August 6, 2001
Human-subject research is well-scrutinized
By Eric Rangus email@example.com
On June 2, a healthy, 24-year-old woman died one month after participating
in a research study at Johns Hopkins University in Baltimore.
When it was determined that the drug being tested, hexamethonium, collapsed
the lungs of Johns Hopkins technician Ellen Roche and led to her death,
the federal government stepped in and suspended all federally financed
medical research involving human subjects at the university.
Fortunately, such measures are extremely rare. But whenever an incident
occurs such as the one experienced at Johns Hopkins, or the death last
year of a gene therapy research subject at the University of Pennsylvania
occurs, the medical community takes notice.
But what is the effect of Roches death on human-subject research
Because of current strong oversight procedures, Emory does not need to
make any changes.
Its not the first incident of its kind, said David
Blake, associate director of the Health Sciences Center. The University,
in fact, has a strong oversight mechanism with its institutional review
board (IRB), which gives approval to all research projects involving human
subjects. It is in place specifically to prevent a tragedy such as the
Johns Hopkins death from happening at Emory.
All Emory human-subject research must conform to federal regulations,
Blake said. Research plans (or protocols) must be submitted
to the IRB, and the wording of consent notices is checked closely so that
it can be understood by a lay person with a high-school education.
While these controls have been the letter of institutional law for a
long time, a couple years ago, following a well-publicized problem at
a peer university, Emory took a look at itself and made some changes to
That was 1999, and the move followed the lifting of a four-day government
ban from enrolling human subjects in research at Duke University. According
to The Chronicle, Dukes independent student newspaper, the
Duke medical center had failed to correct what were seen as organizational
and administrative problems in the universitys procedures in approving
human research projects. In response the Office for Protection from Research
Risks (OPRR), which at the time was the govern-ments watchdog agency,
shut research down until Duke came up with a workable plan. The school
did so within a week.
It was the first time a major academic institution had received such
a suspension, and the fallout was felt at Emory.
At that time, we took a hard look at our own processes, brought
in an external consultant, and satisfied ourselves that we would withstand
in-depth scrutiny, Blake said.
Prior to the Duke incident, Emorys two human investigations committees,
which together made up the IRB, each met once a month. Following the internal
study, the number of committees was increased to four, each meeting monthly.
It also streamlined some of the committees recordkeeping.
The makeup of the four sperate committees, which consist of 18 to 20
people and are a mix of scientists, researchers and outside lay people,
however, was not changed.
It is because of this system, according to Blake, that a death such as
the one that took place at Johns Hopkins, which involved an experiment
that had not been approved for by the Food and Drug Administration (FDA),
could not happen at Emory. The University applies for FDA approval for
experiments that involve investigational drugs.
Human-subject research is quite common at Emory. IRB Director Marcia
Weese said 2,058 protocols are currently active and involve human subjects.
Emory has a rather high profile nationally regarding the subject of human-subjects
research, as well. Robert Rich, executive associate dean of the School
of Medicine, was named to the National Human Research Protections Advisory
Committee (NHRPAC) in December. The committee was formed to strengthen
the protections of human research subjects in clinical trials and reinforce
the responsibilities of research institutions to oversee their clinical
researchers and IRBs.
On July 24, following the submission of a corrective action plan formulated by Johns Hopkins, the Office for Human Research Protections, which replaced OPRR as federal watchdog agency last year, allowed human-subject research to continue at Johns Hopkins.