Students as Lab Animals
Angela Roddey Holder
Duke University Medical Center
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Requiring participation in "research" in order to participate in high school athletics? What were they thinking? It is difficult to imagine on what grounds this "study" was ever considered acceptable (Shamoo and Moreno 2004). Drug abuse screening of students is not a new concept, but those participating in this project should have investigated the history of such research.
In the early 1970s a junior high school administrator developed a questionnaire that was to be administered to eighth-grade students to give a "drug use profile." No effort was made to discover if the children had ever used or in fact ever seen an illegal drug. No parental permission was to be sought (although this changed when the "profile" plan became known to parents) and the students were to be given no opportunity to refuse to participate. The questions included extremely personal ones such as whether the child "was hugged and kissed good night when I was small," if his or her parents "make me feel unloved," and whether the parents "enjoy talking about current events with me." Questions were also asked about the family's religious beliefs and the race of the students.
In addition, all the students in each section of a grade and the teachers were asked to list classmates who "made unusual or odd remarks" (undefined). When the mother who eventually sued to prevent the administration of the questionnaire voiced her initial objections to the principal of her child's school, her son was put in the deviant "at risk" group because of his mother's attitude. These "at risk" children were to be subjected to compulsory counseling designed so the "peer group acts as a leveler or equalizer insuring that its members do not stray too far from its ranks." Deviancy was specifically defined as "any action which violates the group's normative system."1 (Including, one assumes, being at the academic top of the class, because one would not then be "leveled" or "equalized.")
When the mother sued, expert witnesses testified that this questionnaire was not an acceptable
test and in fact could be extremely harmful to the children. They also pointed out that none of the teachers who would be involved had any training in child psychology. The court declared the entire project unconstitutional as violating the students' privacy rights (Merriken v. Cressman, 364F.Supp.913 [1973]).
As the philosopher Santayana (1980) wrote, "Those who cannot remember the past are condemned to repeat it."
The similarities between the questionnaires at the heart of Merriken and the ones used in the SATURN project decades later are obvious. Moreover, in the decades since Merriken, U.S. Department of Education (DOE) regulations have greatly restricted in-school surveys, questionnaires, and other research on drug use or such matters as sexual behavior. DOE regulations provide that such research is subject to parental review under the Protection of Pupil Rights Amendment (20 U.S.C. 1232h) to the Family Educational Rights and Privacy Act (20 U.S.C. 1232g; 34 CFR 99). Parents must be notified at the beginning of each school year of their rights to inspect all research- related materials and their right to forbid their children to participate. No student may be required to submit to a "survey, analysis or evaluation" that reveals "sensitive information" without written parental consent.
Sensitive information includes political affiliation, mental or psychological problems, sexual behavior or attitudes, illegal, antisocial, self-incriminating, or demeaning behavior, (which presumably includes illegal drug use), critical appraisals of other individuals with whom respondents have close family relationships, relations with lawyers, physicians or ministers, religious practices, or income. (20 U.S.C. 1232h)
The U.S. Supreme Court upheld mandatory drug testing for high school athletes in 1995 (Vernonia School District 47J v. Acton, 515 U.S. 646) and for those participating in "competitive extracurricular activities" in 2002 (Board of Education of Independent School District 92 of Pottawatomie County v. Earls, 536 U.S. 822). It did not, however, extend the right to
test to any other students, and it certainly did not include research as part of the drug-testing package. It forbade the use of "unreliable" testing methods.
So it would seem that the Oregon policy violated DOE regulations, imposed an "unreliable" (because research involves attempts to validate something, it is "unreliable" until the conclusions are demonstrated)
test in violation of the Supreme Court's permitted limits, and violated the students' rights to privacy.
It was clear that refusal to participate would mean that the student could not participate in athletics. This is rather far from the Department of Health and Human Services (45 CFR 46.116) and DOE (34 CFR 97.116) definitions [End Page 37] of informed consent to research, which must include
a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefit to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (34 CFR 97.116a8)
Why did it take so long for OHRP to suspend the study? Why was it approved in the first place?
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Angela Roddey Holder, LL.M., is Professor of the Practice of Medical Ethics at the Center for the Study of Medical Ethics and Humanities, Duke University. She is currently on the Institute of Medicine's Committee to Study Clinical Research in Children and has served on the Institute's Committee to Study Pediatric Palliative Care and on the Institute's Committee on Medical Professional Liability and the Delivery of Obstetrical Care. She was President of the American Society of Law and Medicine and is about to become the Public Member of the Board of Directors of the American Board of Pediatrics. She is the author of Legal Issues in Pediatrics and Adolescent Medicine (Yale University Press, 1985).