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,” said
Paolitto. 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 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 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, chair 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 Art Caplan, chair 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.
(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. Informed consent for patients is
governed by the states, while informed consent for
research studies is governed by both state and
federal law.)
“To be valid, informed consent should include four
things,” said Karen Lebacqz, medical ethicist
emerita at the Pacific School of Religion in
Berkeley, CA: 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’s 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
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, said Tait.
At the National Institutes of Health, Dr. Ezekiel
Emanuel [cq], chair
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.
Judy Foreman’s column appears every other week. Past
columns are available on
www.myhealthsense.com.
