We’ve all been there: discussing the case of appendicitis in room six with the on-call surgeon, and the response includes something along the lines of “make sure you get consent.” Hard stop. The fact that this is commonly requested of emergency physicians is a testament to the widespread misunderstanding of informed consent, how it is obtained, and how to document it.

Point One: Informed Consent Is Not a Signed Boilerplate Form on the Chart

True, such documentation is required by hospitals and by CMS, but to confuse the completion of this form with the completion of the informed consent process is a serious error.

This is not to cast aspersions on consulting physicians; it applies equally to emergency physicians who ask medical students or nurses to “get consent.”

While it may be appropriate for another member of the care team to obtain the patient’s signature on the pre-printed form after the physician performing the intervention has had the appropriate discussion with the patient, only that physician can lead an adequate informed consent discussion. Regardless of whether there is a signed form on the chart, the patient has not given informed consent if that discussion has not taken place.

Point Two: Proper Informed Consent Is Critical to Autonomy and the Patient-Physician Relationship

The modern practice of medicine is based in significant part on an ethical model of informed consent. This rests on the patient’s fundamental right to make decisions about his or her own body. Though the patient has, in effect, hired the physician as a learned intermediary to provide medical expertise and recommend a course of therapy, the decision to accept or refuse treatment ultimately lies with the patient.

The provider may make recommendations but should be careful to avoid even the appearance of coercion. This is not to imply that physicians should be compelled to perform treatments that are not medically indicated at the behest of the patient. However, it is crucial to remember how very important the informed consent process is to an ethically and legally sound patient encounter.

‘In 2009, a Maryland jury found no cause for medical malpractice based on the actual course of medical treatment but awarded the plaintiff a $13 million verdict for lack of informed consent.’

Point Three: Proper Informed Consent Is a Key Area of Managing Malpractice Risk

In keeping with the fundamental importance of informed consent to procedures and treatments that carry risk of harm, informed consent itself is often litigated.

For example, in 2009, a Maryland jury found no cause for medical malpractice based on the actual course of medical treatment but awarded the plaintiff a $13 million verdict for lack of informed consent. In that case, failing to advise the patient of alternatives to the recommended therapeutic course was the only malpractice committed and was sufficient to support a significant jury verdict.

Point Four: Only the Appropriately Trained Practitioner May Obtain Informed Consent

Though medical students, nurses, and residents are at times tasked with “consenting the patient” for a procedure such as surgery, an LP, or a sedated orthopedic reduction, they cannot and should not be asked to do this. Particularly in the case of residents (who must ultimately gain competence in this area), practice of this skill is critical; however, resident efforts in this respect cannot be considered definitive.

Further, as noted above in point one, even an emergency department attending physician is not the appropriate person to facilitate the consent discussion for an inpatient or surgical procedure.

Setting aside the consent exception for exigent circumstances, this duty must fall to the surgeon, anesthesiologist, and/or other appropriate practitioners.

‘Studies show that the patient might have no recollection of the specific points of discussion 15 minutes later, let alone months to years later in the event of a dispute adverse outcome.’

Point Five: Boilerplate Forms Are Not the Best Way to Document Informed Consent

In the same manner that “all WNL” is not necessarily effective documentation of physical exam, a boilerplate consent form stating “all risks, benefits, and alternatives to treatment” have been discussed is not necessarily effective documentation of informed consent.

First, it is neither practical nor possible to discuss all risks, benefits, and alternatives to treatment in the emergency department setting.

Second, the precise disclosure standard is elusive and might vary by practice setting. In general, though, it encompasses the expected practice of a reasonable practitioner under the circumstances as well as the expectations of a reasonable patient.

Third, retrospective studies show that the patient might have no recollection of the specific points of discussion 15 minutes later, let alone months to years later in the event of a disputed adverse outcome. Further, the physician is also unlikely to have credible recall of the event years later, and must then rely on the chart.

For these reasons, taking the (precious) time to ensure that the chart and/or consent form reflects specific details of the discussion will improve the strength of documentation for medico-legal purposes.

Final Point: So, If Informed Consent Is Not a Form, What Is It? How Is It Best Documented?

Informed consent is a process. It is a discussion between the appropriate provider and the patient to allow the patient to make informed choices about his or her own body. As is true with the remainder of the physician-patient encounter, the informed consent process must be adequately yet efficiently documented.

While the fine points of documentation may vary by situation and practitioner, it is important to remember that accurate and detailed documentation is medico-legally valuable. A simple phrase such as, “Risks, benefits, and alternatives to treatment discussed, including, but not limited to…” may be a useful addition to an emergency department chart.

Documenting specific topics raised by the patient and noting witnesses (including patient’s friends and family, as well as staff) may further strengthen the chart.

In Conclusion

It is important to remember that proper informed consent (the process, not the form) is a critical part of the delivery of care. Review of case law reveals that documentation of the informed consent process is a critical part of risk management. Because many hospitals rely on a standard boilerplate consent form, careful documentation of an excellent informed consent discussion will improve the medico-legal strength of the record.

Dr. Nordlund is an adjunct professor of Emergency Medicine at the Michigan State University College of Osteopathic Medicine and is admitted to the State Bar of Michigan.

Dr. Koslow is an assistant clinical professor of emergency medicine at Tufts University School of Medicine, staff physician at Steward Good Samaritan Medical Center, and a member of the ACEP Medical Legal Committee.

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ACEP’s Medical Legal Committee sponsors these articles addressing medical-legal topics of interest to ACEP members. If you have legal questions you would like discussed in print, please submit them to Dr. Louise B. Andrew at acep@mdmentor.com. Please don’t disclose any details of a pending legal case. If you need advice regarding litigation stress, please contact Marilyn Bromley, ACEP Director of EM Practice, at 800-798-1822, ext 3231 or mbromley@acep.org.