Uninformed consent - What's missing from the fine print when students sign up as guinea pigs?


Uninformed consent

What's missing from the fine print when students sign up as guinea pigs?

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By Rachel Louise Snyder

March 27, 2000 | When Ali Zaidi visited the University of Rochester hospital in 1994 complaining of respiratory problems, he opened a Pandora's box of miscommunication and half-truths from a community of caregivers who seemed more intent on recruiting human guinea pigs and tallying research grants than on following their Hippocratic oaths. A UR graduate student at the time, Zaidi says he was asked to sign a consent form for a clinical trial he hadn't even been told about by an investigator who called the federal regulations "onerous" and "red tape."

The protocol involved Heliobacter pylori, a bacterium common in gastric ulcer disease, but it was the word "radioactive" that caught his eye just as he was poised to sign. When he inquired about the nature of the study, he was assured that it was perfectly safe. Zaidi refused to sign. After consulting his doctor, he declined to participate in the trial. When he complained about what he called UR's irresponsible recruitment methods, first to the principal investigator, then to the university health services, he says he was disregarded.

It wasn't until 1997 that Zaidi received a terse apology in the mail from William Chey, the principal investigator, that read: "I am sorry to notice that the carbon-14. Urea Breath test was not adequately explained to you to meet your satisfaction. I apologize for the incident." Zaidi, concerned that the study was being conducted with other unwitting participants, had already brought the case to the attention of the Office for Protection From Research Risks at the National Institutes of Health. The Institutional Review Board called a meeting with Zaidi and the principal investigators, none of whom showed up. "There are multiple violations" at the University of Rochester, says Zaidi. "They're not informing people about the risks and it's deceptive. It's immoral. They tried to keep me quiet about it." Zaidi is currently embroiled in a bitter lawsuit against the university.

Though the Heliobacter pylori study was eventually terminated and the researchers placed on probation, such recruitment of subjects for research protocols is common on university campuses across the nation. Subjects earn anywhere from a few to thousands of dollars for participating in these clinical trials. Ads recruiting students for research protocols dot the hallways of universities. They appear in student publications and local newspapers. You can even sign up on the Web at CenterWatch for more than 41,000 research protocols around the country, a mere fraction of the trials under way at any given time. Though researchers typically deny any connection between high student populations and clinical trials, those areas dense with students, such as Boston, the Research Triangle area of North Carolina and Austin, Texas, typically have the most protocols at any given time.

Students as lab rats are nothing new. In the past it was a common requirement for psych majors to participate in their professors' psychology protocols. Students are typically broke, healthy and naive enough not to ask too many questions. But clinical trials have multiplied, and to many investigators, students represent a convenient population from which to draw subjects. "In 1995 we said there were trials across the country that were problematic -- not only with shortcomings but with serious deficiencies," says Ruth Faden, director of the Johns Hopkins Biomedical Institute and chairwoman of President Clinton's 1995 Advisory Committee on Human Radiation Experiments. "In my darker moments I wonder why we don't have more problems."

Problems like Nicole Wan, a University of Rochester sophomore who died in 1996, two days after a routine bronchoscopy (in which cell samples are brushed from lung tissue) taken during a research protocol. Or Jesse Gelsinger, a University of Pennsylvania student who died in September after a gene therapy test.

Eight institutions have had their research protocols involving human subjects halted in recent months after OPRR investigations, the most recent of which were the University of Pennsylvania, the University of Alabama at Birmingham and Virginia Commonwealth University, all of whose trials were suspended in January. Since 1995, 10 percent of the nation's 125 medical schools have been the targets of OPRR investigations, and the office has a staggering 159 investigations under way. This spate of investigations, says OPRR director Gary Ellis, is the result of the OPRR's becoming more efficient in identifying problems in the wake of U.S. Inspector General June Gibbs Brown's criticism of the office in a 1998 report on human subjects protection.

Such research protocols have long been a method for scientific advancement -- and have long been marked by abuse. A recent Chronicle of Higher Education article reported that only 17 percent of the illnesses or deaths suffered during gene therapy trials were promptly reported to the National Institutes of Health. Faden's advisory committee identified 4,000 federally funded radiation experiments between 1944 and 1974 involving human subjects, including the well-publicized 18 people at the University of Rochester who were unknowingly injected with plutonium in the 1940s. From 1932 to 1972, the U.S. Public Health Service conducted the Tuskegee Syphilis Study, in which poor black men in Macon County, Ala., were given free treatment for "bad blood." The "treatment" actually entailed the withholding of treatment for syphilis, which was then epidemic in the area, to see how the disease would progress unchecked. The uncovering of the study eventually led to a formal apology in 1997 by President Clinton.