Informed consent has become a signature, not a choice

When I began studying medical ethics, forty-five years ago, patient autonomy and informed consent (IC) were major issues. While some academics and practitioners today argue that autonomy has been overly emphasized, in my decades of practice and as a patient, I have yet to see IC properly administered.

There is little oversight of medical IC by a federal or state agency, but to state that it is required and its general contents. State professional ethics/licensing boards are chronically underfunded and understaffed, and usually do not act on consent issues unless they are a part of an egregious situation or a pattern of malpractice. It can be an issue for plaintiffs’ attorneys when liability for a poor outcome can be attributed to its inadequate provision.

Multiple parties are at fault in this failure, not just the clinician, who is too often blamed. Medical students are poorly instructed on the rationale for and the mechanics of proper IC. As residents, they only see the inappropriate technique modeled, and this is what they adopt. In addition, the for-profit structure in which many clinicians now practice leaves too little time for them to conduct a proper IC process.

The patient, being less knowledgeable, is seen as a passive recipient of information. In more than 50 percent of instances, this passivity is a deliberate choice that is both legal and ethical, and it should be officially documented (see below). With this option, a clinician should be exempt from any claim of injury or unsatisfactory result if it was included on the IC form unless a provider is grossly negligent or committed malpractice.

Patients are experts on themselves; their values, beliefs, future goals, etc. My position and that of many organizations is that patients have a responsibility, especially with granting consent, to be an active participant. In this sense, I disagree with those who claim autonomy is overemphasized. I suspect they are conflating a patient’s lack of motivation for self-care with decision-making.

However, if a person attempts to read an IC form or listen to a lengthy recitation, they are stymied. Attorneys often draft these forms and argue that they cannot be written plainly because legal concepts cannot be fully expressed in standard English. Very few people, about 9 percent, are conversant with legalese. With prodding, these forms have been restructured to standard English at the 10th- to 12th-grade reading and comprehension levels, which, however, are above the ability of about 75 percent of most Americans. The national average reading and comprehension level is 8th grade, and about 33 percent of people, including those for whom English is a second language, read and comprehend at the 5th-grade level and below. Simplifying IC forms to the 8th-grade level is challenging, but below this, it is likely impossible without sacrificing significant information.

Yet, without full comprehension of what is written and/or stated, consent, regardless of their signature, is invalid. Not only must the legal portion of the form be understood, but also:

• What procedure will be performed
• The significant potential problems that can occur and the likelihood of their occurrence
• What can result if the procedure is not performed
• Possible alternative treatments
• What the procedure may not accomplish (e.g., relieve pain)

All of this has to be done in an unhurried and unbiased manner:

• With time for a patient to formulate questions
• Have them answered to their satisfaction
• Consult with another person if they choose to do so
• Make a reasoned decision

Further, all of this is to occur without coercion. In reality, this rarely, if ever, happens. Most common is a few brief, truncated provider comments, with a form that could be multi-page, obtusely written, yet contain limited helpful information, thrust at the patient, with minimal time to read, much less digest, ask questions, and make a reasoned decision. This is not IC as it was conceived, but coercive, and yields an invalid consent, and technically any subsequent procedure is a criminal (at least, misdemeanor battery) and unethical act.

I experienced this classic example with my last procedure. There were several instances when the IC form could have been provided in an unhurried manner before the procedure but was not. As the transporters entered, a surgical fellow flew in, flung an e-tablet at me, and with machine-gun rapidity, in a monotone and a heavy accent, told me about the procedure, or at least I think they did. I have reduced hearing and vision, and my hearing aids and glasses had been removed; I neither understood nor was able to read the information presented. They then scrolled through several screens and commanded, “Sign.” I had no time to read or consider what was written, to ask questions, or even mention that I had not heard or could read, much less understood, what was said. I had researched the procedure for myself, having the ability to do so, and I was comfortable signing. If I had been an average patient, my signature would have been valueless, as the IC procedure failed to meet any of the required criteria. If my, albeit minor, surgery had gone sideways, I could have had a valid lawsuit based wholly on lacking IC.

I have a couple of suggestions. First, as many patients display no interest in knowing any or much procedure detail, I would place a checkbox at the top of consent forms with a statement attesting to this choice. The patient could mark this, sign the form, and they need not read further or have an oral presentation, and the clinician is absolved, as noted earlier. In addition to emergent situations, it is possible that once a procedure begins, it is determined that what was anticipated is not actuality and something other than what was approved must be performed. A comment regarding such contingency should also be on IC forms and acknowledged by patients.

All individuals who present IC should have good elocution and be capable of accounting for any hearing, visual, and/or speech disabilities. They could inquire about these and adapt the IC process accordingly.

Second is a multi-step process that need not increase a clinician’s burden:

• When the need for a procedure is introduced, the clinician provides the typical discussion and the simplified plain-English consent form to the patient, and encourages them to read the document at their own pace. The material indicates that it must be signed and brought to the procedure.
• A tele-visit is scheduled for a few days later with an RN or another knowledgeable individual to respond to a patient’s questions and/or, if necessary, prompt patient questions. They would also remind the patient to bring the signed consent form with them.
• A day or two after the initial visit, an email, phone call, or text “nudge” is sent to the patient reminding them of the importance of reading the provided information and of the upcoming tele-visit. Researchers have shown that these reminders are effective in activating desired behavior. This message would also include a reminder that the paperwork needs to accompany the patient to the procedure.
• On the day of the procedure, an individual (RN or LPN), in an unhurried manner, reviews the document with the patient to assess understanding, answer any final questions, and obtain their signature if the consent is not already signed or provide a duplicate to sign if the patient forgot to bring the form.

Although these actions would not be a cure-all, they could reduce the likelihood of misunderstanding and ideally provide greater understanding among patients who choose to make a knowledgeable decision about their procedures.

M. Bennet Broner is a medical ethicist.