

Encourage questions. Questions provide insight into the patient’s comprehension of the information and facilitate the dialogue between the patient and the healthcare practitioner. If time permits, consider scheduling a second visit with the patient to review the consent form, clarify expectations, and ensure patient comprehension of the proposed treatment—especially with elective procedures.

Documentation

Documentation is another key component of the informed consent process that cannot be entirely delegated to another member of the healthcare team. If the practitioner-patient discussion proceeds successfully and the patient requests treatment, the practitioner is required in some jurisdictions to write a note in the patient’s record.

To some extent, healthcare practitioners who use an informed consent document can protect themselves further by including a statement to the effect that the form covers information that applies only generally and that the practitioner has personally discussed specific factors with the patient. The consent document must include the patient’s name, healthcare practitioner’s name, diagnosis, proposed treatment plan, alternatives, potential risks, complications, and benefits. Additionally, the consent document must be signed and dated by the patient (or the patient’s legal guardian or representative). Many consent forms also require the healthcare practitioner’s signature.

Consent forms should include statements to be signed by the patient and the healthcare practitioner. The patient attests to understanding the information in the treatment agreement. The practitioner attests to answering all questions fully and to the belief that the patient/legal representative fully understands the information. These statements help defend against any claim that the patient did not understand the information.

Some states have specific requirements for informed consent forms, procedure-specific disclosures, and legal standards for disclosure of risks. For example, Texas maintains lists of procedures and attendant risks and hazards through the Texas Medical Disclosure Panel. Check your state for requirements.

Informed Consent in Special Situations

The informed consent process for same-day surgery patients may occur in the healthcare practitioner’s office before scheduling the procedure. That will allow the patient time to think about the information, ask questions, and make an informed decision.

Hospitalized patients must be informed as far in advance of the procedure as practicable. If time permits in an emergency where the patient cannot provide consent, the healthcare practitioner must contact a legally authorized representative to obtain informed consent. If the nature of the emergency does not permit time to contact a legally authorized representative, 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 healthcare practitioner is legally bound to obtain informed consent from the incompetent patient’s authorized representative, except in an emergency. Thoroughly document this type of consent in the healthcare record.

For risk management strategies regarding obtaining consent for treatment of a minor, see our article, Minor Consent: Challenges for Pediatric Dentistry.

Patient Safety Measures

Consider the following strategies:

• Document informed consent discussions, including the patient’s specific questions and whether anyone else was present during the conversation.
• Obtain written informed consent from the patient using a consent form as required by policy and state law.
• Develop and use procedure-specific forms that the patient can sign when the informed consent discussion takes place. Place the signed consent form in the record.
• Ensure that the consent form risk section is comprehensive—including the risks of pain, bleeding, potential need for additional procedure(s), dissatisfaction with cosmetic outcome, if applicable, and death, if applicable. Medication risks should include black box warnings, off-label use, and common and significant side effects.
• Obtaining consent from the patient after a sedative or sleep-inducing medication is administered is not recommended. However, when a change in the patient’s condition requires a change in treatment, secure the patient’s consent. Document the patient record thoroughly with the facts and conditions surrounding the need for the revised consent.
• Ensure that any additions or corrections to the consent form are dated, timed, and signed by both parties.
• Obtain witness verification of the patient’s signature. Any member of the healthcare 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 the patient’s competency to give consent.
• Address a patient’s questions or lack of understanding about the procedure as soon as possible. The practitioner performing the procedure cannot delegate this responsibility.
• Use a qualified medical interpreter when necessary for the informed consent discussion and document the type (e.g., phone/video/in-person) and name/agency of the interpreter used.
• Translate consent forms to the most common non-English languages encountered in the practice and verify that the form is translated correctly.
• Give the patient and family time to absorb and comprehend the information; do not speed through the process. Preprinted materials are extremely helpful for patient understanding and serve as a trigger for other questions.
• Evaluate patient comprehension using teach-back. Ask patients to explain their understanding of the consent discussion in their own words. Correct any misunderstandings and continue the process until the patient can accurately explain the planned procedure, risks, and benefits. Document a summary of the discussion in a progress note, including questions asked and answered and the patient’s ability to teach-back. This will increase the likelihood that the patient’s expectations are accurate.
• Develop a system for completing the informed consent process, making it easier to avoid omissions and—more importantly—ensuring consistency of application.

If you and your patient have completed the informed consent process and your patient declines your recommendations, see our article on “Informed Refusal” for further guidance.

For assistance, see our checklist “Quick Check: Informed Consent Process” and our Informed Consent Sample Forms, or contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.