Informed Consent: A Hazy Concept

We’re all too familiar with those awkward television commercials for drugs whose names cannot be pronounced because they have too many consonants. To be fair, drug manufacturers have run out of eloquent ways to combine the letters of the alphabet, so they just string them together as best they can. But beyond the alphabet soup, the television voice recites a sometimes-arresting list of possible complications of taking the drug: dizziness, insomnia, tiredness—or the even more arresting—intense sexual or gambling urges and explosive diarrhea, which hopefully do not occur simultaneously! The only thing more potentially alarming than these announcements is the package inserts that come nestled in the boxes with prescription medications whose complications sometimes end with the phrase “. . . or death.” It would take two days and a degree in pharmacology to read and understand all the fine print on those tissue-thin missives, whose main objective seems as much to protect the drug maker as the drug taker. The foundation of it all is the doctrine of informed consent. According to the American Medical Association, “Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.” The doctrine of informed consent didn’t emerge out of the thin air; it has a history.

Early medicine from the Hippocratic era to the mid-20th century was characterized by what has been described as the beneficence model. Physicians pledged not only to “do no harm” but to do good for their patients. Because, it was assumed, patients (literally, sufferers) were experiencing illness and dis-ease—and did not have a background in the science and art of medicine—physicians were obligated to act in the patient’s interest. In most cases, a long tradition of trust developed between patients and their doctors. Patients believed that their doctors were committed to their well-being and not to any alternative motive. In rare cases, beneficence transmuted into paternalism where patients didn’t think they had a voice in their care plan, but this was not the norm. Over time, forces mounted to challenge the reigning paradigm. In their chronicle of the history of informed consent, wife and husband medical ethicists, Ruth Faden and Tom Beauchamp, maintain that “’Informed consent’ first appeared as an issue in American medicine in the late 1950s and early 1960s. Prior to this period, we have not been able to locate a single substantial discussion in the medical literature of consent and patient authorization” (p. 86). Included among the pressure points that led to the codification of informed consent were responses at Nuremberg, Helsinki, NIH, and the FDA to violations of patients’ rights in research protocols.

By 1973, the American Hospital Association had issued its Patient’s Bill of Rights, which includes a list of 15 rights, the first four of which are:

1. The patient has the right to considerate and respectful care.
2. The patient has the right to and is encouraged to obtain from physicians and other direct caregivers relevant, current, and understandable information concerning diagnosis, treatment, and prognosis.
3. Except in emergencies when the patient lacks decision-making capacity and the need for treatment is urgent, the patient is entitled to the opportunity to discuss and request information related to the specific procedures and/or treatments, the risks involved, the possible length of recuperation, and the medically reasonable alternatives and their accompanying risks and benefits.
4. Patients have the right to know the identity of physicians, nurses, and others involved in their care, as well as when those involved are students, residents, or other trainees.

It is #2 that, in my mind, creates the greatest challenge. Just how much and what kind of information about diagnosis, treatment, and prognosis is necessary for a patient to make an “informed decision”? In some cases, it’s relatively easy. I’ve cut my finger. Infection prevention and proper healing will require a few stitches. I get that.

But my mother’s decision whether to have palliative radiation treatment for her back, secondary to metastatic lung cancer involved a much more complicated calculus. She was in agonizing pain from the deterioration of her vertebrae. She was told that the radiation might diminish the pain for an indeterminate period of time until the cancer would eventually end her life, but there was an unknown probability it would help. Mom had no medical training and no previous cancers. She had never watched a friend or relative die of cancer. She had never seen a linear accelerator machine. 

On the other hand, her physicians had the benefit of prestigious medical school training, an equally prestigious residency, specialization in interventional oncology, and years and years of experience treating patients of diverse ages, diagnoses, treatment plans, and prognoses. They were seasoned veterans of patient care for cancer patients. They laid out several options for Mom and were as non-directive as they could have been. “It’s your decision,” they concluded. When my mother replied, “what would you do for your mother?” they deflected the question, putting the onus back on my mother’s desperate, untrained, and inexperienced shoulders. 

Was my mother’s decision based on her consent? Yes. Was it an “informed” decision? Despite the doctors’ best efforts in a 15-minute conversation, not really. Even if she could have become well and truly informed, it would take more than a brief chat.

In an earlier conversation with the oncologist who diagnosed Mom’s cancer she asked, “If my pain gets too bad, will you just put me out of my misery?” The doctor paused a second and replied, “Well, I wouldn’t have a problem with that, but it’s not legal in our state.”  No questions about what she was fearing. No promise to keep her comfortable. If it were legal and she wanted it, he would do it. That conversation raises another clutch of questions about informed consent. If patients have a right to make their own medical decisions, are there any limits to what a doctor is obligated to do if it’s legal and the patient requests it?

In his extraordinary essay, “When Self-Determination Runs Amok,” the late Daniel Callahan, co-founder of the Hastings Center, the oldest bioethics center in the U. S., maintains that Doctors ought to relieve those forms of suffering that medically accompany serious illness and the threat of death. They should relieve pain, do what they can to allay anxiety and uncertainty, and be a comforting presence. As sensitive human beings, doctors should be prepared to respond to patients who ask why they must die, or die in pain. But here the doctor and the patient are at the same level. The doctor may have no better an answer to those old questions than anyone else; and certainly no special insight from his training as a physician. It would be terrible for physicians to forget this, and to think that in a swift, lethal injection, medicine has found its own answer to the riddle of life. It would be a false answer, given by the wrong people. It would be no less a false answer for patients. They should neither ask medicine to put its own vocation at risk to serve their private interests, nor think that the answer to suffering is to be killed by another. The problem is precisely that, too often in human history, killing has seemed the quick, efficient way to put aside that which burdens us. It rarely helps, and too often simply adds to one evil still another. That is what I believe euthanasia would accomplish. It is self-determination run amok.

What’s the answer, then?  I would argue that the physician’s covenant to use her training and gifts for the well-being of the patient should be accompanied not by a patient’s crude determination to do whatever he or she wants to do, but by a negotiated compliance with the physician’s recommendations with the acknowledgement that physicians are not right all the time, and neither are patients. In other words, just as the physician joins a covenant to heal, so the patient joins the covenant to comply and be healed. 

Granted, there are extremes to be avoided and the patient’s body is the patient’s property, as it were. But medicine deserving of the name cannot be governed by naked self-determination. The suffering patient is compromised by dis-ease that he or she presumably cannot remedy. So the patient appeals to the physician who is pledged to aim for the good of the patient. The medical covenant is, therefore, more like a dance than a DIY project. In a dance the partners both have an important role to play. One leads and the other follows, but neither works independently of the other; neither partner is autonomous, and there are rituals, rules, and patterns to follow. 

Granted, there are extremes to be avoided and the patient’s body is the patient’s property, as it were. But medicine deserving of the name cannot be governed by naked self-determination. The suffering patient is compromised by dis-ease that he or she presumably cannot remedy. So the patient appeals to the physician who is pledged to aim for the good of the patient. The medical covenant is, therefore, more like a dance than a DIY project. In a dance the partners both have an important role to play. One leads and the other follows, but neither works independently of the other; neither partner is autonomous, and there are rituals, rules, and patterns to follow.

Contemporary patient care is in desperate need of an ethic that avoids the extremes of both paternalism and autonomy. The patient is a person, as the late Paul Ramsey put it, and so is the physician. The healing dance—or the treatment tango, if you will—requires partners who are willing to respect one another, negotiate their relationship, and take steps together that move the patient toward well-being.

My mother died five weeks after her diagnosis. The radiation therapy not only did not help, but her back pain was so great, and getting her to the cancer center was so excruciating, that she decided to stop before receiving the final three treatments. Her hospice physician and other caregivers were extraordinary and kept her comfortable until a peaceful end.

The Tennessee Center for Bioethics & Culture encourages respectful discussion and debate of bioethics issues, and strongly supports freedom of speech. To that end, we invite and welcome other voices to the discussion of bioethics issues. Invited authors’ views are their own, and do not necessarily represent those of The Tennessee Center for Bioethics & Culture.