DIANA PAOLITTO, a Cambridge psychologist, was lying on a gurney late last year, all prepped for surgery to remove a major vein in her leg. In her 50s, she was alone, nervous, starting to feel the effects of the drugs she was getting through an intravenous tube and unable to see properly without the reading glasses she had handed to her husband for safekeeping. It was at this most inopportune of moments that hospital staff thrust informed consent forms into her hand.
“They didn’t give me any time to process what they were having me sign. I had to sign in three places, the print was tiny and I couldn’t read any of the paragraphs. There was no way I could understand what I was signing,” Paolitto said.
Nor was there anyone around to ask. Though she had had a pre-op visit with her doctor, whom she praises for his surgical skills, they discussed mostly the benefits of the surgery, she recalled, not the risks. The signing of the forms constituted “the entire informed consent process,” said Paolitto, whose surgery went well and who now feels fine.
This is not how informed consent, or a term some ethicists prefer, “informed choice,” is supposed to work. The idea of getting patients to give written consent to procedures they will undergo is obviously a good one. In fact, to maintain accreditation, hospitals must have an informed consent procedure in place. But informed consent is supposed to be a real process, in which the patient and doctor sit down together to discuss the risks and benefits of, as well as alternatives to, the proposed treatment.
The signing of forms is supposed to be the last step in this process, not the only one, said George Annas, chairman of the department of health law, bioethics and human rights at Boston University School of Public Health.
There are no hard figures on how often the process goes awry, but it is “all too common” for patients to have experiences like the Cambridge woman’s, said Dr. Lachlan Forrow, director of ethics programs for Beth Israel Deaconess Medical Center. “This is utterly unacceptable,” he added, noting that “this is the natural outcome when the ideals of informed consent get reduced to creating a paper trail for medico-legal and bureaucratic reasons.”
Often, the informed consent process and in particular the forms patients must sign are geared to “protecting the doctor and hospital from malpractice,” not empowering the patient to understand his or her treatment, said Arthur Caplan, chairman of the department of medical ethics at the University of Pennsylvania. “The informed consent process has become more of a shield than a doorway.”
A series of court cases dating back several decades established the legal standard that a patient must be fully informed of risks, benefits and alternatives, before consenting to a procedure, said Dr. Walter Robinson, assistant professor of pediatrics and medical ethics at Harvard Medical School.
“To be valid, informed consent should include four things,” said Karen Lebacqz, medical ethicist emerita at the Pacific School of Religion in Berkeley. Consent must be voluntary; the person giving consent must be a competent adult who is mentally able to understand what’s going on; the patient must also have received enough information to make a thoughtful decision; and the patient must have genuine understanding of what’s at stake.
Caplan said that even if patients understand what the doctor says in a face-to-face conversation, the written forms were often so long and frightening that many people didn’t even read them. Sometimes, they’re little more than a “truth dump,” he said, “a list of horribles,” with no way to evaluate how likely those horrible events are.
It would help if patients got the consent forms well in advance of a procedure so they could mull them over leisurely and ask any remaining questions before signing them, said Dr. Jeremy Sugarman, a professor of bioethics and medicine at the Johns Hopkins University.
Moreover, many forms are written for people who can read at the 11th- or 12th-grade level or higher, despite the fact that many adults read at the 8th-grade level or below.
In a study published in April, Dr. Alan Tait, director of clinical research in anesthesiology at the University of Michigan Medical School, set out to see if there was a better way to make consent forms more understandable. His team divided 305 parents into four groups, some of whom were presented with the standard form written at the 11th-grade level, some who got a form with graphics, written at the 8th-grade level and some who got each of the written forms along with an interview with a researcher. Those who got the modified forms understood them significantly better than those who got the standard ones, Tait said.
At the National Institutes of Health, Dr. Ezekiel Emanuel, chairman of the department of clinical bioethics, reviewed 42 studies of the informed consent process and ways to improve patients’ comprehension. The only thing that really worked, Emanuel said, was increasing “face-time with a doctor or nurse. The key is people talking.”
So what can you do if you’re a patient? Insist on sitting down with the doctor and asking all the questions you need to make a solid decision. If you can’t do all this in one visit, schedule another.
You should understand your diagnosis, the probable course of your illness and treatment alternatives. If you don’t want to hear all the gory details or read the fine print, that’s fine too. Many people don’t. The key is to be satisfied that you know as much as you want to know.
When you are ready to sign, make sure the forms echo what the doctor told you and cross out any statements you disagree with. Keep a copy of the form.
And remember: Informed consent is supposed to be for you, not the doctor or the hospital.
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Research consent held to a higher standard
Ethicists have established even more rigorous standards of informed consent for research subjects.
Such stringent protections were established after the Nuremberg trials of Nazi doctors who conducted medical experiments on Jewish prisoners.
Although a patient stands to benefit from a recommended procedure -- that’s the whole point -- a research subject often participates in a study not for his or her own potential benefit but for that of society in general.
Informed consent for patients is governed by the states; informed consent for research studies is governed by state and federal law.
-- Judy Foreman