Here, Goldberg, et al., attempt to refute the claims that the SATURN project was unethical, or even worse unconstitutional. I find this to be quite weak, as it is fairly clear that athletes who tested positive would be reprimanded. I am sure only 1 or 2 people will read all this crap (I haven't read it word for word yet to be honest), but even skimming through these posts will show the character of this slime ball who thinly veils his malintentions and corruption of research through his "save the children" smokescreen.
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Orbiting SATURN:
Countering Politically-Charged Misinformation with Facts
Gary T. Chiodo
Oregon Health and Science University
Linn Goldberg
Oregon Health and Science University
Esther L. Moe
Oregon Health and Science University
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Introduction
Adil E. Shamoo and Jonathan D. Moreno (2004) discuss an important and timely issue related to human subjects investigators and institutional review boards (IRBs). While we agree with Shamoo and Moreno's concern for the protection of children who are research participants, we note that they present many factually incorrect statements, assumptions, and more than a modest amount of conjecture. The authors have quoted 13 selected local newspaper articles without understanding the political context of those sources or confirming the accuracy of the statements quoted. They fail to cite any of the supportive editorials and letters printed in news sources.
Based upon inaccurate information and less-than- objective commentaries and reports, Shamoo and Moreno conclude that the SATURN (Student Athletic Testing Using Random Notification) study was unethical and [End Page 43] should not have been performed. As the institution that was the recipient of this peer reviewed, highly scored, R01 grant from the National Institute of Drug Abuse (NIDA) and that conducted the study, we welcome the opportunity to respond.
What Was the Purpose of the SATURN Protocol?
Shamoo and Moreno did not quote a critical portion of the "Background and Significance" section of the grant that embodies the philosophy and intent of the study:
If a policy of drug surveillance can significantly reduce initiation or curtail present [alcohol and drug] use among high school athletes, then drug testing may be a viable option to supplement other prevention efforts. However, if a well-designed intervention, using sophisticated techniques with adequate study power is unsuccessful, current resources targeted to drug testing could be redirected to other drug prevention interventions.
This succinctly describes why the SATURN study was proposed, funded, and performed. We simply do not know if this approach to dealing with alcohol and drug use by children is good, bad, or immaterial. We do know that it is legal and that many schools devote significant time and resources to drug testing. Since the 1995 U.S. Supreme Court decision of Vernonia School District 47J v. Acton (515 U.S. 646), as many as 1,000 school districts in at least 38 states and Puerto Rico have instituted student drug testing programs. More schools are expected to implement drug testing in the wake of the June 2002 U.S. Supreme Court decision (Department of Education 2002, 7-8).
However, the goal of mandatory drug testing programs—to reduce drug use among children—has never been tested to determine if such programs work. Mandatory drug-testing programs might be counterproductive or completely ineffective and, thus, a waste of public resources.
How Was SATURN Designed to Accomplish This Purpose?
SATURN was designed to demonstrate whether a legal policy, when implemented among those engaged in a voluntary activity (school-sponsored sports), curtailed substance use and abuse. In preparation for recruiting schools into a scientifically valid, randomized study designed to measure the effect of a policy, SATURN investigators met with more than 100 school districts in Oregon and Washington state to identify the few school districts meeting the study inclusion criteria:
Nonpunitive policy;
Counseling for positive results;
No punitive academic or legal consequences for positive drug tests; and
No permanent record of tests kept.
To be eligible to participate in the SATURN study, a school must have:
Decided to implement drug testing;
Adopted a drug testing policy;
Adopted a written school consent form for mandatory drug tests;
Been willing to be randomized to either the experimental or control conditions;
Been willing to allow the SATURN investigators to substitute the more accurate (and much more expensive) Olympic standard urinalysis if they were randomized to the experimental condition; and
Been willing to allow the SATURN investigators to perform the research intervention, consisting of distribution of questionnaires.
Each participating school district was responsible for instituting its own drug testing policy with the support and consensus of parents, students, and the local school board. This resulted in different drug-testing policies in the schools, some testing students throughout the school year, no matter when the student participated in sports, and others testing only during the sports season.
The school districts' policies (not the SATURN study) required student athletes to consent to random drug testing. Study participation was voluntary and involved completing a written, confidential survey at the beginning and end of each school year. The SATURN protocol did not require students to take part in the study (i.e., complete the survey) to participate in athletics. Approximately 30% of student athletes and their parents did not consent to participate in the SATURN study. The collected data indicate that the experimental (active drug-
test policy) schools experienced an 11% increase in sports participation during the course of the study. This refutes Shamoo and Moreno's assertion that "all student athletes were automatically enrolled in the research study if they wanted to continue playing a sport." Students were never automatically enrolled in the study, and there was no requirement to be involved in the research.
Shamoo and Moreno state that "disciplinary action ... [included] 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." This statement is incorrect. First, all actions related to positive drug tests were dictated by school policy, not by the study. Second, to be included in the study, the school policy must have met the nonpunitive and counseling-referral criteria.
Shamoo and Moreno state that "because any given
test result might be a false positive, a second specimen
test (at the parents' expense) could be requested." This statement [End Page 44] is incorrect. A second sample could be tested without parent expense.
Finally, students were not "corralled" into special classroom settings. Researchers went to schools on the identified day of survey administration, distributed and collected surveys in sealed envelopes, and responded to student questions. There was no need to "corral" students, and we find Shamoo and Moreno's use of this term to be both pejorative and provocative; it is not appropriate in critical discourse on the ethics of a study design.
What Did the Informed Consent Documents Say?
Separate informed consent documents were used for the experimental (drug testing) and control (delayed drug testing) schools. Shamoo and Moreno's article appears to be citing from the experimental consent documents. The consent documents were supplemented with cover letters and information sheets that were sent to participants and parents or guardians.
In the first three years of the study the informed consent document carried a boldprint statement across the top of the first page that said "This is strictly a voluntary consent form. Your participation in sports or other school programs will NOT be impacted by whether or not you sign this consent form."
Later versions of the informed consent document removed this statement from the first page header but included an "Alternatives" statement that read:
You may choose to not participate in this study, i.e., not to complete the questionnaire. If you choose not to participate in the school's program of athlete drug testing (which is not part of this study), the school may not allow you to participate in school-sponsored athletics. You may also choose to decline drug testing but participate in the study by completing an anonymous questionnaire.
The Oregon Health and Science University (OHSU) Institutional Review Board (IRB) found this statement to be an accurate reflection of the alternative to study participation and to reinforce the difference between the study and the school's drug-testing policy. Shamoo and Moreno's statement that the Alternatives section indicated, "that refusal to enroll will result in not allowing the student to participate in sport" is not true and cannot be inferred from the facts.
Shamoo and Moreno fail to mention the cover letter to parents or guardians that was included with the informed consent documents. The cover letter stated:
If a student or his/her parents prefer not completing the anonymous questionnaire, a student does not have to participate. To not participate, either: 1) tell the staff passing out the questionnaire that you do not want to fill it out; 2.) turn in a blank questionnaire; or 3) call OHSU research team at [number provided] prior to questionnaire administration and give your child's name, the name of the school they attend, and that you do not want them to participate. A student may also simply leave blank any questions.
An information sheet also provided information about what the study was and was not doing and several frequently asked questions. It clearly stated that the study is not a "drug testing program and that random drug testing of high school athletes in Oregon would be occurring whether or not the SATURN study existed."
Shamoo and Moreno selectively quote from the Risks and Benefits sections of the informed consent documents, but their comments are provided out of context and omit important information that was provided to the subjects and their parents. The Risks section of the consent form states:
There are no health risks associated with participation in this study. You may or may not feel uncomfortable or embarrassed by the questionnaire and urinalysis process. Positive urine testing will be reported, thus there is a risk that your results will become known to a school official if your drug and alcohol
test is positive. You will not be asked to give blood or submit to a physical exam.
One could argue that this statement interposes the risks of the study procedure (completing the questionnaires) with the risks of a school's procedure for drug testing of athletes. This point was not overlooked by the IRB. To the contrary, the IRB believed that the research consent form provided an opportunity to remind the student of the risks inherent in their school's procedures.
Shamoo and Moreno similarly paraphrase the Benefits statement out of context. The entire Benefits statement was: "You may or may not personally benefit from participating in this study. The benefits to science include finding out whether drug testing is worthwhile and finding effective ways to prevent drug use in high school student athletes." The IRB felt that the statement "finding out whether drug testing is worthwhile" clarified the foundation of the study's purpose.
What Did the IRB Do?
It is disturbing that Shamoo and Moreno feel qualified to guess that "the community member in this case appears not to have provided the needed input." The IRB chair assigned primary review of SATURN to a community member who is an attorney specializing in child and adolescent law and devoted his career to zealous advocacy for the rights and welfare of children. The SATURN study was held to a very rigorous review by this member who required more than a few changes to both the protocol and the informed consent documents prior to approval.
The IRB and NIDA also considered the least coercive alternatives for the study design. The SATURN study was a randomized, controlled study. An important ethical [End Page 45] justification for randomization in any study is that the condition of
equipoise exists. Within a group setting, such as a school environment, randomization of the "unit" is the least coercive method while enabling the investigators to collect the most valid results. Importantly, the OHSU IRB found that
equipoise existed between the two study conditions, and this was inherent in the specific aims of the study. Because no one knows if random drug testing is worthwhile, no one could know if the control or experimental conditions would be best.
Were Students or Schools Coerced?
Contrary to Shamoo and Moreno's assertion that the study and the schools' policies were "interwoven" and that students who wanted to engage in sports in the experimental schools were "automatically enrolled in the research study," the protocol, consent document, letters, information sheets, and verbal information presented to students and parents all drew a clear distinction between the schools' drug-testing policy and the research goals. Parents and students were clearly and consistently informed that drug testing would be implemented in the experimental schools whether or not the SATURN study existed.
Shamoo and Moreno claim that "punitive steps would be initiated" if the results of the first
test were positive. This statement is incorrect. The study took steps to ensure that schools that had punitive policies were excluded. At most, the policies were protective. If an athlete tested positive for alcohol and/or illicit drugs, allowing that child to participate in sports immediately thereafter would have risked serious injury. We wonder if Shamoo and Moreno can offer an ethical defense for knowingly allowing a drug- or alcohol-impaired student to participate in an activity that taxes the cardiovascular and musculoskeletal systems.
Shamoo and Moreno infer that monetary incentives might have coerced the schools to participate in the SATURN study. In fact there were several disincentives for such participation. School administrators realized that after going through administrative school board hearings; student, parent, and community meetings; and legal counsel consideration, there was a 50% chance they would be asked to defer their policy if they joined the study. Deferred policy schools still would have to supply time for surveys and work with research staff in the consent process, all for the potential benefit of the knowledge to be gained. If this was not an impediment enough, there were three legal challenges to the law that allowed drug testing in high schools. While the courts upheld the constitutionality of the law in all three cases, school administrators likely wondered if it would be less risky to just wait. Lawyers warned school officials that because of the manner in which they would sue the schools their insurance policies would be useless. However, some schools, despite these threats, believed the problem of substance use and abuse deserved sound scientific study and desired to contribute to a process that may determine the effective and ineffective ways of dealing with this problem.
Contextual Issues
We note that in several parts of Shamoo and Moreno's discourse they lapse out of the realm of ethics and into conjecture about what students felt or the study intended. For example, in their discussion of the protocol design they state that the program utilized "ostracism" to reinforce adherence to the schools' drug-testing policy, and they equate this with "peer reinforcement." We disagree that the two are comparable; find no mention of "ostracism" in the protocol; assert that neither the NIH nor the OHSU IRB would have approved a protocol that depended upon ostracism; and do not believe that such an extreme would be necessary to recruit students into a study that is limited to the completion of questionnaires.
A second example of conjecture is apparent in the authors' discussion of an "atmosphere [in the school system] of 'pushing' student athletes" into the study and "corralling" students into settings. The authors conclude that "'student athletes' saw the whole school administration ...as involved in the" study. Aside from a quote from a local newspaper article, which the authors present as "published reports," there is no basis presented for such a statement.
Shamoo and Moreno add further conjecture in their statement that schools had a "built-in incentive" for participating in the study because their drug-testing programs would be paid for. While this statement betrays the authors' understanding that the drug testing was, in fact, not part of the research, it is misleading. The drug testing procedure that is currently used by schools in Oregon and other states is an inexpensive, urine "dipstick"
test. The SATURN study required more accurate data and substituted this dipstick
test with an expensive Olympic-quality
test. The total dollar amount saved by these schools was not a significant portion of their annual operating costs.
Shamoo and Moreno make yet another inaccurate statement based upon conjecture when they infer that the testing laboratory had a financial conflict of interest in performing the urinalyses. No laboratory personnel are or were involved in the study.
Still more conjecture is evident in Shamoo and Moreno's statement that "the researchers also lacked knowledge about the prevalence of drug use, and hence provided no such information in the informed consent form." We wonder how the authors arrived at this unsubstantiated conclusion. Data on the use of drugs in Oregon schools is publicly available every other year (State of Oregon 1999). Both the principal investigator and co-investigator [End Page 46] served on the State of Oregon's Speaker of the House Committee regarding use and abuse of drugs and alcohol. To establish a baseline and confirm the most current substance-use data, voluntary surveys were taken regarding drug and alcohol abuse before drug testing. Likewise schools keep a record of alcohol and drug-use suspensions. When one school district's policy was challenged, a detailed description of substance use was provided (184 OR App.415 [2002]).
Shamoo and Moreno present their article as an ethical analysis of an important issue, yet their statements in this article and their recent actions seem to be at variance. For example, we find it curious that Shamoo and Moreno were members of the U.S. Office for Human Research Protections (OHRP) National Human Research Protections Advisory Committee that urged the Food and Drug Administration to allow teens (as young as 14) to enroll in experimental drug trials without their parents' consent (Marshall 2001).
A second example of the authors' ethical analysis being at odds with their other work is evident in their citation of the Nuremberg Code in support of their conclusion that the SATURN study conflicts "with conventional views of human research ethics, including the inadequate informed consent documents." However, when asked about the first principle of the Nuremberg Code, "the voluntary consent of the human subject is absolutely essential," Moreno stated in an article in The Washington Post Magazine that "[it] is simply too restrictive for some kinds of research. There are a lot of subjects who cannot give informed consent: children, people with mental disorders and dementia" (Washburn 2001).
Finally, much of the information cited in Shamoo and Moreno's article comes from newspaper advocates of their position. Numerous newspaper editorials and reports favored the SATURN study and provided factually correct information. None of these were cited. Thus, as a critical discussion of the study and the controversy that has been generated about it, Shamoo and Moreno's "ethical discussion" appears to be initiated and supported from an agenda; it lacks the objectivity that one would expect from unbiased ethicists.
Conclusions
Shamoo and Moreno state that "mandatory public health interventions can rarely be combined with research without conflicting with" prevailing research ethics principles. We are uncertain how they have come to this conclusion. The Common Rule addresses the area of research "designed to study, evaluate, or otherwise examine ... public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternative to those programs or procedures" and exempts such research from the purview of this federal policy (45 CFR 46.101).
OHRP (1993) presents a thoughtful discussion of the ethics of "Social Policy Experimentation." While IRBs are warned to carefully balance the need for sound research data with the ethical concerns of respect for persons, there is no mention of this type of research being "inherently incompatible with the requirements of freely given informed consent."
Shamoo and Moreno state, that there is no "doubt that a program for the identification and assistance of those young people who use drugs could provide a great social benefit." We agree with this conclusion but wonder how these authors would propose that such programs be defined and implemented if there is no good scientific evidence for what works, what does not work, and what is harmful.
Many schools drug
test athletes without questioning effectiveness. On the heels of the recent Supreme Court decision, many more will implement random, suspicionless drug testing of nonathletes. Drug testing happens regardless of our opinions or the opinions of Shamoo and Moreno. The drug-testing programs initiated by the schools and assessed by the SATURN researchers were acceptable to the NIDA and the IRB because they were nonpunitive models. There was certainly no coercion of students to enter the SATURN protocol just because a student decided to pursue athletic participation.
There is a substance abuse problem in our schools. Drug testing might or might not be an answer. Unless we ask the question and search for the answers, we will never know.
OHSU thanks the young athletes, school boards, and administrators who joined with SATURN researchers to better clarify the utility of drug testing in our schools.
Goldberg's Response to Criticism 
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