most doctors, medical scientists, pharmacists and surgeons are doing research in labs and at hospitals, with patients and cohorts of research participant following something called internal review board or IRB guidelines, which are put in place to ensure accurate and consistent monitoring of research studies and ensure more importantly that the research participants are not harmed in any way.
below is an article from last year, that shares a checklist to look for, when conducting such research.
Source: NY Times
URL: http://www.nytimes.com/2007/12/30/opinion/30gawande.html?ref=opinion
Date published: December 30th 2007
December 30, 2007
Op-Ed Contributor
A Lifesaving Checklist
By ATUL GAWANDE
Boston
IN Bethesda, Md., in a squat building off a suburban parkway, sits a small
federal agency called the Office for Human Research Protections. Its aim is to
protect people. But lately you have to wonder. Consider this recent case
.
A year ago, researchers at Johns Hopkins University published the results of a
program that instituted in nearly every intensive care unit in Michigan a
simple five-step checklist designed to prevent certain hospital infections. It
reminds doctors to make sure, for example, that before putting large
intravenous lines into patients, they actually wash their hands and don a
sterile gown and gloves
.
The results were stunning. Within three months, the rate of bloodstream
infections from these I.V. lines fell by two-thirds. The average I.C.U. cut
its infection rate from 4 percent to zero. Over 18 months, the program saved
more than 1,500 lives and nearly $200 million
.
Yet this past month, the Office for Human Research Protections shut the
program down. The agency issued notice to the researchers and the Michigan
Health and Hospital Association that, by introducing a checklist and tracking
the results without written, informed consent from each patient and health-
care provider, they had violated scientific ethics regulations. Johns Hopkins
had to halt not only the program in Michigan but also its plans to extend it
to hospitals in New Jersey and Rhode Island
.
The governments decision was bizarre and dangerous. But there was a certain
blinkered logic to it, which went like this: A checklist is an alteration in
medical care no less than an experimental drug is. Studying an experimental
drug in people without federal monitoring and explicit written permission from
each patient is unethical and illegal. Therefore it is no less unethical and
illegal to do the same with a checklist. Indeed, a checklist may require even
more stringent oversight, the administration ruled, because the data gathered
in testing it could put not only the patients but also the doctors at risk
by exposing how poorly some of them follow basic infection-prevention
procedures
.
The need for safeguards in medical experimentation has been evident since
before the Nazi physician trials at Nuremberg. Testing a checklist for
infection prevention, however, is not the same as testing an experimental drug
and neither are like-minded efforts now under way to reduce pneumonia in
hospitals, improve the consistency of stroke and heart attack treatment and
increase flu vaccination rates. Such organizational research work, new to
medicine, aims to cement minimum standards and ensure they are followed, not
to discover new therapies. This work is different from drug testing not merely
because it poses lower risks, but because a failure to carry it out poses a
vastly greater risk to peoples lives
.
A large body of evidence gathered in recent years has revealed a profound
failure by health-care professionals to follow basic steps proven to stop
infection and other major complications. We now know that hundreds of
thousands of Americans suffer serious complications or die as a result. Its
not for lack of effort. People in health care work long, hard hours. They are
struggling, however, to provide increasingly complex care in the absence of
effective systematization
.
Excellent clinical care is no longer possible without doctors and nurses
routinely using checklists and other organizational strategies and studying
their results. There need to be as few barriers to such efforts as possible.
Instead, the endeavor itself is treated as the danger
.
If the governments ruling were applied more widely, whole swaths of critical
work to ensure safe and effective care would either halt or shrink: efforts by
the Centers for Disease Control and Prevention to examine responses to
outbreaks of infectious disease; the militarys program to track the care of
wounded soldiers; the Five Million Lives campaign, by the nonprofit Institute
for Healthcare Improvement, to reduce avoidable complications in 3,700
hospitals nationwide
.
I work with the World Health Organization on a new effort to introduce
surgical safety checklists worldwide. It aims to ensure that a dozen basic
safety steps are actually followed in operating rooms here and abroad that
the operating team gives an antibiotic before making an incision, for example
, and reviews how much blood loss to prepare for. A critical component of the
program involves tracking successes and failures and learning from them. If
each of the hundreds of hospitals were trying to draw into the program were
required to obtain permissions for this, even just from research regulators,
few could join
.
Scientific research regulations had previously exempted efforts to improve
medical quality and public health because they hadnt been scientific. Now
that the work is becoming more systematic (and effective), the authorities
have stepped in. And theyre in danger of putting ethics bureaucracy in the
way of actual ethical medical care. The agency should allow this research to
continue unencumbered. If it wont, then Congress will have to
.
Atul Gawande, a surgeon at Brigham and Womens Hospital in Boston and a New
Yorker staff writer, is the author of Better
.
Copyright 2007, NY Times