Human-subject research is well-scrutinized

By Eric Rangus erangus@emory.edu

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 Roche’s death on human-subject research at Emory?

Because of current strong oversight procedures, Emory does not need to make any changes.

“It’s 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 its procedures.

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, Duke’s independent student newspaper, the Duke medical center had failed to correct what were seen as organizational and administrative problems in the university’s procedures in approving human research projects. In response the Office for Protection from Research Risks (OPRR), which at the time was the govern-ment’s 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, Emory’s 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.