U. carefully monitors clinical trials

In the wake of Indiana college student Traci Johnson's suicide following a corporate drug trial of the antidepressant duloxetine, Indiana University Medical Center's Institutional Review Board stepped in to set new restrictions on the study, including banning new participants.

However, IRBs are not monitoring bodies, and they have no power to enforce the conditions they set.

Like all academic research institutions and private companies that conduct human experiments, Penn has an independent IRB to guide researchers' conduct.

In addition, a number of institutions, including Penn and Johns Hopkins University, have other monitoring practices -- such as an additional Office of Human Research -- but they are not the norm at most research institutions.

"There are a few institutions in the country that are doing this, and everyone should be," said Glen Gaulton, vice dean for research and research training in the Penn School of Medicine.

University President Judith Rodin said that Penn has "made enormous progress in the oversight of clinical research."

She later added, "We now, I think, are viewed nationally as the thought leader in having addressed these issues."

At both Penn and Hopkins, the motivation for extra checks on human research was the death of a study participant. Hopkins reformed its human research program after a healthy volunteer, 24-year-old Ellen Roche, died from ingesting a drug to simulate the conditions of asthma in 2001.

Penn's OHR, housed in the Medical School, was created after 18-year-old Jesse Gelsinger's death in 1999. Gelsinger died of organ failure following participation in a gene therapy trial under a Penn professor.

The OHR monitors the execution of research studies termed "high-risk" by the IRB. High-risk studies include any research on a vulnerable population, such as pregnant women or children, among others.

The frequency of monitoring depends on the level of risk.

"Given Penn's history [with gene therapy], literally every patient is checked up on," Gaulton said.

The OHR also educates faculty and staff about good research practices. Investigators and their assistants are required to pass a certification program and exam.

Since Gelsinger's death, Penn has taken other steps to regulate human research. The IRB now has the power to halt research studies, and it has added layers to "keep up with the overload so that we don't run behind," Rodin said.

As a result, costs are now higher for outside researchers using Penn property and resources. The University Health System and Medical School are also doing fewer clinical trials.

Gaulton said, however, that the IRB is still understaffed. There is a two- to six-week backlog of protocols, or research study applications, that are pending review.

Penn's IRB is composed of a panel of experts in the field of clinical research, as well as risk-analysis experts and one or two laymen. Faculty members submit human research protocols that the IRB reviews and sends back with questions and concerns.

The IRB must approve consent forms, publicity materials and other elements of the proposed study.

Despite attempts at increased regulation, the IRB has no authority over private research studies that recruit Penn students for off-campus experiments.

Johnson was a student at Indiana Bible College and was solicited by a private, for-pay Eli Lilly drug trial.

At Penn, there are some restrictions on where advertisements for research studies can be posted, and sometimes the content of postings must be approved by a campus official.

However, pharmaceutical and biotechnology companies often reach students through newspaper advertisements.

Gaulton said that the University's priority is regulating its own research because academic institutions tend to do "the more difficult, the more avant-garde [and] the riskier" human experiments.

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