The Daily Tar Heel

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Wednesday October 20th

Students Participate in a Number of Medical Studies

Common ways of solving that problem include taking part-time jobs, selling CDs back to secondhand music stores and the ever-popular calling home for money.

But junior Karl Schmid has found his own way to resolve his financial woes -- every six weeks, he treks to UNC's Environmental Protection Agency site to undergo a bronchoscopy.

The three-hour process entails the insertion of a flexible tube with a camera on the end into his nose and through his bronchial tubes so that researchers can pass a liquid through and collect cells.

Schmid collects $300 for the process, which he calls "kind of uncomfortable, but really easy and not too painful at all."

Schmid is among many students who volunteer for the myriad of medical experiments conducted on campus each year that use human subjects.

But the range of research tested on humans goes far beyond the occasional study for which the average undergraduate can volunteer -- experiments range from simple to sophisticated and use a wide range of subjects.

The only thing they have in common is that all are overseen by various institutional review boards, which monitor all protocols involving human subjects from conception to implementation.

Tony Waldrop, vice chancellor for research and graduate studies, said there were 4,737 protocols with human subjects conducted in the 2000-01 academic year, 2,833 of which are still active.

Of the active protocols, Waldrop said the School of Medicine has the most, with 1,650 active experiments using human subjects. The medical school is followed by the schools of Public Health, Dentistry, Nursing and academic departments outside the health affairs section of the University.

Waldrop said tests involving humans are divided between medical research and social sciences research, which are conducted in departments such as political science, sociology and psychology.

"They fall into two categories, with medical tests being predominant on campus," he said. "Similarly, the bulk fall into the School of Medicine."

Stephen Bernard, chairman of the UNC Committee on the Protection of the Rights of Human Subjects, said testing on humans is necessary both to gain approval for drugs from the U.S. Food and Drug Administration and to correctly identify the results of a procedure or pharmaceutical treatment.

"You can do initial studies in labs, in cells, in test tubes or in animals such as mice," he said. "If you're going to look for side effects, though, what happens in humans is not always what happens in mice.

"You can take something and identify it chemically, but ultimately, you have to put it in a mouse or a dog, and then in a person."

But like testing involving animals, there is a stringent process in place to oversee testing on human subjects.

UNC has five institutional review boards -- academic affairs, dentistry, medicine, nursing and public health. Each of these boards is made up of between 10 and 20 faculty, staff and community members.

The role of the IRB was brought into the public eye in June 2001, when a healthy 24-year-old woman died at The Johns Hopkins University while undergoing a drug trial designed to learn how healthy lungs fight asthma-like conditions.

In that case, Johns Hopkins' IRB, which each research university is required by federal law to have, was responsible for investigating the incident.

But Daniel Nelson, director of the Office of Human Research Studies at UNC, said the IRBs at UNC are more often concerned with designing valid protocols than with stepping in after errors are made.

"People are realizing we need to be more proactive," Nelson said. "We're doing more educating of investigators and IRB members -- we're trying to anticipate and educate rather than waiting for one more bad thing to happen."

Bernard said the IRB begins the process of research on human subjects by reviewing lengthy applications from investigators, similar to the process for researchers who wish to use animals.

"The investigator submits an application in which they provide an idea of who they're looking for, the risks of the research, what they will do to minimize risk and maximize benefits, how to recruit individuals and whether there are alternatives for therapeutic study," he said.

Bernard said some areas the IRB tends to scrutinize especially carefully involve the consent forms that each participant in the experiment must sign and the way the subjects are selected.

Medical studies tend to fall into one of two categories -- testing a drug or therapeutic treatment for a disease on a patient already suffering from that illness or using a population of healthy volunteers.

But Nelson said the most important part of the initial application review is to determine the potentially negative consequences to the volunteers.

"The whole assessment of risk to human subjects is part and parcel of the review process -- it's embedded in everything we do," he said.

After the protocol is approved, the IRB then serves as a resource for anyone who thinks he is being mistreated during the research or who does not understand what is happening.

Nelson said that the medical IRB usually receives one or two complaints per year and that the IRB can step in and halt the study while it determines what is going on and whether the research is appropriate based on federal guidelines.

In addition to these rules applied by the IRB, UNC is pursuing voluntary accreditation by the Association for the Accreditation of Human Research Protection Programs.

Adrian Shelton, research compliance coordinator at UNC, said AAHRPP accreditation would help the constantly evolving process of developing rules for human testing specific to the University.

"A lot of things will be hastened along," she said. "We are working on developing more standard procedures."

But in the meantime, Bernard and Nelson said the IRBs on campus play a vital role in protecting human subjects.

"The IRB is charged to look out for the subject's best interest," Nelson said. "But of course there is some subjectivity -- it's all based on the data we have to that point. It's just a group of people trying to make an educated guess about risk and benefit."

And Schmid said that in his case, University officials' preparations were on target.

"They told me it would be relatively painless, and it's a procedure that's done 100 times at hospitals a day," he said.

"I wasn't really concerned about the risks."

The University Editor can be reached at udesk@unc.edu.

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