Drug Testing Research in High School Students: Is There a Will or a Way?

The use of students at any level as research subjects raises several challenging ethical and logistical issues. Many of these are exemplified in the SATURN (Student Athletic Testing Using Random Notification) study, a program funded by the National Institute on Drug Abuse and intended to measure the impact of mandatory random drug testing on the drug-use behavior of high school athletes.

Adil E. Shamoo and Jonathan D. Moreno (2004) have criticized the study on ethical grounds, as have others. The U.S. Office for Human Research Protections (OHRP) has criticized the study on legal grounds, citing violations of the federal regulations for protection of human subjects in research (OHRP 2002). Beyond the specific research study, concerns have also been voiced regarding the implementation of mandatory drug testing programs, giving rise to legal challenges on constitutional grounds by students claiming violation of their privacy rights from forced enrollment in the study. The debates and exchanges on these several fronts have been intense, while in the background, quietly ongoing research has called into question the effectiveness of such testing programs so far as modifying student behavior and implementing policies are concerned (Yamaguchi, Johnston, and O'Malley 2003).

The OHRP investigation of the SATURN study was initiated after the office received a formal complaint alleging noncompliance with federal regulations for the protection of human subjects. One should keep in mind that OHRP undertakes compliance oversight investigations only after it determines that the activities in question are within its jurisdiction and that there is sufficient cause. In the case of SATURN, a federally-supported research study performed under an institutional assurance of compliance with applicable federal regulations, the jurisdictional issue was clear.

The OHRP investigation was conducted in accord with the policies and procedures established and published by the office. Whenever appropriate, OHRP enlists the support of expert consultants to deal with technical, scientific, and ethical matters that arise in the course of its investigations. Determinations made by OHRP are based in law; the regulations it enforces were crafted to facilitate application of the ethical principles elaborated in the Belmont Report (U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979). Not uncommonly, complaints made to the office are based on the complainant's perception of the morality or appropriateness of actions taken by investigators in the course of their work, but these perceptions of right and wrong are not always consistent with the applicable law or regulations. There are occasions when activities that are considered morally offensive or unethical by some are not specifically covered by applicable law. Accordingly, OHRP is very cautious about overstepping its authority, and in this case I do not believe that it did. Nevertheless, OHRP's determinations must be taken as a compliance determination and not as a ruling on the ethics of the research study or the practice of mandatory drug testing, which many are likely to find offensive in and of itself.

Without rehashing the OHRP determination, which is publicly available, it seems clear that the SATURN study violated the regulatory requirement for voluntariness of participation in federally-supported research. This fact alone is sufficient grounds to intervene, and OHRP did so. The ethical issues regarding informed consent, coercion, and the right to personal privacy are all relevant and important, as Shamoo and Moreno detail in their article, but the simple fact is that participation in federally-supported human-subjects research must be voluntary and in this case was not. Nor, of course, was participation in the mandatory drug-testing program. Although the investigators and the sponsoring institution might have claimed that the implementation of the drug testing program was not actually part of the research, review of the study documents reveals that this is simply not the case, as the OHRP investigation makes clear.

Much of Shamoo and Moreno's discussion, as...