When you combine the number-one-ranked research institution and the death of a healthy volunteer, you get what senior Ariane Lewis, an experienced researcher, calls a "publicity nightmare."
Two years ago, due to the death of Ellen Roche, the federal government briefly shut down research at Johns Hopkins University. Roche was a healthy, 24 year-old lab technician at the Johns Hopkins Asthma and Allergy Center. There she participated in an asthma study conducted by researcher Alkis Togias, during which she had to inhale a respiratory irritant known as hexamethonium. The purpose of the study was to discover the process through which healthy lungs fight asthma.
Bayview Medical Center's Institutional Review Board (IRB) approved the study, assuming Togias was well informed on the possible risks of hexamethonium. However, five days after inhaling hexamethonium, Roche was admitted to Bayview Medical Center with a consistent dry cough and severe breathing problems. A month later she died of multiple organ failure. ? ?
What happens when a Hopkins- caused death incites grave concern for future research on both the medical and undergraduate campus?
For one thing, getting experiments approved takes more time and causes more frustration for research students. "Things aren't necessarily as different, there is just more paperwork involved," Lewis said.
"It is more crossing of I's and dotting of T's, with stamped consent forms in order to ensure the experiment is carried out by a certain date," said Dr. Howard Egeth, head of the psychological and brain sciences department at Homewood.
According to Egeth, once the chair of the Homewood IRB, the approval procedure is stricter, but the same rules are basically in place. Now, there is more emphasis placed on exactly understanding the intent of an experiment.
For example, there are now online forms that students must fill out before an experiment is considered. Previously, the forms included all of the information they have now but without specifically drawing attention to potential dangers. Now students have to select a yes or no option for each question regarding potential risks in their own experiments.
Many students looking to get experiments approved are enrolled in a required psychology course called Lab in theAnalysis and Psychological Data (LAPD). One misconception among these students is that more elaborate experiments are better. "Some of the best experiments involve looking for clever findings in simple everyday activities," Egeth said.
Usually proposals from undergraduates tend to get approval more readily because students are not at liberty to dispense high-risk drugs. Sometimes, however, student proposals can be rejected. Often times it is for the same reason: the subject's health.
"Sometimes the undergraduate will come up with an idea, such as giving people large doses of caffeine to make them jittery. I tend to think the students are a bit hurried when coming up with ideas like this, and I tell them "think harder,'" Egeth said.
In addition, students need to censor the types of questions asked and how they approach the subjects. "Embarrassing questions that focus on a person's sex life or excessive drinking habits could be asked by a reporter, but not a researcher," said Egeth.
Students usually propose survey type questions , such as, "Are friendships in your senior year a result of placement in freshman housing?" Survey research is most popular amongst LAPD students and is classified as an "exemption' experiment. This defines the experiment as relatively harmless to the subject whereas research deemed as "expedite' or "full board' calls for a closer look. The student when answering "yes' or "no' to the forms online first makes these determinations, and then these forms along with the proposal are submitted to Egeth. They are then either sent back to the student or passed along to the IRB. A proposal marked expedite requires a review by the chair of the board and one member, those categorized as "full board' require the entire 12-person committee approval.
One large change put in place this year is the process of testing potential subjects. In the past a researcher could approach students and ask if they wanted to partake in a study. Now students are required to flyer about the experiment encouraging participation without pressuring potential subjects.
"Generally to avoid coercion, participants have to fill out informed consent forms, so typically they are aware. Students really are not going to respond to flyers unless there is some sort of incentive," said Lewis, who is enrolled in LAPD.
There is now mention that the LAPD will drop the experimental requirement of the class due to a lengthy waiting period in receiving approval from the IRB and the elongated process of finding participants."It would be a shame if they took outside experimentation out of the class. It gives the student an opportunity to learn how to do write-ups, protocol and informed consent forms. When you do it all on your own, you gain a different perspective," said Lewis.
Both Lewis and Dr. Egeth propose two possible ideas for the future of the course. Egeth thinks a breakdown of the class could be best. The first semester class would be mandatory and the second semester optional.
Lewis thinks that they should at least keep the steps of experimentation as part of the course and have students make up false numbers, just to skip the step of awaiting approval from the IRB. At least this way, the student can learn how to set up an experiment and analyze results, eliminating the frustrations of waiting for the paperwork to go through.
The future is uncertain for LAPD students as well as her students and professors seeking approval from the Homewood IRB. If anything the death of Ellen Roche has caused every potential doctors and everyone in the medical profession to look a bit closer at some of the details usually glossed over in the busy life of a Hopkins pre-med.
