Coercion and the SATURN Study

When I read Adil E. Shamoo and Jonathan D. Moreno's (2004) account of the SATURN (Student Athletic Testing Using Random Notification) study, I was amazed that this research proposal made it past the institutional review board (IRB) at the Oregon Health and Science University and the reviewers at the National Institute of Drug Abuse. I was also disturbed that the researchers began the study before they had IRB approval. I am glad that the Office of Human Research Protections (OHRP) suspended the study. The study was, in my judgment, patently unethical because it required participating schools to adopt a coercive drug-testing program. Although there is no evidence that the investigators directly coerced subjects, there is little doubt that they indirectly coerced research subjects through the mandatory drug-testing programs adopted by participating schools.

The overall goal of the SATURN study was to determine whether mandatory drug-testing programs for student athletes reduce drug usage among high school students. Because many schools have adopted such programs, it would be useful to know whether these programs are effective. While the goals of the SATURN study were ethically sound, the means the researchers used to achieve them were not.

The SATURN study used a prospective experimental design. Schools that agreed to participate in the studywere required to enact a mandatory drug-testing program for student athletes. Schools that already had a drug-testing program were not allowed to participate in the study, as this could bias the results of a prospective study. Under the study's drug-testing program, student athletes could be randomly tested for drug use. Students who tested positive for drugs or refused to take a test would face immediate consequences, such as not being allowed to participate in high school sports or suspension from school. Shamoo and Moreno note that at least one student was suspended by a school that adopted the drug-testing policy.

The informed consent document used in the study told subjects that they could refuse to participate in the study, but it also informed students that the school could refuse to allow them to take part in school-sponsored athletics if they did not participate in the study or if they tested positive for drugs. Even though the investigators did not coerce subjects, they enlisted the aid of the participating schools to coerce subjects into participating in the study. Shamoo and Moreno inform us that not only did the school officials adopt coercive drug-testing rules, but they also helped recruit subjects for the study. The study was similar, in some respects, to an experiment on a prison population in which investigators cooperate with prison authorities to compel inmates to participate.

Some of the most egregious cases of unethical conduct in the history of human experimentation, such as Nazi Germany's research on concentration camp prisoners, have involved coercion. Coercion in research or therapy is widely regarded as unethical because it interferes with the subject's ability to make a free (or voluntary) choice (Berg et al. 2001). The ability to make a voluntary choice is one of the key elements of informed consent, which is one of the fundamental ethical principles of human experimentation (Shamoo and Resnik 2002). U.S. federal regulations require that investigators obtain informed consent from subjects (or their legally authorized representatives), except for some clearly defined types of research, such as emergency research (21 CFR 50.24) or research that could not be carried out without a waiver or alteration of informed consent (45 CFR 46.116c).

While it is easy to recognize coercion that results from a direct threat to use physical force against another person, such as a mugger who threatens to shoot you if you do not hand over your wallet, it is not always easy to recognize coercion that results from the potential denial of benefits. For example, if a boss says to his employee, "If you...