Diana Paolitto 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 and 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 given her husband for safekeeping.
It was at this most inopportune moment 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," said Paolitto, a psychologist from Cambridge, Mass. Nor was there anyone around to ask.
Though she'd 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 feels fine now.
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 their accreditation, hospitals must have a 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 the proposed treatment as well as alternatives. 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 Paolitto's, said Dr. Lachlan Forrow, director of ethics programs for Beth Israel Deaconess Medical Center in Boston.
"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" and not helping the patient understand his or her treatment, said Art 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."
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.
(By means of a separate legal track that began with the Nuremberg trials of Nazi doctors who conducted medical experiments on Jewish prisoners, ethicists have established even more rigorous standards of informed consent for research subjects. That's because, while 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 own potential benefit but for that of society in general.)
"To be valid, informed consent should include four things," said Karen Lebacqz, medical ethicist emerita at the Pacific School of Religion in Berkeley, Calif.: Consent must be voluntary; the person giving consent must be a competent adult who is mentally able to understand what's going on; he or she must also have received enough information to make a thoughtful decision; and he or she must have genuine understanding of what is at stake.
Even if patients understand what the doctor says in a face-to-face conversation, the written forms are often so long and frightening that many people don't even read them, said Caplan. 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 a lot if patients got the consent forms well in advance of a procedure so they could read them 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 or below the eighth-grade level.
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 way to make consent forms more understandable.