Emerging military technologies: balancing medical ethics and national security.

• Author: Parasidis, Efthimios
• Position: Frederick K. Cox International Law Center Symposium: International Regulation of Emerging Military Technologies

This article, prepared for the CETMONS-Frederick K. Cox International Law Center's symposium, International Regulation of Emerging Military Technologies, examines the law and ethics of emerging biomedical innovations. In addition to unpacking the legal regime that governs the military biomedical complex, I discuss the ethics and regulation of human subjects research, the overlap between military law and military medicine, and the socio-medical implications of the current framework.

CONTENTS I. INTRODUCTION II. A Tangled Web of Laws and Regulations Governs Military Medicine and Research A. The Development of Federal Guidelines in the United States B. The Framework Governing Military Personnel III. The Military's Emerging Focus on Biomedical Innovations. IV. CONCLUSION I. INTRODUCTION

The twenty-first century is quickly taking shape as the age of the biomedical military. As the U.S. Department of Defense (DoD) candidly states, one of its primary goals is to exploit the life sciences to create soldiers with superior physical, physiological, and cognitive abilities. (2) Projects include: (1) developing drugs that can reduce fear, increase aggressiveness, or keep individuals awake and alert for up to seven days straight; (2) genetically engineering the human immune system so that it is able to recognize and adapt to any pathogen; (3) creating implantable electrodes that permit human-to-human and human-to-computer communication via thought alone; and (4) establishing human-to-computer interfaces that are able to detect a person's neurological state and release neurochemicals that can combat fatigue, enhance mood, suppress or improve memory, or facilitate learning. (3)

Emerging biomedical technologies are creating new paradigms for reevaluating the law and ethics governing the practice of medicine and medical research. Although the motto of the American military physician is to "conserve the fighting force," an integral component of military research concerns physical and cognitive enhancements that endeavor to augment human faculties. While biomedical enhancements have yet to be used on a widespread basis in the theater of war, it may just be a matter of time before enhancements are integrated into military missions. Not only must policy-makers and the military consider the practical implications of enhanced warfighters, a more fundamental question that must be addressed is who should be responsible for balancing national security priorities with medical, social, and ethical concerns.

As with civilian legal doctrine, military law recognizes a distinction between the practice of medicine and medical research. With respect to the former, military law dictates that the DoD can mandate that service members comply with an order to be administered treatment of an FDA-approved medical product that the DoD determines is in the best interest of an individual service member or a military mission. (4) One recent example is the smallpox vaccine mandate that was promulgated in 2002. Although smallpox was eradicated in nature in 1980, many countries have access to the smallpox virus via laboratory stockpiles. (5) After 9/11, the DoD feared that smallpox would be used against U.S. troops as a biological weapon, and thus DoD determined that the smallpox vaccine was needed as prophylaxis. (6) In turn, DoD administered the vaccine to thousands of service members. Although smallpox was not used against U.S. troops, many service members suffered vaccine-related adverse health effects, including serious and unanticipated cardiac adverse events. (7) Notably, since DoD deemed administration of the smallpox vaccine to be a requirement of service, pursuant to military law, a service member who refused the vaccine was subject to court-martial and severe punitive measures, such as docked pay and dishonorable discharge.

With respect to military medical research, federal regulations and DoD guidelines provide safeguards for military personnel who take part in biomedical research conducted or sponsored by the military. In part, these protections aim to ensure that service members are not coerced or compelled into serving as research subjects. (8) At the same time, however, there are exceptions to the regulations that allow the DoD to mandate that non-FDA-approved products be administered to service members. (9) When this occurs, the line between research and practice is blurred, and it becomes unclear whether, and to what extent, protections governing research involving human subjects apply.

The military's emerging focus on biomedical products and human enhancements complicates the legal and bioethical issues that are raised by the coalescence of military medicine and military research. For example, in the context of emerging biomedical technologies, it is unclear what risk-benefit profile is acceptable during battle, and whether that standard should change in times of peace, or when war is imminent. It is also unclear to what extent risk-related information must be provided to service members, and whether they should be afforded the opportunity to opt out of treatment with enhancements or experimental products. Importantly, should a product- or research-related adverse event occurs, injured service members do not have the full spectrum of legal remedies available to them as civilians do.

2. A TANGLED WEB OF LAWS AND REGULATIONS GOVERNS MILITARY MEDICINE AND RESEARCH

   1. The Development of Federal Guidelines in the United States

      Federal regulations governing research on human subjects are a relatively recent construct. Although medical research in the U.S. dates back to the beginning of the republic, a federal framework governing human subjects research was first established in 1974 following "a series of highly publicized abuses" at the hands of government researchers and physicians. (10) The 1974 guidelines established a system that centered on utilization of institutional review boards (IRBs) to review research protocols. (11) Five years later, the National Commission for the Protection of Human Subjects of Biomedical Research and Behavioral Research (the "National Commission") published the Belmont Report, which identified fundamental ethical principles that should govern research involving human subjects. (12) A series of amendments to the federal regulations followed, culminating, in 1991, with the publication of the Common Rule. (13)

      The Common Rule sets forth guidelines that apply to government-funded research with human subjects. (14) Under the Common Rule, there are three primary mechanisms for protecting research subjects: informed consent, review by an IRB, and institutional assurances of compliance with federal policies. (15) Among its provisions, the Common Rule requires that risks to research subjects are minimized, and that risks are reasonable in relation to the anticipated benefits. (16) The Common Rule also provides additional protections for "vulnerable populations," which are defined as populations that are subject to coercion or undue influence. Currently, these subpopulations include pregnant women, children, human fetuses and neonates, and prisoners. (17) The supplemental protections include procedural guidelines addressing membership on IRBs that review research protocols involving vulnerable populations, as well as substantive guidelines that IRBs must consider in reviewing and monitoring the research. (18)

      In 2011, the U.S. government published an Advanced Notice of Proposed Rulemaking, which highlighted the drastic change in the research landscape since the time the Common Rule was adopted and the need for amendments to the law to account for these changes. In calling for amendments to the Common Rule, the U.S. Department of Health and Human Service (HHS) and the Office of Human Research Protection (OHRP) emphasized the fact that the law has "not kept pace with the evolving human research enterprise," and highlighted areas, including "advanced technologies" and "genomics," where this has been the case. (19) To date, however, no amendments to the Common Rule have been enacted.

   2. The Framework Governing Military Personnel

      The DoD has adopted the Common Rule, (20) and Executive Order 12333 mandates that the Central Intelligence Agency (CIA) comply with the guidelines outlined in the Common Rule. (21) In addition, DoD Directives provide additional safeguards for service members who are solicited for, or enrolled in, clinical trials that are conducted or sponsored by the government. (22) At the same time, however, a number of laws and regulations provide exceptions that negate many of the protections. The following is a snapshot of the tangled web of laws and regulations that apply to military personnel:

      * DoD Directive 3216.02, issued November 8, 2011, defines a key triggering term for Common Rule protections--"research involving human subjects"--to exclude: (1) "activities carried out solely for purposes of diagnosis, treatment, or prevention of injury and disease in Service members and other mission essential personnel under force health protection programs"; and (2) activities related to an "operational test and evaluation" (OTE) project. (23) Under 10 U.S.C. [section] 139, an OTE project is a "field test, under realistic combat conditions, of any item (or key component of) weapons, equipment, or munitions for the purpose of determining the effectiveness and suitability of the weapons, equipment, or munitions for use in combat by typical military users." (24)

      * The Project BioShield Act of 2004 creates the Emergency Use Authorization (EUA) process, which provides...