Linn Goldberg no stranger to unethical research

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The commentary below provided by professional critics of Linn Goldberg's unethical research shows that he is no stranger to unethical, nonsensical research. This was in the American Journal of Bioethics, and I will post Goldberg's response next. Since I am a student, I have access to databases such as these and I will certainly look for more examples of him disgracing those who conduct research.



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Ethics of Research Involving Mandatory Drug Testing of High School Athletes in Oregon
Adil E. Shamoo
University of Maryland
Jonathan D. Moreno
University of Virginia Health System

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Abstract
There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research.
Keywords
drug testing, research, adolescents, students, athletes, children, coercion, duress, madatory
Introduction
Since the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979) three principles have guided the ethical conduct of research with human subjects: respect for persons, beneficence, and justice. For adults the principle of respect for persons is embodied in research with human subjects in the practice of informed consent. In the case of children whose decisional capacity is still in question, a parent or a guardian must give permission to enroll the child in a research study. Within the principle of respect for persons lies the concept of "freedom from duress and coercion." The view that research participation must take place without duress and coercion was prominent in the Nuremberg Code (1947) and is embodied in the federal regulations at 45 CFR 46a, known as the "Common Rule." Ethically questionable research projects involving children include using children in high-risk, nonbeneficial research (Shamoo and Tauer 2002) and knowingly allowing children to remain in unsafe environments in order to carry out a study (Shamoo 2002). This article concerns the question of whether research that includes a mandatory drug testing program in which Oregon high school students are enrolled can be conducted in accordance with prevailing ethical standards.

Mandatory Drug Testing for High School Athletes
Under a three-year, $3.6 million grant from the National Institute on Drug Abuse, a part of the National Institutes of Health (NIH), a project began in 1999 to study drug testing on high school athletes (Denn 2000; Card 2000). The principal investigator was a professor at the Oregon Health and Science University in Portland, Oregon, which was the official recipient of the grant. The program was named "SATURN"(Student Athletic Testing Using Random Notification). Under the study design each school in the Oregon public-school system could have, if it chose, a mandatory drug- testing program (separate and independent of the research study) for high school student-athletes. A state district court decision upheld such mandatory [End Page 25] drug testing, and the U.S. Supreme Court affirmed it (Tallmadge 2001). Initially, 18 public high schools agreed to participate in the program.

The study was designed to identify drug use among student-athletes, evaluating the influence of random drug testing on high school athletes (Goldberg 2000). The drug testing was used to validate survey data and identify individuals who did not report drug use. As was mentioned, each school could opt to have mandatory drug testing or not. However, the study required that each participating school agree to a mandatory drug testing program for athletes before the initiation of the study at their school. Moreover, any school that already had a mandatory drug testing program in place was not eligible for the study, because the existing drug testing program might contaminate the study outcome. When the drug testing program became the school's policy, the school had to declare drug testing a "pre-requisite for playing sports" (Goldberg 2000).

The stated purpose of the study was to:

1) assess the use of drug and alcohol among high school athletes and non-athletes; 2) determine the influence of drug testing on risk of substance abuse and protective factors among adolescents; and 3) examine whether drug and alcohol testing of high school athletes leads to reduced drug and alcohol use. (Goldberg 1999)
Even though alcohol is mentioned, the proposal emphasizes drugs.

The literature contains much discussion of mandatory drug testing in high schools, primarily regarding the issues of efficacy and privacy (Palmer 1992; Tymowski 2001). Although the issue is beyond the scope of this paper, a recent study by Yamaguchi, Johnston, and O'Malley (2003) indicates that drug testing is not effective in reducing illicit drug use among school students. Goldberg and colleagues (2003) recently published a pilot study of the SATURN project from two schools using what appears to be the same protocol discussed in this paper.

The SATURN research project has been criticized by students, parents, the American Civil Liberties Union, newspaper articles, and editorials objecting to its overall conduct (Kimberling 2000; O'Donnell 2000; Sabo 2000a; 2000b; Tallmadge 2001; Lawrence-Turner 2002; Rozas-Burke 2002a; 2002b). The U.S. Office for Human Research Protections initiated an investigation of the SATURN study in response to a complaint by an advocate in Oregon (Eder 2002). The principal investigator has been vocal in defending his study on the grounds that it might significantly reduce drug use by the athletes and, in turn, among the student population in general(Goldberg 2000; 2001;The Oregonian 2001).

Design of the Protocol
The investigation was a "prospective, randomized study" targeted toward "selected risk groups" (Goldberg 2000). The proposal suggests that SATURN is school-based "prevention intervention" research. The proposal involves 11 sequential, well-coordinated parts. The first two parts explain drug testing procedures and how the study will follow established methods in schools. The third part indicates that drug testers and coaches will receive training in all of the necessary procedures. The fourth part is to rely on peer reinforcement and ostracism to ensure student adherence to the testing policy. The fifth part requires that the school's administration adhere to a "drug-free" policy as a prerequisite to athletic participation; it further enlists coaches and athletes to endorse the policy. The sixth part requires researchers to ensure family involvement, adherence, and promotion of the drug-free policy. The seventh part envisions that involvement in a drug testing program is similar to "Olympic" athletics and will enhance self-esteem. In this manner the program will establish the accepted "norms" of the "drug climate." Part ten states: "Testing and threat of immediate consequences (e.g., not being able to participate in school sports) provide the basis of a decision to not use drugs or alcohol." Parts eight, nine, and ten relate to norms, refusal skills, and decision-making and social skills. The final, eleventh part states: "Repeated surveillance during the entire school year (all three sport seasons), for all student- athletes; seasonal repetition of instructional session re: testing procedure; during each season (three/year) and subsequent years."

The protocol further stipulates that all schools involved in the study must agree to a mandatory drug testing policy for athletes (Goldberg 2000). The protocol envisions two separate subject samples for athletes and two for nonathletes. It envisions the participation of 85% of the (on average) 425 athletes per school. A total of 19,200 athletes and nonathletes were expected to be asked to participate. [End Page 26] They were to be divided into groups of experimental schools and control schools. The experimental group was to be subject to all of the interventions, such as drug testing, whereas the control school was to receive only a survey. In order to capture the nonathletes, the protocol envisions conducting a "condensed" survey of all athletes and nonathletes. The surveys request information from all students, athletes and non-athletes, including detailed histories of drug use, behavior, and psychological issues such as depression, as well as students' knowledge of and attitudes toward drugs. The surveys were to be conducted during school-mandated gatherings, with athletes in one large area (e.g., a classroom) and non-athletes in a different area. All student athletes in the experimental schools were subject to random drug testing once during the school year but not necessarily during the season for their particular sport. Those randomly selected to be drug tested had to inform the investigator of all medications or drugs taken in the previous two weeks. Well-trained medical personnel of the same gender observed the collection of urine samples. The school was notified of all positive tests and was obligated to follow its declared policy on drug users. Efforts to ensure the accurate, valid collection of urine samples for random testing were to be strictly enforced. The tests looked for opiates, cocaine, amphetamines, phencyclidine, anabolic steroids, and cannabis. Testing was followed by a survey questionnaire with unique identifying numbers for longitudinal tracking. A second informed consent was administered to all athletes and their parents or guardians but was not a prerequisite for study participation. The program proposal clearly states that student athletes in experimental schools may be drug tested as a condition for athletic participation, regardless of their consent: "These students will be eligible for drug testing, whether or not they sign the consent to participate in the study."

The school districts' policy pronouncements were the same as those adopted for regular mandatory drug testing approved in 1995. A positive drug test would result in a meeting being scheduled with the principal, parents, and student, and disciplinary actions could be imposed, including a two-week suspension and drug and alcohol testing at any time during the school year. Because any given test result might be a false positive, a second specimen test (at the parents' expense) could be requested. If the second sample also tested positive, another meeting would be scheduled with the parents, and further disciplinary action could be taken, including suspension for the remainder of the year; suspension the following year from the specific sport; and, if the student wanted to participate in another sport, submission to random testing and a drug/alcohol assistance program. If the student tested positive a third time, then he or she would be suspended from sports participation for a total of three years.

Informed Consent Documents
SATURN used two nearly identical informed consent forms. One form was addressed to student-athletes in the experimental schools and one was addressed to athletes in the control schools. The control groups were told that they would not be involved in the drug testing. The informed consentforms were less than two pages, including a large section on procedure (how the urine sample would be obtained and how same-gender research staff would accompany the student to the bathroom).

The only risk mentioned in the informed consent form (Goldberg 1999) is the loss of confidentiality if the drug test is positive. The form mentions as benefits the advancement of science and the potential for the prevention of drug abuse among high school athletes. The form does not list any alternatives to enrolling, except to mention, "You may choose to not participate." However, it also states that "the school may not allow you to participate in school-sponsored athletics" if the student refuses to participate in the study or if the drug test is positive. The official Oregon Health and Science University Survey Information Sheet states that opting out of enrollment will have no effect on "your relationship with your teacher, school." However, at least one school district document states that "No student shall be allowed to participate in athletics without such consent [i.e., signing an informed consent form to participate]" (Oakridge School District 76 2000). (The document also notes the penalty, suspension from participation, for refusing a drug test or for a positive test.) Each student athlete was asked to sign two serially administered informed consent forms. The first consent form was required under the grant proposal and included the following underlined statement: "Signing the first consent form will be a requirement for athletes to participate in sports" (Goldberg 2000). The second informed consent [End Page 27] form was not required for athletic participation but only for study participation.

Recruitment
The study protocol did not require students' recruitment per se. Once the school had agreed to be a part of the study, then all student athletes were automatically enrolled in the research study if they wanted to continue playing a sport. The student-athlete was informed of the time and place to begin the research study and had to show a student photo identification or have a picture taken for identification purposes. The protocol claims that coercion is reduced because the students' parents need not sign the consent form in order for their children to play sports. However, the protocol relies completely on the school's compliance with mandatory drug-testing policy and thus with the student-athlete's parent or guardian signing both informed-consent forms.

Ethical Criteria
Institutional review boards (IRBs) are, by federal regulation, the gatekeepers for the protection of human subjects in research. Usually an IRB must answer a series of questions (Shamoo and Resnik 2002), of which one is the most pertinent to the mandatory drug testing at issue in this paper- informed consent. We will describe how the study design might have contributed to coercion of the participants in light of our description of the study protocol, informed-consent document, and recruitment process.

Children are among the vulnerable groups recognized by the National Commission for the Protection of Human Subjects (1979) for additional protections. These additional protections are reflected in 45 CFR 46d, which classifies research into four risk-related categories. The SATURN research study presents either minimal risk to the subjects, a minor increment over minimal risk, or, given hindsight and given the risks posed by this study, "greater than minimal risk and no direct medical benefits" (45 CFR 46.106). We do not have a record of the SATURN IRB's decision concerning the level of risk of the study. We presume it falls under either the first or second category. However, regardless of the risk category the SATURN study, like all protocols, must comply with the principle of respect for persons. When a subject becomes involved in a research study that might impose risks to subjects, respect for persons requires an informed consent process free of duress and coercion and with a reasonable guarantee of confidentiality.

Was Informed Consent Adequate?
The SATURN informed consent documents fail to include the following elements:

a detailed description of the project;
an explanation of randomization;

a statement that parents will be informed if their child tests positive; and

an indication to parents of whether the study entails both survey research and drug testing.

Finally, under the heading of "Alternatives," the consent form correctly indicates that refusal to enroll will result in not allowing the student to participate in sport. Moreover, the research study staff contacted a number of students prior to their signing of the assent form (Office of Human Research Protections 2002b). Researchers also lacked knowledge about the prevalence of drug use, and hence provided no such information in the informed consent form. Furthermore, neither the informed consent form nor any other study document seen by students or parents discusses the consequences if the first test result is a false positive (punitive steps would be initiated). The first consent form appears to be coercive and unethical.

In its determination letter of 4 October 2002 the U.S. Office of Human Research Protections (OHRP 2002a) found the Oregon Health and Science University in violation of numerous federal regulations for the protection of human subjects, but it stated that it was not yet prepared to address the SATURN study. In its subsequent 24 October 2002 determination letter OHRP (2002b) suspended the SATURN program (2002b). Among OHRP's findings were that "the goal of mandatory drug testing of student-athletes and the scientific aims of the study are so closely interwoven as to be indistinguishable." OHRP also found that the study failed to meet the requirement that informed consent should be obtained under circumstances that would minimize coercion and undue influence: OHRP cited the linkage of athletic participation and a drug-testing requirement, as well as the use of formal classrooms and coaches during the contact with students. In addition OHRP found that the study was initiated prior to obtaining IRB approval and that the informed-consent [End Page 28] form lacked complete descriptions of elements such as randomization, parental notification if a drug test was positive, and the longitudinal nature of the study. On 10 December 2002 OHRP (2002c) further elaborated on its findings concerning the general problems associated with the protections of the human subjects and suggested remedies for the institution to follow.

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Was the Design of the Study Coercive to Participants?
Informed consent is known to be a process that begins with recruitment and continues until the end of the study. According to published reports (O'Donnell 2000; The Oregonian 2001), from the outset of the study school systems maintained an atmosphere of "pushing" student-athletes to participate in the mandatory drug testing. The push is alleged to have come in the form of threats and community pressure. When originally approached by the principal investigator, most schools did not have mandatory drug testing. However, schools were obliged to require mandatory testing in order to participate in the study (OHRP 2002b). School administrators' might therefore have been motivated to reduce illicit drug use without cost to their schools. The study protocol is literally interwoven into the mandatory drug-testing program. The student-athletes saw the whole school administration (principals and coaches) as involved in the recruitment of participants. In fact, investigators admitted to OHRP site visitors that the study was an integral part of the mandatory drug-testing program (OHRP 2002b). For example, the director of the drug-testing laboratory was listed as staff for the SATURN program. This listing therefore conflates the regular nonresearch drug testing program with the SATURN program. The project paid for drug testing, a built-in incentive for schools to participate in the program.

Of course, the most important coercive aspect of the program to participants was the threat that athletes would be disqualified from their sports if they refused to participate. One honor student- athlete was suspended for refusing to sign the informed-consent/assent form (Kimberling 2000), and the involvement of the school administrators and coaches in corralling the students into special classroom settings gives the impression that they were involved in recruitment of the students into the study. In fact, the schools' administrations were involved in project coordination in general. Further, the informed consent form contains no mention of alternatives to participation in the study, and probably none existed. There were also no additional protections provided to this vulnerable group, such as the right to refuse, an essential condition for a truly voluntary program. The federal regulations clearly state, "When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children ..., additional safeguards have been included in the study to protect the rights and welfare of these subjects" (45 CFR 46.111b).

The study appears to have adopted no additional safeguards to protect these children. But students were threatened with loss of participation in student athletic programs and with suspension from school if they tested positive. One of the required elements of informed consent in the federal regulations is the statement that "participation is voluntary, refusal to participate will involve no penalty or loss of benefits 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" (45 CFR 46.116a8). Unfortunately, the SATURN study violated every element of this statement, because refusal to participate resulted in loss of benefits (O'Donnell 2000; The Oregonian 2001).

With regard to the SATURN program, these high school students were also under the specific duress of the power differential between them and their coaches and school administrators. Besides the general lack of control experienced by persons obliged to participate in the research study or face punitive actions by those more powerful, the loss of the opportunity to participate in a highly-valued activity in their peer group is a nontrivial threat. Recruitment of medical students and college students by their professors for studies that present physical or social risk are viewed with increasing skepticism (Moreno 1998). It would be odd if students aged 18 and younger were not granted at least the equivalent consideration as their older counterparts.

It is of interest that the local IRB did not provide basic protections for these subjects. A key element of IRB approval is that it allows input from members of the community at large (nonresearchers). Unfortunately, the community member in this case appears not to have provided the needed input. An editorial in The Oregonian (2000) expressed the views of many: "The government is forcing kids to participate in invasive research in [End Page 29] order to participate in an educational activity—which is what sports are. Even if it works, it isn't educational. And it sure ain't science."

Finally, the investigators could have avoided coercion in the experimental design if they had ensured that the student-athletes and their parents knew that SATURN was a research project not in any way linked to the mandatory drug-testing program. The study protocol could further have made clear that a student's refusal to participate might result in adverse consequences to them or to their relationship to the school.

Was Confidentiality Protected?
In this study confidentiality is lost if an athlete tests positive for drug use. The loss of confidentiality occurs due to the suspension of the student-athlete, which is again in violation of the federal standard (45 CFR 46.11.7b). Considering the profound social and psychological importance of peer relationships among adolescents, the loss of confidentiality results in humiliation as well as the public airing of drug-using status, assuming that the test result is a true positive. Confidentiality requires that the consequences of trial participation not be subject to publicity of any form in which individuals are reasonably at risk of identification.

Was the Selection of Subjects Equitable?
Federal regulations require that "selection of subjects is equitable" (45 CFR 46.111.3). This requirement is based on the principle of justice, which according to the National Commission (1979) seeks to ensure that no particular group bears an unfair burden of research participation. The SATURN study targets athletes for drug testing even though drug abuse is a school-wide concern. By targeting athletes, the study places an inappropriate burden upon a particular group of students. In combination with the lack of confi- dentiality, this inappropriate burden also stigmatizes the student-athletes.

Could This Study Have Been Conducted under Prevailing Ethical Standards?
A rarely noted implication of our prevailing research ethics principles is that mandatory public-health interventions can rarely be combined with research without conflicting with those ethical principles. Such activities are inherently incompatible with the requirements of freely given informed consent. To take another example, a research study connected to a routine, required screening program for infectious disease agents in a nursing home would face similar difficulties with regard to lack of voluntary informed consent, as many of the residents are likely to have impaired decision-making capacity, and their institutionalized status makes them severely dependent upon the facility. In the SATURN protocol are still more elements that caused it to conflict with conventional views of human research ethics, including the inadequate informed consent documents, the problems with confidentiality, and the young age and social status-related vulnerabilities of the subjects.

There can be no disagreement that adolescent drug use is a serious problem, both in its magnitude for society and in its consequences for the drug user. Nor can there be doubt that a program for the identification and assistance of those young people who use drugs could provide great social benefit. It is beyond the scope of this paper to engage in a discussion of the morality of mandatory drug testing for high school students per se. However, we can all agree that what is legal is not necessarily ethical. Perhaps other study designs that are not inherently coercive could be developed, though they might be less efficient and provide somewhat less secure conclusions. However, a prospective study that provides answers to these questions in connection with a mandatory drug-testing program cannot be executed without violation of core ethical values. This result should not be surprising. One of the essential lessons of medical ethics following the Nuremberg trials is that certain avenues to knowledge are forbidden to science. The subject matter of this study is no exception.


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Adil E. Shamoo, Ph.D., is the Editor-in-Chief of Accountability in Research. He is Professor and former Chairman of the Graduate Faculty of Applied Professional Ethics at the University of Maryland, Baltimore, where he is also affiliated with the Center for Biomedical Ethics. He is coauthor, with David Resnik, of Responsible Conduct of Research (Oxford University Press, 2002) and coauthor, with Felix Gyi, of Ethics of the Use of Human Subjects in Research (Garland, 2003).
Jonathan D. Moreno, Ph.D., is Emily Davie and Joseph S. Kornfeld Professor of Biomedical Ethics and Director of the Center for Biomedical Ethics at the University of Virginia. Among his books are In the Wake of Terror: Medicine and Morals in a Time of Crisis (MIT Press, 2003), Undue Risk: Secret State Experiments on Humans (Routledge, 2001), and Deciding Together: Bioethics and Moral Consensus (Oxford University Press, 1995).
Received 30 May 2003; accepted 7 August 2003; revised manuscript received 7 August 2003; posted for commentary 22 August 2003.
Acknowledgment
The authors wish to thank Jonathan Eder of Portland, Oregon, who brought the original complaint to OHRP. One of the authors (AES) counseled Mr.Eder on the subject.

References
Card, S. 2000. Student-athlete drug tests stopped. The Newport News-Times, 4 October. Available from: http://www.newportnewstimes.com/2000...l/nt_news.html.

Denn, R. 2000. Oregon students in 3-year drug test program; Washington won't participate in study, though 2 [End Page 30] districts in state test already. Seattle Post-Intelligencer, 2October, B1.

Eder, J. 2002. Letter to Dr. Michael Carome, Office for Human Research Protections, 28 March.

Goldberg, L. 1999. Informed consent form: Drug testing schools. Title: SATURN: Student Athlete Testing Using Random Notification, L. Goldberg, Principal Investigator, IRB #4682, approved 19 November 1999.

——. 2000. SATURN: Student Athlete Testing Using Random Notification, Grant from the National Institutes of Health.

——. 2001. Drug tests help athletes [Editorial]. The Oregonian, 19 April, D15.

Goldberg, L., D. L. Elliot, D. P. MacKinnon et al. 2003. Drug testing athletes to prevent substance abuse: Background and pilot student results of the SATURN (Student Athlete Testing Using Random Notification) study. Journal of Adolescent Health 32:16-25.

Kimberling, G. 2000. Taft High parent joins protest over student drug testing. The News-Times, 4 October, A1.

Lawrence-Turner, J. 2002. Recent high school graduates Beth Wade and Amy Cordy say a federally funded OHSU study violated privacy. Statement Journal, 11 July.

Moreno, J. 1998. Convenient and captive populations. In Beyond consent: Seeking justice in research, ed. J. P. Kahn, A. C. Mastroianni, and J. Sugarman, 111-30. New York: Oxford University Press.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Washington: GPO.

Nuremberg Code. 1947. Available from: http://ohsr.od.nih.gov/nuremberg.php3.

Oakridge School District 76. 2000. Student athletic drug testing—Procedure/consent form.

O'Donnell, L. 2000. Toledo couple fights student drug testing as constitutional violation. News-Times, 4 October.

Office for Human Research Protections. 2002a. Determination letter to P. O. Kohler, M.D., President, Oregon Health and Science University, 4 October. Available from: http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/oct2002. htm.

-------. 2002b. Determination letter to P. O. Kohler, President, Oregon Health and Science University, 24 October. Available from: http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/oct02d.pdf.

-------. 2002c. Determination letter to P. O, Kohler, President, Oregon Health and Science University, 10 December. Available from: http://ohrp.osophs.dhhs.gov/detrm_le...02/dec2002.htm.

Oregonian, The. 2001. Editorial. 12 April.

Palmer, C. A. 1992. Drugs vs. privacy: The new game in sports. Marquette Sport Law Journal 2:175-209.

Rozas-Burke, J. 2002a. OHSU, school districts named in drug lawsuit. The Oregonian, 3 July.

------. 2002b. Feds investigate OHSU drug use study. The Oregonian, 10 July.

Sabo, M. 2000a. Oakridge bars student from volleyball team; The action comes after the girls' parents' refuse to sign a consent form for an OHSU Drug-Testing Study. The Oregonian, 11 October, E15.

------. 2000b. Toledo parents sue to halt testing; High school athletes must sign drug testing consent form that is needed for a university study on abuse. The Oregonian, 28 September, E6.

Shamoo, A. E. 2002. Ethically questionable research with children—The Kennedy Krieger lead abatement study. Accountability in Research 9(3/4):167-75.

Shamoo, A. E., and D. B. Resnik. 2002. Responsible conduct of research. Oxford: Oxford University Press.

Shamoo, A. E., and C. A. Tauer. 2002. Ethically questionable research with children—The fenfluramine study. Accountability in Research 9(3/4):143-66.

Tallmadge, A. 2001. Ruling allows modified drug tests in school, a judge says an Oakridge girl's rights were violated but upholds mandatory screening of student athletes. The Oregonian, 1 March, B4.

——. 2002. Court will rule on drug tests; An Oakridge teen continues her battle to compete in school athletics without submitting to random drug screenings. The Sunday Oregonian, 17 March, A17.

Tymowski, G. 2001. Rights and wrongs: Children's participation in high-performance sports. In Research in global child advocacy, vol. 1, ed., I. R. Berson, M. J. Berson, and B. C. Cruz. Greenwich: Information Age Publishing.

Yamaguchi, R., L. D. Johnston, and P. M. O'Malley. 2003. Relationship between student illicit drug use and school drug-testing policies. Journal of School Health 73:159-67.

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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).