Extended Commentary: Military Service without the Common Rule.

• Author: Garland, Harwood R., II.

Madison Powers, a senior research scholar at the Kennedy Institute of Ethics and a professor of philosophy at Georgetown, wrote that "Reliance on individual consent alone is not adequate to protect persons from exploitation under conditions of grossly unequal bargaining power, information, and human need." (1) According to such reasoning, and as a conscionable reaction to medical research atrocities such as those of the Tuskegee Syphilis Study and the Nuremberg Trials, the United States Department of Health and Human Services (HHS) developed the US Federal Policy for the Protection of Human Subjects, also known as the "Common Rule" (45 CFR 46) to throttle researches involving those most vulnerable to exploitation. Subparts of the Common Rule prescribe protections for pregnant women, human fetuses, neonates, prisoners and children. (2) The Common Rule does not mention military service members, and hence does not protect them as a vulnerable class of people. Other laws offer protection in relations to clinical research on U.S. military service members, but they are far from the straightforward protections offered by the Common Rule. 21 CFR Parts 50 and 312, which govern the Food and Drug Administration (FDA), for example, states: "Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's... informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests." (3) As military member's employer, the Department of Defense (DOD) forces service members to continue their voluntary service under threat of legal penalty, dictates much of the living arrangements of service members (such as whether a service member lives in Hawaii or Iraq or on a ship) and--this is a key component--provides healthcare to the service member, may legally request that the president override a service member's wish to receive or not to receive experimental medicines.

There is great practicality to the waiving of a service member's right to refuse medical care, but there is also great risk in dismissing the importance of this step. This risk is what makes service members--and especially junior enlisted service members--a class of individuals vulnerable to research exploitation and warrants consideration for their protection under the Common Rule. For example, in 1802 a French army invaded Haiti to restore French authority over the island and bolster French forces in the New World. Before the worst of the fighting began, an enormous portion of the French army was hospitalized with yellow fever. As a result the French lost control of Haiti and Napoleon cut his losses by selling the Louisiana Territory to the United States in 1803. If a useful immunization had then been available, Napoleon would have ordered his military physicians to prescribe the immunization to his soldiers so long as the number of soldiers expected to die from the immunization was tolerable. Had the French army been immunized, the Haitian forces would likely have been defeated and the history of the New World set on a much different course. A soldier who refused the immunization under these conditions would have been court-martialed and either discharged or forced to receive the immunization anyway--as receipt of this medicine was tactically essential to military achievement. Tactical necessity trumps individual rights in the military--such is the price of victory.

Over the next century, yellow fever epidemics continued to flare up in the New World. Construction of the Panama Canal had to be abandoned because yellow fever was killing so many workers. Epidemics in Memphis, Philadelphia, and many other...