Teenager Issue

However, several highly publicized deaths following drug trials -- including those of 18-year-old Penn student Jesse Gelsinger in 1999 and 19-year-old Philadelphia native Traci Johnson last weekend in Indiana -- have sparked debate about the ethics and safety of recruiting college students for studies with potential health risks.

Gelsinger, who suffered from a mild form of the liver disease ornithine transcarbamylase deficiency, died of organ failure following injection with an experimental gene therapy treatment.

Johnson enrolled in January as a healthy participant in a trial of the antidepressant duloxetine. Four and a half days after she was taken off the drug, she committed suicide. Johnson was previously a student at Indiana Bible College but left school to take part in the Eli Lilly & Company study, which paid $150 a day.

Though Eli Lilly has initially ruled out the drug as the cause of Johnson's suicide, the investigation is ongoing, according to David Shaffer, a company spokesman.

Johnson's death has attracted national media attention partly because it came on the heels of a recent federal advisory panel announcement that said the Food and Drug Administration should issue stronger warnings about potential suicide risks for young people taking a certain class of antidepressants, including duloxetine.

Whether or not investigators conclude that duloxetine played a role in Johnson's suicide, the publicity surrounding both deaths raises questions about the place of college students in potentially life-threatening experiments.

Federal guidelines require representation in drug trials by the entire target user population, often including people under age 21. Because only people 18 or older are legally competent to enter into contracts, the undergraduate community spanning the ages 18-20 is coveted for participation in research studies.

Despite the technical definition of competency, some say that college undergraduates are too immature to give informed consent, or that their poverty makes them more likely to be lured by promises of compensation.

Shaffer called these types of generalizations an insult to young adults who are old enough to serve in the military.

"It would be, in our view, unethical and irresponsible to ... exclude undergraduates, knowing the medication is likely to be used by them," Shaffer said.

On the issue of compensation, he added that there are clear restrictions on the number of times that people can participate in research studies.

The Penn Institutional Review Board, which approves all human research studies, asks if "the level of compensation [is] going to lure people into the study inappropriately" according to Glen Gaulton, vice dean for research and research training in the Medical School.

Vice Chairman of the Psychiatry Department Charles O'Brien pointed out that the people who participate in research studies tend to be poor -- college students or not -- so good measures must be in place to make sure that all participants consent willingly.

He added that typical compensation for most studies is approximately $50.

The IRB subjects proposals to rigid scrutiny about consent, compensation and publicity. All studies planning to include people under 21 -- defined as a "vulnerable population" -- are tagged high-risk, Gaulton said.

O'Brien, however, said that college students are not given special treatment.