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How “Informed” is Informed Consent?

Discussing your health care with mutual respect and concern.

I’m a senior physician with both clinical and clinical research experience. Before this year, I had undergone bilateral total hip replacements and a right total shoulder replacement. (As a younger man, my athletic ambition far outstripped my ability.)

Two months ago, I returned to the major medical center where I had my previous surgeries and where I had also been on staff. I was about to have a second—left—total shoulder. My considerably younger surgeon said, “I don’t think anyone could have a better idea of what informed consent for this surgery involves.”

Subsequently, I’ve thought a lot about that. I agreed with his reasoning, and willingly signed the consent form. Yet I wonder if anyone, when put in the patient role, really understands informed consent.

Christine Grady from the National Institutes of Health (Grady, 2015) [Citation Gra15\l1033]1 wrote, “Consent is a long-standing practice in some areas of medicine, yet only in the last century has informed consent been accepted as a legal and ethical concept integral to medical practice and research. Informed consent, in principle, is authorization of an activity based on an understanding of what that activity entails and in the absence of control by others. Laws and regulations dictate the current informed-consent requirements, but the underlying values are deeply culturally embedded—specifically, the value of respect for persons’ autonomy and their right to define their own goals and make choices designed to achieve those goals. (Italics added) This right applies to all types of health-related interventions, including life-sustaining interventions.”

Think about what that means to you and me as patients. We are giving our consent for others—strangers, really—to treat us with the cultural assumption that we retain our autonomy and the rights to our own goals and choices.

As I thought about my own granting of informed consent, I was tempted to conclude that, if understanding possible outcomes is the goal, obtaining (as a health care professional) or granting (as a patient) truly informed consent is fundamentally impossible. Neither party to the transaction can possibly understand and weight the probabilities of various outcomes. Then I began to wonder, is that vast unpredictable probability set really what it’s all about?

I had made the trip to see this particular surgeon, in this particular place, because the orthopedist who had done my hip surgery, an individual I trusted and respected, had made the referral.

When I checked the shoulder surgeon’s credentials, I found that, decades apart, we had attended the same medical school and done our residencies in the same hospital.

My “informed consent” was not a matter of understanding all the potential risks and benefits, although I certainly grasped both issues. I understood that my surgeon had the technical ability to do the operation and that the institution had all the necessary resources to support the procedure. But the most important aspect of my consent was that we had established a cultural understanding. He would do his very best to take good care of me. I would do my best to follow his instructions. We could discuss my goals and objectives with mutual respect and trust. This was just what Grady had said about patients in her paper, “…their decisions are driven more by trust in their doctor or by deference to authority than by the information provided.”

After the surgery, he proposed leaving a pain control infusion catheter in place for a couple of days. My goal, with three other joint replacements in place, was to avoid any risk of infection. That was more important to me than some post-operative discomfort. He quickly agreed, and the catheter came out.

In our recently published book, 240 Beats per Minute. Life with an Unruly Heart, my friend Bernie Witholt described a conversation with his cardiologist. The conversation occurred after Bernie realized that his recently implanted defibrillator would terminate his episodes of tachycardia but would not prevent them.

There had to be something more than the ICD. Perhaps the device was the gold standard, but it alone was not sufficient, not for a fifty-nine-year-old who still wanted to be active.

“What would you suggest?” he enquired, doubtless mindful of my [negative] reaction to his amiodarone prescription.

“The best you have to offer,” I responded, desperate for impossible magic.

“It is all trial and error,” said Dr. Candinas.

“Yes, your trial, my error…” I ventured, and we laughed a little—he more than I, perhaps.

“Ah, medicine. A beautiful occupation, were it not for the patients,” sighed my specialist.

I could only agree, since my laboratory bacteria never complained. They simply kept on doing what they were fated to do. It was up to us to understand them a little, but we had plenty of time and no one worried about a few bacteria more or less at the end of a day of experiments.

“Maybe we should try flecainide,” he continued.

This dialogue illustrates the heart of informed consent. Bernie made it clear that his ICD device alone was “not sufficient.” On his part, the cardiologist made it clear that there was no treatment approach recognized as effective: “It is all trial and error.” The outcome of the discussion was that Bernie realized that the physician cared for him and respected him. The doctor-patient relationship was different from that of scientist and the bacteria.

From the cultural point of view, the mutual respect and concern in this conversation is the very essence of informed consent.

Those issues also carry over to informed consent for clinical research. In a Guest Column for Clinical Leader on January 23, 2018, I quoted research across a diverse population of over 1,600 adults asked to rate motivators for participation in clinical research. “How well the research study is explained to me” was most important.3 [Citation: Kurub \l1033] (Kurt, 2016) In other words, the critical motivator for patients to participate in clinical research is an investigator or study nurse who explains the study to potential subjects with respect and care.

I’ve looked at informed consent in both clinical care and clinical research from both sides now: as a physician and as a patient. The informed consent process is critically important, not just for medical-legal documentation, but as a cultural transaction. By asking for consent, the physician operationalizes his/her respect for the patient’s personal goals and for the patient’s autonomy. By consenting, the patient indicates his trust and respect for the physician’s professionalism.

If we think this is all just “paperwork,” we really don’t understand the process.

References

1. Grady, C. 2015. "Enduring and Emerging Challenges of Informed Consent." N Engl J Med 2015;372:855-62. [Citation Gra15\l1033]

2. Mills RM. https://www.clinicalleader.com/doc/what-s-behind-the-gender-and-ethnici…

3. Kurt A, Semler L, Jacoby JL, et al. 2016. J Racial Ethn Health Disparities. 2016 Sep 8. [Epub ahead of print] [Citation: Kurub \l1033]

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