Progress in patient safety research could slow to a
crawl unless regulators work out a host of
ethical issues, Johns Hopkins researchers assert in an
upcoming opinion piece.
"We can't apply a clinical paradigm to patient safety
research. It just isn't the right fit," said
Nancy Kass, deputy director for public health at the
Johns Hopkins
Berman Institute of Bioethics and an author of the
article.
The piece, published in the June issue of The Joint
Commission Journal on Quality and Patient
Safety, was sparked by a 2006 study led by Peter
Pronovost, professor of
anesthesiology, critical care medicine and surgery at
the Johns Hopkins School of Medicine. In the study,
Pronovost, an
expert on patient safety, implemented a checklist in
intensive care units at 67 Michigan hospitals
aimed at preventing bloodstream infections whenever doctors
insert catheters.
The results were markedly positive: Bloodstream
infections from catheters fell by two-thirds
and, on average, infection rates in the ICUs went from 4
percent to zero. Over the course of the
study, the program saved more than 1,500 lives and nearly
$200 million.
Shortly after the study's results were published,
however, an anonymous complaint led to a
federal re-examination of the ethical oversight of the
study. As in most human research, Pronovost's
study had been reviewed by an institutional review board,
an internal group required at most research
institutions to use federal regulations to make sure
research studies protect the welfare of human
subjects.
Because Pronovost's study enforced safety measures
already known to be effective, and
because no data were ever collected from patients by name,
the Johns Hopkins IRB classified
Pronovost's study as "exempt" from further IRB review. This
designation meant that informed consent
was not necessary from the ICU patients and that IRB review
from each of the 67 Michigan hospitals
that participated wasn't required. However, after the
anonymous complaint, the federal Office for
Human Research Protections, a branch of the Department of
Health and Human Services that
oversees IRBs, determined that patient consent and Michigan
hospital IRB review should have taken
place.
According to Kass, who served for more than 10 years
on a Johns Hopkins IRB and is an expert
in the ethics of human research, such a decision ignores
the differences between patient safety
research of this sort and other types of research that
include riskier and more burdensome
interventions and procedures, such as human trials for new
drugs.
While well-informed consent is crucial for all
patients participating in new drug research, for
example, it may not be necessary for studies like
Pronovost's research, in which the proposed
intervention — a checklist to remember to follow
steps, all known to make the ICU safer — is virtually
risk-free; where data are lumped together so individual
patients' names and information are never
collected; and where the consent process may be burdensome
to very sick patients. Also, according to
Kass, since many small hospitals don't have IRBs, requiring
every hospital to get an IRB review for
patient safety evaluations would hinder many hospitals from
participating in these studies and
contributing their experiences to widespread
evaluations.
"All of us want to make sure that patients are
protected in any type of research," Kass said,
"but it is also critical to recognize which studies are
low-risk and should easily move through the
system, and which ones are high-risk and require
considerably more scrutiny."
Kass added that working through these issues is
crucial to advancing patient safety research, a
field that has the potential to greatly advance public
health.
"When the public thinks about important medical
research, they might think about a cure for a
horrible disease," she said. "I think the average person
has heard very little about the fact that many
more people die in the hospital of medical errors than they
do from lots of diseases.
"There is an ethical imperative to do patient safety
research," she said. "We need to find a
review system that works so that important research in this
field won't be compromised."
Other authors of the article are Pronovost, leader of
the 2006 checklist study; Jeremy
Sugarman; Christine A. Goeschel; Lisa H. Lubomski; and Ruth
Faden.