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.