MME Scenario Collection

Author: Dr phil Daniel Messelken | ZH Center for Military Medical Ethics.

Military medicine has generated a number of novel and innovative treatments which are now used in general medicine as well (Kitchen & Vaughn, 2007; Ling et al., 2010; Ratto-Kim et al., 2018). Conflicts may even serve as a catalysator for the development of novel approaches “with the casualty imperative driving” (Hodgetts, 2014, 86). For example, “[t]he lessons of Vietnam and the development of trauma systems, the ‘golden hour,’ and air medical services provide additional reminders of the mutual benefits gained by military and civilian practice.” (De Lorenzo, 2004, 129)

However, military contexts with e.g. hierarchies and mixed interests can also pose ethical challenges for the conduct of medical research; unfortunately, “[h]istorically, military researchers have been negligent in protecting the rights of research subjects” (Frisina, 2003, 538). Still, medical research within the military medical services is not per se unethical or automatically more problematic than medical research in clinical contexts. Much depends on the organization, the study design, and the researchers who are involved.

Medical practice and the limits of research

The Belmont Report introduced the distinction between ordinary medical practice and research. It defines practice as “interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.” In contrast, research “designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge”. (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979, Part A, Section A. Emphasis added.) The boundaries between practice and research cannot always be clear cut for obvious reasons. An illustrating example of has been the use of investigational agents for preventive treatment to protect soldiers against the effects of possible biological and chemical warfare during the Persian Gulf War in 1990/91 (cf. Frisina, 2003, 550f.).

In between the two lies the blurry area of innovation as it refers to methods that are neither standard practice already nor medical research in the strict sense. Innovation in medicine can also consist in using a non-standard treatment in individual cases. Such “unproven interventions in clinical practice” are usually employed in the absence of an effective standard treatment when no other means are available (cf. Beauchamp, 2008; Swiss Academy of Medical Sciences, 2015, 2017; World Medical Association, 2013 (1964)). Doctors who treat patients with such forms of treatment must make sure to respect (ordinary) medical ethics.

It is clear that the advancement of medicine ultimately has to be based on research on human research subjects. It is not the involvement of human research subjects per se that makes medical research ethically problematic, but the studies’ design or the non-respect of ethical principles (cf. World Medical Association, 2013 (1964), § 5&6). Ordinary medical ethics must be respected when doing research in medicine and some additional principles apply, that shall now briefly be introduced.

Ethical restrictions of research in medicine

Basic principles for medical research ethics are spelled out in the Nuremberg Code from 1947 (see e.g. Annas & Grodin, 2008), the World Medical Association’s Declaration of Helsinki from 1964 (World Medical Association, 2013 (1964)), the Belmont Report from 1979 (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) and more recently in the World Health Organization’s Standards and operational guidance for ethics review of health-related research with human participants (World Health Organization, 2011).

The most important ethical principles for research in medicine according to these documents and regulations are summarized in the following list:

• Scientific design of the research.
  Research must never be “wild” experimentation. Studies involving human research subjects must build on hypotheses that are based on solid assumptions and prior research. (World Health Organization, 2011, 13). Thus, research cannot be conducted spontaneously but has to be planned in advance and must be properly designed.
• Respect for persons: the necessity of voluntary informed consent.
  “It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.” (World Medical Association, 2013 (1964), § 9) Respect for the principle of informed consent is of utmost importance. The requirement of informed consent should be understood as a process that consist in an interactive dialogue between the research staff and prospective participants. It focuses on informing and protecting research participants from misunderstandings with regard to what they can and have to expect (cf. World Medical Association, 2013 (1964), § 25-32).
• Beneficence: distribution of risk and benefit.
  Medical research must not involve risks and burdens to the human research subjects that are disproportionate to the potential benefits. It must be clear that “risks are reasonable in relation to probable benefits” (Beauchamp, 2008, 151), and it must be clear that “the risks have been adequately assessed and can be satisfactorily managed.” (World Medical Association, 2013 (1964), § 18)
  A purely utilitarian justification of (abusive) research that would put few at a great risk for the (potential) benefit of many cannot be tolerated under any circumstances.
• Justice: selection of research participants and distribution of resources.
  Research ethics requires “fairness in the distribution of both the burdens and the benefits of research” (Beauchamp, 2008, 151). This means that “no group or class of persons bears more than its fair share of the burdens [… and] no group should be deprived of its fair share of the benefits of research” (World Health Organization, 2011, 13). In practice, this principle can be specified in many different ways, one of which is that researchers must not abuse dependencies and have to consider that “[s]ome groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged” (World Medical Association, 2013 (1964), § 19). This is especially important when power is distributed asymmetrically and in situations where knowledge is not available and accessible to everyone.

Discussion of some specific challenges for research in the military context

Military interests

A first concern with regard to medical research in a military context is that of mixed interests. According to Frisina (2003, 540) “military biomedical research does present a double-edge sword. Most often what is learned in the area of biomedical research has potential uses for both good and evil.” For example, by developing protective means against biological weapons, medical research may contribute to making the actual use of these weapons more likely.

A related issue consists in mixing military interests with that of patient-soldiers. Gross (2006, 103) argues that “[w]hile medical personnel work to provide good medical care, they are obligated to provide the care necessary to maintain soldiers as a fighting force—that is, a corporate personality. […] Soldiers do not receive medical care to guarantee their health as individuals but to preserve the health of a larger organism, a common good quite distinct from the interests of the soldier as patient.”

Thus, one should at least keep in mind that there can be a “a tension, if not competition, between protecting the rights of research subjects on the one hand and conducting research that some view essential to national security interests on the other.” (cf. Frisina, 2003, 538) Historical experiences can caution make sure that a study actually meets the ethical requirements and respects the rights of the human research subjects (cf. Bonham & Moreno, 2008).

Vulnerable or captive populations

Another major ethical concern for medical research in military contexts consists in the involvement of “vulnerable” or “captive populations”. Even though the term “vulnerable” may sound strange with regard to young and fit soldiers (and they themselves certainly often would not accept it), it makes sense as a term to highlight an ethical challenge with regard to consent to medical research.

Vulnerable or captive patients lack “in some critical sense […] the ability to exercise free choice” (Bonham & Moreno, 2008). People can for example be “desperately poor and frightened” (Leaning, 2001, 1432), feeling they not to have a choice; or they can be in a superior-subordinate relationship as for example military service members (Amoroso & Wenger, 2003). As a result, there is a danger that “military expediency may be used, albeit sub-consciously, to authorize research in soldiers that would not be permitted in the general population.” (Bonham & Moreno, 2008, 472) Or, in the words of De Lorenzo (2004, 129), “in the context of a research study, this special physician-researcher and service member–subject relationship is complex and not completely understood, even by those in uniform.” Generally, ethical issues when doing research with vulnerable populations may emerge because “they are unequal players and may thereby have a diminished ability to exercise free choice”. (Bonham & Moreno, 2008)

Conflict settings

Working conditions in a “forward-deployed, austere, and hostile war zone” (De Lorenzo, 2004, 128) are probably not adapted to the systematic testing of new methods and treatments. This may one of the reasons why the law governing armed conflict stipulates that “medical or scientific experiments or any other medical procedure not indicated by the state of health of the person concerned and not consistent with generally accepted medical standards are prohibited.” (Henckaerts & Doswald-Beck, 2005, 320)

Of course, this should not be read as an argument to completely ban research from conflict settings. Much can be learned in these contexts (and historically has) and in the end civilian medicine profits as well (McManus et al., 2005). However, ethical restrictions of research are important and must be applied to avoid obvious and less obvious pitfalls for malpractice and possible abuse of human research subjects.

Ethics review boards

One way of trying to guarantee “coherent and consistent application of the ethical principles articulated in international guidance documents” (World Health Organization, 2011, 12) during research on human beings is the independent and ex ante evaluation of the research project by an institutional or external ethics review board.

Example Scenarios

Currently, the present collection does not contain a very large number of scenarios illustrating ethical issues of research in the military. There are two cases that reflect the use of (mandatory) vaccination against expected biological threats (click to read scenario 1 and scenario 2). In addition, there is one case description of applying an unproven method in treating a local kid. More cases will be added, and you can then find them on the section overview page.

If you have a scenario that fits into this category, do not hesitate to send it to us anonymously.

Key Points

• Medical research must respect ordinary medical ethics as well as a number of additional ethical restrictions. The health of the (individual) patient has to be the first consideration.
• Medical research in military contexts is not per se unethical but the respect of ethical principles should be cautiously sought for.
• Typical ethical challenges like mixed interests and dealing with vulnerable populations must be reflected when designing studies and (international) regulations for the ethical conduct of medical research should be consulted.

Selected professional ethics documents

• WMA Declaration of Helsinki from 1964, revised 2003 (link to website) 
• WHO Standards and operational guidance for ethics review of health-related research with human participants (link to website)
• Nuremberg Code 1947 (link to PDF)
• Belmont Report from 1979 (link to website)

References and further reading

• Amoroso, P.J., & Wenger, L.L. (2003). The human volunteer in military biomedical research. In T.E. Beam, & L.R. Sparacino (Eds.), Military Medical Ethics Vol. 2 pp. 563-603). Washington D.C.: Office of The Surgeon General, United States Army.
• Annas, G.J., & Grodin, M.A. (2008). The Nuremberg Code.  The Oxford Textbook of Clinical Research Ethics pp. 136-140): Oxford University Press New York.
• Beauchamp, T.L. (2008). The Belmont Report. The Oxford textbook of clinical research ethics, 21-28.
• Bonham, V.H., & Moreno, J.D. (2008). Research with captive populations: Prisoners, students, and soldiers.
• De Lorenzo, R.A. (2004). Emergency medicine research on the front lines. Annals of Emergency Medicine, 44, 128-130.
• Frisina, M.E. (2003). Medical Ethics in Military Biomedical Research. In T.E. Beam, & L.R. Sparacino (Eds.), Military Medical Ethics Vol. 2 pp. 533–561). Washington D.C.: Office of The Surgeon General, United States Army.
• Gross, M.L. (2006). Bioethics and armed conflict. Moral dilemmas of medicine and war. Cambridge, Mass.: MIT Press.
• Henckaerts, J.-M., & Doswald-Beck, L. (2005). Customary international humanitarian law. Cambridge: Cambridge University Press.
• Hodgetts, T.J. (2014). A roadmap for innovation. British Medical Journal Publishing Group.
• Kitchen, L.W., & Vaughn, D.W. (2007). Role of US military research programs in the development of US-licensed vaccines for naturally occurring infectious diseases. Vaccine, 25, 7017-7030.
• Leaning, J. (2001). Ethics of research in refugee populations. The Lancet, 357, 1432-1433.
• Ling, G.S., Rhee, P., & Ecklund, J.M. (2010). Surgical innovations arising from the Iraq and Afghanistan wars. Annual review of medicine, 61, 457-468.
• McManus, J., Mehta, S.G., McClinton, A.R., De Lorenzo, R.A., & Baskin, T.W. (2005). Informed Consent and Ethical Issues in Military Medical Research. Academic Emergency Medicine, 12, 1120-1126.
• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
• Ratto-Kim, S., Yoon, I.-K., Paris, R.M., Excler, J.-L., Kim, J.H., & O’Connell, R.J. (2018). The US Military Commitment to Vaccine Development: A Century of Successes and Challenges. Frontiers in Immunology, 9.
• Swiss Academy of Medical Sciences (2015). Research with human subjects. A manual for practitioners. Bern: Swiss Academy of Medical Sciences.
• Swiss Academy of Medical Sciences (2017). Distinguishing between standard treatment and experimental treatment in individual cases. Bern: Swiss Academy of Medical Sciences.
• World Health Organization (2011). Standards and operational guidance for ethics review of health-related research with human participants. Geneva: WHO.
• World Medical Association (2013 (1964)). WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Geneva: World Medical Association.