Federal authorities are investigating Oregon Health & Science University's handling of a controversial study of school-based testing for drug use



The Office for Human Research Protections confirmed this week that it began its investigation in May, several weeks before a recent class-action lawsuit was filed against OHSU and 14 Oregon school districts.

The lawsuit, filed June 28 in U.S. District Court in Oregon, alleges that thousands of high school students were coerced to take part in the study and suffered "psychological, social and economic harm." It seeks compensation for students and parents and an injunction to halt the study, called Saturn -- or Student Athletic Testing Using Random Notification.

OHSU said its researchers have complied with all state and federal regulations and that the Saturn study has passed annual reviews by an institutional review board, the university's in-house panel of doctors, scientists and lawyers responsible for the safety of research subjects. Dr. Linn Goldberg, an OHSU professor, designed the study to measure the prevalence of drug and alcohol use among school athletes and examine whether a program of random testing leads to reduced usage.

Student athletes at seven participating high schools face random urine tests for a variety of drugs, as well as breath tests for alcohol. Students at six other schools serve as a control group with no drug testing. One of the 14 school districts in the lawsuit has dropped out of the study.

Researchers are surveying the students to measure differences, if any, in the prevalence of drug use between the two groups. The National Institutes of Health awarded Goldberg a $3.6 million grant in 2000, and the study is scheduled to continue for another year.

The Office for Human Research Protections has taken no action against OHSU. It has the authority to cut federal research funding to institutions that endanger human subjects. A spokeswoman declined to say what prompted its investigation of the Saturn study and said the office can't discuss the potential violations involved until the investigation is concluded.

The lawsuit on behalf of students alleges that investigators coerced subjects to take part. Students who refused to submit to drug tests as part of the study were barred from playing sports and subjected to harassment and intimidation, according to the lawsuit.

"You cannot coerce the subjects into signing the informed consent documents," said Alan Milstein, the attorney from Pennsauken , N.J., who is leading the lawsuit. "That is principle No. 1" in protecting study volunteers, he said.

OHSU maintains that schools -- not the Saturn researchers -- imposed the mandatory drug testing. Random testing of students has been upheld by the U.S. Supreme Court.

According to OHSU, participation in the Saturn study involves nothing more than filling out confidential questionnaires on drug use twice a year, and that students are under no obligation to respond to the surveys.

Before enrolling students in the study, researchers obtained signatures from students and their parents attesting to understanding and accepting the terms of the research.

"You have been invited to take part in this study," the agreement says in part, "because of your participation on an athletic team at a school that supports this research project and recently implemented an athletic drug testing policy."

Milstein argues that the schools imposed drug testing because of the Saturn study, which is paying for the collection and laboratory analysis of samples.

"You have schools that did not have drug testing programs and would not have had drug testing programs were it not for the Saturn study," Milstein said.

School districts have declined to comment on the lawsuit because they have yet to be served with the complaint. Milstein said he and other attorneys are working on an amendment to the original filing before serving.