Required "Volunteers" for Human Investigations--Just Say No!

Prospective subjects must demonstrate the ability ... to deliberate on alternatives, including the alternative not to participate [emphasis added] in the research.

National Bioethics Advisory Commission (1998, 23), quoting High (1994)

The U.S. government's attitude toward illegal drugs has been expressed by the Office of National Drug Control Policy (1998): these substances "impair rational thinking ... destroy personal liberty ... [and] drain the physical, intellectual, spiritual, and moral strength of America." Federal regulations state that consent to participate in federally-funded scientific research must be obtained "only under circumstances that provide the prospective subject or the [legally authorized] representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence" (45 CFR 46.116). Adil E. Shamoo and Jonathan D. Moreno (2004) have forcefully documented one instance, SATURN (Student Athletic Testing Using Random Notification), in which federal regulations were contravened and "rational thinking," "personal liberty," and even the "moral strength" of the American democratic system were sacrificed by those doing research, funding research, ethically vetting research, and publishing research dealing with drug abuse.

Whether the reader agrees or disagrees (and I disagree), the U.S. Supreme Court has ruled that the government possesses constitutional authority to subject students to random drug screens as a condition for participation in public school-sanctioned sports (Vernonia School District 47J v. Acton, 515 U.S. 646 [1995]) and, indeed, in all extracurricular activities conducted by the public school system (Board of Education of Independent School District 92 of Pottawatomie County v. Earls, 536 U.S. 822 [2002]). It is not surprising, at least to a cynical observer, that the Supreme Court repudiated this same intrusive practice when applied to politicians seeking public office (Chandler v. Miller, 520 U.S. 305 [1997]). The permissibility of these searches, however, is not the theme of my commentary. Society has reached an ethical consensus that regardless of the goals of a scientific study, and irrespective of the quality of the research itself, coercion may not be used to advance subject recruitment. I join Shamoo and Moreno in strong opposition to the concept that the "War on Drugs" justifies coerced participation in a human research project, regardless of how laudable its purported aims. At the same time, I will elaborate on the authors' comments without in any way detracting from their fundamental thesis.

By focusing on informed consent, Shamoo and Moreno have somewhat diluted the thrust of their argument. I do not denigrate informed consent as an ethical necessity for participation in experimental studies; consent without appropriate information is tantamount to coercion through ignorance. Yet, even full disclosure can never erase the ethical wrong inherent in compelled participation in any study—informed consent must be accompanied by freedom to refuse. I served on active duty in the United States Army from 1964 to 1966. During that time I was ordered to receive an experimental vaccine against a disease whose name could not be revealed. When I brought up the notion of "informed consent," I was presented with a novel interpretation of this concept—I inform you that if you do not consent to be immunized and studied, you will be court-martialed! It should be obvious that even had the nature of the vaccine and the disease been divulged along with a complete and accurate listing of risks and benefits, the ethical wrong inherent in forcing me to be an experimental subject would not have been mitigated. I submit that this military vignette is woefully similar to the "informed consent" detailed by the principal SATURN investigator (Goldberg 1999): "You may choose not to participate [in this study. However, if you take this action] the school may not allow you to participate in school-sponsored athletics."

Participation in high school athletics can be quite important, and not just from the standpoint of peer approval (as noted by Shamoo and Moreno) or self-esteem...