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.
