What is Informed Consent?

Informed consent is one of the most debated and litigated topics in healthcare law, yet it seems like there is no general consensus as to what it actually is. There unfortunately is no perfect document that would establish consent on every signature (if only!). While I wouldn't pretend to have the ability to nail down an exact definition of informed consent, it is worthwhile to explore the subject, to have a better understand of how this nebulous concept actually works in practicality.

Informed consent is much better descried as a conversation.

Informed Consent Conversation

Rather than a document, informed consent is much better described as a conversation. In fact, in clinical studies, the operative term is “informed consent conversation,” or ICC, rather than a particular document that has all of the magic words. This is indicative that informed consent is more about the state of mind of the patient, than it is about signing a piece of paper. The purpose behind all informed consent is to allow a patient to make a decision about their own body or healthcare treatment, based on accurate and dependable information about the procedure in question.

The question understandably follows: How is a physician supposed to know how much to tell a patient? How does one know when a patient's decision is informed?

Physician Centric and Patient Centric

Courts use two primary standards to determine whether a patient's decision was actually informed. The first is Physician Centric, and the second is Patient Centric.

Physician Centric

Most jurisdictions look to a physician level standard, either the custom among physicians for a particular procedure, or what an ordinary, competent physician would disclose in a given situation. 88 A.L.R. 3d 1008.

A case in New York demonstrates this standard: Good v. Presbyterian Hosp. in City of New York, 934 F. Supp. 107 (S.D.N.Y. 1996). In this case, a child passed away in 1990 after receiving a heart and lung transplant. The organs that the child received were CMV positive, and the child’s parents sued because the doctor did not inform them that the organs were CMV positive, nor did he disclose the risk of using CMV positive organs in this procedure. The surgeon won summary judgment, because he was able to establish, uncontroverted, that physicians at that time and under those circumstances, especially with children, affirmatively and intentionally did not discuss CMV with patients or their representatives.

This seems relatively simple. Ask yourself: "What would my peers or colleagues do?"

Patient Centric

There is a movement towards a patient centric standard of informed consent, which dictates that a physician should disclose all relevant information that the ordinary patient would consider important to their decision about the procedure. 88 A.L.R. 3d 1008.

A case from Wisconsin illustrates this concept nicely. In Martin by Scoptur v. Richards, a father brought his daughter, who had a moderately serious head injury, to the Emergency Room. The ER doctor reasonably diagnosed a serious concussion, and suggested that the daughter stay at the hospital for a time. However, the doctor failed to disclose that the hospital was capable of doing further diagnosis with a CT scan, and also that the hospital did not have a neurosurgeon on the premises. The father, after listening to the doctor, decided to allow his daughter to stay at the hospital, and to seek out no further diagnostic tests.

The daughter’s head injury was much more serious than first diagnosed, and she ended up permanently paralyzed. A CT scan would have revealed the true extent of the injury, and the lack of a neurosurgeon at the hospital significantly delayed the daughter’s receiving the necessary care. The jury determined, and the Wisconsin Supreme Court found their decision to be sound, that the reasonable person would have considered it important to know that the hospital could do a CT scan, and that there was no neurosurgeon on the premises. Thus, in this case, the father’s decision to consent to his daughter staying that the hospital, and to not undergo further diagnostic procedure, was not an informed decision, and as such he did not give informed consent. Martin by Scoptur v. Richards, 192 Wis. 2d 156, 182, 531 N.W.2d 70, 81 (1995)

The key factor in these cases is whether an ordinary patient would consider the information important to make a decision.

These two cases show that, in order to obtain truly informed consent, a physician must disclose to a patient all things that an ordinary physician in his shoes would, or everything that an ordinary patient would consider important.

So, if informed consent is not actually signing a paper, then why is there a document?

The Informed Consent document serves as an acknowledgement that the conversation took place, and that the patient understood what was going on to a degree that allowed him or her to make a reasonable decision regarding health care. While the patient’s signature on the document is not dispositive (fancy legal word meaning that something, in and of itself, resolves a dispute), it is vital for a physician’s defense, should a dispute arise.

By signing a properly prepared Informed Consent form, the patient is essentially acknowledging that they think that they have made an informed decision.

Every informed consent document will be different, and that is how it should be. The informed consent document should be tailored to describe, with reasonable detail, each procedure, with its accompanying benefits and drawbacks. That means that, yes, one physician could have several different informed consent documents.

Conclusion

The point of this whole discussion is to shed some light on how informed consent actually works in the courtroom, and what you need to do in order to protect yourself. There is no one exact right answer, but here are some principles to keep in mind:

- Informed consent is about the state of mind of the patient. The more a physician can help the patient to understand their medical situation, the better.

- Have a tailored and detailed conversation with each patient before any major medical treatments.

- Maintain separate documents for each procedure, because consent will vary depending on the topic of the conversation.

While dealing with these things may seem tedious (because they are!), you will be grateful that you did.

-Jeff