The new era of informed consent: active and informed patient participation

The Supreme Court ruling

The case involved a woman with diabetes who claimed that she had not been informed of the risk of shoulder dystocia during childbirth, an event that resulted in severe fetal brain hypoxia. While the obstetrician stated that the risk had not been discussed to avoid encouraging a cesarean section, which was not considered the preferred option under the circumstances, the Supreme Court ruled in favor of the patient.

The Court established that the standard for what physicians must disclose about treatment risks, benefits, and alternatives should not be determined by what the physician considers necessary, but by what a reasonable and well-informed patient would consider important when making a decision.

Challenges in communicating informed consent

This new approach, known as the “reasonable patient standard,” has already been adopted in nearly half of the United States. However, significant limitations still exist in the way informed consent is communicated.

Information about risks, benefits, and treatment alternatives is often missing details that are critical to patient decision-making. Consent materials may be generic and defensive in nature, designed primarily to protect healthcare professionals or institutions. They are frequently written in complex language, difficult to understand, and are sometimes presented at inappropriate moments, such as immediately before treatment begins, when patients may be particularly vulnerable and less likely to ask questions.

These challenges stem partly from a lack of recognition of the value of the informed consent process within healthcare systems. They are also related to barriers commonly described as “professional indifference” and “organizational inertia.” Such barriers include limited familiarity with decision-support tools, time constraints, competing priorities, perceived workload, and financial considerations.

How can informed consent communication be improved?

Given the importance of informed consent in the physician-patient relationship, what should an effective, patient-centered communication process look like?

Complete, transparent, and unbiased communication is essential, but it is not sufficient on its own.

One important element is the availability of written consent documents that are easy to read, potentially supported by figures, illustrations, and patient experiences. Communication between healthcare professionals and patients should be collaborative, taking into account not only clinical evidence but also the patient’s values, preferences, and personal goals.

During the discussion, patients should be given the opportunity to express their values, preferences, and treatment objectives. The informed consent process should also allow patients to better understand their prognosis and discuss any concerns regarding treatment safety, potential outcomes, or rehabilitation.

In addition, patients should be encouraged to request further information, seek a second opinion, or involve a family member or trusted individual in the decision-making process.

Toward a shared informed consent model

Only by adopting the reasonable patient standard can healthcare providers fully respect a patient’s right to information, personal preferences, safety, and autonomy.

Furthermore, implementing this standard through a shared informed consent process benefits not only patients but also healthcare systems and society as a whole. Patients who play a more active role in healthcare decisions are more likely to understand their options and receive care that is aligned with their values, goals, and preferences.

A truly patient-centered informed consent process therefore represents not only a legal requirement, but also an opportunity to strengthen communication, support shared decision-making, and improve the overall quality of care.